<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/NCT01698775</url>
  </required_header>
  <id_info>
    <org_study_id>3102-019</org_study_id>
    <secondary_id>2012-002332-85</secondary_id>
    <nct_id>NCT01698775</nct_id>
  </id_info>
  <brief_title>A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)</brief_title>
  <official_title>A Phase III, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects With Type 2 Diabetes Mellitus With Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of omarigliptin in&#xD;
      participants with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency&#xD;
      or end stage renal disease on dialysis with inadequate glycemic control. The primary&#xD;
      hypothesis of the study is that omarigliptin compared to placebo produces greater reduction&#xD;
      in glycosylated hemoglobin (A1C) after 24 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2012</start_date>
  <completion_date type="Actual">January 19, 2016</completion_date>
  <primary_completion_date type="Actual">January 19, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)</measure>
    <time_frame>Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)</measure>
    <time_frame>Up to 58 weeks (including 28 days following the last dose of study therapy)</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)</measure>
    <time_frame>Up to 54 weeks</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in A1C at Week 54</measure>
    <time_frame>Baseline and Week 54</time_frame>
    <description>A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FPG at Week 54</measure>
    <time_frame>Baseline and Week 54</time_frame>
    <description>Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with end stage renal disease (ESRD) on dialysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in eGFR at Week 54</measure>
    <time_frame>Baseline and Week 54</time_frame>
    <description>Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with ESRD on dialysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">213</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Omarigliptin (Phase A) → Omarigliptin (Phase B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) will receive matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to omarigliptin (Phase A) → Glipizide (Phase B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) will receive glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omarigliptin</intervention_name>
    <description>Participants with moderate renal insufficiency will receive one omarigliptin 25 mg capsule orally once a week; participants with severe renal insufficiency or end stage renal disease will receive one omarigliptin 12.5 mg capsule orally once a week</description>
    <arm_group_label>Omarigliptin (Phase A) → Omarigliptin (Phase B)</arm_group_label>
    <other_name>MK-3102</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to omarigliptin</intervention_name>
    <description>Matching placebo to omarigliptin capsule administered orally once a week</description>
    <arm_group_label>Placebo to omarigliptin (Phase A) → Glipizide (Phase B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glipizide</intervention_name>
    <description>Phase A: Participants may receive open-label glipizide as rescue therapy up to Week 24 of the study. Phase B: Participants who received placebo to omarigliptin during Phase A and are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study Week 1 through Week 24) will receive glipizide capsule(s) 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
    <arm_group_label>Omarigliptin (Phase A) → Omarigliptin (Phase B)</arm_group_label>
    <arm_group_label>Placebo to omarigliptin (Phase A) → Glipizide (Phase B)</arm_group_label>
    <other_name>Glucotrol</other_name>
    <other_name>Glucotrol XL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to glipizide</intervention_name>
    <description>Matching placebo to glipizide daily</description>
    <arm_group_label>Omarigliptin (Phase A) → Omarigliptin (Phase B)</arm_group_label>
    <arm_group_label>Placebo to omarigliptin (Phase A) → Glipizide (Phase B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Insulin</intervention_name>
    <description>Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.</description>
    <arm_group_label>Omarigliptin (Phase A) → Omarigliptin (Phase B)</arm_group_label>
    <arm_group_label>Placebo to omarigliptin (Phase A) → Glipizide (Phase B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus and be at least 30 years of age&#xD;
&#xD;
          -  Moderate or severe chronic renal insufficiency or end stage renal disease on dialysis&#xD;
&#xD;
          -  Meet one of the following criteria:&#xD;
&#xD;
               1. is currently not on an antihyperglycemic agent (AHA) and has A1C &gt;=7% and &lt;=10%&#xD;
                  at screening&#xD;
&#xD;
               2. is currently on a single oral AHA or low-dose dual oral combination AHA and has&#xD;
                  A1C &gt;=6.5% and &lt;=9% at screening&#xD;
&#xD;
               3. is currently on a stable insulin regimen (&gt;= 15 U/day) for &gt;= 10 weeks, with no&#xD;
                  oral AHA, and has A1C &gt;=7.5% and &lt;=10% and FPG &gt;130 mg/dL at screening&#xD;
&#xD;
          -  (1) Male; (2) female not of reproductive potential; or (3) female of reproductive&#xD;
             potential who agrees to remain abstinent or use alone or in conjunction with their&#xD;
             partner 2 methods of contraception to prevent pregnancy during the study and for 28&#xD;
             days after the last dose of study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of type 1 diabetes mellitus or a history of ketoacidosis&#xD;
&#xD;
          -  Treated with any incretin mimetic or thiazolidinedione (TZD) within 12 weeks prior to&#xD;
             screening or with omarigliptin at any time prior to study participation&#xD;
&#xD;
          -  History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor&#xD;
&#xD;
          -  History of intolerance or hypersensitivity to glipizide or insulin glargine or any&#xD;
