drugset / Trial / NCT03215069
Empagliflozin and the Preservation of Beta-cell Function in Women with Recent Gestational Diabetes
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Double-blind, parallel arm, randomized controlled trial, in which non-lactating women with recent GDM who are between 6 to 36 months postpartum to be randomized to either empagliflozin 10 mg daily or matching placebo. The duration of treatment will be 48-weeks. Beta-cell function will be assessed by Insulin Secretion-Sensitivity Index-2 (ISSI-2), measured on oral glucose tolerance test (OGTT) at baseline, 24-weeks, 48-weeks, and after a 4-week washout.
Timeline
- Start
- 2018-07-01
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |