<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/NCT01703221</url>
  </required_header>
  <id_info>
    <org_study_id>3102-020</org_study_id>
    <secondary_id>132239</secondary_id>
    <nct_id>NCT01703221</nct_id>
  </id_info>
  <brief_title>Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)</brief_title>
  <official_title>A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy</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>
      The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as&#xD;
      monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up&#xD;
      to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1)&#xD;
      Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated&#xD;
      hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in&#xD;
      participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in&#xD;
      participants treated with sitagliptin 50 mg daily.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week&#xD;
      open-label period (Phase B). Participants will receive in Phase A: omarigliptin 25 mg once&#xD;
      weekly, sitagliptin 50 mg once daily or placebo and in Phase B: omarigliptin 25 mg once&#xD;
      weekly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2012</start_date>
  <completion_date type="Actual">April 25, 2014</completion_date>
  <primary_completion_date type="Actual">April 25, 2014</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event During Phase A</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study</measure>
    <time_frame>Up to 52 weeks</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study</measure>
    <time_frame>Up to 52 weeks</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24</measure>
    <time_frame>Baseline and Week 24</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 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">414</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Omarigliptin 25 mg (Phase A+B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sitagliptin (Phase A) switching to Omarigliptin (Phase B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Phase A) switching to Omarigliptin (Phase B)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omarigliptin</intervention_name>
    <description>Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly</description>
    <arm_group_label>Omarigliptin 25 mg (Phase A+B)</arm_group_label>
    <arm_group_label>Placebo (Phase A) switching to Omarigliptin (Phase B)</arm_group_label>
    <arm_group_label>Sitagliptin (Phase A) switching to Omarigliptin (Phase B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin</intervention_name>
    <description>Sitagliptin 50 mg tablet administered orally once daily</description>
    <arm_group_label>Sitagliptin (Phase A) switching to Omarigliptin (Phase B)</arm_group_label>
    <other_name>Januvia®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to omarigliptin</intervention_name>
    <description>Placebo to omarigliptin 25 mg capsule administered orally once weekly</description>
    <arm_group_label>Placebo (Phase A) switching to Omarigliptin (Phase B)</arm_group_label>
    <arm_group_label>Sitagliptin (Phase A) switching to Omarigliptin (Phase B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to sitagliptin</intervention_name>
    <description>Placebo to sitagliptin 50 mg tablet administered orally once daily</description>
    <arm_group_label>Omarigliptin 25 mg (Phase A+B)</arm_group_label>
    <arm_group_label>Placebo (Phase A) switching to Omarigliptin (Phase B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has type 2 diabetes mellitus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of type 1 diabetes mellitus or a history of ketoacidosis&#xD;
&#xD;
          -  History of any of the following medications: thiazolidinediones and/or insulin within&#xD;
             12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 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>Japan</country>
  </removed_countries>
  <results_reference>
    <citation>Gantz I, Okamoto T, Ito Y, Okuyama K, O'Neill EA, Kaufman KD, Engel SS, Lai E; the Omarigliptin Study 020 Group. A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1602-1609. doi: 10.1111/dom.12988. Epub 2017 Jul 6.</citation>
    <PMID>28449368</PMID>
  </results_reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <results_first_submitted>September 29, 2015</results_first_submitted>
  <results_first_submitted_qc>September 29, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 29, 2015</results_first_posted>
  <last_update_submitted>August 15, 2019</last_update_submitted>
  <last_update_submitted_qc>August 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sitagliptin Phosphate</mesh_term>
  </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=3102-020&amp;kw=3102-020&amp;tab=access</doc_url>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Forty-eight sites in Japan received IRB approval and were shipped clinical supplies in this study and randomized at least one participant. One hundred and seventeen participants were not randomized; the most common reason for participants not being randomized was screen failure.</recruitment_details>
      <pre_assignment_details>In Phase A, participants were randomized to receive either omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo for 24 weeks in a blinded manner. In Phase B, all participants received open-label omarigliptin 25 mg once weekly for 28 weeks.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Omarigliptin (Phase A+B)</title>
          <description>Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)</description>
        </group>
        <group group_id="P2">
          <title>Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)</title>
          <description>Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)</description>
        </group>
        <group group_id="P3">
          <title>Placebo (Phase A) Switching to Omarigliptin (Phase B)</title>
          <description>Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Phase A (Up to 24 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="166"/>
                <participants group_id="P2" count="165"/>
                <participants group_id="P3" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="159"/>
                <participants group_id="P2" count="161"/>
