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

NCT03215069 | Completed Phase 3

• 1 other identifier: 16-0226-A
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes

Keywords

gestational diabetes, SGLT-2 inhibitor, empagliflozin

Outcome Measures

Primary Outcomes (1)

• Baseline-adjusted ISSI-2 at 48-weeks

  The primary outcome will be measured by ISSI-2. ISSI-2 is a validated OGTT-derived measure of beta-cell function analogous to the disposition index obtained from the intravenous glucose tolerance test. ISSI-2 is defined as the product of (i) insulin secretion measured by the ratio of the area-under-the-insulin-curve (AUCins) to the area-under-the-glucose curve (AUCgluc) and (ii) insulin sensitivity measured by the Matsuda index.

  48-weeks

Secondary Outcomes (1)

• Glucose tolerance status at 48-weeks

  48-weeks

Other Outcomes (6)

• Baseline-adjusted ΔISR0-120/Δgluc0-120 × Matsuda index at 48 weeks

  48-weeks

• Baseline-adjusted insulinogenic index/HOMA-IR at 48-weeks

  48-weeks

• Body mass index at 48-weeks

  48-weeks

Study Arms (2)

Empagliflozin

EXPERIMENTAL

Empagliflozin 10 mg PO daily

Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR

Matched placebo PO daily

Drug: Placebo oral capsule

Interventions

Empagliflozin 10 MG DRUG

Empagliflozin 10 mg PO daily

Empagliflozin

Placebo oral capsule DRUG

Placebo PO daily

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Women with history of gestational diabetes
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Leadership Sinai Centre foe Diabetes - Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

Related Publications (1)

• 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.

  PMID: 40964955 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Caroline kramer, MD PhD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 12, 2017
• Study Start: July 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)