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

Study acronym: SERENA
StatusRecruiting
PhasePhase 3
Started2023-09-14
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Jun 2029 → Mar 2030
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Universitaire Ziekenhuizen KU Leuven

Amendment history

2026-09-16
Primary completion pushed: 2029-06 → 2030-03
Completion pushed: 2029-12 → 2030-05
2026-07-02
Study Status, Outcome Measures, Eligibility v7
Primary endpoint(s) modified1 entry, revised
Wastype 2 diabetes
NowDevelopment of T2DM
Eligibility criteria+54 characters
InclusionEligible Criteria: Voluntaryparticipants writtenare informed consent of the participant has been obtained prior to any screening procedures Womenwomen aged ≥18 years Use, ofwith highlya effective methods of birth control Historyhistory of GDM diagnosed according to the 2013 WHO criteria (at 24-32 weeks gestation or <24 weeks for early GDM). DiagnosisParticipants ofmust have prediabetes diagnosed between 6 weeks and 12 months postpartum according to ADA c [...] cose 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 in [...] [...]
Secondary endpoints29 to 33 entries
medicationNeed for diabetesglucose-lowering (rescue) therapy Frequency of prediabetes based on FPG, OGTT, and/or HbA1c Regression to normoglycaemia waistChange in body weight Waist circumference waist/Waist-to-hip ratio Proportion of participants achieving ≥5% weight loss Proportion of participants achieving ≥10% weight loss Proportion of participants achieving ≥15% weight loss bodyBody fat percentage assessed by bioelectrical impedance analysis (Bodystat 1500®) β-cell function, assessed by HOMA-B Insulinogenic index insulinogenic index ISSI-2divided index theby Stumvoll index. Matsuda index H [...] [...]
2026-05-28
Study Status, Sponsor/Collaborators, Study Description, Eligibility, Contacts/Locations, IPDSharing v6
Eligibility criteria-592 characters
[...] icipant has been obtained prior to any screening procedures Women aged ≥18 years Use of highly effective methods of birth control History of GDM (diagnosed withaccording to the 2013 WHO criteria (at 24-32 weeks ofgestation pregnancy)or and glucose intolerance 6-<24 weeks for early GDM) Diagnosis of prediabetes between 6 weeks and 12 months postpartum (basedaccording on theto 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%]) Needs to be able to understand and speak Dutch, French or English Exclusion Criteria: 1. Participant has a histo [...] [...]
Study description+1,870 characters
[...] ng glycaemia (IFG) and/or impaired glucose tolerance (IGT)] 66weeks -24 weeks12 months postpartum. Participants will be 1/1 randomized to semaglut [...] is the development of T2DM by 160 weeks defined by fasting glycaemiaplasma glucose, OGTT and/or HbA1c according to the ADA criteria. Important secondary endpoints are assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication) and include: Glycaemic the needoutcomes Need for glucose-lowering (rescue) therapy; Frequency forof diabetesprediabetes based on FPG, regressionOGTT, and/or HbA1c; Regre [...] [...]
Study sites13 entries, revised
OLV-Aalst-AsseAZORG ZNA,ZAS
Collaborators13 to 12 entries
Jessa Hospital Ziekenhuis Netwerkaan Antwerpende (ZNA)Stroom
2026-04-28
Study Identification, Study Status v5
Primary completion date2028-07→2029-06
Completion date2028-12→2029-12
Study titlerevised
Semaglutide for the Treatment of Glucose Intolerance in Women withWith Prior Gestational Diabetes
2025-02-06
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Contacts/Locations v4
Study sites11→13
Study descriptionrevised
[...] and comparison: Belgian multi-centric double blind RCT with 1113 centers to compare semaglutide (once weekly) with placebo i [...]
Collaborators11 to 13 entries
Jan Yperman Ziekenhuis AZ DeltaTurnhout AZ Sint-Lucas Brugge
Study titlerevised
Semaglutide for the Treatment of Glucose Intolerance in Women Withwith Prior Gestational Diabetes
Show 3 earlier versions
2023-09-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-09→confirmed 2023-09-14
Study sitesdetails revised at 11 of 11 sites
2023-05-23
Study Status v2
Primary completion date2028-02→2028-07
Completion date2028-08→2028-12
Start date2023-05→2023-09
2023-02-15
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v1
Primary completion date2027-12→2028-02
Completion date2028-04→2028-08
Start date2023-03→2023-05
Enrollment target206→252
Study sites12→11
Eligibility criteria+41 characters
[...] ory of pancreatitis, family or personal history of medullary thyroid carcinoma or personal history of thyroid carcinoma or multiple endocrine neoplasia syndrome [...]
Secondary endpointsdetails revised at 29 of 29 entries
Study description+4 characters
[...] effect, weight loss and cardiovascular protective effects. WeThe investigators hypothesize that in women with prior GDM and glucose intole [...] and comparison: Belgian multi-centric double blind RCT with 1211 centers to compare semaglutide (once weekly) with placebo i [...] ants will receive a 75g oral glucose tolerance test (OGTT) 3-6 months after the stop of the intervention. Randomization wi [...] MI at the early postpartum visit (<25; 25-29.9 and ≥30Kg/m²) and result of the early postpartum OGTT (IFG, IGT or IFG and IGT combined). Outcomes: The primary endpoint is the development of T2DM by 160 weeks defined [...] [...]
2022-10-03
Original filing
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.
Trial Details
NCT Number NCT05569772
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Collaborators: University Hospital, Antwerp, Universitair Ziekenhuis Brussel, General Hospital Groeninge, Vitaz, Centre Hospitalier Universitaire de Liege, Erasme University Hospital, Centre Hospitalier Mouscron, Jan Yperman Ziekenhuis, AZ Turnhout, AZ Sint-Lucas Brugge, Ziekenhuis aan de Stroom, Onze Lieve Vrouw Hospital
Conditions Glucose Intolerance After a Recent History of Gestational Diabetes
Enrollment 252 participants
Start Date 2023-09-14
Primary Completion 2030-03 (estimated)
Study Completion 2030-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-15