Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
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.
Timeline
- Start
- 2018-02-19
- Primary completion
- 2019-05-22
- Completion
- 2020-05-30
Outcome
Met primary endpoint
Stopped (Business): “Study terminated prematurely for financial reasons and Covid-19 pandemic.”
registry analysis (superiority test); Placebo vs Sotagliflozin 400 mg; p <0.0001; Difference in Least Squares (LS) Means -0.45 (95% CI -0.649 to -0.250); ANCOVA NCT03386344 ↗
registry analysis (superiority test); Placebo vs Sotagliflozin 200 mg; p <0.0001; Difference in LS Means -0.43 (95% CI -0.634 to -0.235); ANCOVA NCT03386344 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotagliflozin | Small molecule | 200 mg | Oral |
| Subject | Sotagliflozin | Small molecule | 400 mg | Oral |