<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/NCT01697592</url>
  </required_header>
  <id_info>
    <org_study_id>3102-015</org_study_id>
    <secondary_id>132242</secondary_id>
    <nct_id>NCT01697592</nct_id>
  </id_info>
  <brief_title>Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)</brief_title>
  <official_title>A Phase III, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of Addition of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Oral Antihyperglycemic Agent Monotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the safety and efficacy of the addition of omarigliptin in Japanese&#xD;
      participants with type 2 diabetes mellitus who have inadequate glycemic control on&#xD;
      diet/exercise therapy and oral antihyperglycemic agent monotherapy.&#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). During Phase A, participants will received either omarigliptin&#xD;
      25 mg or a matching placebo. During Phase, B all participants will receive omarigliptin 25&#xD;
      mg. All participants will remain on a stable dose and administration of a single oral&#xD;
      antihyperglycemic basal medication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2012</start_date>
  <completion_date type="Actual">May 8, 2014</completion_date>
  <primary_completion_date type="Actual">May 8, 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>Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of &gt;240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG &gt;200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of &gt;240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG &gt;200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of &gt;240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG &gt;200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 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 a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.</description>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">585</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SUs throughout the duration of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omarigliptin 25 mg/Glinides (Phase A+B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of glinides throughout the duration of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BGs throughout the duration of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZDs throughout the duration of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omarigliptin 25 mg/α-GIs (Phase A+B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GIs) inhibitors throughout the duration of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SUs throughout the duration of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of glinides throughout the duration of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BGs throughout the duration of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZDs throughout the duration of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GIs inhibitors throughout the duration of the study.</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. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).</description>
    <arm_group_label>Omarigliptin 25 mg/Glinides (Phase A+B)</arm_group_label>
    <arm_group_label>Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)</arm_group_label>
    <arm_group_label>Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)</arm_group_label>
    <arm_group_label>Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)</arm_group_label>
    <arm_group_label>Omarigliptin 25 mg/α-GIs (Phase A+B)</arm_group_label>
    <arm_group_label>Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)</arm_group_label>
    <arm_group_label>Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)</arm_group_label>
    <arm_group_label>Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)</arm_group_label>
    <arm_group_label>Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)</arm_group_label>
    <arm_group_label>Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching placebo to omarigliptin</intervention_name>
    <description>Matching placebo to omarigliptin 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).</description>
    <arm_group_label>Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)</arm_group_label>
    <arm_group_label>Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)</arm_group_label>
    <arm_group_label>Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)</arm_group_label>
    <arm_group_label>Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)</arm_group_label>
    <arm_group_label>Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has type 2 diabetes mellitus&#xD;
&#xD;
          -  Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic&#xD;
             agent monotherapy&#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 (TZD) (for&#xD;
             participants whose basal medication is not TZD) and/or insulin within 12 weeks prior&#xD;
             to study participation, omarigliptin 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, Sato A, Okuyama K, O'Neill EA, Engel SS, Lai E; Omarigliptin Study 015 Group. A Randomized, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Adding Omarigliptin to Antihyperglycemic Therapies in Japanese Patients with Type 2 Diabetes and Inadequate Glycemic Control. Diabetes Ther. 2017 Aug;8(4):793-810. doi: 10.1007/s13300-017-0270-7. Epub 2017 Jun 6.</citation>
    <PMID>28589493</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 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 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <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 Snyopsis</doc_type>
      <doc_url>http://www.merck.com/clinical-trials/study.html?id=3102-015&amp;kw=3102-015&amp;tab=access</doc_url>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Sixty-seven sites in Japan received IRB approval and were shipped clinical supplies in this study and randomized at least one participant. A total of 772 participants were screened of which 187 participants were excluded. The most common reason for participants not being randomized was screen failure (meeting exclusionary laboratory values).</recruitment_details>
      <pre_assignment_details>In Phase A, participants were randomized to receive either omarigliptin (MK-3102) 25 mg once weekly 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 25 mg/Sulfonylureas (SU) (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
        </group>
        <group group_id="P2">
          <title>Omarigliptin 25 mg/Glinides (Gln) (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
        </group>
        <group group_id="P3">
          <title>Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
        </group>
        <group group_id="P4">
          <title>Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
        </group>
        <group group_id="P5">
          <title>Omarigliptin 25 mg/α-GI (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GI) throughout the duration of the study.</description>
        </group>
        <group group_id="P6">
          <title>Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)</title>
