<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/NCT03770728</url>
  </required_header>
  <id_info>
    <org_study_id>EFC15337</org_study_id>
    <secondary_id>U1111-1205-1291</secondary_id>
    <nct_id>NCT03770728</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea</brief_title>
  <acronym>AMPLITUDE-S</acronym>
  <official_title>A 30-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hanmi Pharmaceutical Company Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to&#xD;
      placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus&#xD;
      (T2DM) inadequately controlled with metformin alone or in combination with sulfonylurea (SU).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To demonstrate the superiority of once weekly injection of efpeglenatide in comparison&#xD;
           to placebo on glycemic control.&#xD;
&#xD;
        -  To demonstrate the superiority of once weekly injection of efpeglenatide in comparison&#xD;
           to placebo on body weight.&#xD;
&#xD;
        -  To evaluate the safety of once weekly injection of efpeglenatide.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study duration per participant was approximately 39 weeks including an up to 3-week Screening&#xD;
      Period, a 30-week Treatment Period, and a 6-week safety Follow-up Period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision to cancel TRIAL, not related to safety concern&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Actual">December 27, 2020</completion_date>
  <primary_completion_date type="Actual">November 28, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Week 30 in HbA1c</measure>
    <time_frame>Baseline to Week 30</time_frame>
    <description>This analysis included all Week 30 assessment values available.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HbA1c &lt;7.0%</measure>
    <time_frame>Week 30</time_frame>
    <description>Participants who had no available assessment for HbA1c &lt;7% at Week 30 were considered as non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>Baseline to Week 30</time_frame>
    <description>This analysis included all Week 30 assessment values available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 30 in Body Weight</measure>
    <time_frame>Baseline to Week 30</time_frame>
    <description>This analysis included all Week 30 assessment values available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia &lt;3.0 mmol/L [&lt;54 mg/dL], Severe Hypoglycemia)</measure>
    <time_frame>Baseline up to Week 30</time_frame>
    <description>Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of &lt;54 milligrams per deciliter (mg/dL) (&lt;3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia &lt;3.0 mmol/L [&lt;54 mg/dL] and Severe Hypoglycemia) Per Participant-Year</measure>
    <time_frame>Baseline up to Week 30</time_frame>
    <description>Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of &lt;54 mg/dL (&lt;3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">312</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo (matched to Efpeglenatide) subcutaneous (SC) injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Efpeglenatide 2 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Efpeglenatide 4 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Efpeglenatide 6 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Efpeglenatide SAR439977</intervention_name>
    <description>Pharmaceutical form: solution for injection Route of administration: subcutaneous</description>
    <arm_group_label>Efpeglenatide 2 mg</arm_group_label>
    <arm_group_label>Efpeglenatide 4 mg</arm_group_label>
    <arm_group_label>Efpeglenatide 6 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pharmaceutical form: solution for injection Route of administration: subcutaneous</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Background therapy: Metformin alone or in combination with SU</intervention_name>
    <description>Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling.</description>
    <arm_group_label>Efpeglenatide 2 mg</arm_group_label>
    <arm_group_label>Efpeglenatide 4 mg</arm_group_label>
    <arm_group_label>Efpeglenatide 6 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Participant must be greater than or equal to (&gt;=)18 years of age at the time of&#xD;
             signing the informed consent.&#xD;
&#xD;
          -  Participants with T2DM.&#xD;
&#xD;
          -  Diabetes diagnosed at least 1 year before screening.&#xD;
&#xD;
          -  Participants on metformin alone or in combination with SU, for at least 3 months prior&#xD;
             to screening.&#xD;
&#xD;
          -  Glycated hemoglobin between 7.0% and 10.0% (inclusive) measured by the central&#xD;
             laboratory at screening.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  History of severe hypoglycemia requiring emergency room admission or hospitalization&#xD;
             within 3 months prior to screening.&#xD;
&#xD;
          -  Retinopathy or maculopathy with one of the following treatments, either recent (within&#xD;
             3 months prior to screening) or planned: intravitreal injections or laser or&#xD;
             vitrectomy surgery.&#xD;
&#xD;
          -  Clinically relevant history of gastrointestinal disease associated with prolonged&#xD;
             nausea and vomiting, including (but not limited to) gastroparesis, unstable and not&#xD;
             controlled gastroesophageal reflux disease requiring medical treatment within 6 months&#xD;
             prior to screening or history of surgery affecting gastric emptying.&#xD;
&#xD;
          -  History of pancreatitis (unless pancreatitis was related to gallstones and&#xD;
             cholecystectomy has been performed), pancreatitis during previous treatment with&#xD;
             incretin therapies, chronic pancreatitis, pancreatectomy.&#xD;
&#xD;
          -  Personal or family history of medullary thyroid cancer (MTC) or genetic conditions&#xD;
             that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).&#xD;
&#xD;
          -  Body weight change of &gt;=5 kilograms within the last 3 months prior to screening.&#xD;
&#xD;
          -  Systolic blood pressure greater than (&gt;)180 millimeters of mercury (mmHg) and/or&#xD;
             diastolic blood pressure &gt;100 mmHg at randomization.&#xD;
&#xD;
          -  Severe renal disease as defined by estimated glomerular filtration rate (eGFR) of &lt;30&#xD;
             milliliters per minute per 1.73 square meter.&#xD;
&#xD;
          -  Laboratory findings at the screening visit:&#xD;
&#xD;
               -  Alanine aminotransferase or aspartate aminotransferase &gt;3*upper limit of the&#xD;
