NCT05569772 Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes
| NCT ID | NCT05569772 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Glucose Intolerance After a Recent History of Gestational Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2023-09-14 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 252 participants in total. It began in 2023-09-14 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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, the investigators aim 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.
Eligibility Criteria
Inclusion Criteria: 1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures 2. Women aged ≥18 years 3. Use of highly effective methods of birth control 4. History of GDM diagnosed according to the 2013 WHO criteria (at 24-32 weeks gestation or \<24 weeks for early GDM) 5. Diagnosis of prediabetes 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 \[5.7-6.4%\]) Exclusion Criteria: 1. Presence of autoantibodies suggestive of type 1 diabetes, normal glucose tolerance, history of pancreatitis, previous bariatric surgery or planned surgery within two years 2. Unable to understand and speak Dutch, French or English 3. Female who is pregnant or intends to become pregnant within the next year 4. Female who wants to give breastfeeding \>22 months 5. Use of medication with significant impact on glycaemia (such as high dose glucocorticoids or metformin)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05569772 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Glucose Intolerance After a Recent History of Gestational Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05569772 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 252 participants.
Is NCT05569772 currently recruiting?
Yes, NCT05569772 is actively recruiting participants. Contact the research team at katrien.benhalima@uzleuven.be for enrollment information.
Where is the NCT05569772 trial being conducted?
This trial is being conducted at Aalst, Belgium, Antwerp, Belgium, Antwerp, Belgium, Bruges, Belgium and 9 additional locations.
Who is sponsoring the NCT05569772 clinical trial?
NCT05569772 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 252 participants.
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