<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02202161</url>
  </required_header>
  <id_info>
    <org_study_id>201351</org_study_id>
    <nct_id>NCT02202161</nct_id>
  </id_info>
  <brief_title>A Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 Administered With Metformin to Type 2 Diabetes Patients</brief_title>
  <official_title>A Randomized, Placebo Controlled, Repeat Dose, Double Blind (Sponsor Unblind) Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 Administered With Metformin to Type 2 Diabetes Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and&#xD;
      pharmacodynamics of GSK2330672 compared to sitagliptin when administered with metformin for&#xD;
      14 days to subjects with type 2 diabetes mellitus (T2DM). Approximately 72 male and female&#xD;
      subjects aged 30-64 years with T2DM and currently taking metformin will be recruited for this&#xD;
      study. Eligible subjects will begin a run-in period of 13-15 days to stabilize on metformin&#xD;
      850 milligram (mg) twice a day (BID). Subjects will then be randomized to GSK2330672 10 mg,&#xD;
      20 mg, 30 mg, 90 mg, matching placebo or open-label sitagliptin 50 mg for 14 days BID.&#xD;
      Subjects will return for a follow-up visit 7-10 days after discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2014</start_date>
  <completion_date type="Actual">January 30, 2015</completion_date>
  <primary_completion_date type="Actual">January 30, 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour])</measure>
    <time_frame>Baseline (Day -1) and Day 14 (Fasting Pre-dose [within 15 minutes of dose], 30 minutes, 1, 1.5, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, 14 [bed time] and 24 hours) and Day 7 (30 minutes, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, and 24 hours)</time_frame>
    <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. It was assessed on Baseline, Day 7 and 14. Data for fasting and weighted mean (WM) AUC(0-24 hour) glucose is provided. Statistics for least square mean is provided and participants withdrawing early were excluded. Results were based on an analysis of covariance (ANCOVA) model: change from Baseline = Baseline + treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 14 days (treatment period)</time_frame>
    <description>An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition and alanine aminotransferase (ALT) &gt;= 3× upper limit of normal (ULN) and total bilirubin &gt;=2 × ULN (&gt;35% direct) or ALT &gt;=3 × ULN and international normalized ratio &gt;1.5.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI)</measure>
    <time_frame>Up to Day 15</time_frame>
    <description>Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Clinical Chemistry With PCI</measure>
    <time_frame>Up to Day 15</time_frame>
    <description>Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, total carbon dioxide and triglycerides. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. The normal range (NR) and PCI definition for abnormal parameters are: ALT (NR: 0-44, 0-32, 2-33; PCI: &gt;=2×upper limit of normal [ULN]); AST (NR: 0-40; PCI: &gt;=2× ULN) and total bilirubin (NR: 0.00-20.52; PCI: &gt;=1.5× ULN).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Urinalysis Data</measure>
    <time_frame>Baseline (pre-dose Day -1), Day 7 and 15</time_frame>
    <description>Urinalysis included urine occult blood: trace to 3+, glucose: negative to 3+, protein: negative to 2+ and ketones: trace to negative by dipstick and microscopic examination included cast, cellular cast, granular cast, hyaline cast (none seen to 1) and RBC: 0-2, 3-10, 11-30, &gt;30, WBC: none seen, 0-5, 1, 2, 4, &lt;5, 6-10, 11-30, 19, &gt;30). The plus sign increases with a higher level of occult blood, glucose, ketones, proteins, RBC, WBC in the urine: 1+: slightly positive, 2+: positive, 3+: high positive. Participants were categorized as none seen or 1 based on the absence or presence, respectively, of cast, cellular cast, granular cast and hyaline cast. Higher value indicates higher abnormality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of Urinalysis Data-mean Specific Gravity</measure>
    <time_frame>Baseline (pre-dose Day -1), Day 7 and 15</time_frame>
    <description>Data for mean specific gravity is provided. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of Urinalysis Data-mean pH</measure>
    <time_frame>Baseline (pre-dose Day -1), Day 7 and 15</time_frame>
    <description>Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline</measure>
    <time_frame>Up to Day 15</time_frame>
    <description>Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG is presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Signs Assessments-temperature</measure>
    <time_frame>Baseline (pre-dose Day -1) and, Day 7, 15</time_frame>
    <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline (pre-dose Day -1) and Day 7, 15</time_frame>
    <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Signs Assessments-heart Rate</measure>
    <time_frame>Baseline (pre-dose Day -1) and Day 7, 15</time_frame>
    <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14</measure>
    <time_frame>Up to Day 15 (administered after every in-house bowel movement)</time_frame>
    <description>The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14</measure>
    <time_frame>Up to Day 15 (administered after every in-house bowel movement)</time_frame>
    <description>The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms &gt;=2 Levels)</measure>
    <time_frame>Day 7 and 14</time_frame>
    <description>GSRS is a rating scale consisting of 15 items. Each item was scored from 1: no discomfort at all, 2: minor discomfort, 3: mild discomfort, 4: moderate discomfort, 5: moderately severe discomfort, 6: severe discomfort, 7: very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 1 to 7; a score of 1 indicates that no symptoms are present, and a score of 7 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity. There were 5 defined syndrome scores and 1 overall score that was derived by computing the mean of the scores for specific subsets of questions as indicated below: abdominal pain (1, 4, 5); reflux syndrome (2, 3); diarrhea syndrome (11, 12, 14); indigestion syndrome (6, 7, 8, 9); constipation syndrome (10, 13, 15) and overall GSRS (1-15). The data is presented for participants with worsening of symptoms in &gt;=2 levels.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding</measure>
    <time_frame>Up to Day 15</time_frame>
    <description>Testing cards were provided to participants for assessments. Participants with abnormal not clinically significant and abnormal clinically significant is presented. The Day -1 sample was obtained any time starting Day -2 and prior to GSK2330672 dosing on Day 1. The Day 14 sample was collected any time after dosing on Day 14 and prior to discharge on Day 15.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax)</measure>
    <time_frame>Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14</time_frame>
    <description>The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Statistics for geometric least square mean provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax)</measure>
    <time_frame>Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14</time_frame>
    <description>The time at which Cmax observed was determined directly from the raw concentration-time data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10])</measure>
    <time_frame>Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14</time_frame>
    <description>PK population. Only those participants available at the specified time points were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides</measure>
    <time_frame>Baseline (pre-dose Day -1) and Day 7, 14</time_frame>
    <description>Data for fasting low-density cholesterol (LDL) cholesterol, high-density cholesterol (HDL) cholesterol, total cholesterol, non-HDL cholesterol and triglycerides is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio to Baseline in Fasting Apolipoprotein B</measure>
    <time_frame>Baseline (pre-dose Day -1) and Day 7, 14</time_frame>
    <description>Data for fasting apolipoprotein B is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses</measure>
    <time_frame>Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14</time_frame>
    <description>The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Cmax1 and Cmax2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses</measure>
    <time_frame>Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14</time_frame>
    <description>The time at which Cmax was observed by determining directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Tmax1 and Tmax2). If data permits, Tmax2 was defined as the time of Cmax following the second dose of sitagliptin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-AUC(0-10)</measure>
    <time_frame>Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner) on Day 14</time_frame>
    <description>The AUC(0-10) following the first dose and prior to the second dose of sitagliptin was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>GSK2330672 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 10 mg BID for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSK2330672 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 20 mg BID for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSK2330672 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 30 mg BID for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSK2330672 90 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 90 mg BID for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSK2330672-matched placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by matching placebo (of GSK2330672) BID for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sitagliptin 50 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by Sitagliptin 50 mg BID for 14 days. In this study, sitagliptin 50 mg BID will be provided as open-label (unblinded) study treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK2330672</intervention_name>
    <description>GSK2330672 will be available in 10 mg, 20 mg, 30 mg, and 90 mg oral solution to be administered BID for 14 days. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed</description>
    <arm_group_label>GSK2330672 10 mg</arm_group_label>
    <arm_group_label>GSK2330672 20 mg</arm_group_label>
    <arm_group_label>GSK2330672 30 mg</arm_group_label>
    <arm_group_label>GSK2330672 90 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo will be available as oral solution to be administered for 14 days, BID. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed</description>
    <arm_group_label>GSK2330672-matched placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin</intervention_name>
    <description>Sitagliptin will be available as film-coated tablets Tablet of 50 mg to be administered orally, BID, for 14 days</description>
    <arm_group_label>Sitagliptin 50 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Metformin will be available as 850 mg white to off-white, film-coated tablets; to be administered BID orally during run-in through Day 14</description>
    <arm_group_label>GSK2330672 10 mg</arm_group_label>
    <arm_group_label>GSK2330672 20 mg</arm_group_label>
    <arm_group_label>GSK2330672 30 mg</arm_group_label>
    <arm_group_label>GSK2330672 90 mg</arm_group_label>
    <arm_group_label>GSK2330672-matched placebo</arm_group_label>
    <arm_group_label>Sitagliptin 50 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between 30 and 64 years of age inclusive, at the time of signing the&#xD;
             informed consent&#xD;
&#xD;
          -  Subjects with a diagnosis of T2DM for at least 3 months prior to screening, taking&#xD;
             metformin for at least 4 weeks prior to screening, taking a metformin daily dose of&gt;=&#xD;
             1000 mg and having an Glycosolated haemoglobin A1c (HbA1c) value of 7-11% inclusive at&#xD;
             screening. The investigator should make an effort to obtain documentation of medical&#xD;
             history or prescription of metformin to substantiate the diagnosis of T2DM&#xD;
&#xD;
          -  Fasting plasma glucose &lt;280 milligram per deciliter (mg/dl) at screening. A subject&#xD;
             with a fasting plasma glucose at Day 1 that is more than 100 mg/dl lower than the&#xD;
             screening value must not be randomized&#xD;
&#xD;
          -  All T2DM subjects must meet the label recommendations for metformin and sitagliptin,&#xD;
             including: Adequate renal function, as evidenced by an estimated glomerular filtration&#xD;
             rate &gt;= 80 milliliter per minute (mL/min) using the modification of diet in renal&#xD;
             disease (MDRD) equation or chronic kidney disease epidemiology collaboration (CKD-EPI)&#xD;
             formula in the study procedures manual (SPM); No conditions which make hypoxia,&#xD;
