<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/NCT03761134</url>
  </required_header>
  <id_info>
    <org_study_id>EFC15193</org_study_id>
    <secondary_id>U1111-1195-6143</secondary_id>
    <nct_id>NCT03761134</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Chinese Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone or Metformin in Combination With Sulfonylurea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c&#xD;
      (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic&#xD;
      control on metformin alone or metformin in combination with sulfonylurea.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To compare sotagliflozin dose 1 versus placebo for change in 2-hour postprandial glucose&#xD;
      (PPG) following a mixed meal tolerance test (MMTT), change in fasting plasma glucose (FPG),&#xD;
      and change in body weight.&#xD;
&#xD;
        -  To compare sotagliflozin dose 2 versus placebo for change in HbA1c, change in 2-hour PPG&#xD;
           following a MMTT, change in FPG, and change in body weight.&#xD;
&#xD;
        -  To compare sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo for change in&#xD;
           systolic blood pressure (SBP) for all patients, and change in SBP for patients with&#xD;
           baseline SBP ≥130 mmHg.&#xD;
&#xD;
        -  To evaluate the safety of sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total study duration is up to 30 weeks, including a screening period consisting of a&#xD;
      screening phase of up to 2 weeks and a 2-week single-blind placebo run-in phase, a 24-week&#xD;
      double-blind treatment period, and a 2-week post-treatment follow-up visit period to collect&#xD;
      safety information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sanofi ended collaboration with Lexicon for Sotagliflozin. In China no regulatory pathway to&#xD;
    transfer sponsorship during the conduct of ongoing studies.&#xD;
  </why_stopped>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">April 29, 2020</completion_date>
  <primary_completion_date type="Actual">April 29, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in hemoglobin A1c (HbA1c)</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 1)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT)</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Absolute change from baseline to week 24 in 2-hour PPG following a MMTT (for sotagliflozin dose1 and 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose (FPG)</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Absolute change from baseline to week 24 in FPG (for sotagliflozin dose 1 and 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Absolute change from baseline to week 24 in body weight (for sotagliflozin dose1 and 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in systolic blood pressure (SBP) for all patients</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Absolute change from baseline to week 12 in SBP for all patients (for sotagliflozin dose 1 and 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SBP for patients with baseline SBP ≥130 mmHg</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Absolute change from baseline to week 12 in SBP for patients with baseline SBP ≥130 mmHg (for sotagliflozin dose 1 and 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Number of patients with adverse events</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">377</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Sotagliflozin dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sotagliflozin dose 1, given as two (2) dose 2 tablets, once daily, before the first meal of the day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sotagliflozin dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sotagliflozin dose 2, given as 1 sotagliflozin dose 2 tablet and 1 sotagliflozin-matching placebo tablet (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two sotagliflozin-matching placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sotagliflozin (SAR439954)</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Sotagliflozin dose 1</arm_group_label>
    <arm_group_label>Sotagliflozin dose 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Sotagliflozin dose 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>metformin</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Sotagliflozin dose 1</arm_group_label>
    <arm_group_label>Sotagliflozin dose 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sulfonylurea</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Sotagliflozin dose 1</arm_group_label>
    <arm_group_label>Sotagliflozin dose 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Chinese patients with T2D diagnosed for at least 1 year, who are treated with&#xD;
             diet/exercise and:&#xD;
&#xD;
          -  Metformin alone at a stable dose ( ≥1500 mg/day or maximum tolerated dose&#xD;
             [documented]) for at least 8 weeks before the screening visit OR&#xD;
&#xD;
          -  Metformin in combination with sulfonylurea (≥ half maximum-labelled dose or maximum&#xD;
             tolerated dose [documented]) each at a stable dose for at least 8 weeks before the&#xD;
             screening visit.&#xD;
&#xD;
          -  Signed written informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age &lt;18 years at the screening visit.&#xD;
&#xD;
          -  Type 1 diabetes.&#xD;
&#xD;
          -  Hemoglobin A1c &lt;7% or &gt;10.5% measured by the central laboratory at the screening&#xD;
             visit.&#xD;
&#xD;
          -  Fasting plasma glucose &gt;15 mmol/L (&gt;270 mg/dL) measured by the central laboratory at&#xD;
             the screening visit and confirmed by a repeat test (&gt;15 mmol/L [&gt;270 mg/dL]) before&#xD;
             randomization.&#xD;
&#xD;
          -  Body mass index (BMI) ≤20 or &gt;45 kg/m2 at the screening visit.&#xD;
&#xD;
          -  Women of childbearing potential not willing to use highly effective method(s) of birth&#xD;
             control during the study treatment period and the follow-up period, or who are&#xD;
             unwilling or unable to be tested for pregnancy during the study.&#xD;
&#xD;
          -  Previous use of any antidiabetic drug other than metformin and sulphonylurea within&#xD;
             the 12 weeks prior to the screening visit.&#xD;
&#xD;
          -  Previous use of any types of insulin for &gt;1 month within 12 months before screening.&#xD;
&#xD;
          -  History of gastric surgery including history of gastric banding or inflammatory bowel&#xD;
             disease within 3 years prior to the screening visit.&#xD;
&#xD;
          -  History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar coma within 12&#xD;
             weeks prior to the screening visit.&#xD;
&#xD;
          -  History of serious hypoglycemia resulting in unconsciousness, seizure or&#xD;
             hospitalization within 6 months prior to the screening visit.&#xD;
&#xD;
          -  Mean of 3 separate blood pressure measurements &gt;180 mmHg (SBP) or &gt;100 mmHg (diastolic&#xD;
             blood pressure DBP (DBP)).&#xD;
&#xD;
          -  History of hypertensive emergency within 12 weeks prior to the screening visit.&#xD;
&#xD;
          -  Patients with severe anemia, severe cardiovascular (CV) (including congestive heart&#xD;
             failure New York Heart Association (NYHA) IV), respiratory, hepatic, neurological,&#xD;
