Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy

Up to 34 weeks, including a Screening Period consisting of a Screening Phase of up to 2 weeks
and a 2-week single-blind placebo Run-in Phase, a 26-week double-blind Treatment Period, and
a 4-week post-treatment Follow-up visit to collect safety information.

Inclusion criteria :

- Patients (male and female) with T2D, who are treated with diet and exercise only
during the 12 weeks prior to screening.

- 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 contraceptive
method(s) of birth control during the study treatment period and the follow up period
or who are unwilling or unable to be tested for pregnancy during the study.

- Treated with an antidiabetic pharmacological agent within the 12 weeks prior to the
Screening Visit.

- Previous use of any types of insulin for >1 month (at any time, except for treatment
of gestational diabetes).

- History of 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 (systolic) or >100 mmHg
(diastolic).

- History of hypertensive 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 that, according to the Investigator, will preclude their
safe participation in this study, or will make 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.
Current enrollment in any other clinical study involving an investigational study
treatment or any other type of medical research.

- Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.

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

- 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.

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

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