             dehydration, or sepsis likely; No cardiac disease (including no history of myocardial&#xD;
             infarction, stroke, hospitalization for acute coronary syndrome, or heart failure)&#xD;
&#xD;
          -  Body mass index (BMI) within the range 24 - 40 kilogram per meter square (kg/m^2)&#xD;
             (inclusive)&#xD;
&#xD;
          -  Other than T2DM, subjects should be in good general health with (in the opinion of the&#xD;
             investigator) no clinically significant and relevant abnormalities of medical history&#xD;
             or physical examination that would introduce additional risk factors or interfere with&#xD;
             study procedures or objectives, based on a medical evaluation including medical&#xD;
             history, physical examination, vital signs, and laboratory tests&#xD;
&#xD;
          -  A female subject is eligible to participate if she is of non-childbearing potential&#xD;
             defined as: Pre-menopausal females with a documented tubal ligation, bilateral&#xD;
             oophorectomy, or hysterectomy [for this definition, &quot;documented&quot; refers to the outcome&#xD;
             of the investigator's/designee's review of the subject's medical history for study&#xD;
             eligibility, as obtained via a verbal interview with the subject or from the subject's&#xD;
             medical records]; OR Postmenopausal defined as 12 months of spontaneous amenorrhea. In&#xD;
             questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH)&#xD;
             &gt; 40 million international units (MlU)/mL and estradiol &lt; 40 picogram (pg)/mL (&lt;147&#xD;
             picomol per liter) is confirmatory. Females on hormone replacement therapy (HRT) and&#xD;
             whose menopausal status is in doubt will be required to use one of the contraception&#xD;
             methods as described by the Investigator/designee, if they wish to continue their HRT&#xD;
             during the study. Otherwise, they must discontinue HRT to allow confirmation of&#xD;
             post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4&#xD;
             weeks will elapse between the cessation of therapy and the blood draw; this interval&#xD;
             depends on the type and dosage of HRT. Following confirmation of their post-menopausal&#xD;
             status, they can resume use of HRT during the study without use of a contraceptive&#xD;
             method&#xD;
&#xD;
          -  Male subjects with female partners of child-bearing potential must agree to use one of&#xD;
             the contraception methods as described by the Investigator/designee. This criterion&#xD;
             must be followed from the time of the first dose of study medication until the&#xD;
             follow-up visit&#xD;
&#xD;
          -  Subjects must be willing to discontinue their usual dose of metformin and take the&#xD;
             study dose of 850 mg immediate release formulation metformin BID for the 13-15 day&#xD;
             run-in period and the 2-week treatment period&#xD;
&#xD;
          -  Capable of giving written informed consent, which includes compliance with the&#xD;
             requirements and restrictions listed in the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The use of approved non-metformin anti-diabetic agents within 3 months of the&#xD;
             screening visit&#xD;
&#xD;
          -  Hypoglycemia unawareness. T2DM subjects are excluded if, in the opinion of the&#xD;
             investigator, they have significant hypoglycemia unawareness (for example, no symptoms&#xD;
             of hypoglycemia when the blood glucose level is &lt;70 mg/dl)&#xD;
&#xD;
          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities&#xD;
             (with the exception of Gilbert's syndrome). Subjects with a history of cholelithiasis,&#xD;
             biliary colic, inflammatory gall bladder disease and/or cholestatic liver disease are&#xD;
             excluded, unless this results in curative cholecystectomy 3 months or more before&#xD;
             screening and with the approval of the GlaxoSmithKline (GSK) Medical Monitor&#xD;
&#xD;
          -  History of chronic or acute pancreatitis. Approval from the GSK Medical Monitor must&#xD;
             be obtained for subjects with a past history of pancreatitis more than 12 months from&#xD;
             the start of the Treatment Period (subjects with a history of pancreatitis within 12&#xD;
             months prior to the start of the Treatment Period are excluded). NOTE: Subjects with a&#xD;
             lipase value above the upper limit of normal (ULN) at screening are excluded. A single&#xD;
             repeat assessment is allowed within 3 days of the original test&#xD;
&#xD;
          -  History of Gastrointestinal (GI) disease (e.g., irritable bowel disease, chronic or&#xD;
             current diarrhea, inflamed bowel, steatorrhoea/fat malabsorption, celiac disease,&#xD;
             symptomatic lactose intolerance, small bowel resection). Subjects with gastroparesis&#xD;
             requiring treatment are excluded. Subjects with history of prolapsed or bleeding&#xD;
             haemorrhoids within 1 month of screening are excluded unless approved by the GSK&#xD;
             Medical Monitor&#xD;
&#xD;
          -  History of autonomic neuropathy&#xD;
&#xD;
          -  History of epilepsy and/or use of anti-convulsants, including but not limited to&#xD;
             phenobarbitone, phenytoin, carbamazepine, valproate&#xD;
&#xD;
          -  History of serious, severe, or unstable physical or psychiatric illness including&#xD;
             depression, suicidal thoughts, schizophrenia, bipolar disorder, or generalized anxiety&#xD;
             disorder. In addition to elicited symptoms and signs, this should include specific&#xD;
             questions relating to known psychiatric diagnoses and medications used&#xD;
&#xD;
          -  History of significant cardiovascular disease not covered by the label recommendations&#xD;
             for metformin, for example, ventricular tachyarrhythmias, peripheral arterial disease,&#xD;
             and pulmonary embolism, within the previous 12 months&#xD;
&#xD;
          -  Uncontrolled hypertension, as evidenced by systolic pressure &gt;160 millimeters of&#xD;
             mercury (mmHg) or diastolic pressure &gt;90 mmHg on a single assessment. If systolic&#xD;
             pressure &gt;140 mmHg or diastolic pressure &gt;90 mmHg, a single repeat is allowed within 1&#xD;
             hour. Subjects whose blood pressure is well-controlled by taking anti-hypertensive&#xD;
             medications (e.g., beta blockers, angiotensin converting enzyme(ACE) inhibitors,&#xD;
             angiotensin II receptor antagonists, calcium channel blockers, and thiazide diuretics)&#xD;
             are permitted&#xD;
&#xD;
          -  History of untreated pernicious anemia or who have laboratory parameters suggestive of&#xD;
             subclinical megaloblastic anemia (e.g., increased mean corpuscular volume [MCV] with&#xD;
             low red blood cells [RBC] count and/or haemoglobin [Hb] level).&#xD;
&#xD;
          -  Thyroid disease: Uncorrected Thyroid Dysfunction as Fasting plasma thyroid stimulating&#xD;
             hormone (TSH) outside of the normal range, as determined at the screening visit.&#xD;
             Subjects on stable thyroid replacement therapy and with TSH in the normal range are&#xD;
             eligible if approved by the GSK Medical Monitor. Unevaluated thyroid nodule or goiter&#xD;
             at screening&#xD;
&#xD;
          -  History of regular alcohol consumption within 6 months of the study defined as: An&#xD;
             average weekly intake of &gt;14 drinks for males or &gt;7 drinks for females. One drink is&#xD;
             equivalent to 12 gram (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of&#xD;
             wine or 1.5 ounces (45 mL) of 80 proof distilled spirits&#xD;
&#xD;
          -  History of sensitivity to heparin or heparin-induced thrombocytopenia&#xD;
&#xD;
          -  History of sensitivity to any of the study medications, or components thereof, or a&#xD;
             history of drug or other allergy (including other Dipeptidyl Peptidase-IV [DPP-IV]&#xD;
             inhibitors) that, in the opinion of the investigator or GSK Medical Monitor,&#xD;
             contraindicates their participation&#xD;
&#xD;
          -  Current or relevant previous significant medical disorder that may require treatment&#xD;
             or make the subject unlikely to fully complete the study, or any condition that, in&#xD;
             the opinion of the investigator, presents undue risk from the study medication or&#xD;
             procedures&#xD;
&#xD;
          -  Alanine aminotransferase (ALT)&gt;2xULN and bilirubin &gt;1.5xULN (isolated bilirubin&#xD;
             &gt;1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin &lt;35%)&#xD;
&#xD;
          -  Fasting triglycerides &gt;= 400 mg/dl for subjects without a history of pancreatitis or&#xD;
             &gt;250 mg/dl for subjects with a history of pancreatitis. Approval from the GSK Medical&#xD;
             Monitor must be obtained for subjects with a past history of pancreatitis more than 12&#xD;
             months from the start of the treatment period (subjects with a history of pancreatitis&#xD;
             within 12 months prior to the start of the treatment period are excluded). Subjects&#xD;
             taking statins, ezetimibe, or Vytorin are permitted in the study. Subjects taking&#xD;
             other lipid therapies, including but not limited to niacin, bile acid sequestrants&#xD;
             and/or fibrates are not eligible&#xD;
&#xD;
          -  C-peptide of &lt;0.8 nanogram (ng)/mL at screening&#xD;
&#xD;
          -  Urine albumin-to-creatinine ratio &gt;0.3 mg albumin/mg creatinine&#xD;
&#xD;
          -  Positive fecal occult blood test at screening or during the run-in period&#xD;
&#xD;
          -  Significant ECG abnormalities, defined as follows: Heart Rate (resting) was &lt;50 and&#xD;
             &gt;100 beats per minute (bpm); PR Interval between &lt;120 and &gt;220 millisecond (msec); QRS&#xD;
             duration between &lt;70 and &gt;120 msec&#xD;
&#xD;
          -  Based on averaged QTcF of triplicate ECGs obtained at least 1 minute apart within&#xD;
             approximately 15 minutes: QT duration corrected for heart rate by Fridericia's formula&#xD;
             (QTcF) &gt;= 450 msec; OR QTcF &gt;= 480 msec in subjects with right Bundle Branch Block&#xD;
             (subjects with left bundle branch block are excluded)&#xD;
&#xD;
          -  A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody&#xD;
             result within 3 months of screening&#xD;
&#xD;
          -  A positive test for HIV antibody&#xD;
&#xD;
          -  A positive urine drug screen or alcohol breath test at screening or during the run-in&#xD;
             or treatment periods&#xD;
&#xD;
          -  A subject with a positive urine cotinine test result will be excluded from the study&#xD;
             unless in the judgment of the investigator the subject will be able to abstain from&#xD;
             using tobacco for the duration of the in-clinic treatment period of the study&#xD;
&#xD;
          -  Where participation in the study would result in donation of blood or blood products&#xD;
             in excess of 500 mL within a 56 day period&#xD;
&#xD;
          -  The subject has participated in a clinical trial and has received an investigational&#xD;
             product within the following time period prior to the first dosing day in the current&#xD;
             study: 30 days, 5 half-lives or twice the duration of the biological effect of the&#xD;
             investigational product (whichever is longer)&#xD;
&#xD;
          -  Exposure to more than four new chemical entities within 12 months prior to the first&#xD;
             dosing day&#xD;
&#xD;
          -  Subjects who have participated in a previous study with GSK2330672 are excluded&#xD;
&#xD;
          -  Because of the potential impact on bile acid synthesis and secretion in the liver, use&#xD;
             of rifampicin and/or other pregnane X receptor (PXR) inducers, including but not&#xD;
             limited to St. John's Wort, is cause for subject exclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <results_first_submitted>August 28, 2017</results_first_submitted>
  <results_first_submitted_qc>October 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 6, 2017</results_first_posted>
  <disposition_first_submitted>May 14, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>May 14, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">June 4, 2015</disposition_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pharmacokinetic</keyword>
  <keyword>intestinal bile acid transporter inhibitor</keyword>
