NCT05569772RecruitingPhase 3
Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes
Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes: a Double Blind RCT
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 252 (estimated)
- First submitted
- 28 Sept 2022
- Start date
- 14 Sept 2023
- Primary completion date
- Mar 2030
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Type 2 diabetes
- NCT number
- NCT05569772
- EU CT number
- 2022-502082-22-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 252
- From 14 Sept 2023 to the primary completion date, Mar 2030
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.