             contraindication to glipizide or insulin glargine&#xD;
&#xD;
          -  On a weight loss program and is not in the maintenance phase, or has been on a weight&#xD;
             loss medication in the past 6 months, or has undergone bariatric surgery within 12&#xD;
             months prior to study participation&#xD;
&#xD;
          -  Undergone a surgical procedure within 4 weeks prior to screening or has planned major&#xD;
             surgery during the trial&#xD;
&#xD;
          -  On or likely to require treatment for &gt;=2 consecutive weeks or repeated courses of&#xD;
             corticosteroids (note: inhaled, nasal or topical corticosteroids are permitted)&#xD;
&#xD;
          -  Currently being treated for hyperthyroidism or is on thyroid replacement therapy and&#xD;
             has not been on a stable dose for at least 6 weeks&#xD;
&#xD;
          -  If on dialysis, does not regularly adhere to dialysis schedule&#xD;
&#xD;
          -  Diagnosis of congestive heart failure with New York Heart Association (NYHA) Class IV&#xD;
&#xD;
          -  Medical history of active liver disease (other than non-alcoholic hepatic steatosis),&#xD;
             including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic&#xD;
             gallbladder disease&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  New or worsening coronary heart disease, congestive heart failure, myocardial&#xD;
             infarction, unstable angina, coronary artery intervention, stroke, or transient&#xD;
             ischemic neurological disorder within the past 3 months&#xD;
&#xD;
          -  Poorly controlled hypertension&#xD;
&#xD;
          -  Severe active peripheral vascular disease&#xD;
&#xD;
          -  History of malignancy &lt;=5 years prior to study participation, except for adequately&#xD;
             treated basal cell or squamous cell skin cancer, or in situ cervical cancer&#xD;
&#xD;
          -  Clinically important hematological disorder (such as aplastic anemia,&#xD;
             myeloproliferative or myelodysplastic syndromes, thrombocytopenia)&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the&#xD;
             trial, including 28 days following the last dose of study drug&#xD;
&#xD;
          -  User of recreational or illicit drugs or has had a recent history of drug abuse or&#xD;
             routinely consumes &gt;2 alcoholic drinks per day or &gt;14 alcoholic drinks per week, or&#xD;
             engages in binge drinking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 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>Australia</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>Czech Republic</country>
    <country>Georgia</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Malaysia</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Chacra A, Gantz I, Mendizabal G, Durlach L, O'Neill EA, Zimmer Z, Suryawanshi S, Engel SS, Lai E. A randomised, double-blind, trial of the safety and efficacy of omarigliptin (a once-weekly DPP-4 inhibitor) in subjects with type 2 diabetes and renal impairment. Int J Clin Pract. 2017 Jun;71(6):e12955. doi: 10.1111/ijcp.12955. Epub 2017 Apr 27.</citation>
    <PMID>28449320</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>January 3, 2017</results_first_submitted>
  <results_first_submitted_qc>January 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2017</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">August 9, 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>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glipizide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Omarigliptin (Phase A) → Omarigliptin (Phase B)</title>
          <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
        </group>
        <group group_id="P2">
          <title>Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)</title>
          <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Phase A</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
                <participants group_id="P2" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Kidney [transplant]</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Phase B</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="86"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Hyperglycemia Discontinuation Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omarigliptin (Phase A)</title>
          <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Placebo to Omarigliptin (Phase A)</title>
          <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="107"/>
            <count group_id="B2" value="106"/>
            <count group_id="B3" value="213"/>
          </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="65.9" spread="9.4"/>
                    <measurement group_id="B2" value="64.5" spread="9.7"/>
                    <measurement group_id="B3" value="65.2" spread="9.6"/>
                  </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="39"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24</title>
        <description>A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A)</title>
            <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo to Omarigliptin (Phase A)</title>
            <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24</title>
          <description>A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
          <population>Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.</population>
          <units>Percent</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.77" lower_limit="-1.00" upper_limit="-0.54"/>
                    <measurement group_id="O2" value="-0.44" lower_limit="-0.67" upper_limit="-0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.035</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.63</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)</title>
        <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
        <time_frame>Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)</time_frame>
        <population>All-Participants-as-Treated (APaT) population consists of all randomized participants who took at least 1 dose of trial treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A)</title>
