Using semaglutide to prevent type 2 diabetes in women with past gestational diabetes

Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes: a Double Blind RCT

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: PHASE3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Universitaire Ziekenhuizen KU Leuven (other)
• Locations: 13 sites (Aalst and 12 other locations)
• Trial ID: NCT05569772 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 6-24 weeks postpartum who have a history of gestational diabetes and are experiencing glucose intolerance.

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.

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 performed: Other studies have shown promising results with GLP-1 agonists in similar populations, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures
2. Use of highly effective methods of birth control
3. History of GDM (diagnosed with 2013 WHO criteria 24-32 weeks of pregnancy) and glucose intolerance 6-24 weeks postpartum (based on the ADA criteria)
4. Needs to be able to understand and speak Dutch, French or English

Exclusion Criteria:

* 1\. Participant has a history of any type of diabetes or auto-antibodies for type 1 diabetes, history of pancreatitis, family or personal history of medullary thyroid carcinoma or personal history of thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, severe psychiatric disorder in the past year, heart failure NYHA class 4, end-stage renal disease (eGFR \<15) or dialysis, or history of bariatric surgery 2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol 3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial 4. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 5. Participation in an interventional Trial with an investigational medicinal product or device 6. Age \<18 years, breastfeeding \>24 weeks postpartum or HbA1c≥6.5% at the time of the OGTT in pregnancy 7. Use of medication with significant impact on glycaemia (such as high dose glucocorticoids or metformin)

Where this trial is running

Aalst and 12 other locations

• OLV-Aalst-Asse — Aalst, Belgium (RECRUITING)
• UZA — Antwerp, Belgium (RECRUITING)
• ZNA, — Antwerp, Belgium (RECRUITING)
• AZ St Jan Brugge — Bruges, Belgium (RECRUITING)
• Erasme — Brussels, Belgium (RECRUITING)
• UZ Brussel — Brussels, Belgium (RECRUITING)
• 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

Conditions: Glucose Intolerance After a Recent History of Gestational Diabetes, gestational diabetes, glucose intolerance postpartum, prevention, type 2 diabetes, GLP-1 agonist, semaglutide