drugset / Trial / NCT03386344
Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
RandomizedParallel-groupQuadruple-blindTreatment
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotagliflozin | Small molecule | 200 mg | Oral |
| Subject | Sotagliflozin | Small molecule | 400 mg | Oral |