<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/NCT03285594</url>
  </required_header>
  <id_info>
    <org_study_id>EFC14868</org_study_id>
    <secondary_id>2016-001804-43</secondary_id>
    <secondary_id>U1111-1190-7567</secondary_id>
    <nct_id>NCT03285594</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents</brief_title>
  <acronym>SOTA-INS</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with&#xD;
      respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus&#xD;
      (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes&#xD;
      drugs (OADs).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose&#xD;
           (FPG), body weight, systolic blood pressure (SBP), and HbA1c.&#xD;
&#xD;
        -  To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG,&#xD;
           and SBP.&#xD;
&#xD;
        -  To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 60 weeks (Screening phase of up to 2 weeks, a 4-week Lantus titration/single-blind&#xD;
      placebo Run-in phase), a 52-week double blind Treatment Period, and a 2-week post-treatment&#xD;
      Follow-up Period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">September 27, 2019</completion_date>
  <primary_completion_date type="Actual">September 17, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18</measure>
    <time_frame>Baseline and Week 18</time_frame>
    <description>An analysis of covariance (ANCOVA) model was used for the analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18</measure>
    <time_frame>Baseline and Week 18</time_frame>
    <description>FPG was performed in fasting state, that is, without any food intake (except for water) for at least 8 hours. An ANCOVA model was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight at Week 18</measure>
    <time_frame>Baseline and Week 18</time_frame>
    <description>An ANCOVA model was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>An ANCOVA model was used for the analysis. Here, N is the number of participants with data available at a given time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SBP at Week 12 for All Participants</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>An ANCOVA model was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HbA1c at Week 52</measure>
    <time_frame>Baseline and Week 52</time_frame>
    <description>An ANCOVA model was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight at Week 52</measure>
    <time_frame>Baseline and Week 52</time_frame>
    <description>An ANCOVA model was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs)</measure>
    <time_frame>First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks</time_frame>
    <description>An AE is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Hypoglycemic Events</measure>
    <time_frame>Up to 55.7 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">571</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Following a 4-week run-in period, participants were randomized to matching placebo to sotagliflozin 200 milligrams (mg) administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sotagliflozin 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sotagliflozin 400 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sotagliflozin</intervention_name>
    <description>Pharmaceutical form: Tablet&#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>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin glargine (HOE901)</intervention_name>
    <description>Pharmaceutical form: Solution&#xD;
Route of administration: Subcutaneous</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Sotagliflozin 200 mg</arm_group_label>
    <arm_group_label>Sotagliflozin 400 mg</arm_group_label>
    <other_name>Lantus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pharmaceutical form: Tablet&#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>Oral Antidiabetes Drugs (OADs)</intervention_name>
    <description>OADs (including metformin) as prescribed by the investigator as per local labeling.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Sotagliflozin 200 mg</arm_group_label>
    <arm_group_label>Sotagliflozin 400 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Participants with Type 2 Diabetes Mellitus (T2DM) using any types of basal insulin&#xD;
             alone or in combination with up to 2 OADs.&#xD;
&#xD;
          -  Participants have given written informed consent to participate in the study in&#xD;
             accordance with local regulations.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  At the time of Screening age &lt;18 years or &lt;legal age of majority, whichever is&#xD;
             greater.&#xD;
&#xD;
          -  Type 1 diabetes mellitus.&#xD;
&#xD;
          -  Oral antidiabetic drugs dose not stable for 8 weeks before Screening.&#xD;
&#xD;
          -  Use of basal insulin therapy (e.g., insulin glargine, Neutral Protamine Hagedorn&#xD;
             (NPH), detemir, or degludec) for less than 6 months before Screening.&#xD;
&#xD;
          -  Dose of basal insulin (e.g., insulin glargine, NPH, detemir, or degludec) not stable&#xD;
             for 8 weeks before Screening (i.e., total daily insulin dose increased or decreased by&#xD;
             more than 20%).&#xD;
&#xD;
          -  Known unstable proliferative diabetic retinopathy or any other rapidly progressive&#xD;
             diabetic retinopathy or macular edema that is likely to require laser, surgical&#xD;
             treatment during study period.&#xD;
&#xD;
          -  Use of injectable diabetes drugs other than basal insulin (e.g., insulin glargine,&#xD;
             NPH, detemir, or degludec), i.e., prandial or rapid-acting insulins, short-acting&#xD;
             insulins, glucagon-like peptide 1 (GLP-1) receptor agonists, or inhaled prandial&#xD;
             insulin (Afrezza) within 8 weeks of Screening.&#xD;
&#xD;
          -  Use of a selective sodium-glucose cotransporter type 2 (SGLT2) inhibitor (e.g.,&#xD;
             canagliflozin, dapagliflozin, or empagliflozin) within 3 months prior to the trial.&#xD;
&#xD;
          -  Use of systemic glucocorticoids (excluding topical, intra articular, or ophthalmic&#xD;
             application, nasal spray or inhaled forms) for more than 10 consecutive days within 90&#xD;
             days prior to the Screening Visit.&#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 that, according&#xD;
             to the Investigator, will preclude their safe participation in this study, or will&#xD;
             make implementation of the protocol or 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;
          -  Known presence of factors that interfere with the Central Lab HbA1c measurement (e.g.,&#xD;
             genetic hemoglobin (Hb) variants) compromising the reliability of HbA1c assessment or&#xD;
             medical conditions that affect interpretation of HbA1c results (e.g., blood&#xD;
             transfusion or severe blood loss in the last 3 months prior to randomization, any&#xD;
             condition that shortens erythrocyte survival).&#xD;
&#xD;
          -  Participants who has taken other investigational drugs or prohibited therapy for this&#xD;
             study within 12 weeks or 5 half-lives from prior to Screening, whichever is longer.&#xD;
&#xD;
          -  Participants unwilling to perform self-monitoring of blood glucose (SMBG), complete&#xD;
             the patient diary, or comply with study visits and other study procedures as required&#xD;
             per protocol.&#xD;
&#xD;
          -  HbA1c &lt;7.5% or HbA1c &gt;10.5% measured by the central laboratory at Screening.&#xD;
&#xD;
          -  HbA1c &lt;7% measured by the central laboratory at Visit 5 (Week -1).&#xD;
&#xD;
          -  History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior&#xD;
             to the Screening Visit.&#xD;
&#xD;
          -  Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.&#xD;
&#xD;
          -  Women of childbearing potential not willing to use highly effective method(s) of birth&#xD;
             control during the study treatment period and the follow-up period, or who are&#xD;
             unwilling or unable to be tested for pregnancy during the study.&#xD;
&#xD;
          -  Mean of 3 separate blood pressure measurements &gt;180 mmHg (systolic blood pressure&#xD;
             [SBP]) or &gt;100 mmHg (diastolic blood pressure [DBP]).&#xD;
&#xD;
          -  History of gastric surgery including history of gastric banding or inflammatory bowel&#xD;
             disease within 3 years prior to the Screening Visit.&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;3 times the upper&#xD;
             limit of the normal laboratory range&#xD;
&#xD;
          -  Total bilirubin &gt;1.5 times the upper limit of the normal laboratory range (except in&#xD;
             case of Gilbert's syndrome).&#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 8406028</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85213-5226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406013</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406020</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406006</name>
      <address>
        <city>Huntington Park</city>
        <state>California</state>
        <zip>90255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406053</name>
      <address>
        <city>Lincoln</city>
        <state>California</state>
        <zip>95648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406040</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 8406043</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406008</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406030</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406003</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406029</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406052</name>
      <address>
        <city>Ocoee</city>
        <state>Florida</state>
        <zip>34761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406001</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406022</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33700</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406025</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406002</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401-3430</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406054</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406027</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406042</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406044</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 8406051</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406024</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406016</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406011</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406010</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 8406018</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016-6023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406034</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406046</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406026</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406038</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406036</name>
      <address>
        <city>Hickory</city>
        <state>North Carolina</state>
        <zip>28601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406015</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 8406019</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406031</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406023</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406005</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406004</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406033</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406032</name>
      <address>
        <city>Moncks Corner</city>
        <state>South Carolina</state>
        <zip>29461-5017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406009</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406045</name>
      <address>
        <city>Seymour</city>
        <state>Tennessee</state>
        <zip>37865-5270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406047</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406017</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406048</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406037</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406039</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406050</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406021</name>
      <address>
        <city>Shavano Park</city>
        <state>Texas</state>
        <zip>78231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406035</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84102-1553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8406014</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088-8865</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1006009</name>
      <address>
        <city>Gabrovo</city>
        <zip>5300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1006003</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1006004</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1006001</name>
      <address>
        <city>Ruse</city>
        <zip>7003</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1006006</name>
      <address>
        <city>Smolyan</city>
        <zip>4700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1006002</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1006010</name>
      <address>
        <city>Sofia</city>
        <zip>1750</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1006005</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1006007</name>
      <address>
        <city>Varna</city>
        <zip>9000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1246003</name>
      <address>
        <city>Brampton</city>
        <zip>L6S 0C9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1246005</name>
      <address>
        <city>Burlington</city>
        <zip>L7R 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1246004</name>
      <address>
        <city>Etobicoke</city>
        <zip>M9R 4E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1246002</name>
      <address>
        <city>Toronto</city>
        <zip>M4G 3E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1246001</name>
      <address>
        <city>Vancouver</city>
        <zip>V5Y 3W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2036003</name>
      <address>
        <city>Holesov</city>
