Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents
Summary
Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs). Secondary Objectives: * To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c. * To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP. * To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.
Timeline
- Start
- 2017-09-15
- Primary completion
- 2019-09-17
- Completion
- 2019-09-27
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Sotagliflozin 200 mg; p <0.0001; Difference in Least Square (LS) Means -0.45 (95% CI -0.638 to -0.271); ANCOVA NCT03285594 ↗
registry analysis (superiority test); Placebo vs Sotagliflozin 400 mg; p <0.0001; Difference in LS Means -0.55 (95% CI -0.706 to -0.387); ANCOVA NCT03285594 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotagliflozin | Small molecule | 200 mg | Oral |
| Subject | Sotagliflozin | Small molecule | 400 mg | Oral |
| Background | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |