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Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02926937
Recruitment Status : Completed
First Posted : October 6, 2016
Results First Posted : June 21, 2021
Last Update Posted : June 21, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 5, 2016
First Posted Date  ICMJE October 6, 2016
Results First Submitted Date  ICMJE April 16, 2021
Results First Posted Date  ICMJE June 21, 2021
Last Update Posted Date June 21, 2021
Actual Study Start Date  ICMJE November 11, 2016
Actual Primary Completion Date April 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2021)
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo) [ Time Frame: Baseline to Week 26 ]
An analysis of covariance (ANCOVA) model was used for the analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
Change from Baseline in HbA1c [ Time Frame: Baseline to Week 26 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2021)
  • Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo) [ Time Frame: Baseline to Week 26 ]
    An ANCOVA model was used for the analysis.
  • Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo) [ Time Frame: Baseline to Week 26 ]
    An ANCOVA model was used for the analysis.
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo) [ Time Frame: Baseline to Week 26 ]
    An ANCOVA model was used for the analysis.
  • Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 Millimeter of Mercury (mmHg) (Sotagliflozin 400 mg Versus Placebo) [ Time Frame: Baseline to Week 12 ]
    An ANCOVA model was used for the analysis.
  • Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo) [ Time Frame: Baseline to Week 12 ]
    An ANCOVA model was used for the analysis.
  • Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo) [ Time Frame: Baseline to Week 12 ]
    An ANCOVA model was used for the analysis.
  • Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo) [ Time Frame: Baseline to Week 26 ]
    An ANCOVA model was used for the analysis.
  • Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo) [ Time Frame: Baseline to Week 26 ]
    An ANCOVA model was used for the analysis.
  • Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo) [ Time Frame: Week 26 ]
  • Percentage of Participants With HbA1c <7.0% at Week 26 (Sotagliflozin 400 mg Versus Placebo) [ Time Frame: Week 26 ]
  • Change From Baseline in HbA1c at Week 26 (Sotagliflozin 200 mg Versus Placebo) [ Time Frame: Baseline to Week 26 ]
    An ANCOVA model was used for the analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
  • Change from baseline in 2-hour PPG following a mixed meal [ Time Frame: Baseline to Week 26 ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline to Week 26 ]
  • Change from baseline in systolic blood pressure (SBP) for patients with baseline SBP ≥130 mmHg [ Time Frame: Baseline to Week 12 ]
  • Change from baseline in SBP for all patients [ Time Frame: Baseline to Week 12 ]
  • Change from baseline in body weight [ Time Frame: Baseline to Week 26 ]
  • Percentage of patients with HbA1c <6.5% [ Time Frame: At Week 26 ]
  • Percentage of patients with HbA1c <7.0% [ Time Frame: At Week 26 ]
Current Other Pre-specified Outcome Measures
 (submitted: June 3, 2021)
  • Percentage of Participants With Hypoglycemic Events (Sotagliflozin 400 mg Versus Placebo) [ Time Frame: Week 26 ]
    Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤70 mg/dL]. Participants may be reported in more than one category.
  • Percentage of Participants With Hypoglycemic Events (Sotagliflozin 200 mg Versus Placebo) [ Time Frame: Week 26 ]
    Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤70 mg/dL]. Participants may be reported in more than one category.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin as Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Brief Summary

Primary Objective:

To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise.

Secondary Objectives:

  • To compare Sotagliflozin 400 mg versus placebo based on:
  • Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.
  • Change from baseline in fasting plasma glucose (FPG).
  • Change from baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter per mercury (mmHg).
  • Change from baseline in SBP for all participants.
  • Change from baseline in body weight.
  • Proportion of participants with HbA1c <6.5%, <7.0%.
  • To compare Sotagliflozin 200 mg versus placebo based on:
  • Change from baseline in HbA1c.
  • Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.
  • Change from baseline in body weight.
  • Change from baseline in SBP for all participants.
  • To evaluate the safety of Sotagliflozin 400 and 200 mg versus placebo.
Detailed Description Up to 34 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 26-week double-blind Treatment Period, and a 4-week post-treatment Follow-up visit to collect safety information.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Sotagliflozin (SAR439954)

    Pharmaceutical form: tablet;

    Route of administration: oral

  • Drug: Placebo

    Pharmaceutical form: tablet;

    Route of administration: oral

Study Arms  ICMJE
  • Experimental: Sotagliflozin 400 mg
    Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 milligrams (mg) administered as two 200 mg tablets, once daily (QD), before the first meal of the day in the double-blind treatment period for up to 26 weeks.
    Intervention: Drug: Sotagliflozin (SAR439954)
  • Experimental: Sotagliflozin 200 mg
    Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 Sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
    Interventions:
    • Drug: Sotagliflozin (SAR439954)
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2020)
399
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2016)
240
Actual Study Completion Date  ICMJE May 17, 2019
Actual Primary Completion Date April 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Participants (male and female) with T2D, who are treated with diet and exercise only during the 12 weeks prior to screening.
  • Signed written informed consent.

Exclusion criteria:

  • Age <18 years at Screening or < legal age of majority, whichever is greater.
  • Type 1 diabetes mellitus.
  • Body Mass Index (BMI) ≤20 or >45 kilogram per meter square (kg/m^2) at Screening.
  • Hemoglobin A1c (HbA1c) <7% or >10% via central laboratory test at Screening.
  • Fasting plasma glucose (FPG) >15 millimole per liter (mmol/L) (270 milligram per deciliter [mg/dL]) measured by the central laboratory at screening (Visit 1) and confirmed by a repeat test (>15 mmol/L [270 mg/dL]) before randomization.
  • Women of childbearing potential not willing to use highly effective contraceptive method(s) of birth control during the study treatment period and the follow up period or who are unwilling or unable to be tested for pregnancy during the study.
  • Treated with an antidiabetic pharmacological agent within the 12 weeks prior to the Screening Visit.
  • Previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes).
  • History of gastric surgical procedure including gastric banding within 3 years before the Screening Visit.
  • History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
  • Mean of 3 separate blood pressure measurements >180 millimeter of mercury (mmHg) (systolic) or >100 mmHg (diastolic).
  • History of hypertensive emergency within 12 weeks prior to Screening.
  • Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association [NYHA] IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or participants with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
  • Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit of the normal laboratory range.
  • Total bilirubin: >1.5 times the upper limit of the normal laboratory range (except in case of Gilbert's syndrome).
  • Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
  • Participants who has taken other investigational drugs or prohibited therapy for this study within 12 weeks or 5 half-lives from screening or randomization, whichever is longer. Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research.
  • Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.
  • Severe renal disease as defined by estimated glomerular filtration rate (eGFR) of <30 millimeter per minute (mL/min)/1.73 meter square (m^2)² at screening by the 4 variable Modification of Diet in Renal Disease (MDRD) equation.
  • Participant is unwilling or unable to perform self-monitoring of blood glucose (SMBG), complete the participants diary, or comply with study visits and other study procedures as required per protocol.
  • Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.

The above information is not intended to contain all considerations relevant to a Participant potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02926937
Other Study ID Numbers  ICMJE EFC14833
2016-001799-31 ( EudraCT Number )
U1111-1180-6169 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lexicon Pharmaceuticals
Original Responsible Party Sanofi
Current Study Sponsor  ICMJE Lexicon Pharmaceuticals
Original Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.
PRS Account Lexicon Pharmaceuticals
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP