<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/NCT02973321</url>
  </required_header>
  <id_info>
    <org_study_id>DRI13940</org_study_id>
    <secondary_id>2016-001328-77</secondary_id>
    <secondary_id>U1111-1179-4786</secondary_id>
    <nct_id>NCT02973321</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus</brief_title>
  <official_title>A 26-Week Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      The primary objective of this study was to assess the dose-response relationship of SAR425899&#xD;
      versus placebo in terms of glycemic control as measured by the change in glycosylated&#xD;
      hemoglobin (HbA1c).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To assess the effect of SAR425899 on body weight.&#xD;
&#xD;
        -  To assess the safety and immunogenicity profile of SAR425899, including assessment of&#xD;
           the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor.&#xD;
&#xD;
        -  To assess the proportion of participants achieving predefined HbA1c targets of &lt;7% and&#xD;
           &lt;6.5% as well as the proportion of participants achieving &gt;=5% and &gt;=10% body weight&#xD;
           loss.&#xD;
&#xD;
        -  To assess the effect of once daily dosing of SAR425899 on additional parameters of&#xD;
           glycemic control and lipid metabolism.&#xD;
&#xD;
        -  To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic&#xD;
           (PD) biomarkers.&#xD;
&#xD;
        -  To assess the pharmacokinetic (PK) profile and parameters of SAR425899, inter-individual&#xD;
           and inter-occasion variability in PK parameters using a population PK approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total study duration will be approximately 30 weeks, consisting of 3 weeks screening&#xD;
      period at the site, a 26 weeks treatment period, and 3 days post treatment follow up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2016</start_date>
  <completion_date type="Actual">December 27, 2017</completion_date>
  <primary_completion_date type="Actual">December 27, 2017</primary_completion_date>
  <phase>Phase 2</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 in HbA1c to Week 26</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based multiple imputation (MI) method under the missing not at random framework.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Body Weight to Week 26</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing post- baseline values were imputed by placebo control-based MI method under the missing not at random framework.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reached HbA1c Target of &lt;6.5% or &lt;7% at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving &gt;=5% or &gt;=10% Body Weight Loss at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based MI method under the missing not at random framework.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>Change in 7-point SMPG profile from baseline to Week 26 was assessed by summary statistics. 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, and Week 26): pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) is defined as 2 hours after the start of the meal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Requiring Rescue Therapy</measure>
    <time_frame>Baseline up to 26 weeks</time_frame>
    <description>Rescue medication was introduced in case FPG or HbA1c values were above pre-defined thresholds, and if no reasons were found for insufficient glucose control, and appropriate action failed to decrease FPG / HbA1c under the threshold values (from baseline to Week 8: FPG &gt;270 mg/dL 15.0 mmol/L, from Week 8 to Week 14: FPG &gt;13.3 mmol/L, and from Week 14 to Week 26: FPG &gt;11.1 mmol/L or HbA1c&gt;8%). The choice of rescue therapy was at the Investigator's discretion with the exception of using glucagon-like peptide-1 receptor (GLP-1R) agonists or dipeptidyl peptidase 4 (DPP4) inhibitors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Beta-Cell Function to Week 26</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>Beta-cell function was assessed by homeostatic model assessment (HOMA)-beta, derived from FPG and fasting plasma insulin (FPI). HOMA-beta was derived from FPG and FPI as (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value*100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Insulin Resistance to Week 26</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>Insulin Resistance was assessed by homeostasis model assessment for insulin resistance (HOMA-IR), derived from FPG and FPI. HOMA-IR was derived from FPG and FPI as (FPI [micro units per milliliter] * FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences</measure>
    <time_frame>Baseline,Week 26</time_frame>
    <description>Waist circumference was measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, using a stretch-resistant tape providing a constant 100 gm tension. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. Each measurement was repeated twice; if the measurements were within 1 cm of one another, the average was calculated, and if the difference exceeded 1 cm, the measurements were repeated.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">296</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>Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAR425899 0.12 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAR425899 0.16 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAR425899 0.20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liraglutide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAR425899</intervention_name>
    <description>Self-administered by SC injection using a solution for injection in cartridge.</description>
    <arm_group_label>SAR425899 0.12 mg</arm_group_label>
    <arm_group_label>SAR425899 0.16 mg</arm_group_label>
    <arm_group_label>SAR425899 0.20 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Self-administered by SC injection using a solution for injection in cartridge.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liraglutide</intervention_name>
    <description>Self-administered by SC injection using a pre-filled pen.</description>
    <arm_group_label>Liraglutide</arm_group_label>
    <other_name>Victoza</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Orally administered at a stable dose , &gt;=1500 mg daily stable dose or maximal tolerated dose.</description>
    <arm_group_label>Liraglutide</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>SAR425899 0.12 mg</arm_group_label>
    <arm_group_label>SAR425899 0.16 mg</arm_group_label>
    <arm_group_label>SAR425899 0.20 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Participants with type-2 diabetes mellitus (T2DM) for at least 3 months before the&#xD;
             screening visit.&#xD;
&#xD;
          -  On diet/exercise and/or treatment with metformin (stable dose of ≥1500 mg/day or&#xD;
             maximal tolerated dose) for at least 3 months prior to screening.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  At screening, participant's age &lt; legal age of adulthood and &gt;80 years.&#xD;
&#xD;
          -  Glycated hemoglobin at screening visit &lt;7.0% or &gt;10.0%.&#xD;
&#xD;
          -  Body mass index (BMI) &lt;25 kg/m^2 or &gt;45.0 kg/m^2.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of&#xD;
             birth control and/or who are unwilling or unable to be tested for pregnancy.&#xD;
&#xD;
          -  Diagnosis of type 1 diabetes mellitus.&#xD;
&#xD;
