Trial record 1 of 1 for: NCT05569772

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

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ClinicalTrials.gov Identifier: NCT05569772

Recruitment Status : Not yet recruiting

First Posted : October 6, 2022

Last Update Posted : May 25, 2023

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

University Hospital, Antwerp

Universitair Ziekenhuis Brussel

General Hospital Groeninge

Onze Lieve Vrouw Hospital

AZ Delta

Jessa Hospital

Ziekenhuis Netwerk Antwerpen (ZNA)

Vitaz

Centre Hospitalier Universitaire de Liege

Erasme University Hospital

Centre Hospitalier Mouscron

Information provided by (Responsible Party):

Universitaire Ziekenhuizen KU Leuven

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Glucose Intolerance After a Recent History of Gestational Diabetes	Drug: Semaglutide Pen Injector Drug: Semaglutide placebo	Phase 3

Detailed Description:

Patient population: Women with a recent history of gestational diabetes (GDM) and persistent glucose intolerance in early postpartum are a particularly high risk group, with about 50% developing type 2 diabetes (T2DM) within 5 years after the delivery. Semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) agonist with multiple beneficial metabolic effects, including glucose lowering effect, weight loss and cardiovascular protective effects. The investigators hypothesize that in women with prior GDM and glucose intolerance in early postpartum, treatment with semaglutide will reduce the risk to develop T2DM on the long-term compared to placebo.

Intervention and comparison: Belgian multi-centric double blind RCT with 11 centers to compare semaglutide (once weekly) with placebo in women with a recent history of GDM and glucose intolerance [impaired fasting glycaemia (IFG) and/or impaired glucose tolerance (IGT)] 6-24 weeks postpartum. Participants will be 1/1 randomized to semaglutide or placebo on a background of lifestyle measures. Semaglutide will be uptitrated to 1mg/week over a 8-week period. Participants will be followed-up for 3 years. Participants will receive a 75g oral glucose tolerance test (OGTT) 3-6 months after the stop of the intervention. Randomization will be stratified according to BMI at the early postpartum visit (<25; 25-29.9 and ≥30Kg/m²).

Outcomes: The primary endpoint is the development of T2DM by 160 weeks defined by fasting glycaemia, OGTT and/or HbA1c according to the ADA criteria. Important secondary endpoints include the need for rescue therapy for diabetes, regression to normoglycaemia, weight loss, beta-cell function, insulin resistance and the metabolic syndrome. To achieve 80% power, we plan a sample size of 252 to detect an estimated 50% reduction in the risk to develop T2DM between both groups, assuming a 30% loss to follow-up during the study.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	252 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	multi-centric double blind RCT
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Prevention
Official Title:	Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes: a Double Blind RCT
Estimated Study Start Date :	September 2023
Estimated Primary Completion Date :	July 2028
Estimated Study Completion Date :	December 2028

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gestational diabetes

Drug Information available for: Semaglutide

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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	Drug: Semaglutide Pen Injector maintenance dose of 1mg SC once weekly Other Name: Ozempic
Placebo Comparator: placebo placebo SC once weekly, the same dose-escalation regimen, using matching injections, treatment duration of max. 3 years	Drug: Semaglutide placebo maintenance dose of 1mg SC once weekly

Outcome Measures

Primary Outcome Measures :

type 2 diabetes [ Time Frame: by 160 weeks ]
development of type 2 diabetes defined by fasting glycaemia, oral glucose tolerance test and/or HbA1c according to the ADA criteria