                <participants group_id="P3" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </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="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Phase B - (Week 25 to 52)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="159"/>
                <participants group_id="P2" count="161"/>
                <participants group_id="P3" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="143"/>
                <participants group_id="P2" count="147"/>
                <participants group_id="P3" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omarigliptin (Phase A+B)</title>
          <description>Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)</description>
        </group>
        <group group_id="B2">
          <title>Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)</title>
          <description>Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)</description>
        </group>
        <group group_id="B3">
          <title>Placebo (Phase A) Switching to Omarigliptin (Phase B)</title>
          <description>Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="166"/>
            <count group_id="B2" value="165"/>
            <count group_id="B3" value="83"/>
            <count group_id="B4" value="414"/>
          </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="60" spread="11"/>
                    <measurement group_id="B2" value="60" spread="9"/>
                    <measurement group_id="B3" value="61" spread="9"/>
                    <measurement group_id="B4" value="60" spread="10"/>
                  </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="62"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24</title>
        <description>HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A)</title>
            <description>Omarigliptin 25 mg once weekly for 24 weeks (Phase A)</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin (Phase A)</title>
            <description>Sitagliptin 50 mg once daily for 24 weeks (Phase A)</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Phase A)</title>
            <description>Placebo for 24 weeks (Phase A)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24</title>
          <description>HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).</description>
          <population>The Full Analysis Set (FAS) consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.</population>
          <units>Percent HbA1c</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="166"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" lower_limit="-0.76" upper_limit="-0.57"/>
                    <measurement group_id="O2" value="-0.65" lower_limit="-0.74" upper_limit="-0.55"/>
                    <measurement group_id="O3" value="0.13" lower_limit="-0.00" upper_limit="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal analysis</method>
            <method_desc>Terms for treatment, prior oral antihyperglycemic agent (AHA), time, time by: treatment, prior AHA therapy status, and treatment by prior AHA status.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.96</ci_lower_limit>
            <ci_upper_limit>-0.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal analysis</method>
            <method_desc>Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-0.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.94</ci_lower_limit>
            <ci_upper_limit>-0.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>Omarigliptin will be considered non-inferior to sitagliptin if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in least squares means for change from baseline in HbA1c at Week 24 (omarigliptin minus sitagliptin) is not more than 0.3% (non-inferiority margin).</non_inferiority_desc>
            <p_value>0.792</p_value>
            <method>Constrained longitudinal analysis</method>
            <method_desc>Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.15</ci_lower_limit>
            <ci_upper_limit>0.12</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Event During Phase A</title>
        <description>An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
        <time_frame>Up to 24 weeks</time_frame>
        <population>All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A)</title>
            <description>Omarigliptin 25 mg once weekly for 24 weeks (Phase A)</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin (Phase A)</title>
            <description>Sitagliptin 50 mg once daily for 24 weeks (Phase A)</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Phase A)</title>
            <description>Placebo for 24 weeks (Phase A)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event During Phase A</title>
          <description>An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
          <population>All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="49.4"/>
                    <measurement group_id="O3" value="65.9"/>
                  </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 During the Overall Study</title>
        <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.</description>
        <time_frame>Up to 52 weeks</time_frame>
        <population>The ASaT Population included all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A+B)</title>
            <description>Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)</description>
          </group>
          <group group_id="O2">
            <title>Omarigliptin (Phase B)-S</title>
            <description>Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin</description>
          </group>
          <group group_id="O3">
            <title>Omarigliptin (Phase B)-P</title>
            <description>Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study</title>
          <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.</description>
          <population>The ASaT Population included all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.</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="166"/>
                <count group_id="O2" value="161"/>
                <count group_id="O3" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.9"/>
                    <measurement group_id="O2" value="47.2"/>
                    <measurement group_id="O3" value="56.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A</title>
        <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
