<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/NCT03292653</url>
  </required_header>
  <id_info>
    <org_study_id>PDY15079</org_study_id>
    <secondary_id>2017-002774-39</secondary_id>
    <secondary_id>U1111-1190-7962</secondary_id>
    <nct_id>NCT03292653</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure</brief_title>
  <official_title>An Exploratory, Randomized, Double-blind, Placebo-controlled, Parallel Arm Trial of the Safety and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Patients Hospitalized With Worsening Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lexicon Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Lexicon Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objectives:&#xD;
&#xD;
        -  Assess the safety and tolerability of sotagliflozin in hemodynamically stable&#xD;
           participants with worsening of heart failure, compared to placebo.&#xD;
&#xD;
        -  Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable&#xD;
           participants with worsening of heart failure, compared to placebo.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma&#xD;
           erythropoietin levels, in hemodynamically stable participants with worsening of heart&#xD;
           failure, compared to placebo.&#xD;
&#xD;
        -  Explore the effect of sotagliflozin on changes in plasma N-terminal prohormone of brain&#xD;
           natriuretic peptide (NT-proBNP) levels, in hemodynamically stable participants with&#xD;
           worsening of heart failure, compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total study duration will be approximately 27-40 days, including a screening period of&#xD;
      1-10 days, a treatment period of 14 days, and a follow-up period of 14±2 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    1st two cohorts provided the required data, therefore 3rd cohort was not deemed necessary&#xD;
  </why_stopped>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Actual">August 17, 2019</completion_date>
  <primary_completion_date type="Actual">August 17, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths</measure>
    <time_frame>Baseline up to Day 14</time_frame>
    <description>AE: is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participants at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. AESI: is an adverse event (serious or nonserious) of scientific and medical concern, specific to the IMP or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hemoconcentration as Assessed by Changes in Albumin to Day 14</measure>
    <time_frame>Baseline to Day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hemoconcentration as Assessed by Changes in Hematocrit to Day 14</measure>
    <time_frame>Baseline to Day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hemoconcentration as Assessed by Changes in Hemoglobin to Day 14</measure>
    <time_frame>Baseline to Day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hemoconcentration as Assessed by Changes in Total Protein to Day 14</measure>
    <time_frame>Baseline to Day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes From Baseline in Plasma Volume to Day 14</measure>
    <time_frame>Baseline to 14 Days</time_frame>
    <description>Change in plasma volume in milliliters (mL) was assessed by the indicator dilution method using 131I-labelled human albumin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Erythropoietin to Day 14</measure>
    <time_frame>Baseline to Day 14</time_frame>
    <description>Change in erythropoietin international units per liter (IU/L) was measured by chemiluminescent enzyme-labelled immunometric assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) to Day 14</measure>
    <time_frame>Baseline to Day 14</time_frame>
    <description>Change in NT-proBNP picomoles per liter (pmol/L) was measured by standard electrochemiluminescence immunoassay.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Cardiac Failure Aggravated</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sotagliflozin 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sotagliflozin 400 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sotagliflozin</intervention_name>
    <description>Pharmaceutical form: Tablet; 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>Placebo</intervention_name>
    <description>Pharmaceutical form: Tablet; Route of administration: Oral</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Sotagliflozin 200 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
          -  18 years of age or older.&#xD;
&#xD;
          -  Participants admitted to the hospital or had urgent visit to emergency department or&#xD;
             heart failure unit/clinic or infusion center for Congestive Heart Failure (CHF),&#xD;
             defined by:&#xD;
&#xD;
          -  Presence of ≥2 of the following clinical signs and symptoms of congestion: jugular&#xD;
             venous distension, pitting edema in lower extremities greater than trace, dyspnea,&#xD;
             rales heard on auscultation, radiographic pulmonary congestion, weight gain above&#xD;
             historical dry weight of at least 5 pounds (lbs) (2.27 Kilograms (kg)).&#xD;
&#xD;
          -  Requiring treatment with intravenous (IV) diuretics.&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) ≥30 milliliter per minute (mL/min)/1.73&#xD;
             square meter (m^2) at the screening or randomization visit by the 4 variable&#xD;
             Modification of Diet in Renal Disease (MDRD) equation.&#xD;
&#xD;
          -  Female participants must use a double contraception method during the study including&#xD;
             a highly effective method of birth control, except if she has undergone sterilization&#xD;
             at least 3 months earlier or is postmenopausal.&#xD;
&#xD;
          -  Male participants, unless vasectomized and confirmed sterile by sperm analysis, must&#xD;
             use condoms during the study and refrain from donating sperm up to 90 days after the&#xD;
             day of last dose. If the participant has a female partner of childbearing potential,&#xD;
             the participant must wear a condom and female partner must use at least 1 highly&#xD;
             effective method of birth control during the study treatment period and the Follow-up&#xD;
             period.&#xD;
&#xD;
          -  Transitioning from IV to oral diuretics, and oral diuretic treatment has been&#xD;
             prescribed or administered.&#xD;
&#xD;
          -  Hemodynamically stable, defined as systolic blood pressure (SBP) &gt;100 millimeters of&#xD;
