drugset / Trial / NCT05569772
Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes
Phase 3
Recruiting
252 enrolled
Universitaire Ziekenhuizen KU Leuven
AZ Sint-Lucas Brugge · collabAZ Turnhout · collabCentre Hospitalier Mouscron · collabCentre Hospitalier Universitaire de Liege · collabErasme University Hospital · collabGeneral Hospital Groeninge · collabJan Yperman Ziekenhuis · collabOnze Lieve Vrouw Hospital · collabUniversitair Ziekenhuis Brussel · collabUniversity Hospital, Antwerp · collabVitaz · collabZiekenhuis aan de Stroom · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2023-09-14
- Primary completion
- 2029-06
- Completion
- 2029-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Semaglutide | Peptide | 1 mg | Subcutaneous |