  <keyword>metformin</keyword>
  <keyword>sitagliptin</keyword>
  <keyword>GSK2330672</keyword>
  <keyword>pharmacodynamic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Sitagliptin Phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>201351</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201351</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201351</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201351</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201351</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201351</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201351</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted from 27 August 2014 to 30 January 2015. After interim analysis of safety, tolerability, pharmacodynamic and/or pharmacokinetic (PK) data, GSK2330672 10 and 20 milligram (mg) doses were dropped and GSK2330672 60 mg was added.</recruitment_details>
      <pre_assignment_details>A total of 187 participants were screened, of these, 112 were screen failures and 75 entered the run-in period. Five participants were withdrawn prior to taking a metformin dose in the 14 days of run-in period. A total of 64 participants were randomized to receive investigational product, as 6 participants were withdrawn prior to randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally twice daily (BID) for 14 days. Participants drank the contents of dosing bottle (45 milliliters [mL]) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="P2">
          <title>GSK2330672 10 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="P3">
          <title>GSK2330672 20 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="P4">
          <title>GSK2330672 30 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="P5">
          <title>GSK2330672 60 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="P6">
          <title>GSK2330672 90 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="P7">
          <title>Sitagliptin 50 mg BID</title>
          <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="P8">
          <title>Run-in Only</title>
          <description>Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="10"/>
                <participants group_id="P7" count="13"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="9"/>
                <participants group_id="P7" count="13"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet continuation criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="B2">
          <title>GSK2330672 10 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="B3">
          <title>GSK2330672 20 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="B4">
          <title>GSK2330672 30 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="B5">
          <title>GSK2330672 60 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="B6">
          <title>GSK2330672 90 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="B7">
          <title>Sitagliptin 50 mg BID</title>
          <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="B8">
          <title>Run-in Only</title>
          <description>Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="5"/>
            <count group_id="B4" value="9"/>
            <count group_id="B5" value="9"/>
            <count group_id="B6" value="10"/>
            <count group_id="B7" value="13"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="70"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.1" spread="6.97"/>
                    <measurement group_id="B2" value="54.0" spread="4.30"/>
                    <measurement group_id="B3" value="56.2" spread="8.50"/>
                    <measurement group_id="B4" value="57.1" spread="5.86"/>
                    <measurement group_id="B5" value="55.0" spread="4.27"/>
                    <measurement group_id="B6" value="54.8" spread="7.47"/>
                    <measurement group_id="B7" value="53.7" spread="6.79"/>
                    <measurement group_id="B8" value="55.5" spread="3.51"/>
                    <measurement group_id="B9" value="54.5" spread="6.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour])</title>
        <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. It was assessed on Baseline, Day 7 and 14. Data for fasting and weighted mean (WM) AUC(0-24 hour) glucose is provided. Statistics for least square mean is provided and participants withdrawing early were excluded. Results were based on an analysis of covariance (ANCOVA) model: change from Baseline = Baseline + treatment.</description>
        <time_frame>Baseline (Day -1) and Day 14 (Fasting Pre-dose [within 15 minutes of dose], 30 minutes, 1, 1.5, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, 14 [bed time] and 24 hours) and Day 7 (30 minutes, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, and 24 hours)</time_frame>
        <population>Safety population was used which was defined as all participants enrolled into the study who received at least one dose of study drug (including GSK2330672, GSK2330672-matched placebo, sitagliptin and metformin). Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour])</title>
          <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. It was assessed on Baseline, Day 7 and 14. Data for fasting and weighted mean (WM) AUC(0-24 hour) glucose is provided. Statistics for least square mean is provided and participants withdrawing early were excluded. Results were based on an analysis of covariance (ANCOVA) model: change from Baseline = Baseline + treatment.</description>
          <population>Safety population was used which was defined as all participants enrolled into the study who received at least one dose of study drug (including GSK2330672, GSK2330672-matched placebo, sitagliptin and metformin). Only those participants available at the specified time points were analyzed.</population>
          <units>Mg/deciliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fasting, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.58" spread="16.357"/>
                    <measurement group_id="O2" value="-8.25" spread="6.500"/>
                    <measurement group_id="O3" value="-1.40" spread="23.050"/>
                    <measurement group_id="O4" value="-38.56" spread="24.744"/>
                    <measurement group_id="O5" value="-34.38" spread="19.398"/>
                    <measurement group_id="O6" value="-24.78" spread="13.414"/>
                    <measurement group_id="O7" value="-24.54" spread="33.955"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fasting, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.00" spread="19.207"/>
                    <measurement group_id="O2" value="-22.75" spread="11.354"/>
                    <measurement group_id="O3" value="-16.20" spread="28.709"/>
                    <measurement group_id="O4" value="-48.67" spread="32.650"/>
                    <measurement group_id="O5" value="-36.13" spread="23.117"/>
                    <measurement group_id="O6" value="-40.22" spread="19.156"/>
                    <measurement group_id="O7" value="-38.38" spread="16.439"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WM AUC(0-24 hour), Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.91" spread="20.668"/>
                    <measurement group_id="O2" value="-12.14" spread="11.828"/>
                    <measurement group_id="O3" value="-7.01" spread="17.262"/>
                    <measurement group_id="O4" value="-25.33" spread="25.819"/>
                    <measurement group_id="O5" value="-21.47" spread="18.419"/>
                    <measurement group_id="O6" value="-14.84" spread="18.569"/>
                    <measurement group_id="O7" value="-26.63" spread="23.610"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WM AUC(0-24 hour), Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.94" spread="18.458"/>
                    <measurement group_id="O2" value="-22.44" spread="15.928"/>
                    <measurement group_id="O3" value="-17.80" spread="16.990"/>
                    <measurement group_id="O4" value="-37.48" spread="32.909"/>
                    <measurement group_id="O5" value="-32.22" spread="22.948"/>
                    <measurement group_id="O6" value="-45.54" spread="21.010"/>
                    <measurement group_id="O7" value="-35.85" spread="20.233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.61</ci_lower_limit>
            <ci_upper_limit>23.27</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>13.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.84</ci_lower_limit>
            <ci_upper_limit>36.27</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-21.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.43</ci_lower_limit>
            <ci_upper_limit>-2.10</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-23.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-42.63</ci_lower_limit>
            <ci_upper_limit>-3.57</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-11.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.85</ci_lower_limit>
            <ci_upper_limit>7.28</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-10.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.66</ci_lower_limit>
            <ci_upper_limit>7.57</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-15.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.72</ci_lower_limit>
            <ci_upper_limit>7.43</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-2.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.66</ci_lower_limit>
            <ci_upper_limit>19.45</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-20.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-38.75</ci_lower_limit>
            <ci_upper_limit>-2.57</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-21.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-39.70</ci_lower_limit>
            <ci_upper_limit>-3.71</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-10.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-28.62</ci_lower_limit>
            <ci_upper_limit>7.38</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-26.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.94</ci_lower_limit>
            <ci_upper_limit>-10.12</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 7</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-12.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.56</ci_lower_limit>
            <ci_upper_limit>9.36</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 14</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>4.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.91</ci_lower_limit>
            <ci_upper_limit>24.57</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 14</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-25.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-42.56</ci_lower_limit>
            <ci_upper_limit>-8.02</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 14</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-19.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.12</ci_lower_limit>
            <ci_upper_limit>-2.82</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 14</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-21.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-38.56</ci_lower_limit>
            <ci_upper_limit>-5.08</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 14</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-18.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.48</ci_lower_limit>
            <ci_upper_limit>-2.55</ci_upper_limit>
            <estimate_desc>Comparison for fasting, Day 14</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-11.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.21</ci_lower_limit>
            <ci_upper_limit>10.81</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 14</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>4.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.22</ci_lower_limit>
            <ci_upper_limit>25.81</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 14</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-15.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.86</ci_lower_limit>
            <ci_upper_limit>2.41</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 14</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-17.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.56</ci_lower_limit>
            <ci_upper_limit>0.53</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 14</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-23.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.49</ci_lower_limit>
            <ci_upper_limit>-6.39</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 14</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-19.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.96</ci_lower_limit>
            <ci_upper_limit>-3.93</ci_upper_limit>
