<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/NCT03242252</url>
  </required_header>
  <id_info>
    <org_study_id>EFC14837</org_study_id>
    <secondary_id>2016-004889-26</secondary_id>
    <secondary_id>U1111-1187-8662</secondary_id>
    <nct_id>NCT03242252</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control</brief_title>
  <acronym>SOTA-CKD3</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 Moderate 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 200 milligrams (mg) and Sotagliflozin 400 mg&#xD;
      versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have&#xD;
      inadequate glycemic control and moderate renal impairment.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to&#xD;
           additional measures of glycemic control, blood pressure, and body weight.&#xD;
&#xD;
        -  To evaluate the safety of Sotagliflozin 200 mg and 400 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&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">October 25, 2019</completion_date>
  <primary_completion_date type="Actual">March 25, 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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in HbA1c at Week 26</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>An Analysis of covariance (ANCOVA) model was used for analysis.</description>
  </primary_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 analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>An ANCOVA model was used for 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 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 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>Up to 60 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Hypoglycemic Events</measure>
    <time_frame>Up to 60 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">787</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Chronic Kidney Disease Stage 3</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 period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 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 period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 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 period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 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.&#xD;
Route of administration: Oral</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.&#xD;
Route of administration: Oral</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 moderate renal insufficiency defined by an estimated glomerular filtration&#xD;
             rate (eGFR) (based on the 4 variable Modification of Diet in Renal Disease (MDRD)&#xD;
             equation) of ≥30 and &lt;60 milliliter per minute (mL/min)/1.73 meter square (m^2)&#xD;
             (chronic kidney disease [CKD] 3A, 3B).&#xD;
&#xD;
          -  Participants has given written informed consent to participate in the study in&#xD;
             accordance with local regulations.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Hemoglobin A1c (HbA1c) of &lt;7.0% or &gt;11.0%.&#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 a sodium-glucose cotransporter type 2 (SGLT2) inhibitor (Canagliflozin,&#xD;
             Dapagliflozin, Empagliflozin) during the last 12 months.&#xD;
&#xD;
          -  Uncontrolled high blood pressure.&#xD;
&#xD;
          -  Participants with severe anemia, severe cardiovascular (including congestive heart&#xD;
             failure New York Heart Association IV), respiratory, hepatic, neurological,&#xD;
             psychiatric, or active malignant tumor or other major systemic disease or patients&#xD;
             with short life expectancy that, according to the Investigator, will preclude their&#xD;
             safe participation in this study, or will make implementation of the protocol or&#xD;
             interpretation of the study 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 8404018</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404045</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 8404004</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 8404022</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85050-7500</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404007</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 8404023</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 8404044</name>
      <address>
        <city>Gold River</city>
        <state>California</state>
        <zip>95670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404011</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404003</name>
      <address>
        <city>Norco</city>
        <state>California</state>
        <zip>92860</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404025</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404038</name>
      <address>
        <city>San Dimas</city>
        <state>California</state>
        <zip>91713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404019</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404001</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 8404006</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 8404064</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404043</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 8404013</name>
      <address>
        <city>Palmetto Bay</city>
        <state>Florida</state>
        <zip>33157-5503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404016</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404040</name>
      <address>
        <city>Wauconda</city>
        <state>Illinois</state>
        <zip>60084-2452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404036</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 8404020</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119-6302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404014</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404032</name>
      <address>
        <city>Papillion</city>
        <state>Nebraska</state>
        <zip>68046-3136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404048</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601-1963</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404009</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 8404074</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>00000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404051</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401-6638</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404028</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103-3914</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404029</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103-4027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404026</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 8404052</name>
      <address>
        <city>Lansdale</city>
        <state>Pennsylvania</state>
        <zip>19446-1002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404031</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404021</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404056</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404015</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78726-4061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404050</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404060</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78749</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404005</name>
      <address>
        <city>Beaumont</city>
        <state>Texas</state>
        <zip>77702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404035</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404039</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404055</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404012</name>
      <address>
        <city>Hurst</city>
        <state>Texas</state>
        <zip>76054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404033</name>
      <address>
        <city>Lampasas</city>
        <state>Texas</state>