        <zip>769 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2036002</name>
      <address>
        <city>Krnov</city>
        <zip>794 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2036001</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2036005</name>
      <address>
        <city>Ostrava</city>
        <zip>702 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2036006</name>
      <address>
        <city>Praha 10 - Uhrineves</city>
        <zip>104 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2036007</name>
      <address>
        <city>Praha 4</city>
        <zip>140 46</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2036008</name>
      <address>
        <city>Praha 4</city>
        <zip>149 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2506008</name>
      <address>
        <city>Besançon Cedex</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2506003</name>
      <address>
        <city>Corbeil-Essonnes</city>
        <zip>91106</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2506005</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2506012</name>
      <address>
        <city>Mulhouse</city>
        <zip>68100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2506004</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2506007</name>
      <address>
        <city>Narbonne</city>
        <zip>11100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2506006</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2506010</name>
      <address>
        <city>Pierre-Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2506009</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2506011</name>
      <address>
        <city>Saint-Mande</city>
        <zip>94160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2506002</name>
      <address>
        <city>Vénissieux</city>
        <zip>69200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3486007</name>
      <address>
        <city>Budapest</city>
        <zip>1106</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3486002</name>
      <address>
        <city>Budapest</city>
        <zip>1134</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3486006</name>
      <address>
        <city>Hatvan</city>
        <zip>3000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3486009</name>
      <address>
        <city>Kecskemet</city>
        <zip>6000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3486003</name>
      <address>
        <city>Komarom</city>
        <zip>2900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3486005</name>
      <address>
        <city>Nyíregyháza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3486001</name>
      <address>
        <city>Pécs</city>
        <zip>7623</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3486008</name>
      <address>
        <city>Zalaegerszeg</city>
        <zip>8900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7036004</name>
      <address>
        <city>Bardejov</city>
        <zip>085 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7036008</name>
      <address>
        <city>Bratislava</city>
        <zip>831 06</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7036001</name>
      <address>
        <city>Bratislava</city>
        <zip>85101</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7036010</name>
      <address>
        <city>Kosice</city>
        <zip>040 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7036003</name>
      <address>
        <city>Kosice</city>
        <zip>4014</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7036007</name>
      <address>
        <city>Levice</city>
        <zip>934 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7036009</name>
      <address>
        <city>Levice</city>
        <zip>934 05</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7036011</name>
      <address>
        <city>Lucenec</city>
        <zip>98401</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7036006</name>
      <address>
        <city>Nitra</city>
        <zip>949 11</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7036005</name>
      <address>
        <city>Sabinov</city>
        <zip>08301</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8266002</name>
      <address>
        <city>Darlington</city>
        <zip>DL3 6HX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8266006</name>
      <address>
        <city>Doncaster</city>
        <zip>DN9 2HY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8266008</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8266001</name>
      <address>
        <city>Leicester</city>
        <zip>LE5 4PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8266004</name>
      <address>
        <city>London</city>
        <zip>EC1M 6BQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8266003</name>
      <address>
        <city>Salford</city>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Hungary</country>
    <country>Slovakia</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>April 16, 2021</results_first_submitted>
  <results_first_submitted_qc>April 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 11, 2021</results_first_posted>
  <disposition_first_submitted>August 14, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>August 14, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 20, 2020</disposition_first_posted>
  <last_update_submitted>April 16, 2021</last_update_submitted>
  <last_update_submitted_qc>April 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Glargine</mesh_term>
    <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>March 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03285594/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>December 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03285594/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 101 investigative sites in the United States, Bulgaria, Canada, Czech Republic, France, Hungary, Slovakia, the United Kingdom from 15 September 2017 to 27 September 2019.</recruitment_details>
      <pre_assignment_details>Participants with a diagnosis of Type 2 Diabetes Mellitus were enrolled in 1 of 3 treatment groups, placebo, sotagliflozin 200 milligrams (mg) and sotagliflozin 400 mg. Participants were randomized at a ratio of 1:1:2 respectively to 1 of 3 groups.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without oral antidiabetes drugs [OADs]) continued throughout the study.</description>
        </group>
        <group group_id="P2">
          <title>Sotagliflozin 200 mg</title>
          <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
        </group>
        <group group_id="P3">
          <title>Sotagliflozin 400 mg</title>
          <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
                <participants group_id="P2" count="141"/>
                <participants group_id="P3" count="286"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
                <participants group_id="P2" count="141"/>
                <participants group_id="P3" count="285"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="129"/>
                <participants group_id="P2" count="130"/>
                <participants group_id="P3" count="249"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="37"/>