            <estimate_desc>Comparison for WM AUC(0-24 hour), Day 14</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition and alanine aminotransferase (ALT) &gt;= 3× upper limit of normal (ULN) and total bilirubin &gt;=2 × ULN (&gt;35% direct) or ALT &gt;=3 × ULN and international normalized ratio &gt;1.5.</description>
        <time_frame>Up to 14 days (treatment period)</time_frame>
        <population>Safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition and alanine aminotransferase (ALT) &gt;= 3× upper limit of normal (ULN) and total bilirubin &gt;=2 × ULN (&gt;35% direct) or ALT &gt;=3 × ULN and international normalized ratio &gt;1.5.</description>
          <population>Safety population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI)</title>
        <description>Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided.</description>
        <time_frame>Up to Day 15</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI)</title>
          <description>Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided.</description>
          <population>Safety population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Clinical Chemistry With PCI</title>
        <description>Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, total carbon dioxide and triglycerides. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. The normal range (NR) and PCI definition for abnormal parameters are: ALT (NR: 0-44, 0-32, 2-33; PCI: &gt;=2×upper limit of normal [ULN]); AST (NR: 0-40; PCI: &gt;=2× ULN) and total bilirubin (NR: 0.00-20.52; PCI: &gt;=1.5× ULN).</description>
        <time_frame>Up to Day 15</time_frame>
        <population>Safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Clinical Chemistry With PCI</title>
          <description>Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, total carbon dioxide and triglycerides. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. The normal range (NR) and PCI definition for abnormal parameters are: ALT (NR: 0-44, 0-32, 2-33; PCI: &gt;=2×upper limit of normal [ULN]); AST (NR: 0-40; PCI: &gt;=2× ULN) and total bilirubin (NR: 0.00-20.52; PCI: &gt;=1.5× ULN).</description>
          <population>Safety population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin, hgh</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Urinalysis Data</title>
        <description>Urinalysis included urine occult blood: trace to 3+, glucose: negative to 3+, protein: negative to 2+ and ketones: trace to negative by dipstick and microscopic examination included cast, cellular cast, granular cast, hyaline cast (none seen to 1) and RBC: 0-2, 3-10, 11-30, &gt;30, WBC: none seen, 0-5, 1, 2, 4, &lt;5, 6-10, 11-30, 19, &gt;30). The plus sign increases with a higher level of occult blood, glucose, ketones, proteins, RBC, WBC in the urine: 1+: slightly positive, 2+: positive, 3+: high positive. Participants were categorized as none seen or 1 based on the absence or presence, respectively, of cast, cellular cast, granular cast and hyaline cast. Higher value indicates higher abnormality.</description>
        <time_frame>Baseline (pre-dose Day -1), Day 7 and 15</time_frame>
        <population>Safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Urinalysis Data</title>
          <description>Urinalysis included urine occult blood: trace to 3+, glucose: negative to 3+, protein: negative to 2+ and ketones: trace to negative by dipstick and microscopic examination included cast, cellular cast, granular cast, hyaline cast (none seen to 1) and RBC: 0-2, 3-10, 11-30, &gt;30, WBC: none seen, 0-5, 1, 2, 4, &lt;5, 6-10, 11-30, 19, &gt;30). The plus sign increases with a higher level of occult blood, glucose, ketones, proteins, RBC, WBC in the urine: 1+: slightly positive, 2+: positive, 3+: high positive. Participants were categorized as none seen or 1 based on the absence or presence, respectively, of cast, cellular cast, granular cast and hyaline cast. Higher value indicates higher abnormality.</description>
          <population>Safety population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Urine Occult Blood, Day -1, Trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Occult Blood, Day -1, small</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Occult Blood, Day-1, 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Occult Blood, Day 7, Trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Occult Blood, Day 7, Trace intact</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Occult Blood, Day 7, small</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Occult Blood, Day 7, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Occult Blood, Day 15, Trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Occult Blood, Day 15, small</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Occult Blood, Day 15, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-Casts, Day 7, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-Cellular Casts, Day -1, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-Cellular Casts, Day 7, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-Cellular Casts, Day 15, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-Granular Casts, Day -1, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-Granular Casts, Day 7, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-Granular Casts, Day 15, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Glucose, Day -1, Trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Glucose, Day -1, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Glucose, Day -1, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Glucose, Day -1, 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Glucose, Day 7, Trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Glucose, Day 7, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-Hyaline Casts, Day -1, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-Hyaline Casts, Day 7, None seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-Hyaline Casts, Day 7, 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-Hyaline Casts, Day 15, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Ketones, Day 7, Trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Protein, Day -1, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Protein, Day 7, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Protein, Day 15, Trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Protein, Day 15, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-RBC, Day -1, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-RBC, Day -1, 0-2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-RBC, Day -1, 3-10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-RBC, Day -1, 11-30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-RBC, Day 7, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-RBC, Day 7, 0-2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-RBC, Day 15, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-RBC, Day 7, 3-10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day -1, none seen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day -1, 0-5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day -1, 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day -1, 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day -1, 6-10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day -1, 11-30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day -1, &gt;30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 7, 0-5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 7, 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 7, &lt;5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 7, 11-30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 7, 19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 7, &gt;30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 15, 0-5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 15, 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 15, 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 15, 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 15, 11-30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Microscopy-WBC, Day 15, &gt;30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Summary of Urinalysis Data-mean Specific Gravity</title>
        <description>Data for mean specific gravity is provided. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.</description>
        <time_frame>Baseline (pre-dose Day -1), Day 7 and 15</time_frame>
        <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Urinalysis Data-mean Specific Gravity</title>
          <description>Data for mean specific gravity is provided. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.</description>
          <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day -1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0193" spread="0.00694"/>
                    <measurement group_id="O2" value="1.0182" spread="0.00581"/>
                    <measurement group_id="O3" value="1.0128" spread="0.00421"/>
                    <measurement group_id="O4" value="1.0190" spread="0.00618"/>
                    <measurement group_id="O5" value="1.0172" spread="0.00610"/>
                    <measurement group_id="O6" value="1.0189" spread="0.00780"/>
                    <measurement group_id="O7" value="1.0148" spread="0.00706"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0196" spread="0.00753"/>
                    <measurement group_id="O2" value="1.0208" spread="0.00904"/>
                    <measurement group_id="O3" value="1.0184" spread="0.00896"/>
                    <measurement group_id="O4" value="1.0191" spread="0.00739"/>
                    <measurement group_id="O5" value="1.0194" spread="0.00726"/>
                    <measurement group_id="O6" value="1.0208" spread="0.00859"/>
                    <measurement group_id="O7" value="1.0160" spread="0.00790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0188" spread="0.00403"/>
                    <measurement group_id="O2" value="1.0193" spread="0.00435"/>
                    <measurement group_id="O3" value="1.0158" spread="0.00259"/>
                    <measurement group_id="O4" value="1.0132" spread="0.00471"/>
                    <measurement group_id="O5" value="1.0121" spread="0.00348"/>
                    <measurement group_id="O6" value="1.0160" spread="0.00787"/>
                    <measurement group_id="O7" value="1.0140" spread="0.00815"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Summary of Urinalysis Data-mean pH</title>
        <description>Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).</description>
        <time_frame>Baseline (pre-dose Day -1), Day 7 and 15</time_frame>
        <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Urinalysis Data-mean pH</title>
          <description>Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).</description>
          <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
          <units>Unit on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day -1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.73" spread="0.388"/>
                    <measurement group_id="O2" value="6.00" spread="0.000"/>
                    <measurement group_id="O3" value="6.10" spread="0.224"/>
                    <measurement group_id="O4" value="6.11" spread="0.220"/>
                    <measurement group_id="O5" value="5.83" spread="0.354"/>
                    <measurement group_id="O6" value="5.95" spread="0.438"/>
                    <measurement group_id="O7" value="5.85" spread="0.516"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.83" spread="0.389"/>
                    <measurement group_id="O2" value="5.90" spread="0.224"/>
                    <measurement group_id="O3" value="6.00" spread="0.000"/>
                    <measurement group_id="O4" value="5.89" spread="0.220"/>
                    <measurement group_id="O5" value="5.61" spread="0.486"/>
                    <measurement group_id="O6" value="5.95" spread="0.284"/>
                    <measurement group_id="O7" value="5.69" spread="0.435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.88" spread="0.377"/>
                    <measurement group_id="O2" value="5.88" spread="0.250"/>
                    <measurement group_id="O3" value="6.00" spread="0.000"/>
                    <measurement group_id="O4" value="6.00" spread="0.000"/>
                    <measurement group_id="O5" value="5.72" spread="0.565"/>
                    <measurement group_id="O6" value="6.06" spread="0.167"/>
                    <measurement group_id="O7" value="5.88" spread="0.416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline</title>
        <description>Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG is presented.</description>
        <time_frame>Up to Day 15</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline</title>
          <description>Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG is presented.</description>