        <zip>76550-1820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404053</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404057</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404059</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404010</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 8404008</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 8404042</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404041</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8404047</name>
      <address>
        <city>Kenosha</city>
        <state>Wisconsin</state>
        <zip>53144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0324001</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1429BWN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0324002</name>
      <address>
        <city>Caba</city>
        <zip>1425DES</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0324005</name>
      <address>
        <city>Ciudad Autónoma Buenos Aires</city>
        <zip>1205</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0324008</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0324006</name>
      <address>
        <city>Córdoba</city>
        <zip>X5008HHW</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0324009</name>
      <address>
        <city>La Plata</city>
        <zip>1900</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0324007</name>
      <address>
        <city>Mar Del Plata</city>
        <zip>B7600FYK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0764007</name>
      <address>
        <city>Belo Horizonte</city>
        <zip>30150-240</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0764001</name>
      <address>
        <city>Belém</city>
        <zip>66073-005</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0764002</name>
      <address>
        <city>Curitiba</city>
        <zip>80030-480</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0764008</name>
      <address>
        <city>Curitiba</city>
        <zip>80810-040</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0764005</name>
      <address>
        <city>Rio De Janeiro</city>
        <zip>22271-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0764006</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04266-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 0764004</name>
      <address>
        <city>São Paulo</city>
        <zip>01244-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1244007</name>
      <address>
        <city>Brampton</city>
        <zip>L6S 0C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1244004</name>
      <address>
        <city>Burlington</city>
        <zip>L7R 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1244005</name>
      <address>
        <city>Etobicoke</city>
        <zip>M9R 4E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1244006</name>
      <address>
        <city>Laval</city>
        <zip>H7T 2P5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1244009</name>
      <address>
        <city>Montreal</city>
        <zip>H4A 2C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1244010</name>
      <address>
        <city>Ottawa</city>
        <zip>K2J 0V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1244003</name>
      <address>
        <city>Thornhill</city>
        <zip>L4J 8L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1244002</name>
      <address>
        <city>Toronto</city>
        <zip>M4C 5T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1244008</name>
      <address>
        <city>Toronto</city>
        <zip>M4G 3E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1244001</name>
      <address>
        <city>Vancouver</city>
        <zip>V5Y 3W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1704008</name>
      <address>
        <city>Barranquilla</city>
        <zip>080001</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1704007</name>
      <address>
        <city>Barranquilla</city>
        <zip>80020</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1704004</name>
      <address>
        <city>Bogota</city>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1704009</name>
      <address>
        <city>Bogota</city>
        <zip>110911</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1704006</name>
      <address>
        <city>Ibague</city>
        <zip>730006</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1704001</name>
      <address>
        <city>Manizales</city>
        <zip>170004</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1704002</name>
      <address>
        <city>Medellin / Antioquia</city>
        <zip>50021</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1704005</name>
      <address>
        <city>Zipaquira</city>
        <zip>250252</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2764001</name>
      <address>
        <city>Frankfurt Am Main</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2764002</name>
      <address>
        <city>Hamburg</city>
        <zip>21073</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2764003</name>
      <address>
        <city>Münster</city>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3484008</name>
      <address>
        <city>Baja</city>
        <zip>6500</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3484012</name>
      <address>
        <city>Baja</city>
        <zip>6500</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3484002</name>
      <address>
        <city>Balatonfured</city>
        <zip>8230</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3484007</name>
      <address>
        <city>Budapest</city>
        <zip>1033</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3484011</name>
      <address>
        <city>Debrecen</city>
        <zip>4025</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3484005</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3484001</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3484010</name>
      <address>
        <city>Nyiregyhaza</city>
        <zip>4405</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3484013</name>
      <address>
        <city>Nyregyhza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3484004</name>
      <address>
        <city>Pécs</city>
        <zip>7623</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764001</name>
      <address>
        <city>Ashkelon</city>
        <zip>7830604</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764010</name>
      <address>
        <city>Be'Er-Sheva</city>
        <zip>84101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764007</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764009</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764011</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764003</name>
      <address>
        <city>Nahariya</city>
        <zip>22100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764004</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764006</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764005</name>
      <address>
        <city>Rehovot</city>
        <zip>76100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764002</name>
      <address>
        <city>Tel Aviv</city>
        <zip>61480</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764008</name>
      <address>
        <city>Zefat</city>
        <zip>13100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3764013</name>
      <address>
        <city>Zerifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3804007</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3804005</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3804004</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3804008</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3804002</name>
      <address>
        <city>Napoli</city>
        <zip>80138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3804003</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3804006</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4844009</name>
      <address>
        <city>Chihuahua Chihuahua</city>