          -  Fasting plasma glucose of &gt;15 mmol/L (270 mg/dL) measured by the central laboratory at&#xD;
             screening (Visit 1), and confirmed (&gt;15 mmol/L [270 mg/dL]) by a repeat test before&#xD;
             randomization.&#xD;
&#xD;
          -  Treatment with glucose-lowering agents(s) other than metformin, currently or within&#xD;
             the 3 months prior to screening.&#xD;
&#xD;
          -  Previous insulin use, except for episode(s) of short-term treatment (≤15 consecutive&#xD;
             days) for intercurrent illness or pregnancy, or use of insulin within the last 6&#xD;
             months.&#xD;
&#xD;
          -  Contraindication(s) to metformin use.&#xD;
&#xD;
          -  Contraindication(s) to liraglutide use.&#xD;
&#xD;
          -  Significant change in body weight in the 3 months before screening.&#xD;
&#xD;
          -  Poorly controlled hypertension (a resting systolic blood pressure (SBP) &gt;160 mm Hg&#xD;
             and/or diastolic blood pressure (DBP) &gt;95 mm Hg at screening).&#xD;
&#xD;
          -  History of long QT syndrome and/or QTc more than 450 ms at screening visit.&#xD;
&#xD;
          -  History of pancreatitis or pancreatectomy.&#xD;
&#xD;
          -  History of weight loss surgery.&#xD;
&#xD;
          -  Personal or immediate family history of medullary thyroid cancer (MTC) or genetic&#xD;
             conditions that predispose to MTC.&#xD;
&#xD;
          -  Any prior exposure to drugs belonging to the class of glucagon-like peptide-1 (GLP-1)&#xD;
             receptor agonists/GLP-1 analogs.&#xD;
&#xD;
          -  Contraindications or known hypersensitivity reaction to glucagon.&#xD;
&#xD;
        The above information is 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>80 Years</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 8400028</name>
      <address>
        <city>Sheffield</city>
        <state>Alabama</state>
        <zip>35660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400002</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 8400024</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400001</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 8400012</name>
      <address>
        <city>Port Hueneme</city>
        <state>California</state>
        <zip>93041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400027</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400025</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400007</name>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <zip>34684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400013</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60827</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400016</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400023</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400018</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400019</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400014</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48532-3447</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400003</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400020</name>
      <address>
        <city>Linden</city>
        <state>New Jersey</state>
        <zip>07036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400022</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400005</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400004</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400006</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400021</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400026</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 8400017</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240008</name>
      <address>
        <city>Quebec</city>
        <zip>G1S 2L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240005</name>
      <address>
        <city>Sainte-Foy</city>
        <zip>G1W4R4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240002</name>
      <address>
        <city>Sherbrooke</city>
        <zip>J1L 0H8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240001</name>
      <address>
        <city>Toronto</city>
        <zip>M4G 3E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240003</name>
      <address>
        <city>Vancouver</city>
        <zip>V5Y 3W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2030003</name>
      <address>
        <city>Ceske Budejovice</city>
        <zip>370 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2030001</name>
      <address>
        <city>Krnov</city>
        <zip>79401</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2030004</name>
      <address>
        <city>Praha 10 - Uhrineves</city>
        <zip>104 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2030002</name>
      <address>
        <city>Praha 9 - Klanovice</city>
        <zip>19014</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760003</name>
      <address>
        <city>Berlin</city>
        <zip>10115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760001</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760006</name>
      <address>
        <city>Hohenmölsen</city>
        <zip>06679</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3480001</name>
      <address>
        <city>Balatonfüred</city>
        <zip>8230</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3480002</name>
      <address>
        <city>Budapest</city>
        <zip>1027</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3480008</name>
      <address>
        <city>Budapest</city>
        <zip>1042</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3480005</name>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3480006</name>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3480007</name>
      <address>
        <city>Budapest</city>
        <zip>1213</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4840004</name>
      <address>
        <city>Actopan</city>
        <zip>42500</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4840001</name>
      <address>
        <city>Guadalajara</city>
        <zip>44600</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4840003</name>
      <address>
        <city>Guadalajara</city>
        <zip>44670</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4840002</name>
      <address>
        <city>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4840006</name>
      <address>
        <city>San Juan Del Rio</city>
        <zip>76800</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6430003</name>
      <address>
        <city>Saratov</city>
        <zip>410030</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6430002</name>
      <address>
        <city>St-Petersburg</city>
        <zip>190068</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6430001</name>
      <address>
        <city>St-Petersburg</city>
        <zip>195257</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6430004</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194358</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6430005</name>
      <address>
        <city>Voronezh</city>
        <zip>394018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240005</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240007</name>
      <address>
        <city>Ferrol</city>
        <zip>15405</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240001</name>
      <address>
        <city>La Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240006</name>
