<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/NCT01678820</url>
  </required_header>
  <id_info>
    <org_study_id>0431D-266</org_study_id>
    <nct_id>NCT01678820</nct_id>
  </id_info>
  <brief_title>A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)</brief_title>
  <official_title>A Phase III, Randomized, Double-blind, Clinical Trial to Study the Efficacy and Safety of MK-0431D (a Fixed-dose Combination [FDC] of Sitagliptin and Simvastatin) for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin&#xD;
      fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control&#xD;
      while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks&#xD;
      of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated&#xD;
      with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Merck terminated the study for business reasons in November 2013.&#xD;
  </why_stopped>
  <start_date type="Actual">October 10, 2012</start_date>
  <completion_date type="Actual">November 1, 2013</completion_date>
  <primary_completion_date type="Actual">November 1, 2013</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 (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Experienced at Least One Adverse Event (AE)</measure>
    <time_frame>Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs</time_frame>
    <description>Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Discontinued Study Drug Due to an Adverse Event</measure>
    <time_frame>Up to 16 weeks</time_frame>
    <description>Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>Change from baseline reflects the Week 16 value minus the Week 0 value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Total Cholesterol (TC) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Triglycerides (TG) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With A1C Level &lt;7% at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>Percentage of participants achieving glycemic goal (A1C &lt;7%) after 16 weeks of treatment. Data as observed.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">299</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Sitagliptin/Simvastatin FDC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sitagliptin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin/Simvastatin FDC</intervention_name>
    <description>Sitagliptin 100 mg/Simvastatin 40 mg fixed-dose combination tablet</description>
    <arm_group_label>Sitagliptin/Simvastatin FDC</arm_group_label>
    <other_name>MK-0431D</other_name>
    <other_name>Juvisync™</other_name>
    <other_name>Juvicor®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin</intervention_name>
    <description>Sitagliptin 100 mg tablet</description>
    <arm_group_label>Sitagliptin</arm_group_label>
    <other_name>MK-0431</other_name>
    <other_name>Januvia®</other_name>
    <other_name>Tesavel®</other_name>
    <other_name>Xelevia®</other_name>
    <other_name>Ristaben®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simvastatin</intervention_name>
    <description>Simvastatin 40 mg tablet</description>
    <arm_group_label>Simvastatin</arm_group_label>
    <other_name>MK-0733</other_name>
    <other_name>Zocor®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to sitagliptin</intervention_name>
    <description>Matching placebo to sitagliptin 100 mg tablet</description>
    <arm_group_label>Simvastatin</arm_group_label>
    <arm_group_label>Sitagliptin/Simvastatin FDC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to simvastatin</intervention_name>
    <description>Matching placebo to simvastatin 40 mg tablet</description>
    <arm_group_label>Sitagliptin</arm_group_label>
    <arm_group_label>Sitagliptin/Simvastatin FDC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Sitagliptin/Simvastatin FDC</intervention_name>
    <description>Matching placebo to sitagliptin 100 mg/simvastatin 40 mg FDC tablet</description>
    <arm_group_label>Simvastatin</arm_group_label>
    <arm_group_label>Sitagliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Participants will continue on their stable, pre-screening metformin daily dose of &gt;= 1500 mg for at least 12 weeks prior to randomization and during the study</description>
    <arm_group_label>Simvastatin</arm_group_label>
    <arm_group_label>Sitagliptin</arm_group_label>
    <arm_group_label>Sitagliptin/Simvastatin FDC</arm_group_label>
    <other_name>Fortamet®</other_name>
    <other_name>Glucophage®</other_name>
    <other_name>Glucophage® XR</other_name>
    <other_name>Glumetza®</other_name>
    <other_name>Riomet®</other_name>
    <other_name>Metgluco®</other_name>
    <other_name>Glycoran®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glimepiride</intervention_name>
    <description>Following randomization, participants requiring glycemic rescue may receive open-label glimepiride initiated at a dose of 1 mg/day or 2 mg/day which may be up-titrated to 6 mg/day taken once daily with breakfast or the first main meal of the day.</description>
    <arm_group_label>Simvastatin</arm_group_label>
    <arm_group_label>Sitagliptin</arm_group_label>
    <arm_group_label>Sitagliptin/Simvastatin FDC</arm_group_label>
    <other_name>Amaryl®</other_name>
    <other_name>Glimy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  has T2DM&#xD;
&#xD;
          -  (1) Male; (2) female not of reproductive potential; or (3) female of reproductive&#xD;
             potential who agrees to remain abstinent or use alone or in conjunction with their&#xD;
             partner 2 methods of contraception to prevent pregnancy during the study and for 14&#xD;
             days after the last dose of study drug&#xD;
&#xD;
          -  is currently on metformin monotherapy at a daily dose of at least 1500 mg for at least&#xD;
             10 weeks&#xD;
&#xD;
          -  is not on a lipid-lowering agent for at least 6 weeks prior to entering the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has history of type 1 diabetes mellitus (T1DM), or a history of ketoacidosis or&#xD;
             possibly has T1DM&#xD;
&#xD;
          -  has been on a thiazolidinedione (TZD) within the previous 16 weeks&#xD;
&#xD;
          -  has been treated with a statin or other lipid-lowering agent (including&#xD;
             over-the-counter [OTC] supplements) within the previous 6 weeks&#xD;
&#xD;
          -  currently participating in or has participated in another clinical study within the&#xD;
             past 12 weeks&#xD;
&#xD;
