<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/NCT01682759</url>
  </required_header>
  <id_info>
    <org_study_id>3102-016</org_study_id>
    <secondary_id>MK-3102-016</secondary_id>
    <nct_id>NCT01682759</nct_id>
  </id_info>
  <brief_title>A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)</brief_title>
  <official_title>A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the&#xD;
      sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic&#xD;
      control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks,&#xD;
      the mean change from baseline in hemoglobin A1C (A1C) in participants treated with&#xD;
      omarigliptin is non-inferior compared with that in participants treated with glimepiride.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2012</start_date>
  <completion_date type="Actual">January 26, 2015</completion_date>
  <primary_completion_date type="Actual">January 26, 2015</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 at Week 54</measure>
    <time_frame>Baseline and Week 54</time_frame>
    <description>Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue</measure>
    <time_frame>Up to Week 57</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue</measure>
    <time_frame>Up to Week 54</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose at Week 54</measure>
    <time_frame>Baseline and Week 54</time_frame>
    <description>Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a Hemoglobin A1C of &lt;6.5% at Week 54</measure>
    <time_frame>Week 54</time_frame>
    <description>The percentage of participants who achieved A1C values &lt;6.5% (48 mmol/mol) in the FAS Population at Week 54.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue</measure>
    <time_frame>Up to Week 54</time_frame>
    <description>Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue</measure>
    <time_frame>Baseline and Week 54</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a Hemoglobin A1C of &lt;7.0% at Week 54</measure>
    <time_frame>Week 54</time_frame>
    <description>The percentage of participants who achieved A1C values &lt;7.0% (53 mmol/mol) in the FAS Population at Week 54.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">751</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Omarigliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glimepiride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omarigliptin</intervention_name>
    <arm_group_label>Omarigliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Omarigliptin</intervention_name>
    <arm_group_label>Glimepiride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glimepiride</intervention_name>
    <description>Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.</description>
    <arm_group_label>Glimepiride</arm_group_label>
    <other_name>AMARYL®</other_name>
    <other_name>GLIMY</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glimepiride Placebo</intervention_name>
    <arm_group_label>Omarigliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Participants will continue on their stable dose (&gt;=1500 mg/day) of open-label metformin throughout the trial.</description>
    <arm_group_label>Glimepiride</arm_group_label>
    <arm_group_label>Omarigliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin Glargine</intervention_name>
    <description>Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.</description>
    <arm_group_label>Glimepiride</arm_group_label>
    <arm_group_label>Omarigliptin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with Type 2 diabetes mellitus&#xD;
&#xD;
          -  On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate&#xD;
             glycemic control&#xD;
&#xD;
          -  Females of reproductive potential agree to remain abstinent or use or have their&#xD;
             partner use acceptable methods of birth control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of type 1 diabetes mellitus or a history of ketoacidosis&#xD;
&#xD;
          -  Treated with any antihyperglycemic agents (AHA) therapies other than the&#xD;
             protocol-required metformin within the prior 12 weeks of study participation or with&#xD;
             omarigliptin at any time prior to signing informed consent&#xD;
&#xD;
          -  On a weight loss program and is not in the maintenance phase or has&#xD;
&#xD;
        started a weight loss medication in the past 6 months or has undergone bariatric surgery&#xD;
        within 12 months prior to study participation&#xD;
&#xD;
          -  Medical history of active liver disease (other than non-alcoholic&#xD;
&#xD;
        hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis,&#xD;
        or symptomatic gallbladder disease&#xD;
&#xD;
          -  Human immunodeficiency virus&#xD;
&#xD;
          -  New or worsening coronary heart disease, congestive heart failure, myocardial&#xD;
             infarction, unstable angina, coronary artery intervention, stroke or transient&#xD;
             ischemic neurological disorder within the past 3 months&#xD;
&#xD;
          -  History of malignancy ≤5 years prior to study participation except for adequately&#xD;
             treated basal cell or squamous cell skin cancer, or in situ&#xD;
&#xD;
        cervical cancer&#xD;
&#xD;
          -  Clinically important hematological disorder (such as aplastic anemia,&#xD;
&#xD;
        myeloproliferative or myelodysplastic syndromes, thrombocytopenia)&#xD;
&#xD;
          -  Pregnant or breast-feeding, or is expecting to conceive or donate eggs&#xD;
&#xD;
        during the trial, including 21 days following the last dose of study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Croatia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Korea, Republic of</country>
    <country>Lebanon</country>
    <country>Lithuania</country>
    <country>Malaysia</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Handelsman Y, Lauring B, Gantz I, Iredale C, O'Neill EA, Wei Z, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of omarigliptin, a once-weekly DPP-4 inhibitor, or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Curr Med Res Opin. 2017 Oct;33(10):1861-1868. doi: 10.1080/03007995.2017.1335638. Epub 2017 Jun 28.</citation>