        <zip>31217</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4844008</name>
      <address>
        <city>Durango, Durango</city>
        <zip>34080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4844001</name>
      <address>
        <city>Guadalajara</city>
        <zip>44210</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4844003</name>
      <address>
        <city>Guadalajara</city>
        <zip>44600</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4844006</name>
      <address>
        <city>Merida, Yucatan</city>
        <zip>97130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4844005</name>
      <address>
        <city>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4844004</name>
      <address>
        <city>Xalapa</city>
        <zip>91020</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6164002</name>
      <address>
        <city>Białystok</city>
        <zip>15-435</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6164006</name>
      <address>
        <city>Katowice</city>
        <zip>40-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6164010</name>
      <address>
        <city>Krakow</city>
        <zip>30-033</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6164009</name>
      <address>
        <city>Krakow</city>
        <zip>30-363</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6164004</name>
      <address>
        <city>Krakow</city>
        <zip>31-209</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6164008</name>
      <address>
        <city>Krakow</city>
        <zip>31-530</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6164011</name>
      <address>
        <city>Lodz</city>
        <zip>92-213</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6164005</name>
      <address>
        <city>Oswiecim</city>
        <zip>32-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6164003</name>
      <address>
        <city>Rzeszow</city>
        <zip>35-055</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6164012</name>
      <address>
        <city>Skierniewice</city>
        <zip>96-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6164007</name>
      <address>
        <city>Warszawa</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6424002</name>
      <address>
        <city>Bacau</city>
        <zip>600154</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6424001</name>
      <address>
        <city>Bacau</city>
        <zip>600238</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6424004</name>
      <address>
        <city>Bucuresti</city>
        <zip>010825</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6424009</name>
      <address>
        <city>Bucuresti</city>
        <zip>013764</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6424010</name>
      <address>
        <city>Bucuresti</city>
        <zip>040172</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6424006</name>
      <address>
        <city>Hunedoara</city>
        <zip>331057</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6424011</name>
      <address>
        <city>Oradea</city>
        <zip>410159</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6424003</name>
      <address>
        <city>Targu-Mures</city>
        <zip>540142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6434003</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454047</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6434005</name>
      <address>
        <city>Kemerovo</city>
        <zip>650002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6434002</name>
      <address>
        <city>Krasnodar</city>
        <zip>3500</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6434004</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630091</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6434001</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194358</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6434006</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7104008</name>
      <address>
        <city>Cape Town</city>
        <zip>7531</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7104002</name>
      <address>
        <city>Cape Town</city>
        <zip>7570</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7104001</name>
      <address>
        <city>Johannesburg</city>
        <zip>1685</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7104010</name>
      <address>
        <city>Johannesburg</city>
        <zip>2188</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7104005</name>
      <address>
        <city>Johannesburg</city>
        <zip>2198</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7104006</name>
      <address>
        <city>Pretoria</city>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7244011</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7244007</name>
      <address>
        <city>Granada</city>
        <zip>18012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7244003</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7244006</name>
      <address>
        <city>Palma De Mallorca</city>
        <zip>07010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7244001</name>
      <address>
        <city>Sevilla</city>
        <zip>41071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7244002</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7244009</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8044004</name>
      <address>
        <city>Dnipropetrovsk</city>
        <zip>49005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8044007</name>
      <address>
        <city>Kharkiv</city>
        <zip>61106</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8044010</name>
      <address>
        <city>Kharkiv</city>
        <zip>61166</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8044008</name>
      <address>
        <city>Kiev</city>
        <zip>02002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8044003</name>
      <address>
        <city>Kiev</city>
        <zip>04050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8044009</name>
      <address>
        <city>Kyiv</city>
        <zip>02091</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8044001</name>
      <address>
        <city>Kyiv</city>
        <zip>03037</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8044006</name>
      <address>
        <city>Kyiv</city>
        <zip>03049</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8044005</name>
      <address>
        <city>Lviv</city>
        <zip>79010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8044002</name>
      <address>
        <city>Zaporizhia</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Canada</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>May 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>April 2, 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 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03242252/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 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03242252/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 166 investigative sites in the United States, Argentina, Brazil, Canada, Colombia, Germany, Hungary, Israel, Italy, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, and Ukraine from 16 August 2017 to 25 October 2019.</recruitment_details>
      <pre_assignment_details>Participants with a diagnosis of Type 2 Diabetes Mellitus were enrolled in 1 of 3 treatment groups: Placebo or Sotagliflozin 200 milligrams (mg) or Sotagliflozin 400 mg. Participants were randomly assigned in the ratio of 1:1:1 to these reporting groups.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Sotagliflozin 200 mg</title>
          <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Sotagliflozin 400 mg</title>
          <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 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="260"/>
                <participants group_id="P2" count="263"/>
                <participants group_id="P3" count="264"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="224"/>
                <participants group_id="P2" count="240"/>
                <participants group_id="P3" count="232"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="32"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>At the Participant's own Request</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor Compliance to Protocol</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </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="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not Specified</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population included all randomized participants or participants analyzed according to their randomized treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Sotagliflozin 200 mg</title>
          <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Sotagliflozin 400 mg</title>
          <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 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="260"/>
            <count group_id="B2" value="263"/>
            <count group_id="B3" value="264"/>
            <count group_id="B4" value="787"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.3" spread="8.1"/>
                    <measurement group_id="B2" value="69.6" spread="7.5"/>
                    <measurement group_id="B3" value="69.5" spread="8.2"/>
                    <measurement group_id="B4" value="69.5" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="112"/>
                    <measurement group_id="B4" value="343"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="152"/>
                    <measurement group_id="B4" value="444"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="198"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="193"/>
                    <measurement group_id="B2" value="196"/>
                    <measurement group_id="B3" value="200"/>
                    <measurement group_id="B4" value="589"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="220"/>
                    <measurement group_id="B2" value="231"/>
                    <measurement group_id="B3" value="215"/>
                    <measurement group_id="B4" value="666"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </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>Colombia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Argentina</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="62"/>
                    <measurement group_id="B4" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brazil</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c (HbA1c)</title>
          <population>Number analyzed specifies the number of participants evaluated for the parameter.</population>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="262"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="786"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.33" spread="1.00"/>
                    <measurement group_id="B2" value="8.33" spread="0.9"/>
                    <measurement group_id="B3" value="8.31" spread="0.94"/>
                    <measurement group_id="B4" value="8.32" spread="0.95"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="260"/>
                    <count group_id="B2" value="263"/>
                    <count group_id="B3" value="264"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="140.59" spread="14.59"/>
                    <measurement group_id="B2" value="140.31" spread="15.15"/>
                    <measurement group_id="B3" value="141.71" spread="15.01"/>
                    <measurement group_id="B4" value="140.87" spread="14.91"/>
                  </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</title>
        <description>An Analysis of covariance (ANCOVA) model was used for analysis.</description>
        <time_frame>Baseline to Week 26</time_frame>
        <population>Intent-to-treat (ITT) population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was 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 period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HbA1c at Week 26</title>
          <description>An Analysis of covariance (ANCOVA) model was used for analysis.</description>
          <population>Intent-to-treat (ITT) population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using control-based copy reference multiple imputation under the missing not at random framework.</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="260"/>
                <count group_id="O2" value="263"/>
                <count group_id="O3" value="264"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="0.061"/>
                    <measurement group_id="O2" value="-0.32" spread="0.060"/>
                    <measurement group_id="O3" value="-0.46" spread="0.060"/>
                  </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, randomization stratum of Chronic Kidney Disease (CKD) stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2095</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in Least Squares (LS) Means</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.076</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.245</ci_lower_limit>
            <ci_upper_limit>0.054</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, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0021</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.077</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.386</ci_lower_limit>
            <ci_upper_limit>-0.085</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 analysis.</description>
        <time_frame>Baseline to Week 26</time_frame>
        <population>ITT population included all randomized participants or participants analyzed according to their randomized treatment. 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 period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 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 analysis.</description>
          <population>ITT population included all randomized participants or participants analyzed according to their randomized treatment. 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="260"/>
                <count group_id="O2" value="263"/>
                <count group_id="O3" value="264"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.374" spread="0.1949"/>
                    <measurement group_id="O2" value="-0.961" spread="0.1715"/>
                    <measurement group_id="O3" value="-0.852" spread="0.1668"/>
                  </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, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0144</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.587</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2397</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0564</ci_lower_limit>
            <ci_upper_limit>-0.1169</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, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0436</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.478</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2368</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.942</ci_lower_limit>
            <ci_upper_limit>-0.0136</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12</title>
        <description>An ANCOVA model was used for analysis.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Analysis population included participants with baseline SBP ≥130 mmHg in ITT population where, ITT population included all randomized participants or participants analyzed according to their randomized treatment. 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 period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12</title>
          <description>An ANCOVA model was used for analysis.</description>
          <population>Analysis population included participants with baseline SBP ≥130 mmHg in ITT population where, ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</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="175"/>
                <count group_id="O2" value="162"/>