      <address>
        <city>Las Palmas De Gran Canaria</city>
        <zip>35016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240002</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240003</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240004</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240008</name>
      <address>
        <city>Sevilla</city>
        <zip>41071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Mexico</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <results_first_submitted>December 3, 2020</results_first_submitted>
  <results_first_submitted_qc>January 21, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 9, 2021</results_first_posted>
  <disposition_first_submitted>December 4, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>December 4, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 7, 2018</disposition_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2022</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>Liraglutide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</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>January 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT02973321/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>September 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT02973321/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 59 centers in 8 countries. A total of 539 participants were screened between 2 December 2016 and 2 June 2017, of whom, 245 participants were screen failures. Screen failures were mainly due to exclusion criteria met. The study was double-blind for SAR425899 vs placebo and open-label for active comparator liraglutide.</recruitment_details>
      <pre_assignment_details>Total of 294 participants were randomized using interactive response technology, however 2 participants were screened failures and were randomized by error in liraglutide and SAR425899 0.20 mg groups, therefore a total of 296 participants were randomized and treated in study. Randomization was stratified by glycosylated hemoglobin(HbA1c) at screening visit(&lt;8% vs &gt;=8%) and body mass index (BMI)(&lt;35.0 kg/m^2 vs &gt;=35.0kg/m^2) at Day 1(start of investigational medicinal product[IMP]administration).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
        </group>
        <group group_id="P2">
          <title>SAR425899 0.12 mg</title>
          <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
        </group>
        <group group_id="P3">
          <title>SAR425899 0.16 mg</title>
          <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
        </group>
        <group group_id="P4">
          <title>SAR425899 0.20 mg</title>
          <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
        </group>
        <group group_id="P5">
          <title>Liraglutide</title>
          <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="66"/>
                <participants group_id="P3" count="66"/>
                <participants group_id="P4" count="64"/>
                <participants group_id="P5" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="51"/>
                <participants group_id="P3" count="52"/>
                <participants group_id="P4" count="48"/>
                <participants group_id="P5" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="13"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
        </group>
        <group group_id="B2">
          <title>SAR425899 0.12 mg</title>
          <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
        </group>
        <group group_id="B3">
          <title>SAR425899 0.16 mg</title>
          <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
        </group>
        <group group_id="B4">
          <title>SAR425899 0.20 mg</title>
          <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
        </group>
        <group group_id="B5">
          <title>Liraglutide</title>
          <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
        </group>
        <group group_id="B6">
          <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="33"/>
            <count group_id="B2" value="66"/>
            <count group_id="B3" value="66"/>
            <count group_id="B4" value="64"/>
            <count group_id="B5" value="67"/>
            <count group_id="B6" value="296"/>
          </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="56.2" spread="9.3"/>
                    <measurement group_id="B2" value="56.8" spread="9.0"/>
                    <measurement group_id="B3" value="54.5" spread="10.1"/>
                    <measurement group_id="B4" value="55.0" spread="10.4"/>
                    <measurement group_id="B5" value="56.1" spread="11.4"/>
                    <measurement group_id="B6" value="55.6" spread="10.2"/>
                  </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="15"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="36"/>
                    <measurement group_id="B6" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="31"/>
                    <measurement group_id="B6" value="153"/>
                  </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>American Indian or Alaska Native</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="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Oriental</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="59"/>
                    <measurement group_id="B5" value="61"/>
                    <measurement group_id="B6" value="269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</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="0"/>
                    <measurement group_id="B6" value="1"/>
                  </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>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="54"/>
                    <measurement group_id="B6" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.07" spread="4.41"/>
                    <measurement group_id="B2" value="33.67" spread="5.37"/>
                    <measurement group_id="B3" value="34.23" spread="4.68"/>
                    <measurement group_id="B4" value="33.63" spread="4.35"/>
                    <measurement group_id="B5" value="34.23" spread="5.51"/>
                    <measurement group_id="B6" value="33.74" spread="4.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline 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="8.04" spread="0.86"/>
                    <measurement group_id="B2" value="7.97" spread="0.88"/>
                    <measurement group_id="B3" value="7.99" spread="0.85"/>
                    <measurement group_id="B4" value="8.14" spread="0.94"/>
                    <measurement group_id="B5" value="8.11" spread="0.86"/>
                    <measurement group_id="B6" value="8.05" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in HbA1c to Week 26</title>
        <description>Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based multiple imputation (MI) method under the missing not at random framework.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>Analysis was performed on Intent-to-treat (ITT) population which included all randomized participants, irrespective of compliance with the study protocol and procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
          </group>
          <group group_id="O2">
            <title>SAR425899 0.12 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
          </group>
