Efficacy and Bone Safety of Sotagliflozin Dose 1 and Dose 2 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Study duration per participant is approximately 110 weeks (Screening period of up to 2 weeks,
2 week single-blind run-in period), a 26-week double-blind core treatment period, a 78-week
double-blind extension period, and a 2- week post treatment follow up period.

DXA scans will be performed to assess Bone Mineral Density and Fat vs. Lean body mass at
baseline and Weeks 26, 52, and 104.

Inclusion criteria :

- Patients with Type 2 Diabetes (T2D) managed with diet and exercise only or with a
stable antidiabetes regimen (in monotherapy or combination therapy that can include
oral antidiabetes medications, insulin, or glucagon-like peptide-1 agonists) for more
than 12 weeks.

- Patient has given written informed consent to participate in the study in accordance
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 kg/m2 or body weight that exceeds the weight limits
of the Dual-energy X-ray absorptiometry (DXA) scanner.

- Hemoglobin A1C (HbA1c) <7.0% or HbA1c >11.0%.

- Use of a selective sodium-glucose cotransporter type 2 (SGLT2) inhibitor or
thiazolidinedione within 24 months.

- Bone mineral density (BMD) T- score <-2.0 at any site (ie, lumbar spine, total hip, or
femoral 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 fractures
within 36 months (eg, bisphosphonates, selective estrogen receptor modulators,
calcitonin, teriparatide, denosumab, strontium ranelate, growth hormone, aromatase
inhibitors, androgen deprivation therapy, carbamazepine, phenytoin, and
phenobarbital). Use of hormonal replacement that includes systemic or transdermal
estrogen or testosterone is excluded unless is stable for at least 24 months prior to
Screening.

- Lower extremity complications (such as skin ulcers, infection, osteomyelitis and
gangrene) identified during the Screening period, and still requiring treatment at
Randomization.

- Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such
as heart failure, active cancer, or other conditions that the Investigator believes
with result in a short life expectancy.

- Renal disease as defined by an estimated glomerular filtration rate (eGFR) <30
mL/min/1.73m² at the Screening Visit by the 4 variable Modification of Diet in Renal
Disease equation.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.