          <description>Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
        </group>
        <group group_id="P7">
          <title>Placebo/Gln. (Phase A) Switching to Omari. 25 mg/Gln (Phase B)</title>
          <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
        </group>
        <group group_id="P8">
          <title>Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)</title>
          <description>Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG. throughout the duration of the study.</description>
        </group>
        <group group_id="P9">
          <title>Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZ (Phase B)</title>
          <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
        </group>
        <group group_id="P10">
          <title>Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)</title>
          <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.</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="126"/>
                <participants group_id="P2" count="65"/>
                <participants group_id="P3" count="66"/>
                <participants group_id="P4" count="65"/>
                <participants group_id="P5" count="67"/>
                <participants group_id="P6" count="63"/>
                <participants group_id="P7" count="34"/>
                <participants group_id="P8" count="33"/>
                <participants group_id="P9" count="34"/>
                <participants group_id="P10" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="62"/>
                <participants group_id="P3" count="65"/>
                <participants group_id="P4" count="63"/>
                <participants group_id="P5" count="67"/>
                <participants group_id="P6" count="62"/>
                <participants group_id="P7" count="32"/>
                <participants group_id="P8" count="33"/>
                <participants group_id="P9" count="34"/>
                <participants group_id="P10" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Phase B (Week 25 to Week 52)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="62"/>
                <participants group_id="P3" count="65"/>
                <participants group_id="P4" count="63"/>
                <participants group_id="P5" count="67"/>
                <participants group_id="P6" count="62"/>
                <participants group_id="P7" count="32"/>
                <participants group_id="P8" count="33"/>
                <participants group_id="P9" count="34"/>
                <participants group_id="P10" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="118"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="64"/>
                <participants group_id="P4" count="60"/>
                <participants group_id="P5" count="67"/>
                <participants group_id="P6" count="60"/>
                <participants group_id="P7" count="31"/>
                <participants group_id="P8" count="32"/>
                <participants group_id="P9" count="32"/>
                <participants group_id="P10" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <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 group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" 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="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" 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="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omarigliptin 25 mg/SU (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
        </group>
        <group group_id="B2">
          <title>Omarigliptin 25 mg/Gln (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
        </group>
        <group group_id="B3">
          <title>Omarigliptin 25 mg/BG (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
        </group>
        <group group_id="B4">
          <title>Omarigliptin 25 mg/TZD (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
        </group>
        <group group_id="B5">
          <title>Omarigliptin 25 mg/α-GI (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
        </group>
        <group group_id="B6">
          <title>Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)</title>
          <description>Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
        </group>
        <group group_id="B7">
          <title>Placebo/Gln (Phase A) Switching to Omari. 25 mg/Gln (Ph. B)</title>
          <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
        </group>
        <group group_id="B8">
          <title>Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)</title>
          <description>Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
        </group>
        <group group_id="B9">
          <title>Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZD (Phase B)</title>
          <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
        </group>
        <group group_id="B10">
          <title>Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)</title>
          <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
        </group>
        <group group_id="B11">
          <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="126"/>
            <count group_id="B2" value="65"/>
            <count group_id="B3" value="66"/>
            <count group_id="B4" value="65"/>
            <count group_id="B5" value="67"/>
            <count group_id="B6" value="63"/>
            <count group_id="B7" value="34"/>
            <count group_id="B8" value="33"/>
            <count group_id="B9" value="34"/>
            <count group_id="B10" value="32"/>
            <count group_id="B11" value="585"/>
          </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="63" spread="9"/>
                    <measurement group_id="B2" value="59" spread="11"/>
                    <measurement group_id="B3" value="59" spread="9"/>
                    <measurement group_id="B4" value="61" spread="10"/>
                    <measurement group_id="B5" value="61" spread="11"/>
                    <measurement group_id="B6" value="63" spread="11"/>
                    <measurement group_id="B7" value="61" spread="10"/>
                    <measurement group_id="B8" value="57" spread="9"/>
                    <measurement group_id="B9" value="61" spread="9"/>
                    <measurement group_id="B10" value="61" spread="11"/>
                    <measurement group_id="B11" value="61" 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="35"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="18"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="10"/>
                    <measurement group_id="B9" value="7"/>
                    <measurement group_id="B10" value="9"/>
                    <measurement group_id="B11" value="169"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="46"/>
                    <measurement group_id="B6" value="45"/>
                    <measurement group_id="B7" value="27"/>
                    <measurement group_id="B8" value="23"/>
                    <measurement group_id="B9" value="27"/>
                    <measurement group_id="B10" value="23"/>