             psychiatric, or active malignant tumor or other major systemic disease or patients&#xD;
             with short life expectancy that, according to Investigator, will preclude their safe&#xD;
             participation in this study, or will make implementation of the protocol or&#xD;
             interpretation of the study results difficult.&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;3 times the upper&#xD;
             limit of the normal (ULN) laboratory range.&#xD;
&#xD;
          -  Total bilirubin &gt;1.5 times the ULN (except in case of Gilbert's syndrome).&#xD;
&#xD;
          -  Use of systemic glucocorticoids (excluding topical or ophthalmic application, nasal&#xD;
             spray, or inhaled forms) for more than 10 consecutive days within 90 days prior to the&#xD;
             screening visit.&#xD;
&#xD;
          -  Patient who has taken other investigational drugs or prohibited therapy for this study&#xD;
             within 12 weeks or 5 half-lives prior to the screening visit, whichever is longer.&#xD;
&#xD;
          -  Use of a selective SGLT2 inhibitor (eg, canagliflozin, dapagliflozin, or&#xD;
             empagliflozin) within 3 months prior to the screening visit.&#xD;
&#xD;
          -  Pregnant (confirmed by serum pregnancy test at the screening visit) or breastfeeding&#xD;
             women.&#xD;
&#xD;
          -  Patients with severe renal disease as defined by an eGFR of &lt;30 mL/min/1.73m² at the&#xD;
             screening visit, based on the 4 variable Modification of Diet in Renal Disease (MDRD)&#xD;
             equation.&#xD;
&#xD;
          -  Patients with contraindication to metformin as per local labelling.&#xD;
&#xD;
          -  Patients with contraindication to sulfonylurea as per local labelling if the patient&#xD;
             is taking metformin with sulfonylurea.&#xD;
&#xD;
          -  Patient unwilling or unable to perform self-monitoring of blood glucose (SMBG),&#xD;
             complete the patient diary, or comply with study visits and other study procedures as&#xD;
             required per protocol.&#xD;
&#xD;
          -  Patients unable to consume at least 50% of the standard meal during the MMTT at&#xD;
             baseline (Day 1, Visit 3) before randomization.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        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>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 1560039</name>
      <address>
        <city>Baotou</city>
        <zip>014010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560040</name>
      <address>
        <city>Baotou</city>
        <zip>014010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560001</name>
      <address>
        <city>Beijing</city>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560038</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560035</name>
      <address>
        <city>Cangzhou</city>
        <zip>061000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560020</name>
      <address>
        <city>Changchun</city>
        <zip>130033</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560012</name>
      <address>
        <city>Changchun</city>
        <zip>130041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560011</name>
      <address>
        <city>Changsha</city>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560021</name>
      <address>
        <city>Changzhou</city>
        <zip>213003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560024</name>
      <address>
        <city>Chongqing</city>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560028</name>
      <address>
        <city>Dalian</city>
        <zip>116011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560010</name>
      <address>
        <city>Dalian</city>
        <zip>116033</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560036</name>
      <address>
        <city>Dalian</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560030</name>
      <address>
        <city>Fuzhou</city>
        <zip>354200</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560032</name>
      <address>
        <city>Guangzhou</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560027</name>
      <address>
        <city>Guangzhou</city>
        <zip>510180</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560041</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560046</name>
      <address>
        <city>Harbin</city>
        <zip>150001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560009</name>
      <address>
        <city>Hefei</city>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560025</name>
      <address>
        <city>Hohhot</city>
        <zip>010017</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560026</name>
      <address>
        <city>Huai'An</city>
        <zip>223300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560006</name>
      <address>
        <city>Jinan</city>
        <zip>250013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560033</name>
      <address>
        <city>Kunming</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560034</name>
      <address>
        <city>Luoyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560014</name>
      <address>
        <city>Nanjing</city>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560018</name>
      <address>
        <city>Pingxiang</city>
        <zip>337055</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560003</name>
      <address>
        <city>Shanghai</city>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560004</name>
      <address>
        <city>Shanghai</city>
        <zip>201700</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560013</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560005</name>
      <address>
        <city>Shenyang</city>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560019</name>
      <address>
        <city>Shijiazhuang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560017</name>
      <address>
        <city>Suzhou</city>
        <zip>215004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560022</name>
      <address>
        <city>Wuhan</city>
        <zip>430014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560023</name>
      <address>
        <city>Wuxi</city>
        <zip>214023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560015</name>
      <address>
        <city>Xiangtan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560043</name>
      <address>
        <city>Yuncheng</city>
        <zip>044000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560042</name>
      <address>
        <city>Zhengzhou</city>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560007</name>
      <address>
        <city>Zhenjiang</city>
        <zip>212001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560037</name>
      <address>
        <city>Zhongshan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560016</name>
      <address>
        <city>Zhuzhou</city>
        <zip>412007</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>(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>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03761134
org study id: EFC15193
secondary id: U1111-1195-6143
nct id: NCT03761134
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Primary Objective:

