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

Phase 3 Completed 91 enrolled Mount Sinai Hospital, Canada Boehringer Ingelheim · collab

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

Outcome

Missed primary endpoint

paper The primary outcome of baseline-adjusted ISSI-2 at 48 weeks was not different between the empagliflozin and placebo group (525 ± 30.4 vs. 560 ± 33.4, p = 0.43). PMID 40964955 ↗

Publications

Murugavel S, Retnakaran R, Feig DS, Zinman B, Kramer CK. Empagliflozin for the preservation of beta-cell function in women with recent gestational diabetes: A randomized placebo-controlled trial. Diabetes Obes Metab. 2025 Dec;27(12):7408-7415. doi: 10.1111/dom.70146. Epub 2025 Sep 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	10 mg	Oral