            <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo to Omarigliptin (Phase A)</title>
            <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)</title>
          <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
          <population>All-Participants-as-Treated (APaT) population consists of all randomized participants who took at least 1 dose of trial treatment.</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="106"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.0"/>
                    <measurement group_id="O2" value="69.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in percentages</param_type>
            <param_value>-3.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.3</ci_lower_limit>
            <ci_upper_limit>8.8</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method stratified by renal status stratum.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)</title>
        <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
        <time_frame>Up to 24 weeks</time_frame>
        <population>APaT population consists of all randomized participants who took at least 1 dose of trial treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A)</title>
            <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo to Omarigliptin (Phase A)</title>
            <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)</title>
          <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
          <population>APaT population consists of all randomized participants who took at least 1 dose of trial treatment.</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="106"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                    <measurement group_id="O2" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in percentages</param_type>
            <param_value>1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.6</ci_lower_limit>
            <ci_upper_limit>7.2</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method stratified by renal status stratum.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)</title>
        <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
        <time_frame>Up to 58 weeks (including 28 days following the last dose of study therapy)</time_frame>
        <population>APaT population consists of all randomized participants who took at least 1 dose of trial treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A) → Omarigliptin (Phase B)</title>
            <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
          </group>
          <group group_id="O2">
            <title>Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)</title>
            <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)</title>
          <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
          <population>APaT population consists of all randomized participants who took at least 1 dose of trial treatment.</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="106"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.4"/>
                    <measurement group_id="O2" value="78.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in percentage</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.2</ci_lower_limit>
            <ci_upper_limit>10.3</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method stratified by renal status stratum.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)</title>
        <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
        <time_frame>Up to 54 weeks</time_frame>
        <population>APaT population consists of all randomized participants who took at least 1 dose of trial treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A) → Omarigliptin (Phase B)</title>
            <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
          </group>
          <group group_id="O2">
            <title>Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)</title>
            <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)</title>
          <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.</description>
          <population>APaT population consists of all randomized participants who took at least 1 dose of trial treatment.</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="106"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6"/>
                    <measurement group_id="O2" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in percentage</param_type>
            <param_value>2.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.6</ci_lower_limit>
            <ci_upper_limit>9.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24</title>
        <description>Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A)</title>
            <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo to Omarigliptin (Phase A)</title>
            <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24</title>
          <description>Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
          <population>FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.6" lower_limit="-35.6" upper_limit="-13.6"/>
                    <measurement group_id="O2" value="-20.7" lower_limit="-31.8" upper_limit="-9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.540</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-3.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.5</ci_lower_limit>
            <ci_upper_limit>8.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in A1C at Week 54</title>
        <description>A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
        <time_frame>Baseline and Week 54</time_frame>
        <population>FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A) → Omarigliptin (Phase B)</title>
            <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
          </group>
          <group group_id="O2">
            <title>Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)</title>
            <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in A1C at Week 54</title>
