Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (SOTA-BONE)
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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.
Sites / Locations
- Investigational Site Number 8409009
- Investigational Site Number 8409010
- Investigational Site Number 8409005
- Investigational Site Number 8409012
- Investigational Site Number 8409011
- Investigational Site Number 8409014
- Investigational Site Number 8409015
- Investigational Site Number 8409002
- Investigational Site Number 8409001
- Investigational Site Number 8409008
- Investigational Site Number 8409004
- Investigational Site Number 8409013
- Investigational Site Number 8409003
- Investigational Site Number 8409007
- Investigational Site Number 0369003
- Investigational Site Number 0369002
- Investigational Site Number 0369004
- Investigational Site Number 1249003
- Investigational Site Number 1249008
- Investigational Site Number 1249005
- Investigational Site Number 1249006
- Investigational Site Number 1249004
- Investigational Site Number 1249007
- Investigational Site Number 1249002
- Investigational Site Number 4109006
- Investigational Site Number 4109005
- Investigational Site Number 4109003
- Investigational Site Number 4109004
- Investigational Site Number 4109001
- Investigational Site Number 4849006
- Investigational Site Number 4849001
- Investigational Site Number 4849003
- Investigational Site Number 4849002
- Investigational Site Number 4849004
- Investigational Site Number 4849005
- Investigational Site Number 5549004
- Investigational Site Number 5549003
- Investigational Site Number 5549001
- Investigational Site Number 5549002
- Investigational Site Number 6439007
- Investigational Site Number 6439005
- Investigational Site Number 6439002
- Investigational Site Number 6439003
- Investigational Site Number 6439001
- Investigational Site Number 6439006
- Investigational Site Number 1589005
- Investigational Site Number 1589008
- Investigational Site Number 1589006
- Investigational Site Number 1589007
- Investigational Site Number 1589001
- Investigational Site Number 1589002
- Investigational Site Number 1589004
- Investigational Site Number 1589003
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo
Sotagliflozin 200 mg
Sotagliflozin 400 mg
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.