             mercury (mmHg) with no requirement for IV inotropes or IV vasodilators.&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
          -  History of Type 1 diabetes mellitus.&#xD;
&#xD;
          -  Appears unlikely or unable to participate in the required study procedures, as&#xD;
             assessed by the study Investigator, study coordinator, or designee (ex:&#xD;
             clinically-significant psychiatric, addictive, or neurological disease), or sectioned&#xD;
             due to an official or court order.&#xD;
&#xD;
          -  Current admission or visit for Worsening Heart Failure (HF) that is clearly and&#xD;
             primarily triggered by causes such as tachyarrhythmia (example: sustained ventricular&#xD;
             tachycardia, or atrial fibrillation/flutter with sustained ventricular response &gt; 130&#xD;
             beats per minute), acute coronary syndrome, pulmonary embolism, cerebrovascular&#xD;
             accident, heart valve disorders (such as severe aortic stenosis), as determined by the&#xD;
             Investigator.&#xD;
&#xD;
          -  Clinically significant myocardial infarction (MI) within past 1 month as determined by&#xD;
             Investigator and with objective evidence from ECG, and/or cardiac imaging and/or&#xD;
             coronary angiography. Small isolated elevations in troponin that often accompany HF&#xD;
             hospitalization are not an exclusion, nor are clinically significant MIs that have&#xD;
             been revascularized without complications.&#xD;
&#xD;
          -  Participants who recently had or scheduled to have cardiac interventions may be&#xD;
             eligible if:&#xD;
&#xD;
          -  Stable 48 hours post procedure.&#xD;
&#xD;
          -  Have diuretic treatment planned for the duration of treatment in this study.&#xD;
&#xD;
          -  Current use of or recent suspension of digoxin therapy with high levels of digoxin&#xD;
             (level should be obtained and must be &lt;1.2 nanograms per milliliter (ng/mL) at&#xD;
             screening.&#xD;
&#xD;
          -  History of heart or kidney transplant.&#xD;
&#xD;
          -  Diagnosis of hypertrophic obstructive cardiomyopathy.&#xD;
&#xD;
          -  End-stage HF defined as requiring left ventricular assist device insertion,&#xD;
             intra-aortic balloon placement (IABP), or any type of mechanical support during the&#xD;
             study period.&#xD;
&#xD;
          -  Pregnancy (demonstrated by serum pregnancy test at screening), breast-feeding, or&#xD;
             inability or refusal to undergo pregnancy testing.&#xD;
&#xD;
          -  Use of any investigational drug(s) or prohibited therapy or sodium-glucose&#xD;
             co-transporter 2 (SGLT2) 5 half-lives prior to screening.&#xD;
&#xD;
          -  Participants with moderate or severe respiratory, hepatic, neurological, psychiatric,&#xD;
             active malignant tumor or other major systemic disease (including any diseases with&#xD;
             evidence of malabsorption), making implementation of the protocol and/or the&#xD;
             interpretation of the study results difficult.&#xD;
&#xD;
          -  Known allergies, hypersensitivity, or intolerance to sotagliflozin or any inactive&#xD;
             component of sotagliflozin or placebo (ie, microcrystalline cellulose, croscarmellose&#xD;
             sodium [disintegrant], talc, silicon dioxide, and magnesium stearate [non-bovine]),&#xD;
             unless the reaction is deemed irrelevant to the study by the PI.&#xD;
&#xD;
          -  Laboratory findings at the Screening Visit:&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;3 times the upper&#xD;
             limit of the normal laboratory range (ULN) (1 repeat lab allowed).&#xD;
&#xD;
          -  Total bilirubin &gt;1.7 times the ULN (except in case of Gilbert's syndrome) (1 repeat&#xD;
             lab allowed).&#xD;
&#xD;
          -  Amylase and/or lipase &gt;3 times the ULN (1 repeat lab allowed).&#xD;
&#xD;
          -  Participants with a severe or persistent in spite of optimal treatment genitourinary&#xD;
             tract infection at time of randomization.&#xD;
&#xD;
          -  Participant is the Investigator or any sub-investigator, research assistant,&#xD;
             pharmacist, study coordinator, other staff or relative thereof directly involved in&#xD;
             the conduct of the protocol.&#xD;
&#xD;
          -  History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 3 months&#xD;
             prior to the screening visit.&#xD;
&#xD;
          -  Lower extremity diabetic complications (such as skin ulcers, infection, osteomyelitis&#xD;
             and gangrene) identified during the Screening period, and still requiring treatment at&#xD;
             randomization.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a&#xD;
        participant's potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suman Wason, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lexicon Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 8400005</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400001</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400007</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400002</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240001</name>
      <address>
        <city>Toronto</city>
        <zip>M5G 2N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5280001</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Italy</country>
  </removed_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 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>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03292653/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>April 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03292653/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 6 investigative sites in the United States, Canada, and the Netherlands from 04 December 2017 to 17 August 2019.</recruitment_details>
      <pre_assignment_details>Participants with a diagnosis of Congestive Heart Failure (CHF), were enrolled in 1 of 3 treatment groups: Placebo, Sotagliflozin 200 milligrams (mg) or Sotagliflozin 400 mg.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
        </group>
        <group group_id="P2">
          <title>Sotagliflozin 200 mg</title>
          <description>Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
        </group>
        <group group_id="P3">
          <title>Sotagliflozin 400 mg</title>
