Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sotagliflozin; Placebo
Intervention description: Pharmaceutical form: Tablet; Route of administration: Oral; Pharmaceutical form: Tablet; 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 376.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg)
      versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2
      diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a
      stable antidiabetes regimen.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants with T2D managed with diet and exercise only or with a stable
             antidiabetes regimen (in monotherapy or combination therapy that can include oral
             antidiabetes medications, insulin, or glucagon-like peptide-1 agonists) for more than
             12 weeks.

          -  Participants has given written informed consent to participate in the study in
             accordance with local regulations.

        Exclusion criteria:

          -  Age <55 years.

          -  Women who have been postmenopausal (or undergone bilateral oophorectomy) for less than
             5 years.

          -  Type 1 diabetes mellitus.

          -  Body mass index (BMI) ≤20 or >45 kilogram per meter square kg/m^2 or bodyweight that
             exceeds the weight limits of the DXA scanner.

          -  Hemoglobin A1C (HbA1c) <7.0% or HbA1c >11.0%.

          -  Use of a selective sodium-glucose cotransporter type 2 (SGLT2) inhibitor or
             thiazolidinedione within 24 months.

          -  Bone mineral density (BMD) T- score <-2.0 at any site (ie, lumbar spine, total hip, or
             femoral neck).

          -  History of fracture within 12 months (except for fractures of the hand/fingers,
             foot/toes, facial bones, and skull).

          -  Treatment with medications known to affect bone mass or modify the risk of fractures
             within 36 months (eg, bisphosphonates, selective estrogen receptor modulators,
             calcitonin, teriparatide, denosumab, strontium ranelate, growth hormone, aromatase
             inhibitors, androgen deprivation therapy, carbamazepine, phenytoin, and
             phenobarbital). Use of hormonal replacement that includes systemic or transdermal
             estrogen or testosterone is excluded unless is stable for at least 24 months prior to
             Screening.

          -  Lower extremity complications (such as skin ulcers, infection, osteomyelitis and
             gangrene) identified during the Screening period, and still requiring treatment at
             randomization.

          -  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.

          -  Renal disease as defined by an estimated glomerular filtration rate (eGFR) <30
             milliliter per minute (mL/min)/1.73 meter square (m^2) at the Screening Visit by the 4
             variable Modification of Diet in Renal Disease equation.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.