                    <measurement group_id="B11" value="416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of &gt;240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG &gt;200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).</description>
        <time_frame>Up to 24 weeks</time_frame>
        <population>All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg/SU (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
          </group>
          <group group_id="O2">
            <title>Omarigliptin 25 mg/Gln (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
          </group>
          <group group_id="O3">
            <title>Omarigliptin 25 mg/BG (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
          </group>
          <group group_id="O4">
            <title>Omarigliptin 25 mg/TZD (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
          </group>
          <group group_id="O5">
            <title>Omarigliptin 25 mg/α-GI (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
          </group>
          <group group_id="O6">
            <title>Placebo/SU (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
          </group>
          <group group_id="O7">
            <title>Placebo/Gln. (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
          </group>
          <group group_id="O8">
            <title>Placebo/BG (Phase A)</title>
            <description>Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
          </group>
          <group group_id="O9">
            <title>Placebo/TZD (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
          </group>
          <group group_id="O10">
            <title>Placebo/α-GI (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of &gt;240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG &gt;200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).</description>
          <population>All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.</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="126"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="65"/>
                <count group_id="O5" value="67"/>
                <count group_id="O6" value="63"/>
                <count group_id="O7" value="34"/>
                <count group_id="O8" value="33"/>
                <count group_id="O9" value="34"/>
                <count group_id="O10" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.5"/>
                    <measurement group_id="O2" value="53.8"/>
                    <measurement group_id="O3" value="54.5"/>
                    <measurement group_id="O4" value="60.0"/>
                    <measurement group_id="O5" value="50.7"/>
                    <measurement group_id="O6" value="60.3"/>
                    <measurement group_id="O7" value="52.9"/>
                    <measurement group_id="O8" value="63.6"/>
                    <measurement group_id="O9" value="52.9"/>
                    <measurement group_id="O10" value="53.1"/>
                  </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 Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of &gt;240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG &gt;200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.</description>
        <time_frame>Up to 52 weeks</time_frame>
        <population>The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg/SU (Phase A+B)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
          </group>
          <group group_id="O2">
            <title>Omarigliptin 25 mg/Gln (Phase A+B)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
          </group>
          <group group_id="O3">
            <title>Omarigliptin 25 mg/BG (Phase A+B)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
          </group>
          <group group_id="O4">
            <title>Omarigliptin 25 mg/TZD (Phase A+B)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
          </group>
          <group group_id="O5">
            <title>Omarigliptin 25 mg/α-GI (Phase A+B)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
          </group>
          <group group_id="O6">
            <title>Omarigliptin 25mg/SU (Phase B)</title>
            <description>Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.&#xD;
Participants continued prestudy basal medication of SU throughout the duration of the study.</description>
          </group>
          <group group_id="O7">
            <title>Omarigliptin 25mg/Gln (Phase B)</title>
            <description>Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.&#xD;
Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
          </group>
          <group group_id="O8">
            <title>Omarigliptin 25mg/BG (Phase B)</title>
            <description>Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
          </group>
          <group group_id="O9">
            <title>Omarigliptin 25mg/TZD (Phase B)</title>
            <description>Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
          </group>
          <group group_id="O10">
            <title>Omarigliptin 25mg/α-GI (Phase B)</title>
            <description>Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of &gt;240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG &gt;200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.</description>
          <population>The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm 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="126"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="65"/>
                <count group_id="O5" value="67"/>
                <count group_id="O6" value="62"/>
                <count group_id="O7" value="32"/>
                <count group_id="O8" value="33"/>
                <count group_id="O9" value="34"/>
                <count group_id="O10" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.2"/>
                    <measurement group_id="O2" value="75.4"/>
                    <measurement group_id="O3" value="80.3"/>
                    <measurement group_id="O4" value="84.6"/>
                    <measurement group_id="O5" value="68.7"/>
                    <measurement group_id="O6" value="56.5"/>
                    <measurement group_id="O7" value="59.4"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="58.8"/>
                    <measurement group_id="O10" value="53.3"/>
                  </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 was defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg/SU (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
          </group>
          <group group_id="O2">
            <title>Omarigliptin 25 mg/Gln (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
          </group>
          <group group_id="O3">
            <title>Omarigliptin 25 mg/BG (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
          </group>
          <group group_id="O4">
            <title>Omarigliptin 25 mg/TZD (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
          </group>
          <group group_id="O5">
            <title>Omarigliptin 25 mg/α-GI (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
          </group>
          <group group_id="O6">
            <title>Placebo/SU (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
          </group>
