Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

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 \<7% or \>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.