          <group group_id="O3">
            <title>SAR425899 0.16 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
          </group>
          <group group_id="O4">
            <title>SAR425899 0.20 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
          </group>
          <group group_id="O5">
            <title>Liraglutide</title>
            <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HbA1c to Week 26</title>
          <description>Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based multiple imputation (MI) method under the missing not at random framework.</description>
          <population>Analysis was performed on Intent-to-treat (ITT) population which included all randomized participants, irrespective of compliance with the study protocol and procedures.</population>
          <units>percentage of HbA1c</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="64"/>
                <count group_id="O5" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.663" spread="0.169"/>
                    <measurement group_id="O2" value="-1.517" spread="0.137"/>
                    <measurement group_id="O3" value="-1.618" spread="0.133"/>
                    <measurement group_id="O4" value="-1.562" spread="0.131"/>
                    <measurement group_id="O5" value="-1.312" spread="0.118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c value (&lt;8, &gt;=8 %), randomization strata of Visit 4 (Day 1) BMI (&lt;35.0 kg/m^2, &gt;=35.0 kg/m^2), and country as fixed effects and baseline HbA1c as a covariate. Overall 1st trend test based on a contrast with coefficients of +3, +1, -1, -3 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide. Here it is test 1 of testing order.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The overall Type 1 error for multiple comparisons of the HbA1c and body weight was controlled by a Hierarchical testing procedure. Testing was performed in following sequence: 1. 1st trend test for HbA1c, 2. 1st trend test for body weight, 3. 2nd trend test for HbA1c, 4. 2nd trend test for body weight, 5. 3rd trend test for HbA1c, 6. 3rd trend test for body weight.</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Hierarchical testing procedure continued only, if the previous comparison was statistically significant. Threshold for significance at 0.05 level.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>1st trend test</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (&lt;8, &gt;=8 %), randomization strata of Visit 4 (Day 1) BMI (&lt;35.0 kg/m^2, &gt;=35.0 kg/m^2), and country as fixed effects and baseline HbA1c as a covariate. Second Trend test based on a contrast with coefficients of 0, +1, 0, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 3 of hierarchical testing sequence.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Hierarchical testing procedure continued only, if the previous comparison was statistically significant.</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>2nd Trend test</method_desc>
            <param_type>LS Mean difference</param_type>
            <param_value>-0.956</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.206</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.359</ci_lower_limit>
            <ci_upper_limit>-0.552</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (&lt;8, &gt;=8 %), randomization strata of Visit 4 (Day 1) BMI (&lt;35.0 kg/m^2, &gt;=35.0 kg/m^2), and country as fixed effects and baseline HbA1c as a covariate. Third Trend test based on a contrast with coefficients of 0, 0, +1, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 5 of hierarchical testing sequence.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Hierarchical testing procedure continued only, if the previous comparison was statistically significant.</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>3rd Trend test</method_desc>
            <param_type>LS Mean difference</param_type>
            <param_value>-0.854</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.209</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.264</ci_lower_limit>
            <ci_upper_limit>-0.444</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Body Weight to Week 26</title>
        <description>Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing post- baseline values were imputed by placebo control-based MI method under the missing not at random framework.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
          </group>
          <group group_id="O2">
            <title>SAR425899 0.12 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
          </group>
          <group group_id="O3">
            <title>SAR425899 0.16 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
          </group>
          <group group_id="O4">
            <title>SAR425899 0.20 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
          </group>
          <group group_id="O5">
            <title>Liraglutide</title>
            <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Body Weight to Week 26</title>
          <description>Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing post- baseline values were imputed by placebo control-based MI method under the missing not at random framework.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>Kg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="64"/>
                <count group_id="O5" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.759" spread="0.734"/>
                    <measurement group_id="O2" value="-4.276" spread="0.564"/>
                    <measurement group_id="O3" value="-5.330" spread="0.549"/>
                    <measurement group_id="O4" value="-4.407" spread="0.559"/>
                    <measurement group_id="O5" value="-4.590" spread="0.521"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Placebo, SAR425899 0.12,0.16,0.20 mg: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (&lt;8, &gt;=8 %), randomization strata of Day 1 BMI (&lt;35.0 kg/m^2, &gt;=35.0 kg/m^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 2 of hierarchical testing sequence.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Hierarchical testing procedure continued only, if the previous comparison was statistically significant.</non_inferiority_desc>
            <p_value>0.0012</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>1st Trend test</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>SAR425899 0.16 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (&lt;8, &gt;=8 %), randomization strata of Day 1 BMI (&lt;35.0 kg/m^2, &gt;=35.0 kg/m^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 4 of hierarchical testing sequence.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Hierarchical testing procedure continued only, if the previous comparison was statistically significant</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>2nd Trend test</method_desc>
            <param_type>LS Mean difference</param_type>
            <param_value>-3.57</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.887</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.309</ci_lower_limit>
            <ci_upper_limit>-1.832</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>3rd Trend Test: SAR425899 0.12 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (&lt;8, &gt;=8 %), randomization strata of Day 1 BMI (&lt;35.0 kg/m^2, &gt;=35.0 kg/m^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 6 of hierarchical testing sequence.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Hierarchical testing procedure continued only, if the previous comparison was statistically significant.</non_inferiority_desc>