                  normal (ULN) or total bilirubin &gt;1.5*ULN (except in case of documented Gilbert's&#xD;
                  syndrome);&#xD;
&#xD;
               -  Amylase and/or lipase: &gt;3*ULN laboratory range;&#xD;
&#xD;
               -  Calcitonin &gt;=5.9 picomoles per liter (20 picograms per milliliter).&#xD;
&#xD;
          -  Gastric surgery or other gastric procedures intended for weight loss within 2 years&#xD;
             prior to screening, or planned during study period.&#xD;
&#xD;
          -  Pregnant (confirmed by serum pregnancy test at screening) or breast-feeding women.&#xD;
&#xD;
          -  Women of childbearing potential not willing to use highly effective method(s) of birth&#xD;
             control or who are unwilling to be tested for pregnancy during the study period and&#xD;
             for at least 5 weeks after the last dose of study intervention.&#xD;
&#xD;
        The above information was not intended to contain all considerations relevant to a&#xD;
        participant's potential participation in a clinical trial.&#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>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 8400038</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400035</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400005</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400042</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400051</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400056</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400057</name>
      <address>
        <city>Huntington Park</city>
        <state>California</state>
        <zip>90255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400009</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400045</name>
      <address>
        <city>Spring Valley</city>
        <state>California</state>
        <zip>91978</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400040</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400047</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400046</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400041</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400025</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400044</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400001</name>
      <address>
        <city>Bridgeton</city>
        <state>New Jersey</state>
        <zip>08302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400039</name>
      <address>
        <city>New Windsor</city>
        <state>New York</state>
        <zip>12553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400036</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400013</name>
      <address>
        <city>Maumee</city>
        <state>Ohio</state>
        <zip>43537</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400048</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400030</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400043</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400037</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560005</name>
      <address>
        <city>Baotou</city>
        <zip>014010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560042</name>
      <address>
        <city>Beijing</city>
        <zip>101199</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560053</name>
      <address>
        <city>Hangzhou</city>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560051</name>
      <address>
        <city>Hefei</city>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560011</name>
      <address>
        <city>Hunan</city>
        <zip>411100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560025</name>
      <address>
        <city>Meihekou</city>
        <zip>135000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560055</name>
      <address>
        <city>Nanchang</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560024</name>
      <address>
        <city>Nanjing</city>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560020</name>
      <address>
        <city>Pingxiang</city>
        <zip>337055</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560031</name>
      <address>
        <city>Shandong</city>
        <zip>250013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560030</name>
      <address>
        <city>Shandong</city>
        <zip>250031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560012</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560013</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560004</name>
      <address>
        <city>Shanghai</city>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560022</name>
      <address>
        <city>Shanghai</city>
        <zip>200090</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560041</name>
      <address>
        <city>Tianjin</city>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560010</name>
      <address>
        <city>Wenzhou</city>
        <zip>325027</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560052</name>
      <address>
        <city>Wuhu</city>
        <zip>241001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560034</name>
      <address>
        <city>Wuxi</city>
        <zip>214000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560026</name>
      <address>
        <city>Xuzhou</city>
        <zip>221006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560044</name>
      <address>
        <city>Yichun</city>
        <zip>336000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560003</name>
      <address>
        <city>Zhengzhou</city>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1580006</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1580003</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1580002</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <results_first_submitted>November 4, 2021</results_first_submitted>
  <results_first_submitted_qc>November 4, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 2, 2021</results_first_posted>
  <last_update_submitted>November 4, 2021</last_update_submitted>
  <last_update_submitted_qc>November 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2021</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>Efpeglenatide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03770728/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03770728/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 48 active sites in 3 countries. A total of 560 participants were screened between 01 August 2019 and 09 August 2020, out of which 248 were screen failures. Screen failures were mainly due to inclusion criteria not met.</recruitment_details>
