Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes
SERENA
2 other identifiers
interventional
252
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2023
Longer than P75 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2022
CompletedFirst Posted
Study publicly available on registry
October 6, 2022
CompletedStudy Start
First participant enrolled
September 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
May 5, 2026
April 1, 2026
5.7 years
September 28, 2022
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
type 2 diabetes
development of type 2 diabetes defined by fasting glycaemia, oral glucose tolerance test and/or HbA1c according to the ADA criteria
by 160 weeks
Secondary Outcomes (29)
medication for diabetes
by 160 weeks
prediabetes
by 160 weeks
normoglycaemia
by 160 weeks
BMI
by 160 weeks
waist circumference
by 160 weeks
- +24 more secondary outcomes
Study Arms (2)
semaglutide
ACTIVE COMPARATORsemaglutide SC once weekly, up titration over 2 month period to 1mg/week (0.25mg once weekly, after 4 weeks 0.5mg once weekly and after 8 weeks the maintenance dose of 1mg once weekly), treatment duration of max. 3 years
placebo
PLACEBO COMPARATORplacebo SC once weekly, the same dose-escalation regimen, using matching injections, treatment duration of max. 3 years
Interventions
Eligibility Criteria
You may qualify if:
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Use of highly effective methods of birth control
- History of GDM (diagnosed with 2013 WHO criteria 24-32 weeks of pregnancy) and glucose intolerance 6-24 weeks postpartum (based on the ADA criteria)
- Needs to be able to understand and speak Dutch, French or English
You may not qualify if:
- \. Participant has a history of any type of diabetes or auto-antibodies for type 1 diabetes, history of pancreatitis, family or personal history of medullary thyroid carcinoma or personal history of thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, severe psychiatric disorder in the past year, heart failure NYHA class 4, end-stage renal disease (eGFR \<15) or dialysis, or history of bariatric surgery 2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol 3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial 4. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 5. Participation in an interventional Trial with an investigational medicinal product or device 6. Age \<18 years, breastfeeding \>24 weeks postpartum or HbA1c≥6.5% at the time of the OGTT in pregnancy 7. Use of medication with significant impact on glycaemia (such as high dose glucocorticoids or metformin)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- University Hospital, Antwerpcollaborator
- Universitair Ziekenhuis Brusselcollaborator
- General Hospital Groeningecollaborator
- Onze Lieve Vrouw Hospitalcollaborator
- Jessa Hospitalcollaborator
- Ziekenhuis Netwerk Antwerpen (ZNA)collaborator
- Vitazcollaborator
- Centre Hospitalier Universitaire de Liegecollaborator
- Erasme University Hospitalcollaborator
- Centre Hospitalier Mouscroncollaborator
- Jan Yperman Ziekenhuiscollaborator
- AZ Turnhoutcollaborator
- AZ Sint-Lucas Bruggecollaborator
Study Sites (13)
OLV-Aalst-Asse
Aalst, Belgium
UZA
Antwerp, Belgium
ZNA,
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2022
First Posted
October 6, 2022
Study Start
September 14, 2023
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share