          -  intends to consume &gt;1.2 liters of grapefruit juice daily during the study&#xD;
&#xD;
          -  is on or likely to require treatment for at least 2 consecutive weeks or repeated&#xD;
             courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)&#xD;
&#xD;
          -  intolerance or hypersensitivity to sitagliptin, simvastatin, metformin or glimepiride&#xD;
&#xD;
          -  is on a weight loss program and not in the maintenance phase or has started a weight&#xD;
             loss medication or has undergone bariatric surgery in the previous 12 months&#xD;
&#xD;
          -  has undergone a surgical procedure in the past 4 weeks or planned major surgery during&#xD;
             the study&#xD;
&#xD;
          -  has symptomatic hyperglycemia that requires immediate initiation, adjustment, or&#xD;
             addition of antihyperglycemic therapy&#xD;
&#xD;
          -  has a history of myopathy or rhabdomyolysis with any statin&#xD;
&#xD;
          -  has cardiovascular disease, a diagnosis of congestive heart failure, or uncontrolled&#xD;
             high blood pressure&#xD;
&#xD;
          -  has a history of active liver disease&#xD;
&#xD;
          -  has chronic progressive neuromuscular disorder, human immunodeficiency virus (HIV),&#xD;
             hematological disorder, or uncontrolled endocrine or metabolic disease&#xD;
&#xD;
          -  is currently being treated for hyperthyroidism or is on thyroid hormone therapy and&#xD;
             has not been on a stable dose for at least 6 weeks&#xD;
&#xD;
          -  has a history of malignancy in the previous 5 years (excluding adequately treated&#xD;
             basal cell or squamous cell skin cancer or in situ cervical cancer)&#xD;
&#xD;
          -  is pregnant or breast feeding, or is expecting to conceive or donate eggs during the&#xD;
             course of the study, including 14 days after the last dose of study drug&#xD;
&#xD;
          -  is a user of recreational or illicit drugs or has had a recent history of drug abuse&#xD;
&#xD;
          -  consumes &gt;2 alcoholic drinks per day or &gt;14 alcoholic drinks per week, or engages in&#xD;
             binge drinking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</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>Colombia</country>
    <country>Croatia</country>
    <country>Czech Republic</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Macedonia, The Former Yugoslav Republic of</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>South Africa</country>
    <country>Thailand</country>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>October 16, 2014</results_first_submitted>
  <results_first_submitted_qc>October 16, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 22, 2014</results_first_posted>
  <last_update_submitted>July 25, 2018</last_update_submitted>
  <last_update_submitted_qc>July 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 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>Metformin</mesh_term>
    <mesh_term>Sitagliptin Phosphate</mesh_term>
    <mesh_term>Glimepiride</mesh_term>
    <mesh_term>Simvastatin</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>
  <study_docs>
    <study_doc>
      <doc_type>CSR Synopsis</doc_type>
      <doc_url>http://www.merck.com/clinical-trials/study.html?id=0431D-266&amp;kw=0431D-266&amp;tab=access</doc_url>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>All participants randomized population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sitagliptin/Simvastatin FDC</title>
          <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
        </group>
        <group group_id="P2">
          <title>Sitagliptin</title>
          <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
        </group>
        <group group_id="P3">
          <title>Simvastatin</title>
          <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="99"/>
                <participants group_id="P3" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated With Double-blind Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="97"/>
                <participants group_id="P3" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="63"/>
                <participants group_id="P3" count="57"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="43"/>
                <participants group_id="P3" count="43"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Specified Criteria</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with study drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not treated with double-blind study drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants randomized population. Study specific baseline characteristics include all randomized participants with data.</population>
      <group_list>
        <group group_id="B1">
          <title>Sitagliptin/Simvastatin FDC</title>
          <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
        </group>
        <group group_id="B2">
          <title>Sitagliptin</title>
          <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
        </group>
        <group group_id="B3">
          <title>Simvastatin</title>
          <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</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="100"/>
            <count group_id="B2" value="99"/>
            <count group_id="B3" value="100"/>
            <count group_id="B4" value="299"/>
          </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="54.9" spread="10.2"/>
                    <measurement group_id="B2" value="54.2" spread="10.3"/>
                    <measurement group_id="B3" value="54.9" spread="10.0"/>
                    <measurement group_id="B4" value="54.7" spread="10.1"/>
                  </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="45"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="146"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c (A1C)</title>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.16" spread="0.94"/>
                    <measurement group_id="B2" value="8.15" spread="1.09"/>
                    <measurement group_id="B3" value="8.22" spread="1.19"/>
                    <measurement group_id="B4" value="8.18" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting plasma glucose (FPG)</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169.9" spread="42.3"/>
                    <measurement group_id="B2" value="175.9" spread="48.6"/>