          <population>Safety population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="6"/>
                    <measurement group_id="O7" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal not clinically significant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal clinically significant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Signs Assessments-temperature</title>
        <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.</description>
        <time_frame>Baseline (pre-dose Day -1) and, Day 7, 15</time_frame>
        <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs Assessments-temperature</title>
          <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.</description>
          <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
          <units>Degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.133" spread="0.2570"/>
                    <measurement group_id="O2" value="-0.280" spread="0.4764"/>
                    <measurement group_id="O3" value="0.040" spread="0.4393"/>
                    <measurement group_id="O4" value="0.033" spread="0.3937"/>
                    <measurement group_id="O5" value="0.033" spread="0.2062"/>
                    <measurement group_id="O6" value="0.010" spread="0.4458"/>
                    <measurement group_id="O7" value="0.015" spread="0.4451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.208" spread="0.3370"/>
                    <measurement group_id="O2" value="0.025" spread="0.1708"/>
                    <measurement group_id="O3" value="-0.040" spread="0.2966"/>
                    <measurement group_id="O4" value="-0.111" spread="0.5622"/>
                    <measurement group_id="O5" value="0.056" spread="0.2744"/>
                    <measurement group_id="O6" value="-0.178" spread="0.5995"/>
                    <measurement group_id="O7" value="0.062" spread="0.3404"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
        <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.</description>
        <time_frame>Baseline (pre-dose Day -1) and Day 7, 15</time_frame>
        <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
          <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.</description>
          <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DBP, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.083" spread="6.8152"/>
                    <measurement group_id="O2" value="-1.600" spread="8.5323"/>
                    <measurement group_id="O3" value="-6.600" spread="1.9494"/>
                    <measurement group_id="O4" value="-1.556" spread="10.7948"/>
                    <measurement group_id="O5" value="-4.111" spread="4.9861"/>
                    <measurement group_id="O6" value="-2.700" spread="6.7007"/>
                    <measurement group_id="O7" value="-2.462" spread="7.6770"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.750" spread="6.1070"/>
                    <measurement group_id="O2" value="-2.750" spread="4.5735"/>
                    <measurement group_id="O3" value="1.800" spread="5.8481"/>
                    <measurement group_id="O4" value="-1.333" spread="9.1104"/>
                    <measurement group_id="O5" value="-1.667" spread="3.9370"/>
                    <measurement group_id="O6" value="-2.667" spread="6.3048"/>
                    <measurement group_id="O7" value="-0.769" spread="5.0852"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.250" spread="8.4544"/>
                    <measurement group_id="O2" value="-4.000" spread="10.2225"/>
                    <measurement group_id="O3" value="-15.600" spread="6.1482"/>
                    <measurement group_id="O4" value="2.222" spread="17.6973"/>
                    <measurement group_id="O5" value="1.222" spread="9.1211"/>
                    <measurement group_id="O6" value="-4.300" spread="10.9245"/>
                    <measurement group_id="O7" value="-5.462" spread="10.3571"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.167" spread="8.5049"/>
                    <measurement group_id="O2" value="-4.500" spread="10.4722"/>
                    <measurement group_id="O3" value="0.600" spread="11.8870"/>
                    <measurement group_id="O4" value="-5.111" spread="11.9105"/>
                    <measurement group_id="O5" value="-1.000" spread="9.3541"/>
                    <measurement group_id="O6" value="-2.111" spread="9.5321"/>
                    <measurement group_id="O7" value="-4.385" spread="9.2334"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Signs Assessments-heart Rate</title>
        <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.</description>
        <time_frame>Baseline (pre-dose Day -1) and Day 7, 15</time_frame>
        <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs Assessments-heart Rate</title>
          <description>The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.</description>
          <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.500" spread="8.1296"/>
                    <measurement group_id="O2" value="9.200" spread="8.2280"/>
                    <measurement group_id="O3" value="4.400" spread="7.4027"/>
                    <measurement group_id="O4" value="0.556" spread="5.2941"/>
                    <measurement group_id="O5" value="4.667" spread="4.0620"/>
                    <measurement group_id="O6" value="1.400" spread="7.0269"/>
                    <measurement group_id="O7" value="-0.769" spread="6.2471"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.083" spread="3.1176"/>
                    <measurement group_id="O2" value="0.250" spread="6.3443"/>
                    <measurement group_id="O3" value="9.200" spread="3.1937"/>
                    <measurement group_id="O4" value="-0.444" spread="8.2932"/>
                    <measurement group_id="O5" value="4.889" spread="7.4237"/>
                    <measurement group_id="O6" value="0.000" spread="8.8034"/>
                    <measurement group_id="O7" value="1.846" spread="9.1364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14</title>
        <description>The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.</description>
        <time_frame>Up to Day 15 (administered after every in-house bowel movement)</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O8">
            <title>Run-in Only</title>
            <description>Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14</title>
          <description>The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.</description>
          <population>Safety population</population>
          <units>Count of bowel movements</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" spread="9.29"/>
                    <measurement group_id="O2" value="28.2" spread="17.47"/>
                    <measurement group_id="O3" value="38.4" spread="10.74"/>
                    <measurement group_id="O4" value="35.0" spread="18.49"/>
                    <measurement group_id="O5" value="37.3" spread="30.72"/>
                    <measurement group_id="O6" value="35.9" spread="21.67"/>
                    <measurement group_id="O7" value="15.0" spread="10.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14</title>
        <description>The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.</description>
        <time_frame>Up to Day 15 (administered after every in-house bowel movement)</time_frame>
        <population>Safety population. Only those participants available at the specified time points were analyzed. For each BSFS scale rating the &quot;Number of Participants Analyzed&quot; represents the number of participants reporting that rating not the number evaluated.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14</title>
          <description>The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.</description>
          <population>Safety population. Only those participants available at the specified time points were analyzed. For each BSFS scale rating the &quot;Number of Participants Analyzed&quot; represents the number of participants reporting that rating not the number evaluated.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BSFS scale rating, 1 event : Events</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BSFS scale rating, 2 events : Events</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O7" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BSFS scale rating, 3 events : Events</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BSFS scale rating, 4 events : Events</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="21"/>
                    <measurement group_id="O6" value="24"/>
                    <measurement group_id="O7" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BSFS scale rating, 5 events : Events</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="26"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="30"/>
                    <measurement group_id="O7" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BSFS scale rating, 6 events : Events</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="81"/>
                    <measurement group_id="O3" value="113"/>
                    <measurement group_id="O4" value="181"/>
                    <measurement group_id="O5" value="250"/>
                    <measurement group_id="O6" value="201"/>
                    <measurement group_id="O7" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BSFS scale rating, 7 events : Events</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="7"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="47"/>
                    <measurement group_id="O4" value="86"/>
                    <measurement group_id="O5" value="50"/>
                    <measurement group_id="O6" value="98"/>
                    <measurement group_id="O7" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms &gt;=2 Levels)</title>
        <description>GSRS is a rating scale consisting of 15 items. Each item was scored from 1: no discomfort at all, 2: minor discomfort, 3: mild discomfort, 4: moderate discomfort, 5: moderately severe discomfort, 6: severe discomfort, 7: very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 1 to 7; a score of 1 indicates that no symptoms are present, and a score of 7 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity. There were 5 defined syndrome scores and 1 overall score that was derived by computing the mean of the scores for specific subsets of questions as indicated below: abdominal pain (1, 4, 5); reflux syndrome (2, 3); diarrhea syndrome (11, 12, 14); indigestion syndrome (6, 7, 8, 9); constipation syndrome (10, 13, 15) and overall GSRS (1-15). The data is presented for participants with worsening of symptoms in &gt;=2 levels.</description>
        <time_frame>Day 7 and 14</time_frame>
        <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms &gt;=2 Levels)</title>
          <description>GSRS is a rating scale consisting of 15 items. Each item was scored from 1: no discomfort at all, 2: minor discomfort, 3: mild discomfort, 4: moderate discomfort, 5: moderately severe discomfort, 6: severe discomfort, 7: very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 1 to 7; a score of 1 indicates that no symptoms are present, and a score of 7 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity. There were 5 defined syndrome scores and 1 overall score that was derived by computing the mean of the scores for specific subsets of questions as indicated below: abdominal pain (1, 4, 5); reflux syndrome (2, 3); diarrhea syndrome (11, 12, 14); indigestion syndrome (6, 7, 8, 9); constipation syndrome (10, 13, 15) and overall GSRS (1-15). The data is presented for participants with worsening of symptoms in &gt;=2 levels.</description>