                <count group_id="O3" value="182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.18" spread="1.462"/>
                    <measurement group_id="O2" value="-7.46" spread="1.597"/>
                    <measurement group_id="O3" value="-7.71" spread="1.247"/>
                  </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 stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2627</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-2.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.034</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.265</ci_lower_limit>
            <ci_upper_limit>1.709</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 stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1602</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-2.53</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.799</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.052</ci_lower_limit>
            <ci_upper_limit>1</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 analysis.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITT population included all randomized participants or participants analyzed according to their randomized treatment. 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 period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 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 analysis.</description>
          <population>ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using the retrieved dropouts &amp; washout imputation method.</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="260"/>
                <count group_id="O2" value="263"/>
                <count group_id="O3" value="264"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.31" spread="1.037"/>
                    <measurement group_id="O2" value="-4.91" spread="1.010"/>
                    <measurement group_id="O3" value="-4.94" spread="0.983"/>
                  </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, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2212</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-1.59</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.301</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.142</ci_lower_limit>
            <ci_upper_limit>0.958</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, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2089</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-1.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.297</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.171</ci_lower_limit>
            <ci_upper_limit>0.912</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 analysis.</description>
        <time_frame>Baseline to Week 26</time_frame>
        <population>ITT population included all randomized participants or participants analyzed according to their randomized treatment. 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 period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight at Week 26</title>
          <description>An ANCOVA model was used for analysis.</description>
          <population>ITT population included all randomized participants or participants analyzed according to their randomized treatment. 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="260"/>
                <count group_id="O2" value="263"/>
                <count group_id="O3" value="264"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="0.262"/>
                    <measurement group_id="O2" value="-1.66" spread="0.246"/>
                    <measurement group_id="O3" value="-1.20" spread="0.257"/>
                  </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, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-1.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.326</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.92</ci_lower_limit>
            <ci_upper_limit>-0.644</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, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0155</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>0.339</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.487</ci_lower_limit>
            <ci_upper_limit>-0.156</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 participants with baseline UACR &gt;30 mg/g in ITT population where, ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was 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 period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 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 participants with baseline UACR &gt;30 mg/g in ITT population where, ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using control-based copy reference multiple imputation under the missing not at random framework.</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="260"/>
                <count group_id="O2" value="263"/>
                <count group_id="O3" value="264"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.71" 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="-43.68" 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="-48.12" 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, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0015</p_value>
            <method>ANCOVA</method>
            <param_type>Percent Difference</param_type>
            <param_value>-30.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.78</ci_lower_limit>
            <ci_upper_limit>-13.07</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, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>ANCOVA</method>
            <param_type>Percent Difference</param_type>
            <param_value>-36.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-49.91</ci_lower_limit>
            <ci_upper_limit>-18.68</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 or participants analyzed according to their randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 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 or participants analyzed according to their randomized treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="260"/>
                <count group_id="O2" value="263"/>
                <count group_id="O3" value="264"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2"/>
                    <measurement group_id="O2" value="5.7"/>
                    <measurement group_id="O3" value="5.7"/>
                  </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 mean SBP (&lt;130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4328</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Percentage Difference</param_type>
            <param_value>1.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.23</ci_lower_limit>
            <ci_upper_limit>5.21</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 mean SBP (&lt;130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4328</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Percentage Difference</param_type>
            <param_value>1.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.2</ci_lower_limit>
            <ci_upper_limit>5.17</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 or participants analyzed according to their randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 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 or participants analyzed according to their randomized treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="260"/>
                <count group_id="O2" value="263"/>
                <count group_id="O3" value="264"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5"/>
                    <measurement group_id="O2" value="19.4"/>
                    <measurement group_id="O3" value="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <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 mean SBP (&lt;130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0614</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Percentage Difference</param_type>
            <param_value>6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.23</ci_lower_limit>