                    <measurement group_id="B3" value="175.7" spread="49.3"/>
                    <measurement group_id="B4" value="173.8" spread="46.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Low-density lipoprotein cholesterol (LDL-C)</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="106.5" spread="26.7"/>
                    <measurement group_id="B2" value="103.9" spread="24.2"/>
                    <measurement group_id="B3" value="100.9" spread="22.0"/>
                    <measurement group_id="B4" value="103.7" spread="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total cholesterol (TC)</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="189.3" spread="30.9"/>
                    <measurement group_id="B2" value="187.7" spread="29.6"/>
                    <measurement group_id="B3" value="183.5" spread="28.4"/>
                    <measurement group_id="B4" value="186.8" spread="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Apolipoprotein B (Apo B)</title>
          <description>Sitagliptin, n=95; Total, n=295</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97.8" spread="19.0"/>
                    <measurement group_id="B2" value="95.4" spread="19.0"/>
                    <measurement group_id="B3" value="94.1" spread="17.2"/>
                    <measurement group_id="B4" value="95.8" spread="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Non high-density lipoprotein cholesterol (non-HDL-C)</title>
          <description>Sitagliptin, n=97; Total, n=297</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="141.7" spread="30.9"/>
                    <measurement group_id="B2" value="139.5" spread="29.9"/>
                    <measurement group_id="B3" value="136.5" spread="27.1"/>
                    <measurement group_id="B4" value="139.2" spread="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglycerides (TG)</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="177.4" spread="101.2"/>
                    <measurement group_id="B2" value="180.8" spread="119.1"/>
                    <measurement group_id="B3" value="184.2" spread="118.6"/>
                    <measurement group_id="B4" value="180.8" spread="112.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High-density lipoprotein cholesterol (HDL-C)</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.6" spread="11.3"/>
                    <measurement group_id="B2" value="48.2" spread="12.1"/>
                    <measurement group_id="B3" value="47.0" spread="11.2"/>
                    <measurement group_id="B4" value="47.6" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Very low-density lipoprotein cholesterol (VLDL-C)</title>
          <description>Sitagliptin, n=97; Total, n=297</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.4" spread="18.8"/>
                    <measurement group_id="B2" value="35.8" spread="20.4"/>
                    <measurement group_id="B3" value="35.7" spread="18.8"/>
                    <measurement group_id="B4" value="35.6" spread="19.3"/>
                  </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 (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)</title>
        <description>A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>Full analysis set (FAS) population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)</title>
          <description>A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures.</description>
          <population>Full analysis set (FAS) population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
          <units>Percent</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="100"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.41" lower_limit="-0.64" upper_limit="-0.17"/>
                    <measurement group_id="O2" value="-0.59" lower_limit="-0.83" upper_limit="-0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.267</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.14</ci_lower_limit>
            <ci_upper_limit>0.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced at Least One Adverse Event (AE)</title>
        <description>Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.</description>
        <time_frame>Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs</time_frame>
        <population>All participants as treated population defined as all randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O3">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced at Least One Adverse Event (AE)</title>
          <description>Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.</description>
          <population>All participants as treated population defined as all randomized participants who received at least one dose of study drug.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in percents</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.2</ci_lower_limit>
            <ci_upper_limit>9.3</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in percents</param_type>
            <param_value>-4.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.7</ci_lower_limit>
            <ci_upper_limit>5.8</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Discontinued Study Drug Due to an Adverse Event</title>
        <description>Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.</description>
        <time_frame>Up to 16 weeks</time_frame>
        <population>All participants as treated population defined as all randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O3">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Study Drug Due to an Adverse Event</title>
          <description>Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.</description>
          <population>All participants as treated population defined as all randomized participants who received at least one dose of study drug.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)</title>
        <description>A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)</title>
          <description>A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.</description>
          <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
          <units>Percent</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="100"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.41" lower_limit="-0.64" upper_limit="-0.17"/>
                    <measurement group_id="O2" value="0.21" lower_limit="-0.02" upper_limit="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.95</ci_lower_limit>