          <group group_id="O7">
            <title>Placebo/Gln. (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
          </group>
          <group group_id="O8">
            <title>Placebo/BG (Phase A)</title>
            <description>Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
          </group>
          <group group_id="O9">
            <title>Placebo/TZD (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
          </group>
          <group group_id="O10">
            <title>Placebo/α-GI (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.</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 was defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.</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="126"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="65"/>
                <count group_id="O5" value="67"/>
                <count group_id="O6" value="63"/>
                <count group_id="O7" value="34"/>
                <count group_id="O8" value="33"/>
                <count group_id="O9" value="34"/>
                <count group_id="O10" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3.1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3.1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2.9"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="3.1"/>
                  </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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of &gt;240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG &gt;200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.</description>
        <time_frame>Up to 52 weeks</time_frame>
        <population>The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg/SU (Phase A+B)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
          </group>
          <group group_id="O2">
            <title>Omarigliptin 25 mg/Gln (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
          </group>
          <group group_id="O3">
            <title>Omarigliptin 25 mg/BG (Phase A+B)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
          </group>
          <group group_id="O4">
            <title>Omarigliptin 25 mg/TZD (Phase A+B)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
          </group>
          <group group_id="O5">
            <title>Omarigliptin 25 mg/α-GI (Phase A+B)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
          </group>
          <group group_id="O6">
            <title>Omarigliptin 25mg/SU (Phase B)</title>
            <description>Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.&#xD;
Participants continued prestudy basal medication of SU throughout the duration of the study.</description>
          </group>
          <group group_id="O7">
            <title>Omarigliptin 25mg/Gln (Phase B)</title>
            <description>Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.&#xD;
Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
          </group>
          <group group_id="O8">
            <title>Omarigliptin 25mg/BG (Phase B)</title>
            <description>Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG. throughout the duration of the study.</description>
          </group>
          <group group_id="O9">
            <title>Omarigliptin 25mg/TZD (Phase B)</title>
            <description>Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
          </group>
          <group group_id="O10">
            <title>Omarigliptin 25mg/α-GI (Phase B)</title>
            <description>Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.</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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of &gt;240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG &gt;200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.</description>
          <population>The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm 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="126"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="65"/>
                <count group_id="O5" value="67"/>
                <count group_id="O6" value="62"/>
                <count group_id="O7" value="32"/>
                <count group_id="O8" value="33"/>
                <count group_id="O9" value="34"/>
                <count group_id="O10" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                    <measurement group_id="O2" value="4.6"/>
                    <measurement group_id="O3" value="1.5"/>
                    <measurement group_id="O4" value="6.2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1.6"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="2.9"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24</title>
        <description>HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>Full Analysis Set (FAS), comprised of all participants who received at least one study drug and have a baseline or post-randomization measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg/SU (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
          </group>
          <group group_id="O2">
            <title>Omarigliptin 25 mg/Gln (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
          </group>
          <group group_id="O3">
            <title>Omarigliptin 25 mg/BG (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
          </group>
          <group group_id="O4">
            <title>Omarigliptin 25 mg/TZD (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
          </group>
          <group group_id="O5">
            <title>Omarigliptin 25 mg/α-GI (Phase A)</title>
            <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
          </group>
          <group group_id="O6">
            <title>Placebo/SU (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
          </group>
          <group group_id="O7">
            <title>Placebo/Gln. (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln. throughout the duration of the study.</description>
          </group>
          <group group_id="O8">
            <title>Placebo/BG (Phase A)</title>
            <description>Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
          </group>
          <group group_id="O9">
            <title>Placebo/TZD (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
          </group>
          <group group_id="O10">
            <title>Placebo/α-GI (Phase A)</title>
            <description>Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24</title>
          <description>HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.</description>
          <population>Full Analysis Set (FAS), comprised of all participants who received at least one study drug and have a baseline or post-randomization measurement.</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="126"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="65"/>
                <count group_id="O5" value="67"/>
                <count group_id="O6" value="63"/>
                <count group_id="O7" value="34"/>
                <count group_id="O8" value="33"/>
                <count group_id="O9" value="34"/>
                <count group_id="O10" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.84" lower_limit="-0.94" upper_limit="-0.73"/>
