RecruitingPhase 3

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

Belgium252 participantsStarted 2023-09-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 3 trial testing semaglutide specifically in women who had gestational diabetes and now have glucose intolerance, would my recent pregnancy history and current blood sugar levels make this worth discussing as an option for me?
2Semaglutide is already used for type 2 diabetes and weight management — what additional risks or unknowns should I be aware of when it's being studied in women who recently had gestational diabetes, especially if I'm breastfeeding or planning another pregnancy?
3The trial is measuring whether semaglutide can prevent the development of type 2 diabetes — how does that goal compare to lifestyle changes like diet and exercise, which are already known to help in my situation, and would those be a better first step for me?
4What would participation actually look like day-to-day — how often would I need to come in for visits, what does taking semaglutide involve, and how might that fit with caring for a new baby?
5If I join this trial and it turns out semaglutide isn't the right fit for me, would I still have access to standard preventive care options, or could participating affect my other treatment choices?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Development of T2DM

Timeframe: by 160 weeks

Trial details

NCT IDNCT05569772

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-06

Contact for this trial

Katrien Benhalima, MD PhD

16340614 katrien.benhalima@uzleuven.be

View on ClinicalTrials.gov More Glucose Intolerance After a Recent History of Gestational Diabetes trials