Clinical Trial

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

Study acronym: SERENA
Recruiting Phase 3
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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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-07-08
Trial Details
NCT Number NCT05569772
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Collaborators: University Hospital, Antwerp, Universitair Ziekenhuis Brussel, General Hospital Groeninge, Vitaz, Centre Hospitalier Universitaire de Liege, Erasme University Hospital, Centre Hospitalier Mouscron, Jan Yperman Ziekenhuis, AZ Turnhout, AZ Sint-Lucas Brugge, Ziekenhuis aan de Stroom, Onze Lieve Vrouw Hospital
Conditions Glucose Intolerance After a Recent History of Gestational Diabetes
Enrollment 252 participants
Start Date 2023-09-14
Primary Completion 2029-06 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-07