Using semaglutide to prevent type 2 diabetes in women with past gestational diabetes
Official title: Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes: a Double Blind RCT
Run by Universitaire Ziekenhuizen KU Leuven · NCT05569772 · Data updated 2026-11-12
This study is testing if the medication semaglutide can help women who had gestational diabetes lower their chances of developing type 2 diabetes after giving birth.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 252 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 13 sites (Aalst and 12 other locations) |
| Status | Recruiting |
| Started | September 14, 2023 |
| Main results expected | March 2030 |
| Study ends | May 2030 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT05569772 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 6-24 weeks postpartum who have a history of gestational diabetes and are experiencing glucose intolerance.
✕Probably not a fit
Patients with a history of any type of diabetes or certain medical conditions, such as pancreatitis or severe psychiatric disorders, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of semaglutide, a GLP-1 agonist, in reducing the risk of developing type 2 diabetes in women who have experienced gestational diabetes and are showing glucose intolerance in the early postpartum period. Conducted as a double-blind, randomized controlled trial across 13 centers in Belgium, participants will be assigned to receive either semaglutide or a placebo, alongside lifestyle interventions, for a duration of three years. The primary outcome will be the incidence of type 2 diabetes, assessed through glucose tolerance tests and fasting glycemia measurements.
Why it matters
Potential benefit: If successful, this treatment could significantly lower the risk of type 2 diabetes in women with a history of gestational diabetes.
How similar studies have gone: Other studies have shown promising results with GLP-1 agonists in similar populations, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Eligible participants are women aged ≥18 years, with a history of GDM diagnosed according to the 2013 WHO criteria (at 24-32 weeks gestation or \<24 weeks for early GDM). Participants must have prediabetes diagnosed between 6 weeks and 12 months postpartum according to ADA criteria (FPG 5.6-6.9 mmol/L, 2-hour OGTT glucose 7.8-11.0 mmol/L and/or HbA1c 39-46 mmol/mol \[5.7-6.4%\]). Additional inclusion criteria include cessation of breastfeeding, no intention to become pregnant within the next year, use of effective contraception and no use of medication affecting glucose metabolism. Written ICF is obtained prior to any study-related procedures. Exclusion criteria include established diabetes, presence of autoantibodies suggestive of type 1 diabetes, normal glucose tolerance, history of pancreatitis, previous bariatric surgery or planned surgery within two years, unable to understand and speak Dutch, French or English and current pregnant or planning to become pregnant within one year after participating in the study.
Where it's running
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Azorg
Aalst, Belgium Recruiting -
Uza
Antwerp, Belgium Recruiting -
Zas
Antwerp, Belgium Recruiting -
AZ St Jan Brugge
Bruges, Belgium Recruiting -
Erasme
Brussels, Belgium Recruiting -
UZ Brussel
Brussels, Belgium Recruiting
Show 7 more locations
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Jan Yperman
Ieper, Belgium Recruiting -
AZ Groeninge Kortrijk
Kortrijk, Belgium Recruiting -
UZ Leuven
Leuven, Belgium Recruiting -
CHU de Liège
Liège, Belgium Recruiting -
Centre Hospitalier Mouscron
Mouscron, Belgium Recruiting -
Vitaz
Sint-Niklaas, Belgium Recruiting -
AZ Turnhout
Turnhout, Belgium Recruiting
Study contacts
- Study coordinator: Katrien Benhalima, MD PhD
- Email: katrien.benhalima@uzleuven.be
- Phone: 16340614
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.