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

ConditionGlucose Intolerance After a Recent History of 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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide Pen Injector

    Drug

    maintenance dose of 1mg SC once weekly

  • Semaglutide placebo

    Drug

    maintenance dose of 1mg SC once weekly

Treatment groups

252 Participants
are divided into 2 treatment groups
Group A: semaglutideActive comparator 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Development of T2DM

Defined by FPG, OGTT, and/or HbA1c according to the ADA criteria

Time frame
by 160 weeks

Secondary outcomes

1

Need for glucose-lowering (rescue) therapy

Percentage need for rescue therapy for diabetes

Time frame
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
2

Frequency of prediabetes based on FPG, OGTT, and/or HbA1c

Percentage of prediabetes based on FPG, OGTT, and/or HbA1c

Time frame
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
3

Regression to normoglycaemia

Percentage regression to normoglycaemia, based on fasting glycaemia, oral glucose tolerance test and/or HbA1c (ADA criteria)

Time frame
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
4

Change in body weight

Change in body weight (kg)

Time frame
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)

Other outcomes

Sponsors 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
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