Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
Condition: Type 2 Diabetes Mellitus; Chronic Kidney Disease Stage 3
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.
Route of administration: Oral; Sotagliflozin 200 mg, tablet, orally once daily.
Route of administration: Oral
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: Triple (Participant, Care Provider, Investigator)
Enrollment: 787.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg
      versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have
      inadequate glycemic control and moderate renal impairment.

      Secondary Objectives:

        -  To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to
           additional measures of glycemic control, blood pressure, and body weight.

        -  To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants 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 milliliter per minute (mL/min)/1.73 meter square (m^2)
             (chronic kidney disease [CKD] 3A, 3B).

          -  Participants 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 a sodium-glucose cotransporter type 2 (SGLT2) inhibitor (Canagliflozin,
             Dapagliflozin, Empagliflozin) during the last 12 months.

          -  Uncontrolled high blood pressure.

          -  Participants 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
        participant's potential participation in a clinical trial.