          <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain/discomfort in upper abdomen, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heartburn, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acid reflux, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hunger pains, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rumbling, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloated, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burping, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Passing gas or flatus, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loose stools, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hard stools, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urgent need to have bowel movement, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensatn not complete empty bowels, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal pain, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reflux syndrome, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indigestion syndrome, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation syndrome, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea syndrome, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall GSRS, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/discomfort in upper abdomen, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heartburn, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acid reflux, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hunger pains, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rumbling, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloated, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burping, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Passing gas or flatus, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loose stools, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hard stools, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urgent need to have bowel movement, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensation not complete empty bowels, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal pain, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reflux syndrome, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indigestion syndrome, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation syndrome, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea syndrome, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall GSRS, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding</title>
        <description>Testing cards were provided to participants for assessments. Participants with abnormal not clinically significant and abnormal clinically significant is presented. The Day -1 sample was obtained any time starting Day -2 and prior to GSK2330672 dosing on Day 1. The Day 14 sample was collected any time after dosing on Day 14 and prior to discharge on Day 15.</description>
        <time_frame>Up to Day 15</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O8">
            <title>Run-in Only</title>
            <description>Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding</title>
          <description>Testing cards were provided to participants for assessments. Participants with abnormal not clinically significant and abnormal clinically significant is presented. The Day -1 sample was obtained any time starting Day -2 and prior to GSK2330672 dosing on Day 1. The Day 14 sample was collected any time after dosing on Day 14 and prior to discharge on Day 15.</description>
          <population>Safety population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abnormal not clinically significant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal clinically significant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax)</title>
        <description>The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Statistics for geometric least square mean provided.</description>
        <time_frame>Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14</time_frame>
        <population>The PK population was used which was defined as participants from the safety population who had plasma metformin, sitagliptin, and/or GSK2330672 PK parameter estimates from any portion of the study. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax)</title>
          <description>The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Statistics for geometric least square mean provided.</description>
          <population>The PK population was used which was defined as participants from the safety population who had plasma metformin, sitagliptin, and/or GSK2330672 PK parameter estimates from any portion of the study. Only those participants available at the specified time points were analyzed.</population>
          <units>Nanograms per milliliter (ng/mL)</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1102.2" spread="26.92"/>
                    <measurement group_id="O2" value="1289.3" spread="41.81"/>
                    <measurement group_id="O3" value="1219.9" spread="23.76"/>
                    <measurement group_id="O4" value="1160.0" spread="18.64"/>
                    <measurement group_id="O5" value="1378.8" spread="22.77"/>
                    <measurement group_id="O6" value="1376.6" spread="21.70"/>
                    <measurement group_id="O7" value="1223.5" spread="27.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>1.17</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.92</ci_lower_limit>
            <ci_upper_limit>1.49</ci_upper_limit>
            <estimate_desc>Mean and confidence interval (CI) for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>1.11</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.38</ci_upper_limit>
            <estimate_desc>Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>1.05</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
            <estimate_desc>Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>1.25</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
            <estimate_desc>Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>1.25</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>1.50</ci_upper_limit>
            <estimate_desc>Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>1.11</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.31</ci_upper_limit>
            <estimate_desc>Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax)</title>
        <description>The time at which Cmax observed was determined directly from the raw concentration-time data.</description>
        <time_frame>Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14</time_frame>
        <population>PK population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax)</title>
          <description>The time at which Cmax observed was determined directly from the raw concentration-time data.</description>
          <population>PK population. Only those participants available at the specified time points were analyzed.</population>
          <units>Hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.510" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="1.000" lower_limit="1.00" upper_limit="1.50"/>
                    <measurement group_id="O3" value="1.000" lower_limit="0.50" upper_limit="3.98"/>
                    <measurement group_id="O4" value="1.050" lower_limit="1.00" upper_limit="1.50"/>
                    <measurement group_id="O5" value="1.750" lower_limit="0.50" upper_limit="4.00"/>
                    <measurement group_id="O6" value="1.500" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O7" value="2.050" lower_limit="1.00" upper_limit="4.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10])</title>
        <description>PK population. Only those participants available at the specified time points were analyzed.</description>
        <time_frame>Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14</time_frame>
        <population>PK population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10])</title>
          <description>PK population. Only those participants available at the specified time points were analyzed.</description>
          <population>PK population. Only those participants available at the specified time points were analyzed.</population>
          <units>Hour×ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6805.8" spread="19.70"/>
                    <measurement group_id="O2" value="5982.0" spread="34.72"/>
                    <measurement group_id="O3" value="7066.2" spread="25.80"/>
                    <measurement group_id="O4" value="7066.5" spread="16.09"/>
                    <measurement group_id="O5" value="8090.5" spread="33.06"/>
                    <measurement group_id="O6" value="8375.3" spread="32.78"/>
                    <measurement group_id="O7" value="8425.4" spread="28.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>0.88</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>1.13</ci_upper_limit>
            <estimate_desc>Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>1.04</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>1.31</ci_upper_limit>
            <estimate_desc>Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>1.04</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.26</ci_upper_limit>
            <estimate_desc>Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>1.19</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
            <estimate_desc>Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>1.23</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>1.49</ci_upper_limit>
            <estimate_desc>Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.</non_inferiority_desc>
            <param_type>Ratio</param_type>
            <param_value>1.24</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>1.48</ci_upper_limit>
            <estimate_desc>Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides</title>
        <description>Data for fasting low-density cholesterol (LDL) cholesterol, high-density cholesterol (HDL) cholesterol, total cholesterol, non-HDL cholesterol and triglycerides is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</description>
        <time_frame>Baseline (pre-dose Day -1) and Day 7, 14</time_frame>
        <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides</title>
          <description>Data for fasting low-density cholesterol (LDL) cholesterol, high-density cholesterol (HDL) cholesterol, total cholesterol, non-HDL cholesterol and triglycerides is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</description>
          <population>Safety population. Only those participants available at the specified time points were analyzed.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cholesterol, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" spread="10.9"/>
                    <measurement group_id="O2" value="0.99" spread="12.1"/>
                    <measurement group_id="O3" value="0.84" spread="12.4"/>
                    <measurement group_id="O4" value="0.84" spread="13.7"/>
                    <measurement group_id="O5" value="0.74" spread="11.0"/>
                    <measurement group_id="O6" value="0.80" spread="3.7"/>
                    <measurement group_id="O7" value="0.97" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" spread="13.1"/>
                    <measurement group_id="O2" value="0.98" spread="14.2"/>
                    <measurement group_id="O3" value="0.81" spread="20.8"/>
                    <measurement group_id="O4" value="0.83" spread="18.5"/>
                    <measurement group_id="O5" value="0.75" spread="8.8"/>
                    <measurement group_id="O6" value="0.75" spread="6.7"/>
                    <measurement group_id="O7" value="0.92" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL cholesterol, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="7.3"/>
                    <measurement group_id="O2" value="1.08" spread="12.8"/>
                    <measurement group_id="O3" value="1.05" spread="8.9"/>
                    <measurement group_id="O4" value="0.97" spread="8.0"/>
                    <measurement group_id="O5" value="0.95" spread="11.4"/>
                    <measurement group_id="O6" value="1.09" spread="15.7"/>
                    <measurement group_id="O7" value="0.97" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL cholesterol, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" spread="6.5"/>
                    <measurement group_id="O2" value="1.11" spread="1.5"/>
                    <measurement group_id="O3" value="1.02" spread="4.0"/>
                    <measurement group_id="O4" value="0.97" spread="8.8"/>
                    <measurement group_id="O5" value="0.96" spread="11.4"/>
                    <measurement group_id="O6" value="1.01" spread="11.6"/>
                    <measurement group_id="O7" value="0.97" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="14.6"/>
                    <measurement group_id="O2" value="0.89" spread="6.4"/>
                    <measurement group_id="O3" value="0.77" spread="21.1"/>
                    <measurement group_id="O4" value="0.73" spread="21.5"/>
                    <measurement group_id="O5" value="0.58" spread="21.2"/>
                    <measurement group_id="O6" value="0.71" spread="6.5"/>
                    <measurement group_id="O7" value="1.00" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="17.6"/>
                    <measurement group_id="O2" value="0.80" spread="4.2"/>
                    <measurement group_id="O3" value="0.69" spread="23.1"/>
                    <measurement group_id="O4" value="0.72" spread="23.7"/>
                    <measurement group_id="O5" value="0.60" spread="15.0"/>
                    <measurement group_id="O6" value="0.67" spread="16.3"/>
                    <measurement group_id="O7" value="0.92" spread="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-HDL Cholesterol, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="13.8"/>
