A Study to Evaluate Safety and Effects of Sotagliflozin Dose 1 and Dose 2 on Glucose Control in Patients With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of
randomized treatment and a visit 4 weeks after completion of the randomized treatment period.

Inclusion criteria :

- Patients with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented
severe renal insufficiency - CKD4 - defined by an estimated glomerular filtration rate
(eGFR) equation (based on the 4 variable modification of diet in renal disease (MDRD)
equation) of ≥15 and <30 mL/min/1.73 m2.

- Signed written informed consent to participate in the study in accordance with local
regulations.

Exclusion criteria:

- At the time of screening, age <18 years.

- Hemoglobin A1c (HbA1c) <7% or >11%.

- Type 1 diabetes.

- Women of childbearing potential (WOCBP) not willing to use highly effective 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.

- Treatment with an SGLT2 inhibitor (canagliflozin, dapagliflozin, empagliflozin) during
the last 12 months.

- 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, will preclude their safe participation in this
study, or will make implementation of the protocol or interpretation of the study
results difficult.

- 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.