                    <measurement group_id="O2" value="-0.68" lower_limit="-0.89" upper_limit="-0.48"/>
                    <measurement group_id="O3" value="-0.94" lower_limit="-1.10" upper_limit="-0.78"/>
                    <measurement group_id="O4" value="-0.88" lower_limit="-1.04" upper_limit="-0.73"/>
                    <measurement group_id="O5" value="-0.74" lower_limit="-0.89" upper_limit="-0.59"/>
                    <measurement group_id="O6" value="0.09" lower_limit="-0.06" upper_limit="0.24"/>
                    <measurement group_id="O7" value="0.30" lower_limit="-0.04" upper_limit="0.64"/>
                    <measurement group_id="O8" value="-0.02" lower_limit="-0.35" upper_limit="0.31"/>
                    <measurement group_id="O9" value="0.28" lower_limit="0.03" upper_limit="0.53"/>
                    <measurement group_id="O10" value="0.06" lower_limit="-0.16" upper_limit="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal data analysis</method>
            <method_desc>Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.10</ci_lower_limit>
            <ci_upper_limit>-0.75</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal data analysis</method>
            <method_desc>Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.37</ci_lower_limit>
            <ci_upper_limit>-0.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal data analysis</method>
            <method_desc>Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.29</ci_lower_limit>
            <ci_upper_limit>-0.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O9</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal data analysis</method>
            <method_desc>Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.</method_desc>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.45</ci_lower_limit>
            <ci_upper_limit>-0.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Constrained longitudinal data analysis</method>
            <method_desc>Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.</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>-1.06</ci_lower_limit>
            <ci_upper_limit>-0.54</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])</time_frame>
      <desc>The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Omarigliptin 25 mg/SU (Phase A)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
        </group>
        <group group_id="E2">
          <title>Omarigliptin 25 mg/Gln (Phase A)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
        </group>
        <group group_id="E3">
          <title>Omarigliptin 25 mg/BG (Phase A)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
        </group>
        <group group_id="E4">
          <title>Omarigliptin 25 mg/TZD (Phase A)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
        </group>
        <group group_id="E5">
          <title>Omarigliptin 25 mg/α-GI (Phase A)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
        </group>
        <group group_id="E6">
          <title>Placebo/ABM (Phase A)</title>
          <description>Placebo to omargliptin administered orally once weekly for 24 weeks during Phase A. Participants continued any pre-study basal medication (ABM)throughout the duration of the study.</description>
        </group>
        <group group_id="E7">
          <title>Omarigliptin 25 mg/SU (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.</description>
        </group>
        <group group_id="E8">
          <title>Omarigliptin 25 mg/Gln (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.</description>
        </group>
        <group group_id="E9">
          <title>Omarigliptin 25 mg/BG (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.</description>
        </group>
        <group group_id="E10">
          <title>Omarigliptin 25 mg/TZD (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.</description>
        </group>
        <group group_id="E11">
          <title>Omarigliptin 25 mg/α-GI (Phase A+B)</title>
          <description>Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.</description>
        </group>
        <group group_id="E12">
          <title>Omarigliptin 25mg/ABM (Phase B)</title>
          <description>Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.&#xD;
Participants continued any prestudy basal medications throughout the duration of the study.</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="126"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="196"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="126"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E12" subjects_affected="7" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Macular hole</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Acute abdomen</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fracture displacement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Chondrocalcinosis pyrophosphate</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Hypopharyngeal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Tongue neoplasm malignant stage unspecified</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Endometrial cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Lip and/or oral cavity cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="196"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </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="33" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="65"/>
                <counts group_id="E5" subjects_affected="19" subjects_at_risk="67"/>
                <counts group_id="E6" subjects_affected="62" subjects_at_risk="196"/>
                <counts group_id="E7" subjects_affected="58" subjects_at_risk="126"/>
                <counts group_id="E8" subjects_affected="29" subjects_at_risk="65"/>
                <counts group_id="E9" subjects_affected="33" subjects_at_risk="66"/>
                <counts group_id="E10" subjects_affected="30" subjects_at_risk="65"/>
                <counts group_id="E11" subjects_affected="26" subjects_at_risk="67"/>
                <counts group_id="E12" subjects_affected="60" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="126"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="196"/>
                <counts group_id="E7" events="8" subjects_affected="7" subjects_at_risk="126"/>
                <counts group_id="E8" events="5" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="196"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="126"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="65"/>
                <counts group_id="E3" events="14" subjects_affected="11" subjects_at_risk="66"/>
                <counts group_id="E4" events="13" subjects_affected="11" subjects_at_risk="65"/>
                <counts group_id="E5" events="14" subjects_affected="13" subjects_at_risk="67"/>
                <counts group_id="E6" events="49" subjects_affected="44" subjects_at_risk="196"/>
                <counts group_id="E7" events="44" subjects_affected="34" subjects_at_risk="126"/>
                <counts group_id="E8" events="30" subjects_affected="23" subjects_at_risk="65"/>
                <counts group_id="E9" events="34" subjects_affected="24" subjects_at_risk="66"/>
