<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/NCT01702298</url>
  </required_header>
  <id_info>
    <org_study_id>0431D-312</org_study_id>
    <nct_id>NCT01702298</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312)</brief_title>
  <official_title>An Open-label Study to Assess the Safety and Tolerability of MK-0431D 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 examine the safety and tolerability of sitagliptin 100&#xD;
      mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus&#xD;
      with inadequate glycemic control on metformin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2012</start_date>
  <completion_date type="Actual">May 29, 2013</completion_date>
  <primary_completion_date type="Actual">May 29, 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event</measure>
    <time_frame>Up to 8 weeks (including 14 days after final dose of study drug)</time_frame>
    <description>An 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 6 weeks</time_frame>
    <description>Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Cholesterol (TC)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Triglycerides (TG)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Sitagliptin 100 mg/simvastatin 40 mg FDC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants will continue pre-study dose of metformin &gt;=1000 mg per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin 100 mg/simvastatin 40 mg FDC</intervention_name>
    <description>Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks</description>
    <arm_group_label>Sitagliptin 100 mg/simvastatin 40 mg FDC</arm_group_label>
    <other_name>MK-0431D</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Participants will continue pre-study dose of metformin tablet(s) &gt;=1000 per day</description>
    <arm_group_label>Sitagliptin 100 mg/simvastatin 40 mg 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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has type 2 diabetes mellitus&#xD;
&#xD;
          -  Male, or female who is not of reproductive potential or if of reproductive potential&#xD;
             agrees to abstain or use (or have their partner use) two acceptable methods of birth&#xD;
             control during the study and for 14 days after the last dose of study drug&#xD;
&#xD;
          -  Currently on metformin monotherapy (&gt;=1000 mg per day) for at least 4 weeks prior to&#xD;
             study participation&#xD;
&#xD;
          -  Not on statin therapy or other lipid-lowering agent for at least 6 weeks prior to&#xD;
             study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of type 1 diabetes mellitus or a history of ketoacidosis&#xD;
&#xD;
          -  History of 2 or more episodes of hypoglycemia resulting in seizure, coma or loss of&#xD;
             consciousness over the past 3 months&#xD;
&#xD;
          -  On a thiazolidinedione (TZD) within the past 12 weeks&#xD;
&#xD;
          -  Has been treated with a statin or other lipid-lowering agent within 6 weeks prior to&#xD;
             study participation&#xD;
&#xD;
          -  Is on or likely to require treatment with a prohibited medication (itraconazole,&#xD;
             ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease&#xD;
             inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, verapamil,&#xD;
             diltiazem, amlodipine, ranolazine, niacin)&#xD;
&#xD;
          -  Intends to consume &gt;1.2 liters of grapefruit juice per day during the study&#xD;
&#xD;
          -  Is on or likely to require treatment for &gt;=2 consecutive weeks or repeated courses of&#xD;
             corticosteroids (inhaled, nasal and topical corticosteroids are permitted)&#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 within 12 months prior to study&#xD;
             participation&#xD;
&#xD;
          -  Has undergone a surgical procedure within 4 weeks of study participation or has&#xD;
             planned major surgery during the study&#xD;
&#xD;
          -  History of myopathy or rhabdomyolysis with any statin&#xD;
&#xD;
          -  History of myocardial infarction, unstable or stable angina, angioplasty, bypass&#xD;
             surgery, myocardial ischemia, peripheral artery disease, abdominal aortic aneurysm,&#xD;
             transient ischemic attacks, stroke of carotid origin or &gt;50% obstruction of a carotid&#xD;
             artery&#xD;
&#xD;
          -  Diagnosis of congestive heart failure with New York Heart Association (NYHA) Class III&#xD;
             or IV cardiac status&#xD;
&#xD;
          -  History of active liver disease (other than non-alcoholic steatosis) including chronic&#xD;
             active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease&#xD;
&#xD;
          -  Chronic progressive neuromuscular disorder&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic&#xD;
             syndromes, thrombocytopenia)&#xD;
&#xD;
          -  Currently being treated for hyperthyroidism or is on thyroid hormone replacement&#xD;
             therapy and has not been on a stable dose for at least 6 weeks&#xD;
&#xD;
          -  History of malignancy &lt;=5 years prior to study participation, except for basal cell or&#xD;
             squamous cell skin cancer or in situ cervical cancer&#xD;
&#xD;
          -  Positive urine pregnancy test&#xD;
&#xD;
          -  Pregnant or breastfeeding, or is expecting to conceive or donate eggs during the&#xD;
             study, including 14 days following the last dose of study drug&#xD;
&#xD;
          -  User of recreational or illicit drugs or has had a recent history of drug abuse&#xD;
&#xD;
          -  Routinely consumes &gt;2 alcoholic drinks per day or &gt;14 alcoholic drinks per week, or&#xD;
             engages in 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>
  <removed_countries>
    <country>Vietnam</country>
  </removed_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <results_first_submitted>May 1, 2014</results_first_submitted>
  <results_first_submitted_qc>May 1, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 30, 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>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-312&amp;kw=0431D-312&amp;tab=access</doc_url>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sitagliptin 100 mg/Simvastatin 40 mg FDC</title>
          <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (&gt;=1000 mg per day).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants enrolled</population>
      <group_list>
        <group group_id="B1">
          <title>Sitagliptin 100 mg/Simvastatin 40 mg FDC</title>
          <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (&gt;=1000 mg per day).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
          </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="48.3" spread="7.1"/>
                  </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="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </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="159.3" spread="40.9"/>
                  </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="109.6" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Cholesterol (TC)</title>
          <units>md/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="195.2" spread="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>(Non-High-Density Lipoprotein Cholesterol (non-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="152.0" spread="37.9"/>
                  </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="225.3" spread="152.5"/>
                  </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="43.1" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG)</title>
        <description>Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>Full analysis set (FAS) defined as all participants who took at least one dose of study medication and had at least one baseline or post-baseline measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin 100 mg/Simvastatin 40 mg FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (&gt;=1000 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG)</title>
          <description>Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.</description>
