Safety and Efficacy Study of Sotagliflozin on Glucose Control in Patients With Type 2 Diabetes, Moderate 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
moderate renal insufficiency defined by an estimated glomerular filtration rate (eGFR)
(based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation) of ≥30
and <60 mL/min/1.73 m2 (CKD 3A, 3B).

- Patient has given written informed consent to participate in the study in accordance
with local regulations.

Exclusion criteria:

- Hemoglobin A1c (HbA1c) of <7.0% or >11.0%.

- 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.

- Patients with severe anemia, severe cardiovascular (including congestive heart failure
New York Heart Association 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.

- 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.