            <p_value>0.0047</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>3rd Trend test</method_desc>
            <param_type>LS Mean difference</param_type>
            <param_value>-2.517</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.891</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.264</ci_lower_limit>
            <ci_upper_limit>-0.77</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Reached HbA1c Target of &lt;6.5% or &lt;7% at Week 26</title>
        <description>The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.</description>
        <time_frame>Week 26</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
          </group>
          <group group_id="O2">
            <title>SAR425899 0.12 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
          </group>
          <group group_id="O3">
            <title>SAR425899 0.16 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
          </group>
          <group group_id="O4">
            <title>SAR425899 0.20 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
          </group>
          <group group_id="O5">
            <title>Liraglutide</title>
            <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reached HbA1c Target of &lt;6.5% or &lt;7% at Week 26</title>
          <description>The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="64"/>
                <count group_id="O5" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with HbA1c Target of &lt;6.5%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1"/>
                    <measurement group_id="O2" value="47.0"/>
                    <measurement group_id="O3" value="51.5"/>
                    <measurement group_id="O4" value="48.4"/>
                    <measurement group_id="O5" value="44.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with HbA1c Target of &lt;7%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.4"/>
                    <measurement group_id="O2" value="66.7"/>
                    <measurement group_id="O3" value="68.2"/>
                    <measurement group_id="O4" value="65.6"/>
                    <measurement group_id="O5" value="67.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving &gt;=5% or &gt;=10% Body Weight Loss at Week 26</title>
        <description>The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.</description>
        <time_frame>Week 26</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
          </group>
          <group group_id="O2">
            <title>SAR425899 0.12 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
          </group>
          <group group_id="O3">
            <title>SAR425899 0.16 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
          </group>
          <group group_id="O4">
            <title>SAR425899 0.20 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
          </group>
          <group group_id="O5">
            <title>Liraglutide</title>
            <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving &gt;=5% or &gt;=10% Body Weight Loss at Week 26</title>
          <description>The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="64"/>
                <count group_id="O5" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants Achieving &gt;=5% Body Weight Loss</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="45.5"/>
                    <measurement group_id="O4" value="35.9"/>
                    <measurement group_id="O5" value="40.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants Achieving &gt;=10% Body Weight Loss</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="12.1"/>
                    <measurement group_id="O3" value="13.6"/>
                    <measurement group_id="O4" value="15.6"/>
                    <measurement group_id="O5" value="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26</title>
        <description>Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based MI method under the missing not at random framework.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
          </group>
          <group group_id="O2">
            <title>SAR425899 0.12 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
          </group>
          <group group_id="O3">
            <title>SAR425899 0.16 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
          </group>
          <group group_id="O4">
            <title>SAR425899 0.20 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
          </group>
          <group group_id="O5">
            <title>Liraglutide</title>
            <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26</title>
          <description>Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based MI method under the missing not at random framework.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>mmol/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="64"/>
                <count group_id="O5" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.931" spread="0.394"/>
                    <measurement group_id="O2" value="-2.408" spread="0.308"/>
                    <measurement group_id="O3" value="-2.548" spread="0.301"/>
                    <measurement group_id="O4" value="-2.318" spread="0.312"/>
                    <measurement group_id="O5" value="-2.124" spread="0.280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26</title>
        <description>Change in 7-point SMPG profile from baseline to Week 26 was assessed by summary statistics. 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, and Week 26): pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) is defined as 2 hours after the start of the meal.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>Analysis was performed on ITT population. Overall number of participants analyzed = participants with at least 1 baseline and 1 post-baseline SMPG assessment during 26 week treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
          </group>
          <group group_id="O2">
            <title>SAR425899 0.12 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
          </group>
          <group group_id="O3">
            <title>SAR425899 0.16 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
          </group>
          <group group_id="O4">
            <title>SAR425899 0.20 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
          </group>
          <group group_id="O5">
            <title>Liraglutide</title>
            <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26</title>
          <description>Change in 7-point SMPG profile from baseline to Week 26 was assessed by summary statistics. 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, and Week 26): pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) is defined as 2 hours after the start of the meal.</description>
          <population>Analysis was performed on ITT population. Overall number of participants analyzed = participants with at least 1 baseline and 1 post-baseline SMPG assessment during 26 week treatment period.</population>
          <units>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="21"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="44"/>
                <count group_id="O5" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.82" spread="3.11"/>
                    <measurement group_id="O2" value="-2.86" spread="2.62"/>
