<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/NCT03242018</url>
  </required_header>
  <id_info>
    <org_study_id>EFC15166</org_study_id>
    <secondary_id>2016-004906-32</secondary_id>
    <secondary_id>U1111-1190-7589</secondary_id>
    <nct_id>NCT03242018</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control</brief_title>
  <acronym>SOTA-CKD4</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Severe Renal Impairment Who Have Inadequate Glycemic Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lexicon Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Lexicon Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with&#xD;
      respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes&#xD;
      who have inadequate glycemic control and severe renal impairment&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To assess the effects of sotagliflozin 200 mg versus placebo based on change from&#xD;
           baseline in HbA1c&#xD;
&#xD;
        -  To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo&#xD;
&#xD;
        -  To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of&#xD;
      randomized treatment and a visit 4 weeks after completion of the randomized treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">December 11, 2019</completion_date>
  <primary_completion_date type="Actual">May 16, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>An analysis of covariance (ANCOVA) model was used for the analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>An ANCOVA model was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>An ANCOVA model was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight at Week 26</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>An ANCOVA model was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>An ANCOVA model was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SBP at Week 12 for All Participants</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>An ANCOVA model was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR &gt;30 Milligrams Per Gram (mg/g)</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HbA1c &lt;6.5% at Week 26</measure>
    <time_frame>Week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HbA1c &lt;7.0% at Week 26</measure>
    <time_frame>Week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Hypoglycemic Events</measure>
    <time_frame>up to 56.3 weeks</time_frame>
    <description>Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL].</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">277</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Chronic Kidney Disease Stage 4</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 milligrams [mg] in appearance) orally once daily for up to 56 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sotagliflozin 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 56 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sotagliflozin 400 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Sotagliflozin 200 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sotagliflozin</intervention_name>
    <description>Sotagliflozin 200 mg, tablet, orally, once daily.</description>
    <arm_group_label>Sotagliflozin 200 mg</arm_group_label>
    <arm_group_label>Sotagliflozin 400 mg</arm_group_label>
    <other_name>SAR439954</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and&#xD;
             documented severe renal insufficiency - CKD4 - defined by an estimated glomerular&#xD;
             filtration rate (eGFR) equation (based on the 4 variable modification of diet in renal&#xD;
             disease (MDRD) equation) of ≥15 and &lt;30 milliliter per minute (mL/min)/1.73 per meter&#xD;
             square (m^2).&#xD;
&#xD;
          -  Signed written informed consent to participate in the study in accordance with local&#xD;
             regulations.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  At the time of screening, age &lt;18 years.&#xD;
&#xD;
          -  Hemoglobin A1c (HbA1c) &lt;7% or &gt;11%.&#xD;
&#xD;
          -  Type 1 diabetes.&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) not willing to use highly effective method(s)&#xD;
             of birth control during the study treatment period and the follow-up period, or who&#xD;
             are unwilling or unable to be tested for pregnancy during the study.&#xD;
&#xD;
          -  Treatment with an sodium-glucose cotransporter type 2 (SGLT2) inhibitor&#xD;
             (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.&#xD;
&#xD;
          -  Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such&#xD;
             as heart failure, active cancer, or other conditions that the Investigator believes&#xD;
             with result in a short life expectancy, will preclude their safe participation in this&#xD;
             study, or will make implementation of the protocol or interpretation of the study&#xD;
             results difficult.&#xD;
&#xD;
          -  Lower extremity complications (such as skin ulcers, infection, osteomyelitis and&#xD;
             gangrene) identified during the Screening period, and still requiring treatment at&#xD;
             Randomization.&#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>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suman Wason, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lexicon Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 8405033</name>
      <address>
        <city>Guntersville</city>
        <state>Alabama</state>
        <zip>35976-2206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405005</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018-2701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405007</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405015</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405032</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405003</name>
      <address>
        <city>Norco</city>
        <state>California</state>
        <zip>92860-3611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405013</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405018</name>
      <address>
        <city>San Dimas</city>
        <state>California</state>
        <zip>91773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405021</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761-2022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405001</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720-0834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405043</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155-4630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405006</name>
      <address>
        <city>Ocoee</city>
        <state>Florida</state>
        <zip>34761-4547</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405025</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174-8187</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405039</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405041</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005-4197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405030</name>
      <address>
        <city>Sellersburg</city>
        <state>Indiana</state>
        <zip>47172-8932</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405019</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405034</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 8405012</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701-2669</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405035</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405014</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405027</name>
      <address>
        <city>Laurelton</city>
        <state>New York</state>
        <zip>11413</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405037</name>
      <address>
        <city>New Bern</city>
        <state>North Carolina</state>
        <zip>28562-5200</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405038</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405009</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45419-4336</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405004</name>
