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

Qualifiers

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

Treatments tested in this trial

  • Semaglutide Pen Injector
  • Semaglutide placebo

Treatment groups

252 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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