Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sotagliflozin (SAR439954); Placebo; Metformin; Sulfonylurea
Intervention description: Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: Metformin; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 507.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on
      Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who
      have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin.

      Secondary Objectives:

        -  To compare Sotagliflozin 400 mg versus placebo based on:

        -  Change from baseline in fasting plasma glucose (FPG).

        -  Change from baseline in systolic blood pressure (SBP) for participants with baseline SBP
           ≥130 millimeter of mercury (mm Hg).

        -  Change from baseline in SBP for all participants.

        -  Change from baseline in body weight.

        -  Percentage of participants with HbA1c <6.5% and <7.0%.

        -  To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week
           trial.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants with T2D treated with a Sulfonylurea (≥half the maximum recommended dose
             as per local label or maximum tolerated dose [documented]) as monotherapy or in
             combination with Metformin (≥1500 mg per day or maximum tolerated dose [documented])
             each at a stable dose for at least 12 weeks without a dose adjustment before
             screening.

          -  Signed written informed consent.

        Exclusion criteria:

          -  At the time of screening, age <18 years or < legal age of majority, whichever is
             greater.

          -  Body Mass Index (BMI) ≤20 or >45 kilograms per meter square (kg/m^2) at Screening.

          -  Hemoglobin A1c (HbA1c) <7% or HbA1c >10% via central lab test at screening.

          -  Fasting plasma glucose (FPG) >15 mmol/L (270 mg/dL) measured by the central laboratory
             at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before
             randomization.

          -  Women of childbearing potential with no effective contraceptive method.

          -  Treated with an antidiabetic pharmacological regimen other than a Sulfonylurea at a
             stable dose with or without Metformin within 12 weeks preceding the screening visit.

          -  Previous insulin use >1 month (at any time, aside from treatment of gestational
             diabetes).

          -  History of prior gastric surgical procedure including gastric banding or inflammatory
             bowel disease within 3 years before the Screening Visit.

          -  History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior
             to the Screening Visit.

          -  History of severe hypoglycemia within 6 months prior to the Screening visit.

          -  Systolic blood pressure (SBP) >180 millimeter per mercury (mmHg) or diastolic blood
             pressure (DBP) >100 mmHg or history of hypertensive emergency.

          -  Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit
             of the normal laboratory range (ULN).

          -  Total bilirubin: >1.5 times ULN (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.

          -  Pregnancy, breastfeeding.

          -  Participants is unwilling to perform self-monitoring of blood glucose (SMBG), and
             complete the participant's diary as required per protocol.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.