      To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c
      (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic
      control on metformin alone or metformin in combination with sulfonylurea.

      Secondary Objectives:

      To compare sotagliflozin dose 1 versus placebo for change in 2-hour postprandial glucose
      (PPG) following a mixed meal tolerance test (MMTT), change in fasting plasma glucose (FPG),
      and change in body weight.

        -  To compare sotagliflozin dose 2 versus placebo for change in HbA1c, change in 2-hour PPG
           following a MMTT, change in FPG, and change in body weight.

        -  To compare sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo for change in
           systolic blood pressure (SBP) for all patients, and change in SBP for patients with
           baseline SBP ≥130 mmHg.

        -  To evaluate the safety of sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo.
Total study duration is up to 30 weeks, including a screening period consisting of a
      screening phase of up to 2 weeks and a 2-week single-blind placebo run-in phase, a 24-week
      double-blind treatment period, and a 2-week post-treatment follow-up visit period to collect
      safety information.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in hemoglobin A1c (HbA1c)
time frame: Baseline to Week 24
description: Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 1)
measure: Change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT)
time frame: Baseline to Week 24
description: Absolute change from baseline to week 24 in 2-hour PPG following a MMTT (for sotagliflozin dose1 and 2)
measure: Change in fasting plasma glucose (FPG)
time frame: Baseline to Week 24
description: Absolute change from baseline to week 24 in FPG (for sotagliflozin dose 1 and 2)
measure: Change in body weight
time frame: Baseline to Week 24
description: Absolute change from baseline to week 24 in body weight (for sotagliflozin dose1 and 2)
measure: Change in HbA1c
time frame: Baseline to Week 24
description: Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 2)
measure: Change in systolic blood pressure (SBP) for all patients
time frame: Baseline to Week 12
description: Absolute change from baseline to week 12 in SBP for all patients (for sotagliflozin dose 1 and 2)
measure: Change in SBP for patients with baseline SBP ≥130 mmHg
time frame: Baseline to Week 12
description: Absolute change from baseline to week 12 in SBP for patients with baseline SBP ≥130 mmHg (for sotagliflozin dose 1 and 2)
measure: Adverse events
time frame: Up to Week 24
description: Number of patients with adverse events
arm group label: Sotagliflozin dose 1
arm group type: Experimental
description: Sotagliflozin dose 1, given as two (2) dose 2 tablets, once daily, before the first meal of the day
arm group label: Sotagliflozin dose 2
arm group type: Experimental
description: Sotagliflozin dose 2, given as 1 sotagliflozin dose 2 tablet and 1 sotagliflozin-matching placebo tablet (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
arm group label: Placebo
arm group type: Placebo Comparator
description: Two sotagliflozin-matching placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
intervention type: Drug
intervention name: sotagliflozin (SAR439954)
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Sotagliflozin dose 1
arm group label: Sotagliflozin dose 2
intervention type: Drug
intervention name: placebo
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Placebo
arm group label: Sotagliflozin dose 2
intervention type: Drug
intervention name: metformin
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Placebo
arm group label: Sotagliflozin dose 1
arm group label: Sotagliflozin dose 2
intervention type: Drug
intervention name: sulfonylurea
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Placebo
arm group label: Sotagliflozin dose 1
arm group label: Sotagliflozin dose 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
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: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org