Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary written informed consent of the participant has been obtained prior to any screening procedures
Women aged ≥18 years
Use of highly effective methods of birth control
History of GDM diagnosed according to the 2013 WHO criteria (at 24-32 weeks gestation or <24 weeks for early GDM)
Disqualifiers
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
Female who is pregnant or intends to become pregnant within the next year
Female who wants to give breastfeeding >22 months
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide Pen Injector
Drugmaintenance dose of 1mg SC once weekly
Semaglutide placebo
Drugmaintenance dose of 1mg SC once weekly
Treatment groups
252 Participants
are divided into 2 treatment groupsGroup A: semaglutideActive comparator 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
by 160 weeksSecondary outcomes
1
medication for diabetes
percentage need for rescue therapy for diabetes
Time frame
by 160 weeks2
prediabetes
percentage prediabetes based on fasting glycaemia, oral glucose tolerance test and/or HbA1c (ADA criteria)
Time frame
by 160 weeks3
normoglycaemia
percentage regression to normoglycaemia, based on fasting glycaemia, oral glucose tolerance test and/or HbA1c (ADA criteria)
Time frame
by 160 weeks4
BMI
mean BMI (Kg/m2)
Time frame
by 160 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
University Hospital, Antwerp
Collaborator
Universitair Ziekenhuis Brussel
Collaborator
General Hospital Groeninge
Collaborator
Vitaz
Collaborator
Centre Hospitalier Universitaire de Liege
Collaborator
Erasme University Hospital
Collaborator
Centre Hospitalier Mouscron
Collaborator
Jan Yperman Ziekenhuis
Collaborator
AZ Turnhout
Collaborator
AZ Sint-Lucas Brugge
Collaborator
Ziekenhuis aan de Stroom
Collaborator
Onze Lieve Vrouw Hospital
Collaborator
Source ClinicalTrials.gov