              </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="10"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor Compliance to Protocol</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason Not Specified</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="8"/>
              </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 irrespective of compliance with the study protocol and procedures.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
        </group>
        <group group_id="B2">
          <title>Sotagliflozin 200 mg</title>
          <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
        </group>
        <group group_id="B3">
          <title>Sotagliflozin 400 mg</title>
          <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</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="144"/>
            <count group_id="B2" value="141"/>
            <count group_id="B3" value="286"/>
            <count group_id="B4" value="571"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.2" spread="8.9"/>
                    <measurement group_id="B2" value="62.1" spread="10.2"/>
                    <measurement group_id="B3" value="62.7" spread="9.1"/>
                    <measurement group_id="B4" value="62.4" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="132"/>
                    <measurement group_id="B4" value="255"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="154"/>
                    <measurement group_id="B4" value="316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="129"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="239"/>
                    <measurement group_id="B4" value="481"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="124"/>
                    <measurement group_id="B3" value="234"/>
                    <measurement group_id="B4" value="475"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="23"/>
                  </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>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="140"/>
                    <measurement group_id="B4" value="279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c (HbA1c)</title>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.76" spread="0.79"/>
                    <measurement group_id="B2" value="8.76" spread="0.83"/>
                    <measurement group_id="B3" value="8.69" spread="0.80"/>
                    <measurement group_id="B4" value="8.72" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic Blood Pressure (SBP)</title>
          <units>millimeter of Mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="137.59" spread="14.12"/>
                    <measurement group_id="B2" value="136.40" spread="15.54"/>
                    <measurement group_id="B3" value="135.84" spread="14.95"/>
                    <measurement group_id="B4" value="136.42" spread="14.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18</title>
        <description>An analysis of covariance (ANCOVA) model was used for the analysis.</description>
        <time_frame>Baseline and Week 18</time_frame>
        <population>Intent-to-treat (ITT) population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18</title>
          <description>An analysis of covariance (ANCOVA) model was used for the analysis.</description>
          <population>Intent-to-treat (ITT) population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method 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="144"/>
                <count group_id="O2" value="141"/>
                <count group_id="O3" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.27" spread="0.073"/>
                    <measurement group_id="O2" value="-0.72" spread="0.073"/>
                    <measurement group_id="O3" value="-0.81" spread="0.056"/>
                  </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 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c 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 Least Square (LS) Means</param_type>
            <param_value>-0.45</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.094</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.638</ci_lower_limit>
            <ci_upper_limit>-0.271</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 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c 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>-0.55</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.081</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.706</ci_lower_limit>
            <ci_upper_limit>-0.387</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18</title>
        <description>FPG was performed in fasting state, that is, without any food intake (except for water) for at least 8 hours. An ANCOVA model was used for the analysis.</description>
        <time_frame>Baseline and Week 18</time_frame>
        <population>ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18</title>
          <description>FPG was performed in fasting state, that is, without any food intake (except for water) for at least 8 hours. An ANCOVA model was used for the analysis.</description>
          <population>ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</population>
          <units>milligram per deciliter (mg/dL)</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="144"/>
                <count group_id="O2" value="141"/>
                <count group_id="O3" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.882" spread="3.6045"/>
                    <measurement group_id="O2" value="-2.975" spread="3.6083"/>
                    <measurement group_id="O3" value="-8.949" spread="2.7550"/>
                  </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 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-15.858</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.6056</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.8845</ci_lower_limit>
            <ci_upper_limit>-6.8309</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 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG 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>-21.832</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.0514</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.7725</ci_lower_limit>
            <ci_upper_limit>-13.8911</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight at Week 18</title>
        <description>An ANCOVA model was used for the analysis.</description>
        <time_frame>Baseline and Week 18</time_frame>
        <population>ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight at Week 18</title>
          <description>An ANCOVA model was used for the analysis.</description>
          <population>ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</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="144"/>
                <count group_id="O2" value="141"/>
                <count group_id="O3" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" spread="0.249"/>
                    <measurement group_id="O2" value="-0.73" spread="0.250"/>
                    <measurement group_id="O3" value="-1.37" spread="0.190"/>
                  </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 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-1.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.716</ci_lower_limit>