          <description>Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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>Did not Receive Treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all randomized participants who had exposure to any amount of Investigational Medicinal Product (IMP).</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
        </group>
        <group group_id="B2">
          <title>Sotagliflozin 200 mg</title>
          <description>Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
        </group>
        <group group_id="B3">
          <title>Sotagliflozin 400 mg</title>
          <description>Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</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="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="11"/>
            <count group_id="B4" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="11"/>
                    <count group_id="B4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.8" spread="13.05"/>
                    <measurement group_id="B2" value="55.1" spread="12.84"/>
                    <measurement group_id="B3" value="65.1" spread="13.41"/>
                    <measurement group_id="B4" value="60.5" spread="13.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="11"/>
                    <count group_id="B4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="11"/>
                    <count group_id="B4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="11"/>
                    <count group_id="B4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <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="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Albumin</title>
          <population>Pharmacodynamic (PD) population included all randomized and treated participants who had valid values of the main PD parameters at baseline.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="9"/>
                    <count group_id="B4" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.9" spread="3.48"/>
                    <measurement group_id="B2" value="38.0" spread="6.76"/>
                    <measurement group_id="B3" value="41.2" spread="2.59"/>
                    <measurement group_id="B4" value="40.1" spread="4.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hematocrit</title>
          <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline.</population>
          <units>percentage of red blood cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="10"/>
                    <count group_id="B4" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.38" spread="0.060"/>
                    <measurement group_id="B2" value="0.42" spread="0.092"/>
                    <measurement group_id="B3" value="0.39" spread="0.052"/>
                    <measurement group_id="B4" value="0.40" spread="0.070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin</title>
          <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="10"/>
                    <count group_id="B4" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="119.6" spread="22.86"/>
                    <measurement group_id="B2" value="138.9" spread="28.23"/>
                    <measurement group_id="B3" value="124.4" spread="22.05"/>
                    <measurement group_id="B4" value="127.6" spread="25.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Protein</title>
          <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="9"/>
                    <count group_id="B4" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.0" spread="6.14"/>
                    <measurement group_id="B2" value="65.3" spread="9.88"/>
                    <measurement group_id="B3" value="69.6" spread="6.23"/>
                    <measurement group_id="B4" value="68.1" spread="7.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Plasma Volume</title>
          <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline.</population>
          <units>milliliter (mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3797.3" spread="1281.16"/>
                    <measurement group_id="B2" value="4489.3" spread="1306.41"/>
                    <measurement group_id="B3" value="3604.7" spread="1100.69"/>
                    <measurement group_id="B4" value="3984.6" spread="1212.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths</title>
        <description>AE: is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participants at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. AESI: is an adverse event (serious or nonserious) of scientific and medical concern, specific to the IMP or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate.</description>
        <time_frame>Baseline up to Day 14</time_frame>
        <population>Safety population included all randomized participants who had exposure to any amount of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths</title>
          <description>AE: is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participants at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. AESI: is an adverse event (serious or nonserious) of scientific and medical concern, specific to the IMP or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate.</description>
          <population>Safety population included all randomized participants who had exposure to any amount of IMP.</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="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="45.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs Leading to Discontinuation From the IMP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoconcentration as Assessed by Changes in Albumin to Day 14</title>
        <time_frame>Baseline to Day 14</time_frame>
        <population>Pharmacodynamic (PD) population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 End of Treatment (EOT). The number of participants analyzed is the number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Participants were randomized to sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoconcentration as Assessed by Changes in Albumin to Day 14</title>
          <population>Pharmacodynamic (PD) population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 End of Treatment (EOT). The number of participants analyzed is the number of participants with available data.</population>
          <units>g/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.17" spread="2.71"/>
                    <measurement group_id="O2" value="2.44" spread="2.40"/>
                    <measurement group_id="O3" value="0.15" spread="2.14"/>
                  </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>Analysis of Covariance (ANCOVA) model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.736</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in Least Squares (LS) Means</param_type>