          <description>A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
          <population>FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.</population>
          <units>Percent</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.79" lower_limit="-1.10" upper_limit="-0.47"/>
                    <measurement group_id="O2" value="-0.83" lower_limit="-1.16" upper_limit="-0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FPG at Week 54</title>
        <description>Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
        <time_frame>Baseline and Week 54</time_frame>
        <population>FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A) → Omarigliptin (Phase B)</title>
            <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
          </group>
          <group group_id="O2">
            <title>Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)</title>
            <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FPG at Week 54</title>
          <description>Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.</description>
          <population>FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.3" lower_limit="-36.5" upper_limit="-2.1"/>
                    <measurement group_id="O2" value="-16.4" lower_limit="-34.4" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24</title>
        <description>Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with end stage renal disease (ESRD) on dialysis.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes participants on dialysis and data after initiation of dialysis. One omarigliptin participant with severe renal impairment was misclassified as ESRD on dialysis in Phase A and was excluded from the Phase A analysis (corrected in Phase B).</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A)</title>
            <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo to Omarigliptin (Phase A)</title>
            <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24</title>
          <description>Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with end stage renal disease (ESRD) on dialysis.</description>
          <population>APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes participants on dialysis and data after initiation of dialysis. One omarigliptin participant with severe renal impairment was misclassified as ESRD on dialysis in Phase A and was excluded from the Phase A analysis (corrected in Phase B).</population>
          <units>mL/min/1.73 m^2</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="85"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" lower_limit="-2.1" upper_limit="1.2"/>
                    <measurement group_id="O2" value="-0.0" lower_limit="-1.8" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.720</p_value>
            <method>cLDA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.7</ci_lower_limit>
            <ci_upper_limit>1.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in eGFR at Week 54</title>
        <description>Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with ESRD on dialysis.</description>
        <time_frame>Baseline and Week 54</time_frame>
        <population>APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes all participants on dialysis and data after initiation of dialysis. Phase B includes 1 omarigliptin participant in the severe renal impairment stratum (not on dialysis) who was misclassified in the ESRD stratum on dialysis during Phase A.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin (Phase A) → Omarigliptin (Phase B)</title>
            <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
          </group>
          <group group_id="O2">
            <title>Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)</title>
            <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in eGFR at Week 54</title>
          <description>Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with ESRD on dialysis.</description>
          <population>APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes all participants on dialysis and data after initiation of dialysis. Phase B includes 1 omarigliptin participant in the severe renal impairment stratum (not on dialysis) who was misclassified in the ESRD stratum on dialysis during Phase A.</population>
          <units>mL/min/1.73 m^2</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="86"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" lower_limit="-4.0" upper_limit="-0.1"/>
                    <measurement group_id="O2" value="-2.3" lower_limit="-4.3" upper_limit="-0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up)</time_frame>
      <desc>APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.</desc>
      <group_list>
        <group group_id="E1">
          <title>Omarigliptin (Phase A)</title>
          <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo to Omarigliptin (Phase A)</title>
          <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Omarigliptin (Phase A) → Omarigliptin (Phase B)</title>
          <description>Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
        </group>
        <group group_id="E4">
          <title>Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)</title>
          <description>Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="106"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Vascular stent restenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Hepatitis C</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Enterococcal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Infected dermal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Coronary artery restenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula site complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Gouty arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Subclavian artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="106"/>