            <ci_upper_limit>-0.462</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 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and 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>-1.73</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.278</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.274</ci_lower_limit>
            <ci_upper_limit>-1.183</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12</title>
        <description>An ANCOVA model was used for the analysis. Here, N is the number of participants with data available at a given time point.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Analysis population included participants with baseline SBP ≥ 130 mmHg in ITT population where, ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12</title>
          <description>An ANCOVA model was used for the analysis. Here, N is the number of participants with data available at a given time point.</description>
          <population>Analysis population included participants with baseline SBP ≥ 130 mmHg in ITT population where, ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</population>
          <units>mmHg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="171"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.67" spread="1.470"/>
                    <measurement group_id="O2" value="-8.58" spread="1.447"/>
                    <measurement group_id="O3" value="-8.50" spread="1.103"/>
                  </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 Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.04</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-3.91</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.904</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.642</ci_lower_limit>
            <ci_upper_limit>-0.178</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 Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0239</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-3.83</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.697</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.161</ci_lower_limit>
            <ci_upper_limit>-0.507</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SBP at Week 12 for All Participants</title>
        <description>An ANCOVA model was used for the analysis.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SBP at Week 12 for All Participants</title>
          <description>An ANCOVA model was used for the analysis.</description>
          <population>ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</population>
          <units>mmHg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="141"/>
                <count group_id="O3" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="1.120"/>
                    <measurement group_id="O2" value="-5.15" spread="1.117"/>
                    <measurement group_id="O3" value="-4.10" spread="0.867"/>
                  </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 Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>-4.94</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.425</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.73</ci_lower_limit>
            <ci_upper_limit>-2.142</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 Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0018</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-3.89</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.246</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.333</ci_lower_limit>
            <ci_upper_limit>-1.448</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HbA1c at Week 52</title>
        <description>An ANCOVA model was used for the analysis.</description>
        <time_frame>Baseline and Week 52</time_frame>
        <population>ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HbA1c at Week 52</title>
          <description>An ANCOVA model was used for the analysis.</description>
          <population>ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method 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="144"/>
                <count group_id="O2" value="141"/>
                <count group_id="O3" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.279"/>
                    <measurement group_id="O2" value="-0.52" spread="0.152"/>
                    <measurement group_id="O3" value="-0.57" spread="0.114"/>
                  </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 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1265</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.185</ci_lower_limit>
            <ci_upper_limit>0.147</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 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.074</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.57</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.199</ci_lower_limit>
            <ci_upper_limit>0.055</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight at Week 52</title>
        <description>An ANCOVA model was used for the analysis.</description>
        <time_frame>Baseline and Week 52</time_frame>
        <population>ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight at Week 52</title>
          <description>An ANCOVA model was used for the analysis.</description>
          <population>ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.</population>
          <units>kg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="141"/>
                <count group_id="O3" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.579"/>
                    <measurement group_id="O2" value="-1.19" spread="0.620"/>
                    <measurement group_id="O3" value="-0.83" spread="0.374"/>
                  </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 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2466</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-1.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.868</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.707</ci_lower_limit>
            <ci_upper_limit>0.696</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 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, &gt;8.5%) at Week -1, randomization strata of mean SBP (&lt;130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.332</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.65</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.672</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.969</ci_lower_limit>
            <ci_upper_limit>0.665</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Adverse Events (AEs)</title>
        <description>An AE is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
        <time_frame>First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events (AEs)</title>
          <description>An AE is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="141"/>
                <count group_id="O3" value="285"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.6"/>
                    <measurement group_id="O2" value="54.6"/>
                    <measurement group_id="O3" value="59.3"/>
                  </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 55.7 weeks</time_frame>
        <population>Safety population included all randomised participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without oral antidiabetes drugs [OADs]) continued throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</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 randomised participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="141"/>
