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

The duration per patient is up to 85 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, and a 2-week post treatment
Follow-up period to collect safety information.

Inclusion criteria :

- Patients with T2D treated with a sulfonylurea (≥half the maximum recommended dose as
per local label or maximum tolerated dose [documented]) as monotherapy or in
combination with metformin (≥1500 mg per day or maximum tolerated dose [documented])
each at a stable dose for at least 12 weeks without a dose adjustment before
screening.

- Signed written informed consent.

Exclusion criteria:

- At the time of screening, age <18 years or < legal age of majority, whichever is
greater.

- Body Mass Index (BMI) ≤20 or >45 kg/m² at Screening

- Hemoglobin A1c (HbA1c) <7% or HbA1c >10% via central lab test at screening.

- Fasting plasma glucose (FPG) >15 mmol/L (270 mg/dL) measured by the central laboratory
at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before
randomization.

- Women of childbearing potential with no effective contraceptive method.

- Treated with an antidiabetic pharmacological regimen other than a sulfonylurea at a
stable dose with or without metformin within 12 weeks preceding the screening visit.

- Previous insulin use >1 month (at any time, aside from treatment of gestational
diabetes).

- History of prior gastric surgical procedure including gastric banding or inflammatory
bowel disease within 3 years before the Screening Visit.

- History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior
to the Screening Visit.

- History of severe hypoglycemia within 6 months prior to the Screening visit.

- Systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >100 mmHg or
history of hypertensive emergency.

- Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit
of the normal laboratory range (ULN).

- Total bilirubin: >1.5 times ULN (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.

- Pregnancy, breastfeeding.

- Patient is unwilling to perform self-monitoring of blood glucose (SMBG), and complete
the patient's diary as required per protocol.

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