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

NCT03215069 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-03-07

No results posted yet for this study

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

Interventions

DRUG

Empagliflozin 10 MG

Empagliflozin 10 mg PO daily

DRUG

Placebo oral capsule

Placebo PO daily

Sponsors & Collaborators

Principal Investigators

  • Caroline kramer, MD PhD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215069 on ClinicalTrials.gov