Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes

• Status: Not yet recruiting
• Trial end date: 2028-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Gestational diabetes (GDM) is an important contributor to the increasing prevalence of type 2 diabetes (T2DM). Women with glucose intolerance in early postpartum are a particularly high-risk group with about 50% who will develop T2DM within 5 years after the delivery. Moreover, women with a history of GDM progress more rapidly to T2DM compared to women with similarly elevated glucose levels. Early intervention after the index pregnancy is therefore crucial to prevent T2DM. With the SERENA project, we aim therefore to reduce the risk to develop T2DM with the long-acting GLP-1 agonist semaglutide in women with a recent history of GDM and glucose intolerance in early postpartum.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: AZ Delta; Centre Hospitalier Mouscron; Centre Hospitalier Universitaire de Liege; Erasme University Hospital; General Hospital Groeninge; Jessa Hospital; Onze Lieve Vrouw Hospital; Universitair Ziekenhuis Brussel; UZA; Vitaz; Ziekenhuis Netwerk Antwerpen (ZNA)

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 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)