                    <measurement group_id="O2" value="0.96" spread="12.6"/>
                    <measurement group_id="O3" value="0.78" spread="18.2"/>
                    <measurement group_id="O4" value="0.80" spread="18.2"/>
                    <measurement group_id="O5" value="0.65" spread="12.0"/>
                    <measurement group_id="O6" value="0.73" spread="5.1"/>
                    <measurement group_id="O7" value="0.98" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-HDL Cholesterol, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="17.7"/>
                    <measurement group_id="O2" value="0.94" spread="17.5"/>
                    <measurement group_id="O3" value="0.74" spread="29.7"/>
                    <measurement group_id="O4" value="0.78" spread="23.7"/>
                    <measurement group_id="O5" value="0.67" spread="7.2"/>
                    <measurement group_id="O6" value="0.68" spread="8.6"/>
                    <measurement group_id="O7" value="0.90" spread="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides, Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="20.6"/>
                    <measurement group_id="O2" value="1.07" spread="51.2"/>
                    <measurement group_id="O3" value="0.93" spread="18.8"/>
                    <measurement group_id="O4" value="1.11" spread="24.5"/>
                    <measurement group_id="O5" value="0.98" spread="19.8"/>
                    <measurement group_id="O6" value="0.93" spread="16.3"/>
                    <measurement group_id="O7" value="0.79" spread="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides, Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="23.0"/>
                    <measurement group_id="O2" value="1.21" spread="63.3"/>
                    <measurement group_id="O3" value="0.96" spread="35.8"/>
                    <measurement group_id="O4" value="1.07" spread="34.3"/>
                    <measurement group_id="O5" value="1.00" spread="16.6"/>
                    <measurement group_id="O6" value="1.00" spread="23.7"/>
                    <measurement group_id="O7" value="0.74" spread="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>0.83</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>0.92</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.92</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.13</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>0.69</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>0.76</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>0.87</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.92</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>1.66</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, triglycerides</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.50</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, triglycerides</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.06</ci_lower_limit>
            <ci_upper_limit>1.61</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, triglycerides</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.96</ci_lower_limit>
            <ci_upper_limit>1.48</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, triglycerides</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>1.42</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, triglycerides</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, triglycerides</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>0.82</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.92</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.92</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>0.71</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>0.80</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, LDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.22</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>0.75</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, non-HDL cholesterol</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>2.00</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, triglycerides</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.75</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, triglycerides</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, triglycerides</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.56</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, triglycerides</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.96</ci_lower_limit>
            <ci_upper_limit>1.57</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, triglycerides</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, triglycerides</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio to Baseline in Fasting Apolipoprotein B</title>
        <description>Data for fasting apolipoprotein B is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</description>
        <time_frame>Baseline (pre-dose Day -1) and Day 7, 14</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 10 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 20 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 30 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 60 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
          </group>
          <group group_id="O7">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio to Baseline in Fasting Apolipoprotein B</title>
          <description>Data for fasting apolipoprotein B is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</description>
          <population>Safety population</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="7"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="10.6"/>
                    <measurement group_id="O2" value="0.95" spread="5.9"/>
                    <measurement group_id="O3" value="0.78" spread="13.9"/>
                    <measurement group_id="O4" value="0.81" spread="13.1"/>
                    <measurement group_id="O5" value="0.69" spread="12.0"/>
                    <measurement group_id="O6" value="0.76" spread="3.8"/>
                    <measurement group_id="O7" value="0.96" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="7"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="14.2"/>
                    <measurement group_id="O2" value="0.85" spread="6.7"/>
                    <measurement group_id="O3" value="0.75" spread="19.0"/>
                    <measurement group_id="O4" value="0.78" spread="19.6"/>
                    <measurement group_id="O5" value="0.67" spread="14.9"/>
                    <measurement group_id="O6" value="0.69" spread="9.3"/>
                    <measurement group_id="O7" value="0.88" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, apolipoprotein B</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, apolipoprotein B</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, apolipoprotein B</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>0.77</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, apolipoprotein B</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, apolipoprotein B</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
            <estimate_desc>Comparison for Day 7, apolipoprotein B</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, apolipoprotein B</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, apolipoprotein B</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, apolipoprotein B</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>0.77</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, apolipoprotein B</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>0.83</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, apolipoprotein B</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>An estimation approach was used.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
            <estimate_desc>Comparison for Day 14, apolipoprotein B</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses</title>
        <description>The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Cmax1 and Cmax2).</description>
        <time_frame>Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14</time_frame>
        <population>PK population.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses</title>
          <description>The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Cmax1 and Cmax2).</description>
          <population>PK population.</population>
          <units>Ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cmax 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="238.2" spread="26.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cmax 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="188.5" spread="25.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses</title>
        <description>The time at which Cmax was observed by determining directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Tmax1 and Tmax2). If data permits, Tmax2 was defined as the time of Cmax following the second dose of sitagliptin.</description>
        <time_frame>Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14</time_frame>
        <population>PK population.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses</title>
          <description>The time at which Cmax was observed by determining directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Tmax1 and Tmax2). If data permits, Tmax2 was defined as the time of Cmax following the second dose of sitagliptin.</description>
          <population>PK population.</population>
          <units>Hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tmax 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.000" lower_limit="1.00" upper_limit="3.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tmax 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.050" lower_limit="2.98" upper_limit="4.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-AUC(0-10)</title>
        <description>The AUC(0-10) following the first dose and prior to the second dose of sitagliptin was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.</description>
        <time_frame>Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner) on Day 14</time_frame>
        <population>PK population.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin 50 mg BID</title>
            <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
          </group>
        </group_list>
        <measure>
          <title>Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-AUC(0-10)</title>
          <description>The AUC(0-10) following the first dose and prior to the second dose of sitagliptin was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.</description>
          <population>PK population.</population>
          <units>Hour×ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1473.5" spread="22.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs and SAEs were collected from run-in period until the follow-up contact (7-10 days after discharge). SAEs and non-SAE were reported from treatment period only (up to 14 days).</time_frame>
      <desc>Safety population used for assessment of safety results.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="E2">
          <title>GSK2330672 10 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="E3">
          <title>GSK2330672 20 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="E4">
          <title>GSK2330672 30 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="E5">
          <title>GSK2330672 60 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="E6">
          <title>GSK2330672 90 mg BID</title>
          <description>Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.</description>
        </group>
        <group group_id="E7">
          <title>Sitagliptin 50 mg BID</title>
          <description>Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia supraventricular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Scleral hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Faeces soft</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastrointestinal sounds abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oral discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Feeling jittery</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anal injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02202161
org study id: 201351
nct id: NCT02202161
lead sponsor: 
has dmc: No
This study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of GSK2330672 compared to sitagliptin when administered with metformin for
      14 days to subjects with type 2 diabetes mellitus (T2DM). Approximately 72 male and female
      subjects aged 30-64 years with T2DM and currently taking metformin will be recruited for this
      study. Eligible subjects will begin a run-in period of 13-15 days to stabilize on metformin
      850 milligram (mg) twice a day (BID). Subjects will then be randomized to GSK2330672 10 mg,
      20 mg, 30 mg, 90 mg, matching placebo or open-label sitagliptin 50 mg for 14 days BID.
