RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Universitaire Ziekenhuizen KU Leuven • ClinicalTrials.gov ID: NCT05569772

Registry updated: 2026-09-15

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Description

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.

Interventions

Semaglutide Pen Injector (Drug)
maintenance dose of 1mg SC once weekly
Semaglutide placebo (Drug)
maintenance dose of 1mg SC once weekly

Eligibility criteria

Eligible participants are women aged ≥18 years, with a history of GDM diagnosed according to the 2013 WHO criteria (at 24-32 weeks gestation or \<24 weeks for early GDM). Participants must have prediabetes diagnosed 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 \[5.7-6.4%\]). Additional inclusion criteria include cessation of breastfeeding, no intention to become pregnant within the next year, use of effective contraception and no use of medication affecting glucose metabolism. Written ICF is obtained prior to any study-related procedures. Exclusion criteria include established diabetes, presence of autoantibodies suggestive of type 1 diabetes, normal glucose tolerance, history of pancreatitis, previous bariatric surgery or planned surgery within two years, unable to understand and speak Dutch, French or English and current pregnant or planning to become pregnant within one year after participating in the study.

Conditions

Glucose Intolerance After a Recent History of Gestational Diabetes

Locations

AZORG — Aalst, Belgium
UZA — Antwerp, Belgium
ZAS — Antwerp, Belgium
AZ St Jan Brugge — Bruges, Belgium
Erasme — Brussels, Belgium
UZ Brussel — Brussels, Belgium
Jan Yperman — Ieper, Belgium
AZ Groeninge Kortrijk — Kortrijk, Belgium
UZ Leuven — Leuven, Belgium
CHU de Liège — Liège, Belgium
Centre Hospitalier Mouscron — Mouscron, Belgium
Vitaz — Sint-Niklaas, Belgium
AZ Turnhout — Turnhout, Belgium

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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