            <param_value>1.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.64</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.4</ci_lower_limit>
            <ci_upper_limit>7.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7694</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-1.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.38</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.22</ci_lower_limit>
            <ci_upper_limit>5.18</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoconcentration as Assessed by Changes in Hematocrit to Day 14</title>
        <time_frame>Baseline to Day 14</time_frame>
        <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoconcentration as Assessed by Changes in Hematocrit to Day 14</title>
          <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
          <units>percentage of red blood cells</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="10"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.02"/>
                    <measurement group_id="O2" value="-0.02" spread="0.02"/>
                    <measurement group_id="O3" value="-0.01" spread="0.02"/>
                  </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>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.184</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3397</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.07</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoconcentration as Assessed by Changes in Hemoglobin to Day 14</title>
        <time_frame>Baseline to Day 14</time_frame>
        <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoconcentration as Assessed by Changes in Hemoglobin to Day 14</title>
          <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
          <units>g/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.16" spread="6.80"/>
                    <measurement group_id="O2" value="-8.91" spread="6.02"/>
                    <measurement group_id="O3" value="-3.94" spread="5.37"/>
                  </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>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.094</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-17.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.12</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.79</ci_lower_limit>
            <ci_upper_limit>-0.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1878</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-12.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.49</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.65</ci_lower_limit>
            <ci_upper_limit>3.46</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoconcentration as Assessed by Changes in Total Protein to Day 14</title>
        <time_frame>Baseline to Day 14</time_frame>
        <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Participants were randomized to sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoconcentration as Assessed by Changes in Total Protein to Day 14</title>
          <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
          <units>g/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.31" spread="4.32"/>
                    <measurement group_id="O2" value="0.49" spread="3.83"/>
                    <measurement group_id="O3" value="-1.05" spread="3.41"/>
                  </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>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4269</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-4.82</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.8</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.45</ci_lower_limit>
            <ci_upper_limit>5.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2684</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-6.36</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.39</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.24</ci_lower_limit>
            <ci_upper_limit>3.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes From Baseline in Plasma Volume to Day 14</title>
        <description>Change in plasma volume in milliliters (mL) was assessed by the indicator dilution method using 131I-labelled human albumin.</description>
        <time_frame>Baseline to 14 Days</time_frame>
        <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Participants were randomized to sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline in Plasma Volume to Day 14</title>
          <description>Change in plasma volume in milliliters (mL) was assessed by the indicator dilution method using 131I-labelled human albumin.</description>
          <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
          <units>mL</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="4"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-525.00" spread="433.19"/>
                    <measurement group_id="O2" value="322.20" spread="359.23"/>
                    <measurement group_id="O3" value="-35.67" spread="392.43"/>
                  </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>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1761</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>847.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>576.98</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-210.46</ci_lower_limit>
            <ci_upper_limit>1904.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4202</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>489.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>579.35</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-572.68</ci_lower_limit>
            <ci_upper_limit>1551.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Erythropoietin to Day 14</title>
        <description>Change in erythropoietin international units per liter (IU/L) was measured by chemiluminescent enzyme-labelled immunometric assay.</description>
        <time_frame>Baseline to Day 14</time_frame>
        <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Erythropoietin to Day 14</title>
          <description>Change in erythropoietin international units per liter (IU/L) was measured by chemiluminescent enzyme-labelled immunometric assay.</description>
          <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
          <units>IU/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="5.92"/>
                    <measurement group_id="O2" value="13.78" spread="6.26"/>
                    <measurement group_id="O3" value="-0.07" spread="5.04"/>
                  </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>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1242</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>13.75</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.53</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.03</ci_lower_limit>
            <ci_upper_limit>28.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9903</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.73</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.49</ci_lower_limit>
            <ci_upper_limit>13.30</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) to Day 14</title>
        <description>Change in NT-proBNP picomoles per liter (pmol/L) was measured by standard electrochemiluminescence immunoassay.</description>
        <time_frame>Baseline to Day 14</time_frame>
        <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Sotagliflozin 200 mg</title>
            <description>Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Sotagliflozin 400 mg</title>
            <description>Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) to Day 14</title>
          <description>Change in NT-proBNP picomoles per liter (pmol/L) was measured by standard electrochemiluminescence immunoassay.</description>
          <population>PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.</population>
          <units>pmol/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.36" spread="78.04"/>
                    <measurement group_id="O2" value="-59.53" spread="81.28"/>
                    <measurement group_id="O3" value="86.10" spread="65.87"/>
                  </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>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2121</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-150.89</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>116.09</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-353.57</ci_lower_limit>
            <ci_upper_limit>51.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9574</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Means</param_type>
            <param_value>-5.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>96.88</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-174.4</ci_lower_limit>
            <ci_upper_limit>163.87</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>First dose of study drug to last dose of study drug (up to Day 14) + 2 weeks</time_frame>
      <desc>Safety population included all randomized participants who had exposure to any amount of IMP.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
        </group>
        <group group_id="E2">
          <title>Sotagliflozin 200 mg</title>
          <description>Participants were randomized to Sotagliflozin 200 mg tablet administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
        </group>
        <group group_id="E3">
          <title>Sotagliflozin 400 mg</title>
          <description>Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (21.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid intake reduced</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </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/NCT03292653
org study id: PDY15079
secondary id: 2017-002774-39
secondary id: U1111-1190-7962
nct id: NCT03292653
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Primary Objectives:

        -  Assess the safety and tolerability of sotagliflozin in hemodynamically stable
           participants with worsening of heart failure, compared to placebo.

        -  Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable
           participants with worsening of heart failure, compared to placebo.

      Secondary Objectives:

        -  Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma
           erythropoietin levels, in hemodynamically stable participants with worsening of heart
           failure, compared to placebo.

        -  Explore the effect of sotagliflozin on changes in plasma N-terminal prohormone of brain
           natriuretic peptide (NT-proBNP) levels, in hemodynamically stable participants with
           worsening of heart failure, compared to placebo.
The total study duration will be approximately 27-40 days, including a screening period of
      1-10 days, a treatment period of 14 days, and a follow-up period of 14±2 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths
time frame: Baseline up to Day 14
description: AE: is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participants at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. AESI: is an adverse event (serious or nonserious) of scientific and medical concern, specific to the IMP or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate.
measure: Change From Baseline in Hemoconcentration as Assessed by Changes in Albumin to Day 14
time frame: Baseline to Day 14
measure: Change From Baseline in Hemoconcentration as Assessed by Changes in Hematocrit to Day 14
time frame: Baseline to Day 14
measure: Change From Baseline in Hemoconcentration as Assessed by Changes in Hemoglobin to Day 14
time frame: Baseline to Day 14
measure: Change From Baseline in Hemoconcentration as Assessed by Changes in Total Protein to Day 14
time frame: Baseline to Day 14
measure: Changes From Baseline in Plasma Volume to Day 14
time frame: Baseline to 14 Days
description: Change in plasma volume in milliliters (mL) was assessed by the indicator dilution method using 131I-labelled human albumin.
measure: Change From Baseline in Erythropoietin to Day 14
time frame: Baseline to Day 14
description: Change in erythropoietin international units per liter (IU/L) was measured by chemiluminescent enzyme-labelled immunometric assay.
measure: Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) to Day 14
time frame: Baseline to Day 14
description: Change in NT-proBNP picomoles per liter (pmol/L) was measured by standard electrochemiluminescence immunoassay.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
arm group label: Sotagliflozin 200 mg
arm group type: Experimental
description: Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
arm group label: Sotagliflozin 400 mg
arm group type: Experimental
description: Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
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: Placebo
description: Pharmaceutical form: Tablet; Route of administration: Oral
arm group label: Placebo
arm group label: Sotagliflozin 200 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.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Netherlands
country: United States
country: Italy
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 