                    <measurement group_id="O3" value="-2.63" spread="2.70"/>
                    <measurement group_id="O4" value="-2.49" spread="3.18"/>
                    <measurement group_id="O5" value="-2.21" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Requiring Rescue Therapy</title>
        <description>Rescue medication was introduced in case FPG or HbA1c values were above pre-defined thresholds, and if no reasons were found for insufficient glucose control, and appropriate action failed to decrease FPG / HbA1c under the threshold values (from baseline to Week 8: FPG &gt;270 mg/dL 15.0 mmol/L, from Week 8 to Week 14: FPG &gt;13.3 mmol/L, and from Week 14 to Week 26: FPG &gt;11.1 mmol/L or HbA1c&gt;8%). The choice of rescue therapy was at the Investigator's discretion with the exception of using glucagon-like peptide-1 receptor (GLP-1R) agonists or dipeptidyl peptidase 4 (DPP4) inhibitors.</description>
        <time_frame>Baseline up to 26 weeks</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
          </group>
          <group group_id="O2">
            <title>SAR425899 0.12 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
          </group>
          <group group_id="O3">
            <title>SAR425899 0.16 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
          </group>
          <group group_id="O4">
            <title>SAR425899 0.20 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
          </group>
          <group group_id="O5">
            <title>Liraglutide</title>
            <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Requiring Rescue Therapy</title>
          <description>Rescue medication was introduced in case FPG or HbA1c values were above pre-defined thresholds, and if no reasons were found for insufficient glucose control, and appropriate action failed to decrease FPG / HbA1c under the threshold values (from baseline to Week 8: FPG &gt;270 mg/dL 15.0 mmol/L, from Week 8 to Week 14: FPG &gt;13.3 mmol/L, and from Week 14 to Week 26: FPG &gt;11.1 mmol/L or HbA1c&gt;8%). The choice of rescue therapy was at the Investigator's discretion with the exception of using glucagon-like peptide-1 receptor (GLP-1R) agonists or dipeptidyl peptidase 4 (DPP4) inhibitors.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="64"/>
                <count group_id="O5" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="1.5"/>
                    <measurement group_id="O4" value="3.1"/>
                    <measurement group_id="O5" value="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Beta-Cell Function to Week 26</title>
        <description>Beta-cell function was assessed by homeostatic model assessment (HOMA)-beta, derived from FPG and fasting plasma insulin (FPI). HOMA-beta was derived from FPG and FPI as (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value*100.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
          </group>
          <group group_id="O2">
            <title>SAR425899 0.12 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
          </group>
          <group group_id="O3">
            <title>SAR425899 0.16 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
          </group>
          <group group_id="O4">
            <title>SAR425899 0.20 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
          </group>
          <group group_id="O5">
            <title>Liraglutide</title>
            <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Beta-Cell Function to Week 26</title>
          <description>Beta-cell function was assessed by homeostatic model assessment (HOMA)-beta, derived from FPG and fasting plasma insulin (FPI). HOMA-beta was derived from FPG and FPI as (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value*100.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>percentage of normal beta cells function</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="64"/>
                <count group_id="O5" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.025" spread="19.785"/>
                    <measurement group_id="O2" value="26.768" spread="15.833"/>
                    <measurement group_id="O3" value="31.122" spread="16.467"/>
                    <measurement group_id="O4" value="17.932" spread="14.397"/>
                    <measurement group_id="O5" value="27.263" spread="13.234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Insulin Resistance to Week 26</title>
        <description>Insulin Resistance was assessed by homeostasis model assessment for insulin resistance (HOMA-IR), derived from FPG and FPI. HOMA-IR was derived from FPG and FPI as (FPI [micro units per milliliter] * FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
          </group>
          <group group_id="O2">
            <title>SAR425899 0.12 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
          </group>
          <group group_id="O3">
            <title>SAR425899 0.16 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
          </group>
          <group group_id="O4">
            <title>SAR425899 0.20 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
          </group>
          <group group_id="O5">
            <title>Liraglutide</title>
            <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Insulin Resistance to Week 26</title>
          <description>Insulin Resistance was assessed by homeostasis model assessment for insulin resistance (HOMA-IR), derived from FPG and FPI. HOMA-IR was derived from FPG and FPI as (FPI [micro units per milliliter] * FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>HOMA-IR Index</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="64"/>
                <count group_id="O5" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.315" spread="0.865"/>
                    <measurement group_id="O2" value="-1.244" spread="0.670"/>
                    <measurement group_id="O3" value="-2.233" spread="0.664"/>
                    <measurement group_id="O4" value="-2.324" spread="0.649"/>
                    <measurement group_id="O5" value="-1.405" spread="0.613"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences</title>
        <description>Waist circumference was measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, using a stretch-resistant tape providing a constant 100 gm tension. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. Each measurement was repeated twice; if the measurements were within 1 cm of one another, the average was calculated, and if the difference exceeded 1 cm, the measurements were repeated.</description>
        <time_frame>Baseline,Week 26</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
          </group>
          <group group_id="O2">
            <title>SAR425899 0.12 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).</description>
          </group>
          <group group_id="O3">
            <title>SAR425899 0.16 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).</description>
          </group>
          <group group_id="O4">
            <title>SAR425899 0.20 mg</title>
            <description>SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).</description>
          </group>
          <group group_id="O5">
            <title>Liraglutide</title>
            <description>Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences</title>