      <address>
        <city>Beaumont</city>
        <state>Texas</state>
        <zip>77702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405036</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405020</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405026</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77099-4307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405047</name>
      <address>
        <city>Hurst</city>
        <state>Texas</state>
        <zip>76054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405031</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405016</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78249-2782</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405008</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041-1200</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8405040</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0325001</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1425DES</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0325003</name>
      <address>
        <city>Launs Este</city>
        <zip>B1824KAJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0325004</name>
      <address>
        <city>Mar Del Plata</city>
        <zip>B7600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0765003</name>
      <address>
        <city>Belém</city>
        <zip>66073-005</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0765001</name>
      <address>
        <city>Fortaleza</city>
        <zip>60170-195</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0765004</name>
      <address>
        <city>Rio De Janeiro</city>
        <zip>22271-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0765002</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01244-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1705004</name>
      <address>
        <city>Barranquilla</city>
        <zip>80020</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1705005</name>
      <address>
        <city>Bogota</city>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1705002</name>
      <address>
        <city>Manizales</city>
        <zip>170004</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1705001</name>
      <address>
        <city>Zipaquira</city>
        <zip>250252</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2765001</name>
      <address>
        <city>Frankfurt Am Main</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2765003</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2765004</name>
      <address>
        <city>Münster</city>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3485005</name>
      <address>
        <city>Baja</city>
        <zip>6500</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3485007</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3485004</name>
      <address>
        <city>Pécs</city>
        <zip>7624</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3765002</name>
      <address>
        <city>Ashkelon</city>
        <zip>78278</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3765001</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3765007</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3765005</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3765004</name>
      <address>
        <city>Rehovot</city>
        <zip>7642001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3765003</name>
      <address>
        <city>Tel Aviv</city>
        <zip>61480</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3765006</name>
      <address>
        <city>Zefat</city>
        <zip>13100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3805003</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3805005</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3805006</name>
      <address>
        <city>Napoli</city>
        <zip>00181</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3805002</name>
      <address>
        <city>Napoli</city>
        <zip>80138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3805001</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3805004</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4845007</name>
      <address>
        <city>Guadalajara Jalisco</city>
        <zip>44130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4845001</name>
      <address>
        <city>Guadalajara</city>
        <zip>44210</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4845004</name>
      <address>
        <city>Guadalajara</city>
        <zip>44600</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4845008</name>
      <address>
        <city>Merida, Yucatan</city>
        <zip>97130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4845006</name>
      <address>
        <city>Monterrey, N.L</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4845003</name>
      <address>
        <city>Morelia</city>
        <zip>58260</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4845002</name>
      <address>
        <city>Queretaro</city>
        <zip>76000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4845005</name>
      <address>
        <city>Xalapa</city>
        <zip>91020</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6165003</name>
      <address>
        <city>Krakow</city>
        <zip>31-209</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6165002</name>
      <address>
        <city>Lodz</city>
        <zip>92-213</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6165004</name>
      <address>
        <city>Oswiecim</city>
        <zip>32-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6165005</name>
      <address>
        <city>Puławy</city>
        <zip>24-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6165001</name>
      <address>
        <city>Rzeszow</city>
        <zip>35-055</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6425005</name>
      <address>
        <city>Bacau</city>
        <zip>600238</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6425002</name>
      <address>
        <city>Bucuresti</city>
        <zip>010825</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6425003</name>
      <address>
        <city>Bucuresti</city>
        <zip>020475</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6425007</name>
      <address>
        <city>Hunedoara</city>
        <zip>331057</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6425004</name>
      <address>
        <city>Lasi</city>
        <zip>700503</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6425001</name>
      <address>
        <city>Targu-Mures</city>
        <zip>540142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6435004</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>4540</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6435005</name>
      <address>
        <city>Kemerovo</city>
        <zip>650002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6435003</name>
      <address>
        <city>Krasnodar</city>
        <zip>350032</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6435006</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630091</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6435001</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194358</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7105003</name>
      <address>
        <city>Cape Town</city>
        <zip>7505</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7105004</name>
      <address>
        <city>Cape Town</city>
        <zip>7570</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7105001</name>
      <address>
        <city>Johannesburg</city>
        <zip>2188</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7105002</name>
      <address>
        <city>Pretoria</city>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7245005</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7245007</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7245003</name>
      <address>
        <city>Ferrol</city>
        <zip>15405</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7245009</name>
      <address>
        <city>Granada</city>