    <PMID>28548024</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>January 6, 2016</results_first_submitted>
  <results_first_submitted_qc>January 6, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 5, 2016</results_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Insulin Glargine</mesh_term>
    <mesh_term>Glimepiride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>In total, 1197 participants at 115 clinical sites were screened and 446 participants were excluded during screening. The most common reason for participants not being randomized was screen failure. The most common reasons for screen failure were participants not meeting the metformin inclusion criteria or meeting exclusionary laboratory values.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Omarigliptin</title>
          <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Glimepiride</title>
          <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="376"/>
                <participants group_id="P2" count="375"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="375"/>
                <participants group_id="P2" count="375"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="307"/>
                <participants group_id="P2" count="305"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omarigliptin</title>
          <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Glimepiride</title>
          <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
        </group>
        <group group_id="B3">
          <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="376"/>
            <count group_id="B2" value="375"/>
            <count group_id="B3" value="751"/>
          </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="57.9" spread="9.6"/>
                    <measurement group_id="B2" value="57.6" spread="9.3"/>
                    <measurement group_id="B3" value="57.7" spread="9.5"/>
                  </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="173"/>
                    <measurement group_id="B2" value="164"/>
                    <measurement group_id="B3" value="337"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="203"/>
                    <measurement group_id="B2" value="211"/>
                    <measurement group_id="B3" value="414"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1C</title>
          <description>For both the Omarigliptin and Glimepiride groups n=375</description>
          <units>A1C (%)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.49" spread="0.75"/>
                    <measurement group_id="B2" value="7.43" spread="0.72"/>
                    <measurement group_id="B3" value="7.46" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting Plamsa Glucose (FPG)</title>
          <description>For both the Omarigliptin and Glimepiride groups n=375</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="155.3" spread="31.4"/>
                    <measurement group_id="B2" value="152.7" spread="30.0"/>
                    <measurement group_id="B3" value="154.0" spread="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Weight</title>
          <description>For both the Omarigliptin and Glimepiride groups n=375</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87.5" spread="18.1"/>
                    <measurement group_id="B2" value="88.7" spread="18.7"/>
                    <measurement group_id="B3" value="88.1" spread="18.4"/>
                  </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 at Week 54</title>
        <description>Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.</description>
        <time_frame>Baseline and Week 54</time_frame>
        <population>The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Glimepiride</title>
            <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1C at Week 54</title>
          <description>Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.</description>
          <population>The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.</population>
          <units>A1C (%)</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="375"/>
                <count group_id="O2" value="375"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.30" lower_limit="-0.39" upper_limit="-0.21"/>
                    <measurement group_id="O2" value="-0.48" lower_limit="-0.57" upper_limit="-0.39"/>
                  </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>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Omarigliptin was considered non-inferior to glimepiride if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference in least-squares (LS) means for change from baseline in A1C at Week 54 (omarigliptin vs. glimepiride) was lower than 0.35%.</non_inferiority_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.06</ci_lower_limit>
            <ci_upper_limit>0.30</ci_upper_limit>
            <estimate_desc>Constrained longitudinal data analysis (cLDA) model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue</title>
        <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.</description>
        <time_frame>Up to Week 57</time_frame>
        <population>All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Glimepiride</title>
            <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue</title>
          <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.</description>
          <population>All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.</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="375"/>
                <count group_id="O2" value="375"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.7"/>
                    <measurement group_id="O2" value="61.6"/>
                  </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 percentages</param_type>
            <param_value>-6.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.9</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
            <estimate_desc>Miettinen &amp; Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue</title>