        <time_frame>Up to 24 weeks</time_frame>
        <population>The ASaT Population consisted of all randomized participants who received at least one study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A)</title>
            <description>Omarigliptin 25 mg once weekly for 24 weeks (Phase A)</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin (Phase A)</title>
            <description>Sitagliptin 50 mg once daily for 24 weeks (Phase A)</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Phase A)</title>
            <description>Placebo for 24 weeks (Phase A)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A</title>
          <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
          <population>The ASaT Population consisted of all randomized participants who received at least one study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="1.2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study</title>
        <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.</description>
        <time_frame>Up to 52 weeks</time_frame>
        <population>The ASaT Population consisted of all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A+B)</title>
            <description>Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)</description>
          </group>
          <group group_id="O2">
            <title>Omarigliptin (Phase B)-S</title>
            <description>Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin</description>
          </group>
          <group group_id="O3">
            <title>Omarigliptin (Phase B)-P</title>
            <description>Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study</title>
          <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.</description>
          <population>The ASaT Population consisted of all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.</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="166"/>
                <count group_id="O2" value="161"/>
                <count group_id="O3" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                    <measurement group_id="O2" value="1.2"/>
                    <measurement group_id="O3" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24</title>
        <description>Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A)</title>
            <description>Omarigliptin 25 mg once weekly for 24 weeks (Phase A)</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin (Phase A)</title>
            <description>Sitagliptin 50 mg once daily for 24 weeks (Phase A)</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Phase A)</title>
            <description>Placebo for 24 weeks (Phase A)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24</title>
          <description>Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.</description>
          <population>The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.</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="166"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.38" lower_limit="-49.53" upper_limit="-35.23"/>
                    <measurement group_id="O2" value="-45.24" lower_limit="-52.31" upper_limit="-38.16"/>
                    <measurement group_id="O3" value="-5.48" lower_limit="-15.13" upper_limit="4.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal analysis</method>
            <method_desc>Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-36.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-48.46</ci_lower_limit>
            <ci_upper_limit>-25.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal analysis</method>
            <method_desc>Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-39.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-51.28</ci_lower_limit>
            <ci_upper_limit>-28.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.555</p_value>
            <method>Constrained longitudinal analysis</method>
            <method_desc>Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>2.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.67</ci_lower_limit>
            <ci_upper_limit>12.39</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24</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 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A)</title>
            <description>Omarigliptin 25 mg once weekly for 24 weeks (Phase A)</description>
          </group>
          <group group_id="O2">
            <title>Sitagliptin (Phase A)</title>
            <description>Sitagliptin 50 mg once daily for 24 weeks (Phase A)</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Phase A)</title>
            <description>Placebo for 24 weeks (Phase A)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24</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 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).</description>
          <population>The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.</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="166"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.52" lower_limit="-21.81" upper_limit="-15.22"/>
                    <measurement group_id="O2" value="-20.75" lower_limit="-24.10" upper_limit="-17.39"/>
                    <measurement group_id="O3" value="-6.23" lower_limit="-10.84" upper_limit="-1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal analysis</method>
            <method_desc>Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-12.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.78</ci_lower_limit>
            <ci_upper_limit>-6.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal analysis</method>
            <method_desc>Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-14.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.04</ci_lower_limit>
            <ci_upper_limit>-8.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.330</p_value>
            <method>Constrained longitudinal analysis</method>
            <method_desc>Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>2.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.27</ci_lower_limit>
            <ci_upper_limit>6.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)</time_frame>
      <desc>The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.</desc>
      <group_list>
        <group group_id="E1">
          <title>Omarigliptin (Phase A)</title>
          <description>Omarigliptin 25 mg once weekly for 24 weeks (Phase A)</description>