        <zip>18012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7245006</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7245004</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7245001</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7245002</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8045004</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8045006</name>
      <address>
        <city>Kiev</city>
        <zip>02002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8045007</name>
      <address>
        <city>Kyiv</city>
        <zip>02091</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8045003</name>
      <address>
        <city>Kyiv</city>
        <zip>04050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8045001</name>
      <address>
        <city>Kyiv</city>
        <zip>3037</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8045002</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Colombia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <results_first_submitted>April 16, 2021</results_first_submitted>
  <results_first_submitted_qc>June 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 25, 2021</results_first_posted>
  <disposition_first_submitted>May 1, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>June 3, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 25, 2021</disposition_first_posted>
  <last_update_submitted>June 3, 2021</last_update_submitted>
  <last_update_submitted_qc>June 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>December 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03242018/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>November 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03242018/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 106 investigative sites in United States, Argentina, Brazil, Colombia, Germany, Hungary, Israel, Italy, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Ukraine from 16 August 2017 to 11 December 2019.</recruitment_details>
      <pre_assignment_details>A total of 277 participants with a diagnosis of Type 2 Diabetes Mellitus were randomized 1:1:1 to 1 of the 3 treatment groups: Placebo, Sotagliflozin 200 milligram (mg) and Sotagliflozin 400 mg.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Sotagliflozin 200 mg</title>
          <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Sotagliflozin 400 mg</title>
          <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="92"/>
                <participants group_id="P3" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>At the Participant's Own Request</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason Not Specified</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Sotagliflozin 200 mg</title>
          <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Sotagliflozin 400 mg</title>
          <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
        </group>
        <group group_id="B4">
          <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="93"/>
            <count group_id="B2" value="92"/>
            <count group_id="B3" value="92"/>
            <count group_id="B4" value="277"/>
          </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="68.0" spread="8.3"/>
                    <measurement group_id="B2" value="66.8" spread="10.0"/>
                    <measurement group_id="B3" value="67.3" spread="9.6"/>
                    <measurement group_id="B4" value="67.4" spread="9.3"/>
                  </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="51"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="142"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="170"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="78"/>
                    <measurement group_id="B4" value="227"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colombia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c (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="8.38" spread="1.06"/>
                    <measurement group_id="B2" value="8.28" spread="1.03"/>
                    <measurement group_id="B3" value="8.25" spread="0.87"/>
                    <measurement group_id="B4" value="8.30" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic Blood Pressure (SBP)</title>
          <units>millimeter of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="144.72" spread="15.56"/>
                    <measurement group_id="B2" value="143.10" spread="14.98"/>
                    <measurement group_id="B3" value="144.20" spread="15.10"/>
                    <measurement group_id="B4" value="144.01" spread="15.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo</title>
        <description>An analysis of covariance (ANCOVA) model was used for the analysis.</description>
        <time_frame>Baseline to Week 26</time_frame>
        <population>Intent-to-treat (ITT) population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo</title>
          <description>An analysis of covariance (ANCOVA) model was used for the analysis.</description>
          <population>Intent-to-treat (ITT) population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</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="93"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="0.151"/>
                    <measurement group_id="O2" value="-0.40" spread="0.131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0962</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in Least Square (LS) Means</param_type>
            <param_value>-0.29</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.173</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.628</ci_lower_limit>
            <ci_upper_limit>0.051</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo</title>
        <description>An ANCOVA model was used for the analysis.</description>
        <time_frame>Baseline to Week 26</time_frame>
        <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo</title>
          <description>An ANCOVA model was used for the analysis.</description>
          <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</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="93"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="0.151"/>
                    <measurement group_id="O2" value="-0.07" spread="0.162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8124</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>0.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.196</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.338</ci_lower_limit>
            <ci_upper_limit>0.431</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26</title>
        <description>An ANCOVA model was used for the analysis.</description>
        <time_frame>Baseline to Week 26</time_frame>
        <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26</title>
          <description>An ANCOVA model was used for the analysis.</description>
          <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</population>
          <units>millimole per liter (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="93"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.069" spread="0.4482"/>
                    <measurement group_id="O2" value="-0.291" spread="0.5056"/>
                    <measurement group_id="O3" value="-0.644" spread="0.4348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5501</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.361</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6033</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5431</ci_lower_limit>
            <ci_upper_limit>0.8220</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1779</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.714</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.5298</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.7524</ci_lower_limit>
            <ci_upper_limit>0.3246</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight at Week 26</title>
        <description>An ANCOVA model was used for the analysis.</description>
        <time_frame>Baseline to Week 26</time_frame>