      <pre_assignment_details>A total of 312 participants were randomized in 1:1:1:1 ratio to either placebo, efpeglenatide 2 milligrams (mg), efpeglenatide 4 mg, or efpeglenatide 6 mg treatment arms, stratified by screening glycated hemoglobin (HbA1c) values (less than [&lt;]8%, greater than or equal to [&gt;=]8%) and sulfonylurea (SU) use at screening (Yes/No).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo (matched to Efpeglenatide) subcutaneous (SC) injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
        </group>
        <group group_id="P2">
          <title>Efpeglenatide 2 mg</title>
          <description>Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
        </group>
        <group group_id="P3">
          <title>Efpeglenatide 4 mg</title>
          <description>Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.</description>
        </group>
        <group group_id="P4">
          <title>Efpeglenatide 6 mg</title>
          <description>Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="77"/>
                <participants group_id="P4" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="80">For safety analysis, participants were included in the treatment group that they were exposed for longer duration. 3 participants randomized to Efpeglenatide 6 mg received 4 mg dose for longer duration; and considered in Efpeglenatide 4 mg group for safety analysis.</participants>
                <participants group_id="P4" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="47"/>
                <participants group_id="P3" count="45"/>
                <participants group_id="P4" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="32"/>
                <participants group_id="P4" count="35"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor compliance to protocol</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on Intent-to-treat (ITT) population, which included all participants randomized irrespective of rescue therapy use and compliance with the study protocol and procedures, and were analyzed according to the treatment group allocated by randomization.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
        </group>
        <group group_id="B2">
          <title>Efpeglenatide 2 mg</title>
          <description>Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
        </group>
        <group group_id="B3">
          <title>Efpeglenatide 4 mg</title>
          <description>Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.</description>
        </group>
        <group group_id="B4">
          <title>Efpeglenatide 6 mg</title>
          <description>Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.</description>
        </group>
        <group group_id="B5">
          <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="79"/>
            <count group_id="B2" value="78"/>
            <count group_id="B3" value="77"/>
            <count group_id="B4" value="78"/>
            <count group_id="B5" value="312"/>
          </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="58.9" spread="10.6"/>
                    <measurement group_id="B2" value="60.1" spread="10.9"/>
                    <measurement group_id="B3" value="57.9" spread="10.5"/>
                    <measurement group_id="B4" value="58.8" spread="11.5"/>
                    <measurement group_id="B5" value="58.9" spread="10.9"/>
                  </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="34"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="48"/>
                    <measurement group_id="B5" value="179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Glycated Hemoglobin (HbA1c %)</title>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.09" spread="0.79"/>
                    <measurement group_id="B2" value="8.07" spread="0.76"/>
                    <measurement group_id="B3" value="8.15" spread="0.69"/>
                    <measurement group_id="B4" value="8.09" spread="0.79"/>
                    <measurement group_id="B5" value="8.10" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kilogram per square meter (kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.2" spread="7.1"/>
                    <measurement group_id="B2" value="31.8" spread="7.7"/>
                    <measurement group_id="B3" value="32.0" spread="6.3"/>
                    <measurement group_id="B4" value="32.4" spread="7.4"/>
                    <measurement group_id="B5" value="32.1" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 30 in HbA1c</title>
        <description>This analysis included all Week 30 assessment values available.</description>
        <time_frame>Baseline to Week 30</time_frame>
        <population>Analysis was performed on Intent-to-treat (ITT) population, which included all participants randomized irrespective of rescue therapy use and compliance with the study protocol and procedures, and were analyzed according to the treatment group allocated by randomization. Here, &quot;Overall number of participants analyzed&quot;= participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O2">
            <title>Efpeglenatide 2 mg</title>
            <description>Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O3">
            <title>Efpeglenatide 4 mg</title>
            <description>Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
          <group group_id="O4">
            <title>Efpeglenatide 6 mg</title>
            <description>Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 30 in HbA1c</title>
          <description>This analysis included all Week 30 assessment values available.</description>
          <population>Analysis was performed on Intent-to-treat (ITT) population, which included all participants randomized irrespective of rescue therapy use and compliance with the study protocol and procedures, and were analyzed according to the treatment group allocated by randomization. Here, &quot;Overall number of participants analyzed&quot;= participants evaluable for this outcome measure.</population>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.27" spread="0.92"/>
                    <measurement group_id="O2" value="-1.05" spread="0.88"/>
                    <measurement group_id="O3" value="-1.46" spread="0.90"/>
                    <measurement group_id="O4" value="-1.36" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HbA1c &lt;7.0%</title>
        <description>Participants who had no available assessment for HbA1c &lt;7% at Week 30 were considered as non-responders.</description>
        <time_frame>Week 30</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O2">
            <title>Efpeglenatide 2 mg</title>
            <description>Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O3">