        </group>
        <group group_id="E2">
          <title>Sitagliptin (Phase A)</title>
          <description>Sitagliptin 50 mg once daily for 24 weeks (Phase A)</description>
        </group>
        <group group_id="E3">
          <title>Placebo (Phase A)</title>
          <description>Placebo for 24 weeks (Phase A)</description>
        </group>
        <group group_id="E4">
          <title>Omarigliptin (Phase A + B)</title>
          <description>Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)</description>
        </group>
        <group group_id="E5">
          <title>Omarigliptin (Phase B)-S</title>
          <description>Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin</description>
        </group>
        <group group_id="E6">
          <title>Omarigliptin (Phase B)-P</title>
          <description>Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.0</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="3" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="164"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="166"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="161"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sick sinus syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Limb traumatic amputation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Trigger finger</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.0</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="21" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="164"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="82"/>
                <counts group_id="E4" subjects_affected="45" subjects_at_risk="166"/>
                <counts group_id="E5" subjects_affected="22" subjects_at_risk="161"/>
                <counts group_id="E6" subjects_affected="17" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="24" subjects_affected="21" subjects_at_risk="166"/>
                <counts group_id="E2" events="22" subjects_affected="18" subjects_at_risk="164"/>
                <counts group_id="E3" events="27" subjects_affected="25" subjects_at_risk="82"/>
                <counts group_id="E4" events="58" subjects_affected="45" subjects_at_risk="166"/>
                <counts group_id="E5" events="30" subjects_affected="22" subjects_at_risk="161"/>
                <counts group_id="E6" events="21" subjects_affected="17" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01703221
org study id: 3102-020
secondary id: 132239
nct id: NCT01703221
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as
      monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up
      to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1)
      Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated
      hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in
      participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in
      participants treated with sitagliptin 50 mg daily.
The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week
      open-label period (Phase B). Participants will receive in Phase A: omarigliptin 25 mg once
      weekly, sitagliptin 50 mg once daily or placebo and in Phase B: omarigliptin 25 mg once
      weekly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24
time frame: Baseline and Week 24
description: HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).
measure: Percentage of Participants Who Experienced at Least One Adverse Event During Phase A
time frame: Up to 24 weeks
description: An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
measure: Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study
time frame: Up to 52 weeks
description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
measure: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
time frame: Up to 24 weeks
description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
measure: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
time frame: Up to 52 weeks
description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
measure: Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24
time frame: Baseline and Week 24
description: Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.
measure: Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24
time frame: Baseline and Week 24
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 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).
arm group label: Omarigliptin 25 mg (Phase A+B)
arm group type: Experimental
description: Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
arm group label: Sitagliptin (Phase A) switching to Omarigliptin (Phase B)
arm group type: Active Comparator
description: Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
arm group label: Placebo (Phase A) switching to Omarigliptin (Phase B)
arm group type: Placebo Comparator
description: Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
intervention type: Drug
intervention name: Omarigliptin
description: Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly
arm group label: Omarigliptin 25 mg (Phase A+B)
arm group label: Placebo (Phase A) switching to Omarigliptin (Phase B)
arm group label: Sitagliptin (Phase A) switching to Omarigliptin (Phase B)
intervention type: Drug
intervention name: Sitagliptin
description: Sitagliptin 50 mg tablet administered orally once daily
arm group label: Sitagliptin (Phase A) switching to Omarigliptin (Phase B)
other name: Januvia®
intervention type: Drug
intervention name: Placebo to omarigliptin
description: Placebo to omarigliptin 25 mg capsule administered orally once weekly
arm group label: Placebo (Phase A) switching to Omarigliptin (Phase B)
arm group label: Sitagliptin (Phase A) switching to Omarigliptin (Phase B)
intervention type: Drug
intervention name: Placebo to sitagliptin
description: Placebo to sitagliptin 50 mg tablet administered orally once daily
arm group label: Omarigliptin 25 mg (Phase A+B)
arm group label: Placebo (Phase A) switching to Omarigliptin (Phase B)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Japan
citation: Gantz I, Okamoto T, Ito Y, Okuyama K, O'Neill EA, Kaufman KD, Engel SS, Lai E; the Omarigliptin Study 020 Group. A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1602-1609. doi: 10.1111/dom.12988. Epub 2017 Jul 6.
PMID: 28449368
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Sitagliptin Phosphate
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: 