efficacy and safety of sotagliflozin versus placebo in participants with type 2 diabetes mellitus on background of sulfonylurea alone or with metformin

Conditions: Type 2 Diabetes Mellitus

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.

the duration per participants is up to 85 weeks, including a screening period consisting of a screening phase of up to 2 weeks and a 2-week single-blind run-in phase, a 26-week double blind core treatment period, a 53 week double blind extension, and a 2-week post treatment follow-up period to collect safety information.

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) \ 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.