Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

Inclusion criteria :

• Participants with Type 2 Diabetes (T2D) treated with metformin at a stable dose ≥1500milligrams per day (mg/day) or maximum tolerated dose (documented) for at least 12weeks prior to Screening Visit; in case of documented lack of tolerance, metformindose <1500 mg/day is acceptable, and the dose should be stable for at least 12 weeksprior to Screening Visit.
• Participants has given written informed consent to participate in the study inaccordance with local regulations.

Exclusion criteria:

• Age <18 years at the Screening Visit or <legal age of majority, whichever is greater.
• Type 1 diabetes mellitus.
• HbA1c, HbA1c <7.0% or HbA1c >10% at Screening.
• Fasting Plasma Glucose (FPG) >15 millimoles per liter (mmol/L) (>270 milligram perdeciliter [mg/dL]) measured by the central laboratory at Screening (Visit 1) andconfirmed by a repeat test (>15 mmol/L [>270 mg/dL]) before randomization.
• Body mass index ≤20 or >45 kilogram per meter square (kg/m^2) at Screening.
• Pregnant (confirmed by pregnancy test at the Screening) or breast-feeding women.
• Women of childbearing potential (WOCBP) not willing to use highly effective method(s)of birth control during the study treatment period and the follow-up period, or whoare unwilling or unable to be tested for pregnancy (see Appendix A) during the study.
• Previous use of any antidiabetic drug other than Metformin within 12 weeks precedingthe Screening Visit.
• Use of a selective Sodium-glucose co-transporter-2 (SGLT2) inhibitor (e.g.,Canagliflozin, Dapagliflozin, or Empagliflozin) within 3 months prior to the Screeningvisit.
• Use of systemic glucocorticoids (excluding topical, or ophthalmic application,intra-articular, nasal spray or inhaled forms) for more than 10 consecutive dayswithin 90 days prior to the Screening Visit.
• Previous insulin use >1 month (at any time, except for treatment of gestationaldiabetes).
• History of prior gastric surgical procedure, including gastric banding, orinflammatory bowel disease within 3 years prior to the Screening Visit.
• Difficulty swallowing such that the participants cannot take the investigationalmedicinal product (IMP).
• History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks priorto the Screening Visit.
• Mean of 3 separate blood pressure measurements >180 millimeter of mercury (mmHg) (SBP)or >100 mmHg (DBP).
• History of hypertensive emergency within 12 weeks prior to Screening.
• Participants who have previously been randomized in any clinical trial ofSotagliflozin/LX4211.
• Participants with severe renal disease as defined by an estimated glomerularfiltration rate (eGFR) of <30 milliliter per minute per meter square (mL/min/1.73 m^2)at Screening, based on the 4 variable Modification of Diet in Renal Disease (MDRD)equation (or according to the renal function restrictions of metformin use defined inthe local approved label).
• Participants with severe anemia, severe cardiovascular (including congestive heartfailure New York Heart Association IV), respiratory, hepatic, neurological,psychiatric, or active malignant tumor or other major systemic disease that, accordingto Investigator, will preclude their safe participation in this study, or will makeimplementation of the protocol or interpretation of the study results difficult.
• Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limitof the normal laboratory range (ULN).
• Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome).
• Participants who have taken other investigational drugs within 12 weeks or 5half-lives from Screening whichever is longer.
• Participants unwilling or unable to perform self-monitoring blood glucose (SMBG),complete the participant diary, or comply with study visits and other study proceduresas required per protocol.
• Participants with contraindication to glimepiride as per local labelling.
• Participants with contraindication to metformin as per local labelling. The above information is not intended to contain all considerations relevant to aParticipants potential participation in a clinical trial.