                <counts group_id="E10" events="29" subjects_affected="19" subjects_at_risk="65"/>
                <counts group_id="E11" events="25" subjects_affected="19" subjects_at_risk="67"/>
                <counts group_id="E12" events="44" subjects_affected="36" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="196"/>
                <counts group_id="E7" events="10" subjects_affected="10" subjects_at_risk="126"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E11" events="3" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E12" events="10" subjects_affected="7" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="196"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E10" events="4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="7" subjects_affected="3" subjects_at_risk="196"/>
                <counts group_id="E7" events="14" subjects_affected="11" subjects_at_risk="126"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E9" events="7" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E12" events="7" subjects_affected="6" subjects_at_risk="191"/>
              </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="126"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="196"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E8" events="5" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E10" events="3" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="191"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="196"/>
                <counts group_id="E7" events="6" subjects_affected="6" subjects_at_risk="126"/>
                <counts group_id="E8" events="4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E9" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E10" events="6" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E11" events="4" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E12" events="11" subjects_affected="10" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="196"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E10" events="4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E11" events="3" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="191"/>
              </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/NCT01697592
org study id: 3102-015
secondary id: 132242
nct id: NCT01697592
lead sponsor: 
has dmc: Yes
This study will examine the safety and efficacy of the addition of omarigliptin in Japanese
      participants with type 2 diabetes mellitus who have inadequate glycemic control on
      diet/exercise therapy and oral antihyperglycemic agent monotherapy.
The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week
      open-label period (Phase B). During Phase A, participants will received either omarigliptin
      25 mg or a matching placebo. During Phase, B all participants will receive omarigliptin 25
      mg. All participants will remain on a stable dose and administration of a single oral
      antihyperglycemic basal medication.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).
measure: Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
measure: Change From Baseline in 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 a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.
arm group label: Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)
arm group type: Experimental
description: Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SUs throughout the duration of the study.
arm group label: Omarigliptin 25 mg/Glinides (Phase A+B)
arm group type: Experimental
description: Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of glinides throughout the duration of the study.
arm group label: Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)
arm group type: Experimental
description: Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BGs throughout the duration of the study.
arm group label: Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)
arm group type: Experimental
description: Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZDs throughout the duration of the study.
arm group label: Omarigliptin 25 mg/α-GIs (Phase A+B)
arm group type: Experimental
description: Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GIs) inhibitors throughout the duration of the study.
arm group label: Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)
arm group type: Placebo Comparator
description: Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SUs throughout the duration of the study.
arm group label: Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)
arm group type: Placebo Comparator
description: Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of glinides throughout the duration of the study.
arm group label: Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)
arm group type: Placebo Comparator
description: Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BGs throughout the duration of the study.
arm group label: Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)
arm group type: Placebo Comparator
description: Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZDs throughout the duration of the study.
arm group label: Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)
arm group type: Placebo Comparator
description: Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GIs inhibitors throughout the duration of the study.
intervention type: Drug
intervention name: Omarigliptin
description: Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).
arm group label: Omarigliptin 25 mg/Glinides (Phase A+B)
arm group label: Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)
arm group label: Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)
arm group label: Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)
arm group label: Omarigliptin 25 mg/α-GIs (Phase A+B)
arm group label: Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)
arm group label: Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)
arm group label: Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)
arm group label: Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)
arm group label: Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)
intervention type: Drug
intervention name: Matching placebo to omarigliptin
description: Matching placebo to omarigliptin 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).
arm group label: Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)
arm group label: Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)
arm group label: Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)
arm group label: Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)
arm group label: Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (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, Sato A, Okuyama K, O'Neill EA, Engel SS, Lai E; Omarigliptin Study 015 Group. A Randomized, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Adding Omarigliptin to Antihyperglycemic Therapies in Japanese Patients with Type 2 Diabetes and Inadequate Glycemic Control. Diabetes Ther. 2017 Aug;8(4):793-810. doi: 10.1007/s13300-017-0270-7. Epub 2017 Jun 6.
PMID: 28589493
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
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: 