            <ci_upper_limit>12.21</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 mean SBP (&lt;130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.023</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Percentage Difference</param_type>
            <param_value>7.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.08</ci_lower_limit>
            <ci_upper_limit>13.65</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
        <time_frame>Up to 60 weeks</time_frame>
        <population>Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
          <population>Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received.</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="260"/>
                <count group_id="O2" value="267"/>
                <count group_id="O3" value="260"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.1"/>
                    <measurement group_id="O2" value="76.8"/>
                    <measurement group_id="O3" value="74.2"/>
                  </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 60 weeks</time_frame>
        <population>Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received.</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 54 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 2-week run-in phase, participants received two tablets, 1 Sotagliflozin 200 mg tablet and 1 placebo tablet (identical to Sotagliflozin 200 mg in appearance), orally once daily for up to 58 weeks. Four participants randomized to Sotagliflozin 400 mg were dosed with both Sotagliflozin 200 mg and 400 mg. These participants were included in the Sotagliflozin 200 mg arm in the safety population.</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 two 200 mg Sotagliflozin tablets, orally once daily for up to 60 weeks. Four participants randomized to Sotagliflozin 400 mg were dosed with both Sotagliflozin 200 mg and 400 mg. These participants were included in the Sotagliflozin 200 mg arm in the safety population.</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 participants who received at least 1 dose of study drug analyzed according to the treatment actually received.</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="260"/>
                <count group_id="O2" value="267"/>
                <count group_id="O3" value="260"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.1"/>
                    <measurement group_id="O2" value="41.9"/>
                    <measurement group_id="O3" value="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented symptomatic hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9"/>
                    <measurement group_id="O2" value="29.6"/>
                    <measurement group_id="O3" value="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe or documented symptomatic hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9"/>
                    <measurement group_id="O2" value="29.6"/>
                    <measurement group_id="O3" value="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 60 weeks</time_frame>
      <desc>Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. 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 period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Sotagliflozin 200 mg</title>
          <description>Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.</description>
        </group>
        <group group_id="E3">
          <title>Sotagliflozin 400 mg</title>
          <description>Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.</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="3" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="44" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Coronary artery insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Iris neovascularisation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Mallory-Weiss syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Corneal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Enterococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Funguria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Infective periostitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Sepsis pasteurella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Tick-borne viral encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Procedural shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>B-cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Breast cancer female</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Malignant melanoma of eyelid</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Neuroendocrine tumour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Rectal adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Uterine neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Basal ganglia infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic unconsciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </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="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Vocal cord polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Extremity necrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Femoral artery aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="260"/>
              </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="80" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="72" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="77" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="267"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="260"/>
              </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/NCT03242252
org study id: EFC14837
secondary id: 2016-004889-26
secondary id: U1111-1187-8662
nct id: NCT03242252
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Primary Objective:

      To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg
      versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have
      inadequate glycemic control and moderate renal impairment.

      Secondary Objectives:

        -  To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to
           additional measures of glycemic control, blood pressure, and body weight.

        -  To evaluate the safety of Sotagliflozin 200 mg and 400 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: Triple (Participant, Care Provider, Investigator)
measure: Change From Baseline in HbA1c at Week 26
time frame: Baseline to Week 26
description: An Analysis of covariance (ANCOVA) model was used for 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 analysis.
measure: Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12
time frame: Baseline to Week 12
description: An ANCOVA model was used for 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 analysis.
measure: Change From Baseline in Body Weight at Week 26
time frame: Baseline to Week 26
description: An ANCOVA model was used for 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: Up to 60 weeks
measure: Percentage of Participants With Hypoglycemic Events
time frame: Up to 60 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 period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
arm group label: Sotagliflozin 200 mg
arm group type: Experimental
description: Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
arm group label: Sotagliflozin 400 mg
arm group type: Experimental
description: Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
intervention type: Drug
intervention name: Placebo
description: Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily.
Route of administration: Oral
arm group label: Placebo
arm group label: Sotagliflozin 200 mg
intervention type: Drug
intervention name: Sotagliflozin
description: Sotagliflozin 200 mg, tablet, orally once daily.
Route of administration: Oral
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.
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country: Argentina
country: Brazil
country: Canada
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: 
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participant flow: 
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reported events: 
certain agreements: 
point of contact: 