A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Condition: Type 2 Diabetes Mellitus; Chronic Kidney Disease Stage 4
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Sotagliflozin
Intervention description: Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.; Sotagliflozin 200 mg, tablet, orally, once daily.
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with
      respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes
      who have inadequate glycemic control and severe renal impairment

      Secondary Objectives:

        -  To assess the effects of sotagliflozin 200 mg versus placebo based on change from
           baseline in HbA1c

        -  To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo

        -  To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants 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 milliliter per minute (mL/min)/1.73 per meter
             square (m^2).

          -  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 sodium-glucose cotransporter type 2 (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
        participant's potential participation in a clinical trial.