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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mount Sinai Hospital, Canada
• Collaborator: Boehringer Ingelheim
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Women with recent gestational diabetes who are between 6-36 months postpartum inclusive and no longer breastfeeding

• Age 20 - 50 years inclusive

• Negative pregnancy test at recruitment

Exclusion Criteria:

• Current breastfeeding

• Current diabetes or treatment with any anti-diabetic medication

• Involvement in any other clinical study requiring drug therapy

• Hypersensitivity to empagliflozin or the formulations of this product

• Any history of diabetic ketoacidosis

• History of recurrent urinary infection (i.e. more than 2 episodes over the past year).

• Renal dysfunction as evidenced by estimated glomerular filtration rate < 45 ml/min by Modification of Diet in Renal Disease (MDRD) formula

• Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases >2.5X the upper limit of normal

• Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)

• Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study or the first 3 months after the study. Reliable contraception includes the following: birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide.

• Any other factor likely to limit adherence to the study, in the opinion of the investigators