            <title>Efpeglenatide 4 mg</title>
            <description>Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
          <group group_id="O4">
            <title>Efpeglenatide 6 mg</title>
            <description>Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HbA1c &lt;7.0%</title>
          <description>Participants who had no available assessment for HbA1c &lt;7% at Week 30 were considered as non-responders.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="33"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)</title>
        <description>This analysis included all Week 30 assessment values available.</description>
        <time_frame>Baseline to Week 30</time_frame>
        <population>Analysis was performed on ITT population. Here, &quot;Overall number of participants analyzed&quot;= participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O2">
            <title>Efpeglenatide 2 mg</title>
            <description>Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O3">
            <title>Efpeglenatide 4 mg</title>
            <description>Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
          <group group_id="O4">
            <title>Efpeglenatide 6 mg</title>
            <description>Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)</title>
          <description>This analysis included all Week 30 assessment values available.</description>
          <population>Analysis was performed on ITT population. Here, &quot;Overall number of participants analyzed&quot;= participants evaluable for this outcome measure.</population>
          <units>millimoles per liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="2.37"/>
                    <measurement group_id="O2" value="-0.97" spread="2.43"/>
                    <measurement group_id="O3" value="-1.75" spread="2.43"/>
                    <measurement group_id="O4" value="-1.20" spread="4.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 30 in Body Weight</title>
        <description>This analysis included all Week 30 assessment values available.</description>
        <time_frame>Baseline to Week 30</time_frame>
        <population>Analysis was performed on ITT population. Here, &quot;Overall number of participants analyzed&quot;= participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O2">
            <title>Efpeglenatide 2 mg</title>
            <description>Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O3">
            <title>Efpeglenatide 4 mg</title>
            <description>Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
          <group group_id="O4">
            <title>Efpeglenatide 6 mg</title>
            <description>Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 30 in Body Weight</title>
          <description>This analysis included all Week 30 assessment values available.</description>
          <population>Analysis was performed on ITT population. Here, &quot;Overall number of participants analyzed&quot;= participants evaluable for this outcome measure.</population>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.89" spread="5.53"/>
                    <measurement group_id="O2" value="-2.49" spread="3.93"/>
                    <measurement group_id="O3" value="-2.72" spread="6.49"/>
                    <measurement group_id="O4" value="-3.87" spread="4.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia &lt;3.0 mmol/L [&lt;54 mg/dL], Severe Hypoglycemia)</title>
        <description>Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of &lt;54 milligrams per deciliter (mg/dL) (&lt;3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.</description>
        <time_frame>Baseline up to Week 30</time_frame>
        <population>Analysis was performed on safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O2">
            <title>Efpeglenatide 2 mg</title>
            <description>Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O3">
            <title>Efpeglenatide 4 mg</title>
            <description>Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
          <group group_id="O4">
            <title>Efpeglenatide 6 mg</title>
            <description>Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia &lt;3.0 mmol/L [&lt;54 mg/dL], Severe Hypoglycemia)</title>
          <description>Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of &lt;54 milligrams per deciliter (mg/dL) (&lt;3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.</description>
          <population>Analysis was performed on safety population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="80"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Documented symptomatic hypoglycemia (&lt;54 mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia &lt;3.0 mmol/L [&lt;54 mg/dL] and Severe Hypoglycemia) Per Participant-Year</title>
        <description>Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of &lt;54 mg/dL (&lt;3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.</description>
        <time_frame>Baseline up to Week 30</time_frame>
        <population>Analysis was performed on safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O2">
            <title>Efpeglenatide 2 mg</title>
            <description>Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
          </group>
          <group group_id="O3">
            <title>Efpeglenatide 4 mg</title>
            <description>Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
          <group group_id="O4">
            <title>Efpeglenatide 6 mg</title>
            <description>Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia &lt;3.0 mmol/L [&lt;54 mg/dL] and Severe Hypoglycemia) Per Participant-Year</title>
          <description>Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of &lt;54 mg/dL (&lt;3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.</description>
          <population>Analysis was performed on safety population.</population>
          <units>events per participant-year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="80"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Documented symptomatic hypoglycemia (&lt;54 mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0.06"/>
                    <measurement group_id="O4" value="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of investigational medicinal product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 34).</time_frame>
      <desc>TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
        </group>
        <group group_id="E2">
          <title>Efpeglenatide 2 mg</title>
          <description>Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.</description>
        </group>
        <group group_id="E3">
