<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/NCT01704261</url>
  </required_header>
  <id_info>
    <org_study_id>3102-022</org_study_id>
    <secondary_id>2012-002612-10</secondary_id>
    <nct_id>NCT01704261</nct_id>
  </id_info>
  <brief_title>Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)</brief_title>
  <official_title>A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the safety and efficacy of the addition of omarigliptin in&#xD;
      participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and&#xD;
      glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with&#xD;
      omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition&#xD;
      of placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2012</start_date>
  <completion_date type="Actual">December 23, 2014</completion_date>
  <primary_completion_date type="Actual">December 23, 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Hemoglobin A1c (A1C) at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event (AE)</measure>
    <time_frame>Up to Week 27</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued From the Study Due to an AE</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Attaining A1C Glycemic Goals of &lt;7% and &lt;6.5% at Week 24</measure>
    <time_frame>24 weeks</time_frame>
    <description>The percentage of participants who achieved A1C values &lt;6.5% (48 mmol/mol) or &lt;7.0% (53 mmol/mol) in the FAS population at Week 24.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">307</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Omarigliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omarigliptin (MK-3102) 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omarigliptin</intervention_name>
    <description>Omarigliptin 25 mg capsule administered orally once a week</description>
    <arm_group_label>Omarigliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching placebo to Omarigliptin</intervention_name>
    <description>Matching placebo to omarigliptin capsule administered orally once a week</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glimepiride</intervention_name>
    <description>Open-label glimepiride tablet(s) administered orally once daily for a total daily dose &gt;=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.</description>
    <arm_group_label>Omarigliptin</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Amaryl®</other_name>
    <other_name>Glimy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose &gt;=1500 mg</description>
    <arm_group_label>Omarigliptin</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Fortamet®</other_name>
    <other_name>Glucophage®</other_name>
    <other_name>Glucophage® XR</other_name>
    <other_name>Glumetza®</other_name>
    <other_name>Riomet®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with type 2 diabetes mellitus&#xD;
&#xD;
          -  Currently taking stable doses of metformin (&gt;=1500 mg/day) and sulfonylurea&#xD;
&#xD;
          -  Male, or female not of reproductive potential or female of reproductive potential who&#xD;
             agrees to remain abstinent or use (or have their partner use) 2 methods of acceptable&#xD;
             contraception to prevent pregnancy during the study and for 21 days after the last&#xD;
             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 antihyperglycemic agent therapies other than the protocol-required&#xD;
             sulfonylurea and metformin within 12 weeks prior to study participation or with&#xD;
             omarigliptin at any time prior to study participation.&#xD;
&#xD;
          -  History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor&#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;
          -  Is on or likely to require treatment for &gt;=2 consecutive weeks or repeated courses of&#xD;
             corticosteroids (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;
          -  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;
          -  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;
          -  Pregnant or breast feeding, or is expecting to conceive or donate eggs during the&#xD;
             trial, including 21 days following the last dose of study drug&#xD;
&#xD;
          -  Current user of recreational or illicit drugs or has had a recent history of drug&#xD;
             abuse or routinely consumes &gt;2 alcoholic drinks per day or &gt;14 drinks per week, or&#xD;
             engages in binge drinking&#xD;
&#xD;
          -  Donated blood products within 8 weeks of study participation, or intends to donate&#xD;
             blood products during the study or has received or anticipates receiving blood&#xD;
             products within 12 weeks prior to study participation or during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director, MD</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Lee SH, Gantz I, Round E, Latham M, O'Neill EA, Ceesay P, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, placebo-controlled clinical trial evaluating the safety and efficacy of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus inadequately controlled by glimepiride and metformin. BMC Endocr Disord. 2017 Nov 6;17(1):70. doi: 10.1186/s12902-017-0219-x.</citation>
    <PMID>29110647</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <results_first_submitted>October 23, 2015</results_first_submitted>
  <results_first_submitted_qc>October 23, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 25, 2015</results_first_posted>
  <last_update_submitted>August 9, 2018</last_update_submitted>
  <last_update_submitted_qc>August 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Glimepiride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>CSR Synopsis Links</doc_type>
      <doc_url>http://www.merck.com/clinical-trials/study.html?id=3102-022&amp;kw=3102-022&amp;tab=access</doc_url>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Fifty-one sites received IEC/IRB approval and were shipped clinical supplies.</recruitment_details>
      <pre_assignment_details>In total, 583 participants were screened and 276 participants were excluded during screening. The most common reason for participants not being randomized was screen failure. The most common reasons for screen failure were not meeting the metformin and glimepiride dose requirements inclusion criterion or meeting exclusionary laboratory values.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Omarigliptin</title>
          <description>Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="154"/>
                <participants group_id="P2" count="153"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
                <participants group_id="P2" count="138"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="15"/>
              </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="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omarigliptin</title>
          <description>Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</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="154"/>
            <count group_id="B2" value="153"/>
            <count group_id="B3" value="307"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.2" spread="8.4"/>
                    <measurement group_id="B2" value="58.4" spread="9.4"/>
                    <measurement group_id="B3" value="57.8" spread="8.9"/>
                  </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="81"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoglobin A1c (A1C) at Week 24</title>
        <description>A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1c (A1C) at Week 24</title>
          <description>A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.</description>
          <population>The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.</population>
          <units>%A1C</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.67" lower_limit="-0.84" upper_limit="-0.50"/>
                    <measurement group_id="O2" value="-0.06" lower_limit="-0.23" upper_limit="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Difference in the least squares means</method>
            <method_desc>Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.85</ci_lower_limit>
            <ci_upper_limit>-0.38</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Event (AE)</title>
        <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.</description>
        <time_frame>Up to Week 27</time_frame>
