NCT05569772

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P50-P75 for phase_3

Timeline
41mo left

Started Sep 2023

Longer than P75 for phase_3

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Sep 2023Dec 2029

First Submitted

Initial submission to the registry

September 28, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

September 14, 2023

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

July 7, 2026

Status Verified

April 1, 2026

Enrollment Period

5.7 years

First QC Date

September 28, 2022

Last Update Submit

July 2, 2026

Conditions

Glucose Intolerance After a Recent History of Gestational Diabetes

Keywords

gestational diabetesglucose intolerance postpartumpreventiontype 2 diabetesGLP-1 agonistsemaglutide

Outcome Measures

Primary Outcomes (1)

  • Development of T2DM

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

    by 160 weeks

Secondary Outcomes (33)

  • Need for glucose-lowering (rescue) therapy

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

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

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

  • Regression to normoglycaemia

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

  • Change in body weight

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

  • BMI

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

  • +28 more secondary outcomes

Study Arms (2)

semaglutide

ACTIVE COMPARATOR

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

Drug: Semaglutide Pen Injector

placebo

PLACEBO COMPARATOR

placebo SC once weekly, the same dose-escalation regimen, using matching injections, treatment duration of max. 3 years

Drug: Semaglutide placebo

Interventions

Semaglutide placeboDRUG

maintenance dose of 1mg SC once weekly

placebo
Semaglutide Pen InjectorDRUG

maintenance dose of 1mg SC once weekly

Also known as: Ozempic
semaglutide

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

AZORG

Aalst, Belgium

RECRUITING

UZA

Antwerp, Belgium

RECRUITING

ZAS

Antwerp, Belgium

RECRUITING

AZ St Jan Brugge

Bruges, Belgium

RECRUITING

Erasme

Brussels, Belgium

RECRUITING

UZ Brussel

Brussels, Belgium

RECRUITING

Jan Yperman

Ieper, Belgium

RECRUITING

AZ Groeninge Kortrijk

Kortrijk, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

CHU de Liège

Liège, Belgium

RECRUITING

Centre Hospitalier Mouscron

Mouscron, Belgium

RECRUITING

Vitaz

Sint-Niklaas, Belgium

RECRUITING

AZ Turnhout

Turnhout, Belgium

RECRUITING

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Katrien Benhalima, MD PhD

CONTACT

16340614katrien.benhalima@uzleuven.be

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: multi-centric double blind RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 6, 2022

Study Start

September 14, 2023

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

July 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Individual participant data will be made available upon reasonable request after study completion, database lock, unblinding, and publication of the primary results, subject to applicable ethical, legal, and data protection requirements.

Locations

BE(13)