Semaglutide for the Treatment of Glucose Intolerance in Women with Prior Gestational Diabetes: a Double Blind RCT

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
OLV-Aalst-Asse
RECRUITING
Aalst
UZA
RECRUITING
Antwerp
ZNA,
RECRUITING
Antwerp
AZ St Jan Brugge
RECRUITING
Bruges
Erasme
RECRUITING
Brussels
UZ Brussel
RECRUITING
Brussels
Jan Yperman
RECRUITING
Ieper
AZ Groeninge Kortrijk
RECRUITING
Kortrijk
UZ Leuven
RECRUITING
Leuven
CHU de Liège
RECRUITING
Liège
Centre Hospitalier Mouscron
RECRUITING
Mouscron
Vitaz
RECRUITING
Sint-niklaas
AZ Turnhout
RECRUITING
Turnhout
Contact Information
Primary
Katrien Benhalima, MD PhD
katrien.benhalima@uzleuven.be
16340614
Time Frame
Start Date: 2023-09-14
Estimated Completion Date: 2028-12
Participants
Target number of participants: 252
Treatments
Active_comparator: semaglutide
semaglutide 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_comparator: placebo
placebo SC once weekly, the same dose-escalation regimen, using matching injections, treatment duration of max. 3 years
Sponsors
Collaborators: General Hospital Groeninge, Vitaz, AZ Sint-Lucas Brugge, Universitair Ziekenhuis Brussel, Centre Hospitalier Universitaire de Liege, Jessa Hospital, Centre Hospitalier Mouscron, Onze Lieve Vrouw Hospital, AZ Turnhout, Erasme University Hospital, University Hospital, Antwerp, Jan Yperman Ziekenhuis, Ziekenhuis Netwerk Antwerpen (ZNA)
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov