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RECRUITING
NCT05569772
PHASE3

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

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2023-09-14

Completion Date

2028-12

Last Updated

2025-02-10

Healthy Volunteers

No

Interventions

DRUG

Semaglutide Pen Injector

maintenance dose of 1mg SC once weekly

DRUG

Semaglutide placebo

maintenance dose of 1mg SC once weekly

Locations (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