        <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight at Week 26</title>
          <description>An ANCOVA model was used for the analysis.</description>
          <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</population>
          <units>kilogram (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="93"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" spread="0.615"/>
                    <measurement group_id="O2" value="-0.43" spread="0.480"/>
                    <measurement group_id="O3" value="-1.02" spread="0.490"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2432</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.82</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.703</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.197</ci_lower_limit>
            <ci_upper_limit>0.557</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0487</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-1.41</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.715</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.810</ci_lower_limit>
            <ci_upper_limit>-0.008</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg</title>
        <description>An ANCOVA model was used for the analysis.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Analysis population included all participants with baseline SBP ≥130 mmHg in ITT population where, ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using control-based copy reference multiple imputation under the missing not at random framework.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg</title>
          <description>An ANCOVA model was used for the analysis.</description>
          <population>Analysis population included all participants with baseline SBP ≥130 mmHg in ITT population where, ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using control-based copy reference multiple imputation under the missing not at random framework.</population>
          <units>mmHg</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="73"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.70" spread="1.815"/>
                    <measurement group_id="O2" value="-4.84" spread="1.882"/>
                    <measurement group_id="O3" value="-7.10" spread="1.842"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3954</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-2.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.515</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.066</ci_lower_limit>
            <ci_upper_limit>2.792</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0716</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-4.40</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.442</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.185</ci_lower_limit>
            <ci_upper_limit>0.386</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SBP at Week 12 for All Participants</title>
        <description>An ANCOVA model was used for the analysis.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using control-based copy reference multiple imputation under the missing not at random framework.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SBP at Week 12 for All Participants</title>
          <description>An ANCOVA model was used for the analysis.</description>
          <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using control-based copy reference multiple imputation under the missing not at random framework.</population>
          <units>mmHg</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="93"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.50" spread="1.762"/>
                    <measurement group_id="O2" value="-5.74" spread="1.752"/>
                    <measurement group_id="O3" value="-7.86" spread="1.794"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1232</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-3.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.103</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.365</ci_lower_limit>
            <ci_upper_limit>0.881</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0098</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-5.36</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.077</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.433</ci_lower_limit>
            <ci_upper_limit>-1.292</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR &gt;30 Milligrams Per Gram (mg/g)</title>
        <description>An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.</description>
        <time_frame>Baseline to Week 26</time_frame>
        <population>Analysis population included all participants with baseline UACR &gt; 30 mg/g in ITT population where, ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR &gt;30 Milligrams Per Gram (mg/g)</title>
          <description>An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.</description>
          <population>Analysis population included all participants with baseline UACR &gt; 30 mg/g in ITT population where, ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</population>
          <units>percent change</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.56" spread="NA">An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.</measurement>
                    <measurement group_id="O2" value="-26.99" spread="NA">An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.</measurement>
                    <measurement group_id="O3" value="-30.66" spread="NA">An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.222</p_value>
            <method>ANCOVA</method>
            <param_type>Percent Difference</param_type>
            <param_value>-20.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.75</ci_lower_limit>
            <ci_upper_limit>14.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1965</p_value>
            <method>ANCOVA</method>
            <param_type>Percent Difference</param_type>
            <param_value>-21.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-45.05</ci_lower_limit>
            <ci_upper_limit>13.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HbA1c &lt;6.5% at Week 26</title>
        <time_frame>Week 26</time_frame>
        <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HbA1c &lt;6.5% at Week 26</title>
          <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures.</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="93"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2"/>
                    <measurement group_id="O2" value="5.4"/>
                    <measurement group_id="O3" value="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2420</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Percentage Difference</param_type>
            <param_value>3.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.17</ci_lower_limit>
            <ci_upper_limit>8.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0513</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Percentage Difference</param_type>
            <param_value>6.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>12.93</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HbA1c &lt;7.0% at Week 26</title>
        <time_frame>Week 26</time_frame>
        <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HbA1c &lt;7.0% at Week 26</title>
          <population>ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures.</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="93"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                    <measurement group_id="O2" value="16.3"/>
                    <measurement group_id="O3" value="17.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0066</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Percentage Difference</param_type>
            <param_value>12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.48</ci_lower_limit>
            <ci_upper_limit>20.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, &gt;8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (&lt;130, ≥130 mmHg) at screening.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0043</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Percentage Difference</param_type>
