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

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.

Inclusion criteria :

- Patients with Type 2 Diabetes currently treated with diet and exercise and on
metformin at a stable dose ≥1500 mg/day for at least 12 weeks. However, patients 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 kg/m2 at Screening

- Hemoglobin A1c <7% or >10% via central laboratory test at screening.

- Fasting plasma glucose (FPG) >15 mmol/L (270 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.

- Patients 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 patients
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.

- Patient 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.

- Patient is unwilling or unable to perform self-monitoring of blood glucose (SMBG),
complete the patient diary, or comply with study visits and other study procedures as
required per protocol.

- Contraindication to metformin as per local labeling.

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