            <ci_upper_limit>-0.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16</title>
        <description>Change from baseline reflects the Week 16 value minus the Week 0 value.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS population defined as all randomized participants who took at least one dose of study drug and who had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O3">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16</title>
          <description>Change from baseline reflects the Week 16 value minus the Week 0 value.</description>
          <population>FAS population defined as all randomized participants who took at least one dose of study drug and who had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
          <units>mg/dL</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="100"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.9" lower_limit="-21.0" upper_limit="5.2"/>
                    <measurement group_id="O2" value="-9.6" lower_limit="-23.4" upper_limit="4.1"/>
                    <measurement group_id="O3" value="21.3" lower_limit="7.9" upper_limit="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.856</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.1</ci_lower_limit>
            <ci_upper_limit>20.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-29.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.9</ci_lower_limit>
            <ci_upper_limit>-10.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16</title>
        <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O3">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16</title>
          <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
          <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
          <units>Percent change</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="100"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.6" lower_limit="-32.3" upper_limit="-10.8"/>
                    <measurement group_id="O2" value="4.0" lower_limit="-6.9" upper_limit="14.9"/>
                    <measurement group_id="O3" value="-26.9" lower_limit="-37.5" upper_limit="-16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-25.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.6</ci_lower_limit>
            <ci_upper_limit>-15.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.286</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>5.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5</ci_lower_limit>
            <ci_upper_limit>15.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Total Cholesterol (TC) at Week 16</title>
        <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O3">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Total Cholesterol (TC) at Week 16</title>
          <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
          <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
          <units>Percent change</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="100"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.4" lower_limit="-26.6" upper_limit="-10.2"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-8.6" upper_limit="7.9"/>
                    <measurement group_id="O3" value="-18.4" lower_limit="-26.4" upper_limit="-10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-18.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.2</ci_lower_limit>
            <ci_upper_limit>-12.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.990</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.0</ci_lower_limit>
            <ci_upper_limit>6.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16</title>
        <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O3">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16</title>
          <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
          <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
          <units>Percent change</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="100"/>
                <count group_id="O2" value="94"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.9" lower_limit="-27.0" upper_limit="-6.8"/>
                    <measurement group_id="O2" value="3.3" lower_limit="-7.1" upper_limit="13.7"/>
                    <measurement group_id="O3" value="-19.8" lower_limit="-30.0" upper_limit="-9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-20.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-28.3</ci_lower_limit>
            <ci_upper_limit>-12.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.469</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.0</ci_lower_limit>
            <ci_upper_limit>10.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16</title>
        <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O3">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16</title>
          <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
          <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
          <units>Percent change</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="100"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.9" lower_limit="-33.9" upper_limit="-13.9"/>
                    <measurement group_id="O2" value="0.6" lower_limit="-9.5" upper_limit="10.7"/>
                    <measurement group_id="O3" value="-24.2" lower_limit="-34.0" upper_limit="-14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-24.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.6</ci_lower_limit>
            <ci_upper_limit>-16.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.937</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.7</ci_lower_limit>
            <ci_upper_limit>8.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Triglycerides (TG) at Week 16</title>
        <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O3">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Triglycerides (TG) at Week 16</title>
          <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
          <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.4" lower_limit="-51.9" upper_limit="11.1"/>
                    <measurement group_id="O2" value="-4.9" lower_limit="-39.5" upper_limit="29.7"/>
                    <measurement group_id="O3" value="-10.1" lower_limit="-52.1" upper_limit="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.068</p_value>
            <method>Robust regression</method>
