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

Sponsor
Mount Sinai Hospital, Canada
Study ID
NCT03215069
Phase
PHASE3
Status
Completed

Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    Empagliflozin 10 mg PO daily
  • Placebo oral capsule — DRUG
    Placebo PO daily

Study Details

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.

Key Dates

Start date
Jul 1, 2018
Status verified
Mar 2025
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
91 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Empagliflozin
    Empagliflozin 10 mg PO daily
  • Placebo Comparator: Placebo
    Matched placebo PO daily

Primary Outcome Measure

Baseline-adjusted ISSI-2 at 48-weeks [ Time Frame: 48-weeks ]

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