<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/NCT02226003</url>
  </required_header>
  <id_info>
    <org_study_id>8835-017</org_study_id>
    <secondary_id>2014-001049-25</secondary_id>
    <secondary_id>B1521047</secondary_id>
    <nct_id>NCT02226003</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)</brief_title>
  <official_title>A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Initial Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Diet and Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in&#xD;
      combination with sitagliptin in the treatment of participants with Type 2 diabetes mellitus&#xD;
      (T2DM) with inadequate glycemic control on diet and exercise. The primary hypothesis of the&#xD;
      study is that ertugliflozin plus sitagliptin is more effective in lowering of hemoglobin A1C&#xD;
      (HbA1C) than placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each participant will be in the study for approximately 39 weeks including: a 1-week&#xD;
      screening period, an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period, a&#xD;
      2-week single-blind placebo run-in period, a 26-week double-blind treatment period, and a&#xD;
      post-treatment telephone contact 14 days after the last dose of study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2014</start_date>
  <completion_date type="Actual">February 23, 2016</completion_date>
  <primary_completion_date type="Actual">February 23, 2016</primary_completion_date>
  <phase>Phase 3</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 Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach</measure>
    <time_frame>Up to Week 28</time_frame>
    <description>An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach</measure>
    <time_frame>Up to Week 26</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HbA1C &lt;7% (&lt;53 mmol/Mol) at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">291</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Ertugliflozin 5 mg and Sitagliptin 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ertugliflozin 15 mg and Sitagliptin 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to Ertugliflozin and Placebo to Sitagliptin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ertugliflozin</intervention_name>
    <description>Ertugliflozin, 5 mg or 15 mg, administered orally, once daily for 26 weeks.</description>
    <arm_group_label>Ertugliflozin 15 mg and Sitagliptin 100 mg</arm_group_label>
    <arm_group_label>Ertugliflozin 5 mg and Sitagliptin 100 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin</intervention_name>
    <description>Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
    <arm_group_label>Ertugliflozin 15 mg and Sitagliptin 100 mg</arm_group_label>
    <arm_group_label>Ertugliflozin 5 mg and Sitagliptin 100 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Ertugliflozin</intervention_name>
    <description>Matching placebo to ertugliflozin administered orally, once daily for 26 weeks.</description>
    <arm_group_label>Ertugliflozin 5 mg and Sitagliptin 100 mg</arm_group_label>
    <arm_group_label>Placebo to Ertugliflozin and Placebo to Sitagliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Sitagliptin</intervention_name>
    <description>Matching placebo to sitagliptin administered orally, once daily for 26 weeks.</description>
    <arm_group_label>Placebo to Ertugliflozin and Placebo to Sitagliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glimepiride</intervention_name>
    <description>Open-label glimepiride rescue therapy will be initiated at 1 or 2 mg/day and may be titrated to the maximum labeled dose or maximum tolerated dose (if lower than labeled dose), as considered appropriate by the investigator, based on blood glucose measurements and in accordance with the local, approved label.</description>
    <arm_group_label>Ertugliflozin 15 mg and Sitagliptin 100 mg</arm_group_label>
    <arm_group_label>Ertugliflozin 5 mg and Sitagliptin 100 mg</arm_group_label>
    <arm_group_label>Placebo to Ertugliflozin and Placebo to Sitagliptin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus as per American Diabetes Association guidelines&#xD;
&#xD;
          -  Not on antihyperglycemic agent (AHA) &gt;=8 weeks with a Visit 1/Screening HbA1C &gt;=8.0%&#xD;
             and &lt;=10.5% (&gt;=64 mmol/mol and &lt;=91 mmol/mol) OR on single allowable AHA (allowable&#xD;
             AHAs prior to screening are: metformin, α-glucosidase inhibitors, sulfonylureas and&#xD;
             glinides) with a Visit 1/Screening HbA1C &gt;=7.5% and &lt;=10.0% (&gt;=58 mmol/mol and &lt;=86&#xD;
             mmol/mol) OR on low-dose dual combination therapy (≤50% of maximum labeled dose of an&#xD;
             AHA) with allowable AHAs with a Visit 1/Screening HbA1C &gt;=7.5% and &lt;=10.0% (&gt;=58&#xD;
             mmol/mol and &lt;=86 mmol/mol)&#xD;
&#xD;
          -  Body mass index (BMI) &gt;=18.0 kg/m^2&#xD;
&#xD;
          -  Male or female not of reproductive potential&#xD;
&#xD;
          -  Female of reproductive potential who agrees to (or have their partner agree to) remain&#xD;
             abstinent from heterosexual activity or to use 2 acceptable combinations of&#xD;
             contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of type 1 diabetes mellitus or diabetic ketoacidosis&#xD;
&#xD;
          -  History of other specific types of diabetes (e.g., genetic syndromes, secondary&#xD;
             pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and&#xD;
             post-organ transplant&#xD;
&#xD;
          -  A known hypersensitivity or intolerance to any sodium glucose co-transporter (SGLT2)&#xD;
             inhibitor or sitagliptin&#xD;
&#xD;
          -  Has been treated with any of the following agents within 12 weeks of study start or&#xD;
             during the pre-randomization period: insulin of any type (except for short-term use&#xD;
             [i.e., &lt;=7 days] during concomitant illness or other stress), other injectable&#xD;
             anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), pioglitazone or&#xD;
             rosiglitazone, other sodium glucose co-transporter 2 (SGLT2) inhibitors,&#xD;
             dipeptidyl-peptidase 4 inhibitors (DPP-4 inhibitors), bromocriptine (Cycloset™),&#xD;
             colesevelam (Welchol™), any other AHA with the exception of the protocol-approved&#xD;
             agents&#xD;
&#xD;
          -  Is on a weight-loss program or weight-loss medication or other medication associated&#xD;
             with weight changes and is not weight stable prior to study start&#xD;
&#xD;
          -  Has undergone bariatric surgery within the past 12 months or &gt;12 months and is not&#xD;
             weight stable prior to study start&#xD;
&#xD;
          -  A history of myocardial infarction, unstable angina, arterial revascularization,&#xD;
             stroke, transient ischemic attack, or New York Heart Association (NYHA) functional&#xD;
             Class III-IV heart failure within 3 months of study start&#xD;
&#xD;
          -  Active, obstructive uropathy or indwelling urinary catheter&#xD;
&#xD;
          -  History of malignancy &lt;=5 years prior to study start, except for adequately treated&#xD;
             basal cell or squamous cell skin cancer or in situ cervical cancer&#xD;
&#xD;
          -  A known history of human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  A blood dyscrasia or any disorder causing hemolysis or unstable red blood cells, or a&#xD;
             clinically important hematological disorder (e.g. aplastic anemia, myeloproliferative&#xD;
             or myelodysplastic syndromes, thrombocytopenia)&#xD;
&#xD;
          -  A medical history of active liver disease (other than non-alcoholic hepatic&#xD;
             steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or&#xD;
             symptomatic gallbladder disease&#xD;
&#xD;
          -  Any clinically significant malabsorption condition&#xD;
&#xD;
          -  Current treatment for hyperthyroidism&#xD;
&#xD;
          -  On thyroid replacement therapy and not on a stable dose for at least 6 weeks prior&#xD;
             study start&#xD;
&#xD;
          -  On a previous clinical study with ertugliflozin&#xD;
&#xD;
          -  Participated in other studies involving investigational drug(s) 30 days prior to study&#xD;
             start&#xD;
&#xD;
          -  Surgical procedure within 6 weeks prior to study start or major surgery planned during&#xD;
             the trial&#xD;
&#xD;
          -  Positive urine pregnancy test&#xD;
&#xD;
          -  Pregnant or breast-feeding, or planning to conceive during the trial, including 14&#xD;
             days following the last dose of study medication&#xD;
&#xD;
          -  Planning to undergo hormonal therapy in preparation for egg donation during the trial,&#xD;
             including 14 days following the last dose of study medication&#xD;
&#xD;
          -  Routinely consumes &gt;2 alcoholic drinks per day or &gt;14 alcoholic drinks per week or&#xD;
             engages in binge drinking&#xD;
&#xD;
          -  Donated blood or blood products within 6 weeks of study start.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Bulgaria</country>
    <country>Czech Republic</country>
    <country>Estonia</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Miller S, Krumins T, Zhou H, Huyck S, Johnson J, Golm G, Terra SG, Mancuso JP, Engel SS, Lauring B. Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study. Diabetes Ther. 2018 Feb;9(1):253-268. doi: 10.1007/s13300-017-0358-0. Epub 2018 Jan 8.</citation>
    <PMID>29313282</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <results_first_submitted>February 23, 2017</results_first_submitted>
  <results_first_submitted_qc>February 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 7, 2017</results_first_posted>
  <last_update_submitted>August 15, 2018</last_update_submitted>
  <last_update_submitted_qc>August 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Sitagliptin Phosphate</mesh_term>
    <mesh_term>Glimepiride</mesh_term>
    <mesh_term>Ertugliflozin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 96 sites received independent ethics committees/institutional review boards' approval and 66 sites in 9 countries enrolled at least 1 participant.</recruitment_details>
      <pre_assignment_details>The study included a 1-week screening period; an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period; and a 2-week single-blind placebo run-in period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
          <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
          <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="96"/>
                <participants group_id="P3" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="95"/>
                <participants group_id="P3" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" 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="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
          <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
          <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
        </group>
        <group group_id="B4">
          <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="98"/>
            <count group_id="B2" value="96"/>
            <count group_id="B3" value="97"/>
            <count group_id="B4" value="291"/>
          </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="56.4" spread="9.3"/>
                    <measurement group_id="B2" value="56.1" spread="10.1"/>
                    <measurement group_id="B3" value="54.3" spread="10.3"/>
                    <measurement group_id="B4" value="55.6" spread="10.0"/>
                  </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="41"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach</title>
        <description>HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 HbA1C endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach</title>
          <description>HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
          <population>FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 HbA1C endpoint.</population>
          <units>Percentage</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.60" lower_limit="-1.82" upper_limit="-1.39"/>
                    <measurement group_id="O2" value="-1.68" lower_limit="-1.90" upper_limit="-1.46"/>
                    <measurement group_id="O3" value="-0.44" lower_limit="-0.69" upper_limit="-0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>
            <p_value>&lt; 0.001</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.49</ci_lower_limit>
            <ci_upper_limit>-0.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.57</ci_lower_limit>
            <ci_upper_limit>-0.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach</title>
        <description>An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
        <time_frame>Up to Week 28</time_frame>
        <population>All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of a study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach</title>
          <description>An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
          <population>All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of a study drug.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.9"/>
                    <measurement group_id="O2" value="44.8"/>
                    <measurement group_id="O3" value="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>
            <param_type>Difference in Percentage vs Placebo</param_type>
            <param_value>2.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.2</ci_lower_limit>
            <ci_upper_limit>16.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage vs Placebo</param_type>
            <param_value>2.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.4</ci_lower_limit>
            <ci_upper_limit>16.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach</title>
        <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
        <time_frame>Up to Week 26</time_frame>
        <population>ASaT population consisted of all randomized participants who received at least one dose of a study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach</title>
          <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
          <population>ASaT population consisted of all randomized participants who received at least one dose of a study drug.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                    <measurement group_id="O2" value="2.1"/>
                    <measurement group_id="O3" value="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach</title>
        <description>Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 FPG endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach</title>
          <description>Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
          <population>FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 FPG endpoint.</population>
          <units>milligrams/deciliter</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-48.25" lower_limit="-56.12" upper_limit="-40.38"/>
                    <measurement group_id="O2" value="-55.36" lower_limit="-63.29" upper_limit="-47.42"/>
                    <measurement group_id="O3" value="-9.30" lower_limit="-18.58" upper_limit="-0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>
            <p_value>&lt; 0.001</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-38.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-49.93</ci_lower_limit>
            <ci_upper_limit>-27.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-46.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-57.09</ci_lower_limit>
            <ci_upper_limit>-35.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach</title>
        <description>Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 2-hour PMG endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach</title>
          <description>Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
          <population>FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 2-hour PMG endpoint.</population>
          <units>milligrams/deciliter</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-82.80" lower_limit="-95.96" upper_limit="-69.64"/>
                    <measurement group_id="O2" value="-90.03" lower_limit="-103.34" upper_limit="-76.71"/>
                    <measurement group_id="O3" value="-20.38" lower_limit="-35.62" upper_limit="-5.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>
            <p_value>&lt; 0.001</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-62.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-80.47</ci_lower_limit>
            <ci_upper_limit>-44.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-69.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-87.83</ci_lower_limit>
            <ci_upper_limit>-51.46</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HbA1C &lt;7% (&lt;53 mmol/Mol) at Week 26</title>
        <description>HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.</description>
        <time_frame>Week 26</time_frame>
        <population>FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline in the Week 26 HbA1C endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HbA1C &lt;7% (&lt;53 mmol/Mol) at Week 26</title>
          <description>HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.</description>
          <population>FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline in the Week 26 HbA1C endpoint.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7"/>
                    <measurement group_id="O2" value="31.3"/>
                    <measurement group_id="O3" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>
            <p_value>&lt; 0.001</p_value>