      Subjects will return for a follow-up visit 7-10 days after discharge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour])
time frame: Baseline (Day -1) and Day 14 (Fasting Pre-dose [within 15 minutes of dose], 30 minutes, 1, 1.5, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, 14 [bed time] and 24 hours) and Day 7 (30 minutes, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, and 24 hours)
description: The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. It was assessed on Baseline, Day 7 and 14. Data for fasting and weighted mean (WM) AUC(0-24 hour) glucose is provided. Statistics for least square mean is provided and participants withdrawing early were excluded. Results were based on an analysis of covariance (ANCOVA) model: change from Baseline = Baseline + treatment.
measure: Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Up to 14 days (treatment period)
description: An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition and alanine aminotransferase (ALT) >= 3× upper limit of normal (ULN) and total bilirubin >=2 × ULN (>35% direct) or ALT >=3 × ULN and international normalized ratio >1.5.
measure: Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI)
time frame: Up to Day 15
description: Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided.
measure: Number of Participants With Abnormal Clinical Chemistry With PCI
time frame: Up to Day 15
description: Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, total carbon dioxide and triglycerides. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. The normal range (NR) and PCI definition for abnormal parameters are: ALT (NR: 0-44, 0-32, 2-33; PCI: >=2×upper limit of normal [ULN]); AST (NR: 0-40; PCI: >=2× ULN) and total bilirubin (NR: 0.00-20.52; PCI: >=1.5× ULN).
measure: Number of Participants With Abnormal Urinalysis Data
time frame: Baseline (pre-dose Day -1), Day 7 and 15
description: Urinalysis included urine occult blood: trace to 3+, glucose: negative to 3+, protein: negative to 2+ and ketones: trace to negative by dipstick and microscopic examination included cast, cellular cast, granular cast, hyaline cast (none seen to 1) and RBC: 0-2, 3-10, 11-30, >30, WBC: none seen, 0-5, 1, 2, 4, <5, 6-10, 11-30, 19, >30). The plus sign increases with a higher level of occult blood, glucose, ketones, proteins, RBC, WBC in the urine: 1+: slightly positive, 2+: positive, 3+: high positive. Participants were categorized as none seen or 1 based on the absence or presence, respectively, of cast, cellular cast, granular cast and hyaline cast. Higher value indicates higher abnormality.
measure: Summary of Urinalysis Data-mean Specific Gravity
time frame: Baseline (pre-dose Day -1), Day 7 and 15
description: Data for mean specific gravity is provided. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.
measure: Summary of Urinalysis Data-mean pH
time frame: Baseline (pre-dose Day -1), Day 7 and 15
description: Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline
time frame: Up to Day 15
description: Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG is presented.
measure: Change From Baseline in Vital Signs Assessments-temperature
time frame: Baseline (pre-dose Day -1) and, Day 7, 15
description: The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.
measure: Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
time frame: Baseline (pre-dose Day -1) and Day 7, 15
description: The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.
measure: Change From Baseline in Vital Signs Assessments-heart Rate
time frame: Baseline (pre-dose Day -1) and Day 7, 15
description: The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.
measure: Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14
time frame: Up to Day 15 (administered after every in-house bowel movement)
description: The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.
measure: Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14
time frame: Up to Day 15 (administered after every in-house bowel movement)
description: The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.
measure: Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels)
time frame: Day 7 and 14
description: GSRS is a rating scale consisting of 15 items. Each item was scored from 1: no discomfort at all, 2: minor discomfort, 3: mild discomfort, 4: moderate discomfort, 5: moderately severe discomfort, 6: severe discomfort, 7: very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 1 to 7; a score of 1 indicates that no symptoms are present, and a score of 7 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity. There were 5 defined syndrome scores and 1 overall score that was derived by computing the mean of the scores for specific subsets of questions as indicated below: abdominal pain (1, 4, 5); reflux syndrome (2, 3); diarrhea syndrome (11, 12, 14); indigestion syndrome (6, 7, 8, 9); constipation syndrome (10, 13, 15) and overall GSRS (1-15). The data is presented for participants with worsening of symptoms in >=2 levels.
measure: Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding
time frame: Up to Day 15
description: Testing cards were provided to participants for assessments. Participants with abnormal not clinically significant and abnormal clinically significant is presented. The Day -1 sample was obtained any time starting Day -2 and prior to GSK2330672 dosing on Day 1. The Day 14 sample was collected any time after dosing on Day 14 and prior to discharge on Day 15.
measure: PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax)
time frame: Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14
description: The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Statistics for geometric least square mean provided.
measure: PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax)
time frame: Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14
description: The time at which Cmax observed was determined directly from the raw concentration-time data.
measure: PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10])
time frame: Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14
description: PK population. Only those participants available at the specified time points were analyzed.
measure: Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides
time frame: Baseline (pre-dose Day -1) and Day 7, 14
description: Data for fasting low-density cholesterol (LDL) cholesterol, high-density cholesterol (HDL) cholesterol, total cholesterol, non-HDL cholesterol and triglycerides is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.
measure: Ratio to Baseline in Fasting Apolipoprotein B
time frame: Baseline (pre-dose Day -1) and Day 7, 14
description: Data for fasting apolipoprotein B is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.
measure: Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses
time frame: Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14
description: The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Cmax1 and Cmax2).
measure: Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses
time frame: Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14
description: The time at which Cmax was observed by determining directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Tmax1 and Tmax2). If data permits, Tmax2 was defined as the time of Cmax following the second dose of sitagliptin.
measure: Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-AUC(0-10)
time frame: Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner) on Day 14
description: The AUC(0-10) following the first dose and prior to the second dose of sitagliptin was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
arm group label: GSK2330672 10 mg
arm group type: Experimental
description: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 10 mg BID for 14 days.
arm group label: GSK2330672 20 mg
arm group type: Experimental
description: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 20 mg BID for 14 days.
arm group label: GSK2330672 30 mg
arm group type: Experimental
description: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 30 mg BID for 14 days.
arm group label: GSK2330672 90 mg
arm group type: Experimental
description: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 90 mg BID for 14 days.
arm group label: GSK2330672-matched placebo
arm group type: Placebo Comparator
description: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by matching placebo (of GSK2330672) BID for 14 days.
arm group label: Sitagliptin 50 mg
arm group type: Active Comparator
description: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by Sitagliptin 50 mg BID for 14 days. In this study, sitagliptin 50 mg BID will be provided as open-label (unblinded) study treatment.
intervention type: Drug
intervention name: GSK2330672
description: GSK2330672 will be available in 10 mg, 20 mg, 30 mg, and 90 mg oral solution to be administered BID for 14 days. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed
arm group label: GSK2330672 10 mg
arm group label: GSK2330672 20 mg
arm group label: GSK2330672 30 mg
arm group label: GSK2330672 90 mg
intervention type: Drug
intervention name: Placebo
description: Matching placebo will be available as oral solution to be administered for 14 days, BID. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed
arm group label: GSK2330672-matched placebo
intervention type: Drug
intervention name: Sitagliptin
description: Sitagliptin will be available as film-coated tablets Tablet of 50 mg to be administered orally, BID, for 14 days
arm group label: Sitagliptin 50 mg
intervention type: Drug
intervention name: Metformin
description: Metformin will be available as 850 mg white to off-white, film-coated tablets; to be administered BID orally during run-in through Day 14
arm group label: GSK2330672 10 mg
arm group label: GSK2330672 20 mg
arm group label: GSK2330672 30 mg
arm group label: GSK2330672 90 mg
arm group label: GSK2330672-matched placebo
arm group label: Sitagliptin 50 mg
criteria: 
gender: All
minimum age: 30 Years
maximum age: 64 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: United States
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Sitagliptin Phosphate
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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