            <param_value>13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.28</ci_lower_limit>
            <ci_upper_limit>21.75</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).</description>
        <time_frame>First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks</time_frame>
        <population>Safety population included all randomized participants who received at least one dose of double-blind IMP. Two participants were randomized to Sotagliflozin 400 mg and dosed with Sotagliflozin 200 mg and 400 mg treatments during the study. Data for these participants were summarized in the Sotagliflozin 200 mg arm in the safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).</description>
          <population>Safety population included all randomized participants who received at least one dose of double-blind IMP. Two participants were randomized to Sotagliflozin 400 mg and dosed with Sotagliflozin 200 mg and 400 mg treatments during the study. Data for these participants were summarized in the Sotagliflozin 200 mg arm in the safety 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="93"/>
                <count group_id="O2" value="94"/>
                <count group_id="O3" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.8"/>
                    <measurement group_id="O2" value="86.2"/>
                    <measurement group_id="O3" value="81.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Hypoglycemic Events</title>
        <description>Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL].</description>
        <time_frame>up to 56.3 weeks</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Hypoglycemic Events</title>
          <description>Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL].</description>
          <population>Safety population included all randomized participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).</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="93"/>
                <count group_id="O2" value="94"/>
                <count group_id="O3" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.9"/>
                    <measurement group_id="O2" value="40.4"/>
                    <measurement group_id="O3" value="38.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented symptomatic hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.5"/>
                    <measurement group_id="O2" value="28.7"/>
                    <measurement group_id="O3" value="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe or documented symptomatic hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.5"/>
                    <measurement group_id="O2" value="30.9"/>
                    <measurement group_id="O3" value="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks</time_frame>
      <desc>Safety population included all randomized participants who received at least one dose of double-blind IMP. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Sotagliflozin 200 mg</title>
          <description>Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Sotagliflozin 400 mg</title>
          <description>Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (22.0)</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="6" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Diastolic dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hepatitis C antibody positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Metatarsalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Peripheral sensorimotor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Chronic respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Painful respiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Tracheomalacia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="90"/>
              </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>Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable subject matter.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Affairs</name_or_title>
      <organization>Lexicon Pharmaceuticals, Inc.</organization>
      <phone>(510) 338-6064</phone>
      <email>medical-information@lexpharma.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/NCT03242018
org study id: EFC15166
secondary id: 2016-004906-32
secondary id: U1111-1190-7589
nct id: NCT03242018
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Primary Objective:

      To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with
      respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes
      who have inadequate glycemic control and severe renal impairment

      Secondary Objectives:

        -  To assess the effects of sotagliflozin 200 mg versus placebo based on change from
           baseline in HbA1c

        -  To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo

        -  To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo
The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of
      randomized treatment and a visit 4 weeks after completion of the randomized treatment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo
time frame: Baseline to Week 26
description: An analysis of covariance (ANCOVA) model was used for the analysis.
measure: Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo
time frame: Baseline to Week 26
description: An ANCOVA model was used for the analysis.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
time frame: Baseline to Week 26
description: An ANCOVA model was used for the analysis.
measure: Change From Baseline in Body Weight at Week 26
time frame: Baseline to Week 26
description: An ANCOVA model was used for the analysis.
measure: Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg
time frame: Baseline to Week 12
description: An ANCOVA model was used for the analysis.
measure: Change From Baseline in SBP at Week 12 for All Participants
time frame: Baseline to Week 12
description: An ANCOVA model was used for the analysis.
measure: Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)
time frame: Baseline to Week 26
description: An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.
measure: Percentage of Participants With HbA1c <6.5% at Week 26
time frame: Week 26
measure: Percentage of Participants With HbA1c <7.0% at Week 26
time frame: Week 26
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
time frame: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks
description: An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).
measure: Percentage of Participants With Hypoglycemic Events
time frame: up to 56.3 weeks
description: Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL].
arm group label: Placebo
arm group type: Placebo Comparator
description: Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 milligrams [mg] in appearance) orally once daily for up to 56 weeks.
arm group label: Sotagliflozin 200 mg
arm group type: Experimental
description: Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 56 weeks.
arm group label: Sotagliflozin 400 mg
arm group type: Experimental
description: Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56 weeks.
intervention type: Drug
intervention name: Placebo
description: Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.
arm group label: Placebo
arm group label: Sotagliflozin 200 mg
intervention type: Drug
intervention name: Sotagliflozin
description: Sotagliflozin 200 mg, tablet, orally, once daily.
arm group label: Sotagliflozin 200 mg
arm group label: Sotagliflozin 400 mg
other name: SAR439954
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suman Wason, MD
role: Study Director
affiliation: Lexicon Pharmaceuticals, Inc.
facility: 
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country: Argentina
country: Brazil
country: Colombia
country: Germany
country: Hungary
country: Israel
country: Italy
country: Mexico
country: Poland
country: Romania
country: Russian Federation
country: South Africa
country: Spain
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
sharing ipd: No
provided document: 
provided document: 
participant flow: 
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certain agreements: 
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