          <description>Waist circumference was measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, using a stretch-resistant tape providing a constant 100 gm tension. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. Each measurement was repeated twice; if the measurements were within 1 cm of one another, the average was calculated, and if the difference exceeded 1 cm, the measurements were repeated.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="64"/>
                <count group_id="O5" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Waist Circumference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="0.75"/>
                    <measurement group_id="O2" value="-5.3" spread="1.34"/>
                    <measurement group_id="O3" value="-2.3" spread="1.61"/>
                    <measurement group_id="O4" value="-3.2" spread="0.66"/>
                    <measurement group_id="O5" value="-4.0" spread="2.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hip Circumference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.42" spread="0.781"/>
                    <measurement group_id="O2" value="-4.46" spread="1.378"/>
                    <measurement group_id="O3" value="-1.97" spread="1.572"/>
                    <measurement group_id="O4" value="-4.09" spread="0.945"/>
                    <measurement group_id="O5" value="-2.56" spread="1.513"/>
                  </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 form until 3 days after last treatment administration (Day 185).</time_frame>
      <desc>Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.</description>
        </group>
        <group group_id="E2">
          <title>SAR425899 0.06 mg</title>
          <description>Participants who were originally randomized to SAR425899 treatment groups and received 0.06 mg QD at Week 8.</description>
        </group>
        <group group_id="E3">
          <title>SAR425899 0.12 mg</title>
          <description>Participants who were originally randomized to SAR425899 treatment groups and received 0.12 mg QD at Week 8, or participants randomized to SAR425899 0.12 mg treatment group and discontinued the study before Week 8.</description>
        </group>
        <group group_id="E4">
          <title>SAR425899 0.16 mg</title>
          <description>Participants who were originally randomized to SAR425899 treatment groups and received 0.16 mg QD at Week 8, or participants randomized to SAR425899 0.16 mg treatment group and discontinued the study before Week 8.</description>
        </group>
        <group group_id="E5">
          <title>SAR425899 0.20 mg</title>
          <description>Participants who were originally randomized to SAR425899 treatment groups and received 0.20 mg QD at Week 8, or participants randomized to SAR425899 0.20 mg treatment group and discontinued the study before Week 8.</description>
        </group>
        <group group_id="E6">
          <title>Liraglutide</title>
          <description>Participants randomized to and received Liraglutide treatment were included in the Liraglutide treatment arm regardless of dose amount participants received.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDra 20.1</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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatic Cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Pancreatitis Chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis Staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastases To Adrenals</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Pancreatic Carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Rectal Adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemic Unconsciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Loss Of Consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDra 20.1</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="10" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="49" subjects_at_risk="72"/>
                <counts group_id="E4" subjects_affected="45" subjects_at_risk="59"/>
                <counts group_id="E5" subjects_affected="34" subjects_at_risk="47"/>
                <counts group_id="E6" subjects_affected="34" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis Coronary Artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="7" subjects_affected="5" subjects_at_risk="59"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="59"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="59"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Chronic Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="72"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="59"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" events="10" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E3" events="23" subjects_affected="15" subjects_at_risk="72"/>
                <counts group_id="E4" events="16" subjects_affected="11" subjects_at_risk="59"/>
                <counts group_id="E5" events="14" subjects_affected="9" subjects_at_risk="47"/>
                <counts group_id="E6" events="10" subjects_affected="8" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E3" events="14" subjects_affected="13" subjects_at_risk="72"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="59"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Gingival Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Irritable Bowel Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E2" events="22" subjects_affected="13" subjects_at_risk="18"/>
                <counts group_id="E3" events="45" subjects_affected="33" subjects_at_risk="72"/>
                <counts group_id="E4" events="41" subjects_affected="33" subjects_at_risk="59"/>
                <counts group_id="E5" events="36" subjects_affected="26" subjects_at_risk="47"/>
                <counts group_id="E6" events="25" subjects_affected="21" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Pyloric Sphincter Insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" events="17" subjects_affected="10" subjects_at_risk="18"/>
                <counts group_id="E3" events="32" subjects_affected="21" subjects_at_risk="72"/>
                <counts group_id="E4" events="23" subjects_affected="14" subjects_at_risk="59"/>
                <counts group_id="E5" events="24" subjects_affected="17" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Injection Site Reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic Steatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament Sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Lipase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </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="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="59"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="59"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic Arteriosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Hot Flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </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>If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Trial Transparency Team</name_or_title>
      <organization>Sanofi</organization>
      <phone>800-633-1610</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/NCT02973321
org study id: DRI13940
secondary id: 2016-001328-77
secondary id: U1111-1179-4786
nct id: NCT02973321
lead sponsor: 
has dmc: Yes
Primary Objective:

      The primary objective of this study was to assess the dose-response relationship of SAR425899
      versus placebo in terms of glycemic control as measured by the change in glycosylated
      hemoglobin (HbA1c).

      Secondary Objectives:

        -  To assess the effect of SAR425899 on body weight.

        -  To assess the safety and immunogenicity profile of SAR425899, including assessment of
           the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor.

        -  To assess the proportion of participants achieving predefined HbA1c targets of <7% and
           <6.5% as well as the proportion of participants achieving >=5% and >=10% body weight
           loss.

        -  To assess the effect of once daily dosing of SAR425899 on additional parameters of
           glycemic control and lipid metabolism.

        -  To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic
           (PD) biomarkers.

        -  To assess the pharmacokinetic (PK) profile and parameters of SAR425899, inter-individual
           and inter-occasion variability in PK parameters using a population PK approach.
The total study duration will be approximately 30 weeks, consisting of 3 weeks screening
      period at the site, a 26 weeks treatment period, and 3 days post treatment follow up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in HbA1c to Week 26
time frame: Baseline, Week 26
description: Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based multiple imputation (MI) method under the missing not at random framework.
measure: Mean Change From Baseline in Body Weight to Week 26
time frame: Baseline, Week 26
description: Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing post- baseline values were imputed by placebo control-based MI method under the missing not at random framework.
measure: Percentage of Participants Reached HbA1c Target of <6.5% or <7% at Week 26
time frame: Week 26
description: The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.
measure: Percentage of Participants Achieving >=5% or >=10% Body Weight Loss at Week 26
time frame: Week 26
description: The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26
time frame: Baseline, Week 26
description: Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based MI method under the missing not at random framework.
measure: Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26
time frame: Baseline, Week 26
description: Change in 7-point SMPG profile from baseline to Week 26 was assessed by summary statistics. 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, and Week 26): pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) is defined as 2 hours after the start of the meal.
measure: Percentage of Participants Requiring Rescue Therapy
time frame: Baseline up to 26 weeks
description: Rescue medication was introduced in case FPG or HbA1c values were above pre-defined thresholds, and if no reasons were found for insufficient glucose control, and appropriate action failed to decrease FPG / HbA1c under the threshold values (from baseline to Week 8: FPG >270 mg/dL 15.0 mmol/L, from Week 8 to Week 14: FPG >13.3 mmol/L, and from Week 14 to Week 26: FPG >11.1 mmol/L or HbA1c>8%). The choice of rescue therapy was at the Investigator's discretion with the exception of using glucagon-like peptide-1 receptor (GLP-1R) agonists or dipeptidyl peptidase 4 (DPP4) inhibitors.
measure: Change From Baseline in Beta-Cell Function to Week 26
time frame: Baseline, Week 26
description: Beta-cell function was assessed by homeostatic model assessment (HOMA)-beta, derived from FPG and fasting plasma insulin (FPI). HOMA-beta was derived from FPG and FPI as (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value*100.
measure: Change From Baseline in Insulin Resistance to Week 26
time frame: Baseline, Week 26
description: Insulin Resistance was assessed by homeostasis model assessment for insulin resistance (HOMA-IR), derived from FPG and FPI. HOMA-IR was derived from FPG and FPI as (FPI [micro units per milliliter] * FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value.
measure: Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences
time frame: Baseline,Week 26
description: Waist circumference was measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, using a stretch-resistant tape providing a constant 100 gm tension. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. Each measurement was repeated twice; if the measurements were within 1 cm of one another, the average was calculated, and if the difference exceeded 1 cm, the measurements were repeated.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
arm group label: SAR425899 0.12 mg
arm group type: Experimental
description: SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
arm group label: SAR425899 0.16 mg
arm group type: Experimental
description: SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
arm group label: SAR425899 0.20 mg
arm group type: Experimental
description: SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
arm group label: Liraglutide
arm group type: Active Comparator
description: Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
intervention type: Drug
intervention name: SAR425899
description: Self-administered by SC injection using a solution for injection in cartridge.
arm group label: SAR425899 0.12 mg
arm group label: SAR425899 0.16 mg
arm group label: SAR425899 0.20 mg
intervention type: Drug
intervention name: Placebo
description: Self-administered by SC injection using a solution for injection in cartridge.
arm group label: Placebo
intervention type: Drug
intervention name: Liraglutide
description: Self-administered by SC injection using a pre-filled pen.
arm group label: Liraglutide
other name: Victoza
intervention type: Drug
intervention name: Metformin
description: Orally administered at a stable dose , >=1500 mg daily stable dose or maximal tolerated dose.
arm group label: Liraglutide
arm group label: Placebo
arm group label: SAR425899 0.12 mg
arm group label: SAR425899 0.16 mg
arm group label: SAR425899 0.20 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: Canada
country: Czechia
country: Germany
country: Hungary
country: Mexico
country: Russian Federation
country: Spain
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Liraglutide
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
provided document: 
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 