Semaglutide to Prevent Diabetes in Women After Gestational Diabetes
Tests semaglutide in adult women with glucose intolerance after gestational diabetes.
Plain-language title generated from the registry record
Registry title: Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes
Key facts
- Where
- Aalst, Antwerp, Bruges, Brussels, Ieper, Kortrijk, Leuven, Liège, Mouscron, Sint-Niklaas, and Turnhout, BelgiumSee the 13 sites
- Phase
- Phase 3
Where in Belgium
- AZORGAalst, BelgiumTaking people
- UZAAntwerp, BelgiumTaking people
- ZASAntwerp, BelgiumTaking people
- AZ St-Jan BruggeBruges, BelgiumTaking people
- ErasmeBrussels, BelgiumTaking people
- UZ BrusselBrussels, BelgiumTaking people
- Jan YpermanIeper, BelgiumTaking people
- AZ Groeninge, KortrijkKortrijk, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
- CHU de LiègeLiège, BelgiumTaking people
- Centre Hospitalier MouscronMouscron, BelgiumTaking people
- VitazSint-Niklaas, BelgiumTaking people
- AZ TurnhoutTurnhout, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaire Ziekenhuizen KU Leuven
- Trial code
- NCT05569772EU 2022-502082-22-00
- Record updated
- 15 September 2026
- Original 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.Read full original descriptionShow less
Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes: a Double Blind RCT
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.
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.