        <population>All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event (AE)</title>
          <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.</description>
          <population>All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.</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="153"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.5"/>
                    <measurement group_id="O2" value="47.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in % Omarigliptin vs Placebo</param_type>
            <param_value>9.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4</ci_lower_limit>
            <ci_upper_limit>20.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued From the Study Due to an AE</title>
        <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The ASaT Population was defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued From the Study Due to an AE</title>
          <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.</description>
          <population>The ASaT Population was defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.</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="153"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6"/>
                    <measurement group_id="O2" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in % Omarigliptin vs Placebo</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>4.3</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>Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24</title>
          <description>Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).</description>
          <population>The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.</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="153"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.6" lower_limit="-26.7" upper_limit="-12.5"/>
                    <measurement group_id="O2" value="-3.0" lower_limit="-10.2" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Difference in the least squares means</method>
            <method_desc>Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.</method_desc>
            <param_type>Difference of the least squares means</param_type>
            <param_value>-16.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.5</ci_lower_limit>
            <ci_upper_limit>-7.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Attaining A1C Glycemic Goals of &lt;7% and &lt;6.5% at Week 24</title>
        <description>The percentage of participants who achieved A1C values &lt;6.5% (48 mmol/mol) or &lt;7.0% (53 mmol/mol) in the FAS population at Week 24.</description>
        <time_frame>24 weeks</time_frame>
        <population>The FAS Population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin</title>
            <description>Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Attaining A1C Glycemic Goals of &lt;7% and &lt;6.5% at Week 24</title>
          <description>The percentage of participants who achieved A1C values &lt;6.5% (48 mmol/mol) or &lt;7.0% (53 mmol/mol) in the FAS population at Week 24.</description>
          <population>The FAS Population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;7.0%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.8" lower_limit="17.5" upper_limit="31.5"/>
                    <measurement group_id="O2" value="4.4" lower_limit="2.1" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;6.5%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" lower_limit="6.1" upper_limit="16.4"/>
                    <measurement group_id="O2" value="2.1" lower_limit="0.7" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Miettinen &amp; Nurminen method</method>
            <method_desc>Between-group confidence intervals and p-value (%) A1C &lt;7.0%; estimated using standard multiple imputation techniques.</method_desc>
            <param_type>Between-group Rate Difference</param_type>
            <param_value>19.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.7</ci_lower_limit>
            <ci_upper_limit>27.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>Miettinen &amp; Nurminen method</method>
            <method_desc>Between-group confidence intervals and p-value (%) A1C &lt;7.0%; estimated using standard multiple imputation techniques.</method_desc>
            <param_type>Between-group Rate Difference (%)</param_type>
            <param_value>8.0</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>14.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 27</time_frame>
      <desc>The ASaT Population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>Omarigliptin</title>
          <description>Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose &gt;=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose &gt;=1500 mg per day).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
              <event>
                <sub_title>Cerebrovascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="153"/>
              </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="153"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="153"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="65" subjects_affected="18" subjects_at_risk="153"/>
                <counts group_id="E2" events="44" subjects_affected="13" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

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


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01704261
org study id: 3102-022
secondary id: 2012-002612-10
nct id: NCT01704261
lead sponsor: 
has dmc: Yes
This study will examine the safety and efficacy of the addition of omarigliptin in
      participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and
      glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with
      omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition
      of placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change From Baseline in Hemoglobin A1c (A1C) at Week 24
time frame: Baseline and Week 24
description: A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.
measure: Percentage of Participants Who Experienced at Least One Adverse Event (AE)
time frame: Up to Week 27
description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
measure: Percentage of Participants Who Discontinued From the Study Due to an AE
time frame: Up to Week 24
description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
time frame: Baseline and Week 24
description: Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).
measure: Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24
time frame: 24 weeks
description: The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) or <7.0% (53 mmol/mol) in the FAS population at Week 24.
arm group label: Omarigliptin
arm group type: Experimental
description: Omarigliptin (MK-3102) 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
intervention type: Drug
intervention name: Omarigliptin
description: Omarigliptin 25 mg capsule administered orally once a week
arm group label: Omarigliptin
intervention type: Drug
intervention name: Matching placebo to Omarigliptin
description: Matching placebo to omarigliptin capsule administered orally once a week
arm group label: Placebo
intervention type: Drug
intervention name: Glimepiride
description: Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.
arm group label: Omarigliptin
arm group label: Placebo
other name: Amaryl®
other name: Glimy
intervention type: Drug
intervention name: Metformin
description: Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg
arm group label: Omarigliptin
arm group label: Placebo
other name: Fortamet®
other name: Glucophage®
other name: Glucophage® XR
other name: Glumetza®
other name: Riomet®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director, MD
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Korea, Republic of
country: Poland
country: Romania
country: Russian Federation
country: South Africa
country: United States
citation: Lee SH, Gantz I, Round E, Latham M, O'Neill EA, Ceesay P, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, placebo-controlled clinical trial evaluating the safety and efficacy of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus inadequately controlled by glimepiride and metformin. BMC Endocr Disord. 2017 Nov 6;17(1):70. doi: 10.1186/s12902-017-0219-x.
PMID: 29110647
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Glimepiride
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
study doc: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 