          <population>Full analysis set (FAS) defined as all participants who took at least one dose of study medication and had at least one baseline or post-baseline measurement.</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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.6" spread="58.4" lower_limit="-46.0" upper_limit="-9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Event</title>
        <description>An 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 8 weeks (including 14 days after final dose of study drug)</time_frame>
        <population>All participants treated population defined as all enrolled participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin 100 mg/Simvastatin 40 mg FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (&gt;=1000 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event</title>
          <description>An 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 treated population defined as all enrolled participants who received at least one dose of study treatment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" lower_limit="2.7" upper_limit="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Discontinued Study Drug Due to an Adverse Event</title>
        <description>Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.</description>
        <time_frame>Up to 6 weeks</time_frame>
        <population>All participants treated population defined as all enrolled participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin 100 mg/Simvastatin 40 mg FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (&gt;=1000 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Study Drug Due to an Adverse Event</title>
          <description>Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.</description>
          <population>All participants treated population defined as all enrolled participants who received at least one dose of study treatment.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)</title>
        <description>Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of LDL-C.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin 100 mg/Simvastatin 40 mg FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (&gt;=1000 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)</title>
          <description>Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
          <population>FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of LDL-C.</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="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.5" spread="17.0" lower_limit="-51.9" upper_limit="-41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Cholesterol (TC)</title>
        <description>Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements.&#xD;
One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of TC.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin 100 mg/Simvastatin 40 mg FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (&gt;=1000 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Cholesterol (TC)</title>
          <description>Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
          <population>FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements.&#xD;
One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of TC.</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="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.7" lower_limit="-37.3" upper_limit="-30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)</title>
        <description>Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of non-HDL-C.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin 100 mg/Simvastatin 40 mg FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (&gt;=1000 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)</title>
          <description>Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
          <population>FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of non-HDL-C.</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="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.1" lower_limit="-47.4" upper_limit="-38.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Triglycerides (TG)</title>
        <description>Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin 100 mg/Simvastatin 40 mg FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (&gt;=1000 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Triglycerides (TG)</title>
          <description>Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).</description>
          <population>FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS.</population>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.8" spread="26.3" lower_limit="-41.1" upper_limit="-18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)</title>
        <description>Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of HDL-C.</population>
        <group_list>
          <group group_id="O1">
            <title>Sitagliptin 100 mg/Simvastatin 40 mg FDC</title>
            <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (&gt;=1000 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)</title>
          <description>Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.</description>
          <population>FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of HDL-C.</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="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="-5.0" upper_limit="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sitagliptin 100 mg/Simvastatin 40 mg FDC</title>
          <description>Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (&gt;=1000 mg per day).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="42"/>
              </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>
    <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/NCT01702298
org study id: 0431D-312
nct id: NCT01702298
lead sponsor: 
has dmc: No
The purpose of this study is to examine the safety and tolerability of sitagliptin 100
      mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus
      with inadequate glycemic control on metformin.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
time frame: Baseline and Week 6
description: Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.
measure: Percentage of Participants Who Experienced at Least One Adverse Event
time frame: Up to 8 weeks (including 14 days after final dose of study drug)
description: An 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 6 weeks
description: Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.
measure: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
time frame: Baseline and Week 6
description: Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
measure: Change From Baseline in Total Cholesterol (TC)
time frame: Baseline and Week 6
description: Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
measure: Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)
time frame: Baseline and Week 6
description: Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
measure: Change From Baseline in Triglycerides (TG)
time frame: Baseline and Week 6
description: Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).
measure: Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
time frame: Baseline and Week 6
description: Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
arm group label: Sitagliptin 100 mg/simvastatin 40 mg FDC
arm group type: Experimental
description: Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants will continue pre-study dose of metformin >=1000 mg per day.
intervention type: Drug
intervention name: Sitagliptin 100 mg/simvastatin 40 mg FDC
description: Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks
arm group label: Sitagliptin 100 mg/simvastatin 40 mg FDC
other name: MK-0431D
intervention type: Drug
intervention name: Metformin
description: Participants will continue pre-study dose of metformin tablet(s) >=1000 per day
arm group label: Sitagliptin 100 mg/simvastatin 40 mg FDC
other name: Fortamet®
other name: Glucophage®
other name: Glucophage® XR
other name: Glumetza®
other name: Riomet®
other name: Metgluco®
other name: Glycoran®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
country: Vietnam
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Sitagliptin Phosphate
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: 
point of contact: 