Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Inclusion criteria :

• Participants with T2D managed with diet and exercise only or with a stableantidiabetes regimen (in monotherapy or combination therapy that can include oralantidiabetes medications, insulin, or glucagon-like peptide-1 agonists) for more than 12 weeks.
• Participants has given written informed consent to participate in the study inaccordance with local regulations.

Exclusion criteria:

• Age <55 years.
• Women who have been postmenopausal (or undergone bilateral oophorectomy) for less than 5 years.
• Type 1 diabetes mellitus.
• Body mass index (BMI) ≤20 or >45 kilogram per meter square kg/m^2 or bodyweight thatexceeds the weight limits of the DXA scanner.
• Hemoglobin A1C (HbA1c) <7.0% or HbA1c >11.0%.
• Use of a selective sodium-glucose cotransporter type 2 (SGLT2) inhibitor orthiazolidinedione within 24 months.
• Bone mineral density (BMD) T- score <-2.0 at any site (ie, lumbar spine, total hip, orfemoral neck).
• History of fracture within 12 months (except for fractures of the hand/fingers,foot/toes, facial bones, and skull).
• Treatment with medications known to affect bone mass or modify the risk of fractureswithin 36 months (eg, bisphosphonates, selective estrogen receptor modulators,calcitonin, teriparatide, denosumab, strontium ranelate, growth hormone, aromataseinhibitors, androgen deprivation therapy, carbamazepine, phenytoin, andphenobarbital). Use of hormonal replacement that includes systemic or transdermalestrogen or testosterone is excluded unless is stable for at least 24 months prior toScreening.
• Lower extremity complications (such as skin ulcers, infection, osteomyelitis andgangrene) identified during the Screening period, and still requiring treatment atrandomization.
• Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, suchas heart failure, active cancer, or other conditions that the Investigator believeswith result in a short life expectancy.
• Renal disease as defined by an estimated glomerular filtration rate (eGFR) <30milliliter per minute (mL/min)/1.73 meter square (m^2) at the Screening Visit by the 4variable Modification of Diet in Renal Disease equation. The above information is not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.