Overview

Empagliflozin and the Preservation of Beta-cell Function in Women With Recent Gestational Diabetes

Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborator:
Boehringer Ingelheim
Treatments:
Empagliflozin