                <count group_id="O3" value="285"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5"/>
                    <measurement group_id="O2" value="56.0"/>
                    <measurement group_id="O3" value="62.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented symptomatic hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="41.8"/>
                    <measurement group_id="O3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe or documented symptomatic hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="41.8"/>
                    <measurement group_id="O3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks</time_frame>
      <desc>Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). 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 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
        </group>
        <group group_id="E2">
          <title>Sotagliflozin 200 mg</title>
          <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</description>
        </group>
        <group group_id="E3">
          <title>Sotagliflozin 400 mg</title>
          <description>Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.</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="2" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="285"/>
              </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="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Ischaemic cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Reperfusion arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal artery thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Retinopathy proliferative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Pancreatitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Enlarged uvula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary dyskinesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Infected bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Osteomyelitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Pyelonephritis chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Renal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Scrotal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Jaw fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Postoperative thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Tendon injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma pancreas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>B-cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cervicobrachial syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic unconsciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Renal haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </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="30" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="45" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="285"/>
              </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="9" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="285"/>
              </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/NCT03285594
org study id: EFC14868
secondary id: 2016-001804-43
secondary id: U1111-1190-7567
nct id: NCT03285594
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Primary Objective:

      To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with
      respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus
      (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes
      drugs (OADs).

      Secondary Objectives:

        -  To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose
           (FPG), body weight, systolic blood pressure (SBP), and HbA1c.

        -  To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG,
           and SBP.

        -  To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.
Up to 60 weeks (Screening phase of up to 2 weeks, a 4-week Lantus titration/single-blind
      placebo Run-in phase), a 52-week double blind Treatment Period, and a 2-week post-treatment
      Follow-up Period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
time frame: Baseline and Week 18
description: An analysis of covariance (ANCOVA) model was used for the analysis.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
time frame: Baseline and Week 18
description: FPG was performed in fasting state, that is, without any food intake (except for water) for at least 8 hours. An ANCOVA model was used for the analysis.
measure: Change From Baseline in Body Weight at Week 18
time frame: Baseline and Week 18
description: An ANCOVA model was used for the analysis.
measure: Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12
time frame: Baseline and Week 12
description: An ANCOVA model was used for the analysis. Here, N is the number of participants with data available at a given time point.
measure: Change From Baseline in SBP at Week 12 for All Participants
time frame: Baseline to Week 12
description: An ANCOVA model was used for the analysis.
measure: Change From Baseline in HbA1c at Week 52
time frame: Baseline and Week 52
description: An ANCOVA model was used for the analysis.
measure: Change From Baseline in Body Weight at Week 52
time frame: Baseline and Week 52
description: An ANCOVA model was used for the analysis.
measure: Percentage of Participants With Adverse Events (AEs)
time frame: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks
description: An AE is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
measure: Percentage of Participants With Hypoglycemic Events
time frame: Up to 55.7 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 4-week run-in period, participants were randomized to matching placebo to sotagliflozin 200 milligrams (mg) administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
arm group label: Sotagliflozin 200 mg
arm group type: Experimental
description: Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
arm group label: Sotagliflozin 400 mg
arm group type: Experimental
description: Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
intervention type: Drug
intervention name: Sotagliflozin
description: Pharmaceutical form: Tablet
Route of administration: Oral
arm group label: Sotagliflozin 200 mg
arm group label: Sotagliflozin 400 mg
other name: SAR439954
intervention type: Drug
intervention name: Insulin glargine (HOE901)
description: Pharmaceutical form: Solution
Route of administration: Subcutaneous
arm group label: Placebo
arm group label: Sotagliflozin 200 mg
arm group label: Sotagliflozin 400 mg
other name: Lantus
intervention type: Drug
intervention name: Placebo
description: Pharmaceutical form: Tablet
Route of administration: Oral
arm group label: Placebo
arm group label: Sotagliflozin 200 mg
intervention type: Drug
intervention name: Oral Antidiabetes Drugs (OADs)
description: OADs (including metformin) as prescribed by the investigator as per local labeling.
arm group label: Placebo
arm group label: Sotagliflozin 200 mg
arm group label: Sotagliflozin 400 mg
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: Bulgaria
country: Canada
country: Czechia
country: France
country: Hungary
country: Slovakia
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Glargine
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: 