            <method_desc>Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.</method_desc>
            <param_type>Difference in estimated means</param_type>
            <param_value>-15.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.2</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.365</p_value>
            <method>Robust regression</method>
            <method_desc>Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.</method_desc>
            <param_type>Difference in estimated means</param_type>
            <param_value>-10.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.6</ci_lower_limit>
            <ci_upper_limit>13.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16</title>
        <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O3">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16</title>
          <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
          <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
          <units>Percent change</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="100"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="-2.7" upper_limit="7.8"/>
                    <measurement group_id="O2" value="2.0" lower_limit="-3.3" upper_limit="7.4"/>
                    <measurement group_id="O3" value="2.1" lower_limit="-3.0" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.857</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.8</ci_lower_limit>
            <ci_upper_limit>5.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.879</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.8</ci_lower_limit>
            <ci_upper_limit>5.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16</title>
        <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O3">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16</title>
          <description>Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.</description>
          <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
          <units>Percent change</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="100"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.5" lower_limit="-33.8" upper_limit="-1.2"/>
                    <measurement group_id="O2" value="12.9" lower_limit="-4.2" upper_limit="29.9"/>
                    <measurement group_id="O3" value="-2.2" lower_limit="-18.9" upper_limit="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-30.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-51.0</ci_lower_limit>
            <ci_upper_limit>-9.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.141</p_value>
            <method>Longitudinal Data Analysis Model</method>
            <method_desc>Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.</method_desc>
            <param_type>Difference in least squares means</param_type>
            <param_value>-15.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.8</ci_lower_limit>
            <ci_upper_limit>5.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With A1C Level &lt;7% at Week 16</title>
        <description>Percentage of participants achieving glycemic goal (A1C &lt;7%) after 16 weeks of treatment. Data as observed.</description>
        <time_frame>Week 16</time_frame>
        <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin/Simvastatin FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin</title>
            <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
          <group group_id="O3">
            <title>Simvastatin</title>
            <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With A1C Level &lt;7% at Week 16</title>
          <description>Percentage of participants achieving glycemic goal (A1C &lt;7%) after 16 weeks of treatment. Data as observed.</description>
          <population>FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of 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="100"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.9"/>
                    <measurement group_id="O2" value="29.6"/>
                    <measurement group_id="O3" value="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in percents</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.2</ci_lower_limit>
            <ci_upper_limit>12.9</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method. Missing data were imputed by multiple impuattions.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in percents</param_type>
            <param_value>12.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7</ci_lower_limit>
            <ci_upper_limit>24.0</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method. Missing data were imputed by multiple imputations.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 18 weeks</time_frame>
      <desc>All participants as treated population defined as all randomized participants who received at least one dose of study drug. Serious adverse events include data after rescue therapy and non-serious adverse events exclude data after rescue therapy.</desc>
      <group_list>
        <group group_id="E1">
          <title>Sitagliptin/Simvastatin FDC</title>
          <description>Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
        </group>
        <group group_id="E2">
          <title>Sitagliptin</title>
          <description>Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
        </group>
        <group group_id="E3">
          <title>Simvastatin</title>
          <description>Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of &gt;=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</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="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="98"/>
              </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 study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study was terminated for business reasons in November 2013.</limitations_and_caveats>
    <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/NCT01678820
org study id: 0431D-266
nct id: NCT01678820
lead sponsor: 
has dmc: No
The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin
      fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control
      while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks
      of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated
      with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)
time frame: Baseline and Week 16
description: A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures.
