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CompletedPhase 3

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

Key facts

Who runs it
Mount Sinai Hospital, Canada
Where
Canada1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
91 people enrolled
Started
1 Jul 2018
Ended
31 Dec 2024
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Empagliflozin 10 MG
  • Placebo oral capsule
Record updated
7 March 2025

Who can take part

Age
20 years to 50 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Current diabetes or treatment with any anti-diabetic medication
  • Involvement in any other clinical study requiring drug therapy
  • Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
  • 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
  • Current breastfeeding
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • EmpagliflozinTreatment being tested

    Empagliflozin 10 mg PO daily

    Treatment: Empagliflozin 10 MG

  • PlaceboPlacebo, for comparison

    Matched placebo PO daily

    Treatment: Placebo oral capsule

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Publications
Record updated
7 March 2025