drugset / Trial / NCT03215069

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

NCT03215069

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

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 10 mg Oral

Indications