            <method>Logistic regression model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>6.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.81</ci_lower_limit>
            <ci_upper_limit>16.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Logistic regression model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>7.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.98</ci_lower_limit>
            <ci_upper_limit>18.31</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach</title>
        <description>Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 body weight endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach</title>
          <description>Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
          <population>FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 body weight endpoint.</population>
          <units>Kilograms</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.94" lower_limit="-3.60" upper_limit="-2.28"/>
                    <measurement group_id="O2" value="-3.04" lower_limit="-3.71" upper_limit="-2.38"/>
                    <measurement group_id="O3" value="-0.94" lower_limit="-1.70" upper_limit="-0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>
            <p_value>&lt; 0.001</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-2.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.99</ci_lower_limit>
            <ci_upper_limit>-1.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-2.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.10</ci_lower_limit>
            <ci_upper_limit>-1.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach</title>
        <description>Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting systolic blood pressure endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach</title>
          <description>Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
          <population>FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting systolic blood pressure endpoint.</population>
          <units>millimeters of mercury</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.04" lower_limit="-4.23" upper_limit="0.16"/>
                    <measurement group_id="O2" value="-3.98" lower_limit="-6.19" upper_limit="-1.78"/>
                    <measurement group_id="O3" value="2.41" lower_limit="-0.34" upper_limit="5.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>
            <p_value>0.011</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-4.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.87</ci_lower_limit>
            <ci_upper_limit>-1.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-6.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.83</ci_lower_limit>
            <ci_upper_limit>-2.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach</title>
        <description>Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>The FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting diastolic blood pressure endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
            <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach</title>
          <description>Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.</description>
          <population>The FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting diastolic blood pressure endpoint.</population>
          <units>millimeters of mercury</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.44" lower_limit="-1.99" upper_limit="1.11"/>
                    <measurement group_id="O2" value="-0.97" lower_limit="-2.52" upper_limit="0.59"/>
                    <measurement group_id="O3" value="1.21" lower_limit="-0.73" upper_limit="3.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>
            <p_value>0.184</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-1.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.09</ci_lower_limit>
            <ci_upper_limit>0.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.080</p_value>
            <method>Constrained Longitudinal Data Analysis</method>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-2.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.62</ci_lower_limit>
            <ci_upper_limit>0.26</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 28</time_frame>
      <desc>The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ertugliflozin 5 mg + Sitagliptin 100 mg</title>
          <description>Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Ertugliflozin 15 mg + Sitagliptin 100 mg</title>
          <description>Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="96"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to arthropod sting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Cellulitis staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Multiple fractures</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Endometrial adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1</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="8" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="96"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="98"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="96"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E3" events="14" subjects_affected="7" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="97"/>
              </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>The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </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/NCT02226003
org study id: 8835-017
secondary id: 2014-001049-25
secondary id: B1521047
nct id: NCT02226003
lead sponsor: 
collaborator: 
has dmc: Yes
This is a study to evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in
      combination with sitagliptin in the treatment of participants with Type 2 diabetes mellitus
      (T2DM) with inadequate glycemic control on diet and exercise. The primary hypothesis of the
      study is that ertugliflozin plus sitagliptin is more effective in lowering of hemoglobin A1C
      (HbA1C) than placebo.