          <title>Efpeglenatide 4 mg</title>
          <description>Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.</description>
        </group>
        <group group_id="E4">
          <title>Efpeglenatide 6 mg</title>
          <description>Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="80"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Enterovesical Fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </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="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Intraductal Proliferative Breast Lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Ovarian Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Pancreatic Carcinoma Metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </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="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Cerebral Ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental Status Changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</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="21" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="36" subjects_at_risk="80"/>
                <counts group_id="E4" subjects_affected="32" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E3" events="16" subjects_affected="13" subjects_at_risk="80"/>
                <counts group_id="E4" events="17" subjects_affected="12" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="78"/>
                <counts group_id="E3" events="17" subjects_affected="16" subjects_at_risk="80"/>
                <counts group_id="E4" events="9" subjects_affected="8" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="80"/>
                <counts group_id="E4" events="16" subjects_affected="10" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="80"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="79"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="80"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lipase Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="80"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="80"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="75"/>
              </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 supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated early by the Sponsor on 09 September 2020. Due to early termination of the study, few efficacy evaluations and analyses originally planned in the protocol were no longer considered to be applicable and were not performed. Primary, and secondary efficacy data were descriptively summarized.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Trial Transparency Team</name_or_title>
      <organization>Sanofi</organization>
      <phone>800-633-1610 ext 6#</phone>
      <email>Contact-US@sanofi.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/NCT03770728
org study id: EFC15337
secondary id: U1111-1205-1291
nct id: NCT03770728
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Primary Objective:

      To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to
      placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus
      (T2DM) inadequately controlled with metformin alone or in combination with sulfonylurea (SU).

      Secondary Objectives:

        -  To demonstrate the superiority of once weekly injection of efpeglenatide in comparison
           to placebo on glycemic control.

        -  To demonstrate the superiority of once weekly injection of efpeglenatide in comparison
           to placebo on body weight.

        -  To evaluate the safety of once weekly injection of efpeglenatide.
Study duration per participant was approximately 39 weeks including an up to 3-week Screening
      Period, a 30-week Treatment Period, and a 6-week safety Follow-up Period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline to Week 30 in HbA1c
time frame: Baseline to Week 30
description: This analysis included all Week 30 assessment values available.
measure: Number of Participants With HbA1c <7.0%
time frame: Week 30
description: Participants who had no available assessment for HbA1c <7% at Week 30 were considered as non-responders.
measure: Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)
time frame: Baseline to Week 30
description: This analysis included all Week 30 assessment values available.
measure: Change From Baseline to Week 30 in Body Weight
time frame: Baseline to Week 30
description: This analysis included all Week 30 assessment values available.
measure: Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)
time frame: Baseline up to Week 30
description: Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 milligrams per deciliter (mg/dL) (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
measure: Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year
time frame: Baseline up to Week 30
description: Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received placebo (matched to Efpeglenatide) subcutaneous (SC) injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
arm group label: Efpeglenatide 2 mg
arm group type: Experimental
description: Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
arm group label: Efpeglenatide 4 mg
arm group type: Experimental
description: Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.
arm group label: Efpeglenatide 6 mg
arm group type: Experimental
description: Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
intervention type: Drug
intervention name: Efpeglenatide SAR439977
description: Pharmaceutical form: solution for injection Route of administration: subcutaneous
arm group label: Efpeglenatide 2 mg
arm group label: Efpeglenatide 4 mg
arm group label: Efpeglenatide 6 mg
intervention type: Drug
intervention name: Placebo
description: Pharmaceutical form: solution for injection Route of administration: subcutaneous
arm group label: Placebo
intervention type: Drug
intervention name: Background therapy: Metformin alone or in combination with SU
description: Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling.
arm group label: Efpeglenatide 2 mg
arm group label: Efpeglenatide 4 mg
arm group label: Efpeglenatide 6 mg
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: China
country: Taiwan
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Efpeglenatide
sharing ipd: No
ipd description: No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.
provided document: 
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated early by the Sponsor on 09 September 2020. Due to early termination of the study, few efficacy evaluations and analyses originally planned in the protocol were no longer considered to be applicable and were not performed. Primary, and secondary efficacy data were descriptively summarized.
point of contact: 