        <time_frame>Up to Week 54</time_frame>
        <population>The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Glimepiride</title>
            <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue</title>
          <population>The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.</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="375"/>
                <count group_id="O2" value="375"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7"/>
                    <measurement group_id="O2" value="2.7"/>
                  </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>
            <param_type>Difference in percentages</param_type>
            <param_value>1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>3.8</ci_upper_limit>
            <estimate_desc>Miettinen &amp; Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose at Week 54</title>
        <description>Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).</description>
        <time_frame>Baseline and Week 54</time_frame>
        <population>The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Glimepiride</title>
            <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose at Week 54</title>
          <description>Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).</description>
          <population>The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.</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="375"/>
                <count group_id="O2" value="375"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" lower_limit="-6.7" upper_limit="1.3"/>
                    <measurement group_id="O2" value="-8.3" lower_limit="-12.4" upper_limit="-4.3"/>
                  </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>
            <param_type>Difference in the least squares means</param_type>
            <param_value>5.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>11.2</ci_upper_limit>
            <estimate_desc>cLDA model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a Hemoglobin A1C of &lt;6.5% at Week 54</title>
        <description>The percentage of participants who achieved A1C values &lt;6.5% (48 mmol/mol) in the FAS Population at Week 54.</description>
        <time_frame>Week 54</time_frame>
        <population>The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Glimepiride</title>
            <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Hemoglobin A1C of &lt;6.5% at Week 54</title>
          <description>The percentage of participants who achieved A1C values &lt;6.5% (48 mmol/mol) in the FAS Population at Week 54.</description>
          <population>The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.</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="375"/>
                <count group_id="O2" value="375"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1" lower_limit="20.6" upper_limit="30.2"/>
                    <measurement group_id="O2" value="28.8" lower_limit="24.1" upper_limit="34.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A1C &lt;6.5%</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Between-group Rate Difference (%)</param_type>
            <param_value>-3.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.6</ci_lower_limit>
            <ci_upper_limit>3.3</ci_upper_limit>
            <estimate_desc>Between-group CIs are calculated via Miettinen &amp; Nurminen method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue</title>
        <description>Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).</description>
        <time_frame>Up to Week 54</time_frame>
        <population>The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Glimepiride</title>
            <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue</title>
          <description>Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).</description>
          <population>The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.</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="375"/>
                <count group_id="O2" value="375"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3"/>
                    <measurement group_id="O2" value="26.7"/>
                  </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>&lt;0.001</p_value>
            <method>Difference in percentages</method>
            <param_type>Difference in percentages</param_type>
            <param_value>-21.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.5</ci_lower_limit>
            <ci_upper_limit>-16.4</ci_upper_limit>
            <estimate_desc>Miettinen &amp; Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue</title>
        <time_frame>Baseline and Week 54</time_frame>
        <population>The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Glimepiride</title>
            <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue</title>
          <population>The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.</population>
          <units>kg</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="375"/>
                <count group_id="O2" value="375"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-0.8" upper_limit="-0.0"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.1" upper_limit="1.9"/>
                  </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>&lt;0.001</p_value>
            <method>Difference in the least squares means</method>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.5</ci_lower_limit>
            <ci_upper_limit>-1.4</ci_upper_limit>
            <estimate_desc>cLDA model including terms for treatment, time, and the interaction of time by treatment with the constraint that the mean baseline is the same for all treatment groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a Hemoglobin A1C of &lt;7.0% at Week 54</title>
        <description>The percentage of participants who achieved A1C values &lt;7.0% (53 mmol/mol) in the FAS Population at Week 54.</description>
        <time_frame>Week 54</time_frame>
        <population>The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Glimepiride</title>