Each participant will be in the study for approximately 39 weeks including: a 1-week
      screening period, an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period, a
      2-week single-blind placebo run-in period, a 26-week double-blind treatment period, and a
      post-treatment telephone contact 14 days after the last dose of study drug.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach
time frame: Baseline and Week 26
description: HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
measure: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach
time frame: Up to Week 28
description: An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
measure: Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach
time frame: Up to Week 26
description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach
time frame: Baseline and Week 26
description: Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
measure: Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach
time frame: Baseline and Week 26
description: Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
measure: Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26
time frame: Week 26
description: HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.
measure: Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach
time frame: Baseline and Week 26
description: Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
measure: Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach
time frame: Baseline and Week 26
description: Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
measure: Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach
time frame: Baseline and Week 26
description: Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
arm group label: Ertugliflozin 5 mg and Sitagliptin 100 mg
arm group type: Experimental
description: Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
arm group label: Ertugliflozin 15 mg and Sitagliptin 100 mg
arm group type: Experimental
description: Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
arm group label: Placebo to Ertugliflozin and Placebo to Sitagliptin
arm group type: Placebo Comparator
description: Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
intervention type: Drug
intervention name: Ertugliflozin
description: Ertugliflozin, 5 mg or 15 mg, administered orally, once daily for 26 weeks.
arm group label: Ertugliflozin 15 mg and Sitagliptin 100 mg
arm group label: Ertugliflozin 5 mg and Sitagliptin 100 mg
intervention type: Drug
intervention name: Sitagliptin
description: Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
arm group label: Ertugliflozin 15 mg and Sitagliptin 100 mg
arm group label: Ertugliflozin 5 mg and Sitagliptin 100 mg
intervention type: Drug
intervention name: Placebo to Ertugliflozin
description: Matching placebo to ertugliflozin administered orally, once daily for 26 weeks.
arm group label: Ertugliflozin 5 mg and Sitagliptin 100 mg
arm group label: Placebo to Ertugliflozin and Placebo to Sitagliptin
intervention type: Drug
intervention name: Placebo to Sitagliptin
description: Matching placebo to sitagliptin administered orally, once daily for 26 weeks.
arm group label: Placebo to Ertugliflozin and Placebo to Sitagliptin
intervention type: Drug
intervention name: Glimepiride
description: Open-label glimepiride rescue therapy will be initiated at 1 or 2 mg/day and may be titrated to the maximum labeled dose or maximum tolerated dose (if lower than labeled dose), as considered appropriate by the investigator, based on blood glucose measurements and in accordance with the local, approved label.
arm group label: Ertugliflozin 15 mg and Sitagliptin 100 mg
arm group label: Ertugliflozin 5 mg and Sitagliptin 100 mg
arm group label: Placebo to Ertugliflozin and Placebo to Sitagliptin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Bulgaria
country: Czech Republic
country: Estonia
country: Hungary
country: Israel
country: Ukraine
country: United Kingdom
country: United States
citation: Miller S, Krumins T, Zhou H, Huyck S, Johnson J, Golm G, Terra SG, Mancuso JP, Engel SS, Lauring B. Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study. Diabetes Ther. 2018 Feb;9(1):253-268. doi: 10.1007/s13300-017-0358-0. Epub 2018 Jan 8.
PMID: 29313282
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Sitagliptin Phosphate
mesh term: Glimepiride
mesh term: Ertugliflozin
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 