                <counts group_id="E3" subjects_affected="44" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="52" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="106"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E4" events="14" subjects_affected="12" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="106"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine phosphokinase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E3" events="25" subjects_affected="7" subjects_at_risk="106"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="84" subjects_affected="21" subjects_at_risk="106"/>
                <counts group_id="E2" events="88" subjects_affected="19" subjects_at_risk="106"/>
                <counts group_id="E3" events="138" subjects_affected="27" subjects_at_risk="106"/>
                <counts group_id="E4" events="161" subjects_affected="25" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="106"/>
              </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. Sponsor review can be expedited to meet publication timelines.</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/NCT01698775
org study id: 3102-019
secondary id: 2012-002332-85
nct id: NCT01698775
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy and safety of omarigliptin in
      participants with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency
      or end stage renal disease on dialysis with inadequate glycemic control. The primary
      hypothesis of the study is that omarigliptin compared to placebo produces greater reduction
      in glycosylated hemoglobin (A1C) after 24 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24
time frame: Baseline and Week 24
description: A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
measure: Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)
time frame: Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)
description: An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
measure: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)
time frame: Up to 24 weeks
description: An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
measure: Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)
time frame: Up to 58 weeks (including 28 days following the last dose of study therapy)
description: An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
measure: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)
time frame: Up to 54 weeks
description: An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
time frame: Baseline and Week 24
description: Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
measure: Change From Baseline in A1C at Week 54
time frame: Baseline and Week 54
description: A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
measure: Change From Baseline in FPG at Week 54
time frame: Baseline and Week 54
description: Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
time frame: Baseline and Week 24
description: Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with end stage renal disease (ESRD) on dialysis.
measure: Change From Baseline in eGFR at Week 54
time frame: Baseline and Week 54
description: Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with ESRD on dialysis.
arm group label: Omarigliptin (Phase A) → Omarigliptin (Phase B)
arm group type: Experimental
description: Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) will receive matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
arm group label: Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
arm group type: Active Comparator
description: Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) will receive glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
intervention type: Drug
intervention name: Omarigliptin
description: Participants with moderate renal insufficiency will receive one omarigliptin 25 mg capsule orally once a week; participants with severe renal insufficiency or end stage renal disease will receive one omarigliptin 12.5 mg capsule orally once a week
arm group label: Omarigliptin (Phase A) → Omarigliptin (Phase B)
other name: MK-3102
intervention type: Drug
intervention name: Placebo to omarigliptin
description: Matching placebo to omarigliptin capsule administered orally once a week
arm group label: Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
intervention type: Drug
intervention name: Glipizide
description: Phase A: Participants may receive open-label glipizide as rescue therapy up to Week 24 of the study. Phase B: Participants who received placebo to omarigliptin during Phase A and are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study Week 1 through Week 24) will receive glipizide capsule(s) 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
arm group label: Omarigliptin (Phase A) → Omarigliptin (Phase B)
arm group label: Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
other name: Glucotrol
other name: Glucotrol XL
intervention type: Drug
intervention name: Placebo to glipizide
description: Matching placebo to glipizide daily
arm group label: Omarigliptin (Phase A) → Omarigliptin (Phase B)
arm group label: Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
intervention type: Biological
intervention name: Insulin
description: Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.
arm group label: Omarigliptin (Phase A) → Omarigliptin (Phase B)
arm group label: Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Australia
country: Canada
country: Croatia
country: Czech Republic
country: Georgia
country: Hong Kong
country: Hungary
country: Israel
country: Malaysia
country: Philippines
country: Poland
country: Russian Federation
country: Serbia
country: South Africa
country: Spain
country: United Kingdom
country: United States
citation: Chacra A, Gantz I, Mendizabal G, Durlach L, O'Neill EA, Zimmer Z, Suryawanshi S, Engel SS, Lai E. A randomised, double-blind, trial of the safety and efficacy of omarigliptin (a once-weekly DPP-4 inhibitor) in subjects with type 2 diabetes and renal impairment. Int J Clin Pract. 2017 Jun;71(6):e12955. doi: 10.1111/ijcp.12955. Epub 2017 Apr 27.
PMID: 28449320
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Renal Insufficiency
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Glipizide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 