            <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Hemoglobin A1C of &lt;7.0% at Week 54</title>
          <description>The percentage of participants who achieved A1C values &lt;7.0% (53 mmol/mol) in the FAS Population at Week 54.</description>
          <population>The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.</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="375"/>
                <count group_id="O2" value="375"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.7" lower_limit="42.3" upper_limit="53.1"/>
                    <measurement group_id="O2" value="58.0" lower_limit="52.7" upper_limit="63.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A1C &lt; 7.0%</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Between-group Rate Difference</param_type>
            <param_value>-10.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.8</ci_lower_limit>
            <ci_upper_limit>-2.8</ci_upper_limit>
            <estimate_desc>Between-group CIs are calculated via Miettinen &amp; Nurminen method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 57</time_frame>
      <desc>Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.</desc>
      <group_list>
        <group group_id="E1">
          <title>Omarigliptin</title>
          <description>Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Glimepiride</title>
          <description>Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</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="24" subjects_at_risk="375"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Rectal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Carbuncle</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Septic arthritis staphylococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Dumping syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Traumatic haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Angiomyolipoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Intraductal proliferative breast lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Trigeminal neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="375"/>
                <counts group_id="E2" subjects_affected="125" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="31" subjects_affected="24" subjects_at_risk="375"/>
                <counts group_id="E2" events="30" subjects_affected="23" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="45" subjects_affected="21" subjects_at_risk="375"/>
                <counts group_id="E2" events="487" subjects_affected="110" subjects_at_risk="375"/>
              </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/NCT01682759
org study id: 3102-016
secondary id: MK-3102-016
nct id: NCT01682759
lead sponsor: 
has dmc: Yes
This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the
      sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic
      control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks,
      the mean change from baseline in hemoglobin A1C (A1C) in participants treated with
      omarigliptin is non-inferior compared with that in participants treated with glimepiride.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Hemoglobin A1C at Week 54
time frame: Baseline and Week 54
description: Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.
measure: Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue
time frame: Up to Week 57
description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
measure: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue
time frame: Up to Week 54
measure: Change From Baseline in Fasting Plasma Glucose at Week 54
time frame: Baseline and Week 54
description: Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).
measure: Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54
time frame: Week 54
description: The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54.
measure: Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue
time frame: Up to Week 54
description: Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).
measure: Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue
time frame: Baseline and Week 54
measure: Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54
time frame: Week 54
description: The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54.
arm group label: Omarigliptin
arm group type: Experimental
description: Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
arm group label: Glimepiride
arm group type: Active Comparator
description: Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
intervention type: Drug
intervention name: Omarigliptin
arm group label: Omarigliptin
intervention type: Drug
intervention name: Placebo to Omarigliptin
arm group label: Glimepiride
intervention type: Drug
intervention name: Glimepiride
description: Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.
arm group label: Glimepiride
other name: AMARYL®
other name: GLIMY
intervention type: Drug
intervention name: Glimepiride Placebo
arm group label: Omarigliptin
intervention type: Drug
intervention name: Metformin
description: Participants will continue on their stable dose (>=1500 mg/day) of open-label metformin throughout the trial.
arm group label: Glimepiride
arm group label: Omarigliptin
intervention type: Drug
intervention name: Insulin Glargine
description: Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.
arm group label: Glimepiride
arm group label: Omarigliptin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Croatia
country: Germany
country: Hungary
country: Korea, Republic of
country: Lebanon
country: Lithuania
country: Malaysia
country: Poland
country: Romania
country: United States
citation: Handelsman Y, Lauring B, Gantz I, Iredale C, O'Neill EA, Wei Z, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of omarigliptin, a once-weekly DPP-4 inhibitor, or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Curr Med Res Opin. 2017 Oct;33(10):1861-1868. doi: 10.1080/03007995.2017.1335638. Epub 2017 Jun 28.
PMID: 28548024
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Insulin Glargine
mesh term: Glimepiride
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 