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

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.

Conditions

• Glucose Intolerance After a Recent History of Gestational Diabetes

Interventions

DRUG

Semaglutide Pen Injector

maintenance dose of 1mg SC once weekly

DRUG

Semaglutide placebo

maintenance dose of 1mg SC once weekly

Sponsors & Collaborators

• University Hospital, Antwerp

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• General Hospital Groeninge

  collaborator OTHER

• Onze Lieve Vrouw Hospital

  collaborator OTHER

• Jessa Hospital

  collaborator OTHER

• Ziekenhuis Netwerk Antwerpen (ZNA)

  collaborator OTHER

• Vitaz

  collaborator OTHER

• Centre Hospitalier Universitaire de Liege

  collaborator OTHER

• Erasme University Hospital

  collaborator OTHER

• Centre Hospitalier Mouscron

  collaborator UNKNOWN

• Jan Yperman Ziekenhuis

  collaborator OTHER

• AZ Turnhout

  collaborator OTHER

• AZ Sint-Lucas Brugge

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-14

Primary Completion

2029-06-30

Completion

2029-12-31

Countries

• Belgium

Study Locations