efficacy and safety of sotagliflozin versus placebo in patients with type 2 diabetes mellitus on background of metformin

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin a1c (hba1c) reduction in participants with type 2 diabetes (t2d) who have inadequate glycemic control with metformin. secondary objectives: * to compare sotagliflozin versus placebo for. * 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 of mercury (mmhg). * change from baseline in sbp for all participants. * change from baseline in body weight. * proportion of participants with hba1c \<6.5% and \<7.0%. * to evaluate the safety of sotagliflozin versus placebo.

the duration of the study period is up to 87 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 period, a 4 week post treatment follow-up period to collect safety information.

Eligibility criteria:
inclusion criteria : * participants with type 2 diabetes currently treated with diet and exercise and on metformin at a stable dose ≥1500 milligrams per day (mg/day) for at least 12 weeks. however, participants on metformin at a dose \<1500 mg/day at the time of enrollment (stable dose for at least 12 weeks before enrollment) may be eligible for screening if documentation of lack of tolerance of a metformin dose ≥1500 mg/day can be provided. * 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 kilograms per meter square (kg/m\^2) at screening * hemoglobin a1c \ 10% via central laboratory test at screening. * fasting plasma glucose (fpg) \>15 millimole per liter (mmol/l) (270 milligrams 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 method(s) of birth control or who are unwilling or unable to be tested for pregnancy during the study. * treated with an antidiabetic pharmacological regimen other than metformin ≥1500 mg per day (or maximum tolerated dose) within the 12 weeks preceding the screening visit. * previous use of any types of insulin for \>1 month (at any time, aside from pregnancy for treatment of gestational diabetes). * history of prior 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 mmhg (sbp) or \>100 mmhg (diastolic blood pressure \[dbp\]). * history of hypertensive urgency or 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 making 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. * pregnant (confirmed by serum pregnancy test at screening) or breastfeeding women. * participants 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. * contraindication to metformin as per local labelling. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.