measure: Number of Participants Who Experienced at Least One Adverse Event (AE)
time frame: Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs
description: Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
time frame: Up to 16 weeks
description: Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
measure: Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)
time frame: Baseline and Week 16
description: A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16
time frame: Baseline and Week 16
description: Change from baseline reflects the Week 16 value minus the Week 0 value.
measure: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16
time frame: Baseline and Week 16
description: Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
measure: Percent Change From Baseline in Total Cholesterol (TC) at Week 16
time frame: Baseline and Week 16
description: Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
measure: Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16
time frame: Baseline and Week 16
description: Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
measure: Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16
time frame: Baseline and Week 16
description: Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
measure: Percent Change From Baseline in Triglycerides (TG) at Week 16
time frame: Baseline and Week 16
description: Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
measure: Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16
time frame: Baseline and Week 16
description: Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
measure: Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16
time frame: Baseline and Week 16
description: Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
measure: Percentage of Participants With A1C Level <7% at Week 16
time frame: Week 16
description: Percentage of participants achieving glycemic goal (A1C <7%) after 16 weeks of treatment. Data as observed.
arm group label: Sitagliptin/Simvastatin FDC
arm group type: Experimental
description: Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
arm group label: Sitagliptin
arm group type: Active Comparator
description: Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
arm group label: Simvastatin
arm group type: Active Comparator
description: Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
intervention type: Drug
intervention name: Sitagliptin/Simvastatin FDC
description: Sitagliptin 100 mg/Simvastatin 40 mg fixed-dose combination tablet
arm group label: Sitagliptin/Simvastatin FDC
other name: MK-0431D
other name: Juvisync™
other name: Juvicor®
intervention type: Drug
intervention name: Sitagliptin
description: Sitagliptin 100 mg tablet
arm group label: Sitagliptin
other name: MK-0431
other name: Januvia®
other name: Tesavel®
other name: Xelevia®
other name: Ristaben®
intervention type: Drug
intervention name: Simvastatin
description: Simvastatin 40 mg tablet
arm group label: Simvastatin
other name: MK-0733
other name: Zocor®
intervention type: Drug
intervention name: Placebo to sitagliptin
description: Matching placebo to sitagliptin 100 mg tablet
arm group label: Simvastatin
arm group label: Sitagliptin/Simvastatin FDC
intervention type: Drug
intervention name: Placebo to simvastatin
description: Matching placebo to simvastatin 40 mg tablet
arm group label: Sitagliptin
arm group label: Sitagliptin/Simvastatin FDC
intervention type: Drug
intervention name: Placebo to Sitagliptin/Simvastatin FDC
description: Matching placebo to sitagliptin 100 mg/simvastatin 40 mg FDC tablet
arm group label: Simvastatin
arm group label: Sitagliptin
intervention type: Drug
intervention name: Metformin
description: Participants will continue on their stable, pre-screening metformin daily dose of >= 1500 mg for at least 12 weeks prior to randomization and during the study
arm group label: Simvastatin
arm group label: Sitagliptin
arm group label: Sitagliptin/Simvastatin FDC
other name: Fortamet®
other name: Glucophage®
other name: Glucophage® XR
other name: Glumetza®
other name: Riomet®
other name: Metgluco®
other name: Glycoran®
intervention type: Drug
intervention name: Glimepiride
description: Following randomization, participants requiring glycemic rescue may receive open-label glimepiride initiated at a dose of 1 mg/day or 2 mg/day which may be up-titrated to 6 mg/day taken once daily with breakfast or the first main meal of the day.
arm group label: Simvastatin
arm group label: Sitagliptin
arm group label: Sitagliptin/Simvastatin FDC
other name: Amaryl®
other name: Glimy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Colombia
country: Croatia
country: Czech Republic
country: Hungary
country: Italy
country: Korea, Republic of
country: Latvia
country: Lithuania
country: Macedonia, The Former Yugoslav Republic of
country: Poland
country: Puerto Rico
country: Romania
country: South Africa
country: Thailand
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Sitagliptin Phosphate
mesh term: Glimepiride
mesh term: Simvastatin
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
study doc: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study was terminated for business reasons in November 2013.
point of contact: 