Secondary Outcome Measures :

medication for diabetes [ Time Frame: by 160 weeks ]
percentage need for rescue therapy for diabetes
prediabetes [ Time Frame: by 160 weeks ]
percentage prediabetes based on fasting glycaemia, oral glucose tolerance test and/or HbA1c (ADA criteria)
normoglycaemia [ Time Frame: by 160 weeks ]
percentage regression to normoglycaemia, based on fasting glycaemia, oral glucose tolerance test and/or HbA1c (ADA criteria)
BMI [ Time Frame: by 160 weeks ]
mean BMI (Kg/m2)
waist circumference [ Time Frame: by 160 weeks ]
mean waist circumference (cm)
waist/hip ratio [ Time Frame: by 160 weeks ]
waist/hip circumference ratio
5% weight loss [ Time Frame: by 160 weeks ]
percentage weight loss ≥5%
10% weight loss [ Time Frame: by 160 weeks ]
percentage weight loss ≥10%
15% weight loss [ Time Frame: by 160 weeks ]
percentage weight loss ≥15%
body fat percentage [ Time Frame: by 160 weeks ]
percentage body fat measured by bioelectrical impedance analysis
HOMA-B index [ Time Frame: by 160 weeks ]
Beta-cell function measured by the HOMA-B index
insulinogenic index [ Time Frame: by 160 weeks ]
Beta-cell function measured by the by the insulinogenic index divided by HOMA-insulin resistance index
ISSI-2 index [ Time Frame: by 160 weeks ]
Beta-cell function measured by theby the insulin-secretion sensitivity-2 index
the Stumvoll index. [ Time Frame: by 160 weeks ]
Beta-cell function measured by the Stumvoll index.
Matsuda index [ Time Frame: by 160 weeks ]
whole body Insulin sensitivity measured by the insulin sensitivity index of Matsuda
HOMA-IR [ Time Frame: by 160 weeks ]
the reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR)
metabolic syndrome [ Time Frame: by 160 weeks ]
percentage of the metabolic syndrome based on the WHO criteria
Hypertension [ Time Frame: by 160 weeks ]
percentage blood pressure ≥140/90mmHg
heart rate [ Time Frame: by 160 weeks ]
mean heart rate
LDL cholesterol [ Time Frame: by 160 weeks ]
percentage LDL cholesterol ≥100mg/dl
Triglycerides [ Time Frame: by 160 weeks ]
percentage triglycerides ≥150mg/dl
hypoglycaemia [ Time Frame: by 160 weeks ]
percentage with hypoglycaemia (<54mg/dl)
gastro-intestinal side effects [ Time Frame: by 160 weeks ]
percentage nausea, vomiting or diarrhea
self-reported quality of life [ Time Frame: by 160 weeks ]
health-related quality of life by SF-36 questionnaire
symptoms of depression [ Time Frame: by 160 weeks ]
the 20-item Center for Epidemiologic Studies-Depression (CES-D) questionnaire
anxiety [ Time Frame: by 160 weeks ]
six-item short-form of the State-Trait Anxiety Inventory questionnaire on anxiety (STAI)
Diabetes risk perception [ Time Frame: by 160 weeks ]
Diabetes Risk perception questionnaire, a validated questionnaire to evaluate the perception to develop diabetes
sleep quality [ Time Frame: by 160 weeks ]
The validated Pittsburg sleep quality index to evaluate sleep quality
diabetes remission [ Time Frame: by 172-184 weeks (3-6 months after end of therapy) ]
diabetes remission rate after treatment stop, defined by fasting, OGTT and/or HbA1c

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Participant has a history of any type of diabetes or auto-antibodies for type 1 diabetes, history of pancreatitis, family or personal history of medullary thyroid carcinoma or personal history of thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, severe psychiatric disorder in the past year, heart failure NYHA class 4, end-stage renal disease (eGFR <15) or dialysis, or history of bariatric surgery 2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol 3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial 4. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 5. Participation in an interventional Trial with an investigational medicinal product or device 6. Age <18 years, breastfeeding >24 weeks postpartum or HbA1c≥6.5% at the time of the OGTT in pregnancy 7. Use of medication with significant impact on glycaemia (such as high dose glucocorticoids or metformin)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05569772

Contacts

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Contact: Katrien Benhalima, MD PhD	16340614 ext 32	katrien.benhalima@uzleuven.be

Locations

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Belgium
OLV-Aalst-Asse
Aalst, Belgium
Contact: Katrien Wierckx
UZA
Antwerp, Belgium
Contact: Niels Bochanen
ZNA,
Antwerp, Belgium
Contact: Ann Verhaegen
Erasme
Brussel, Belgium
Contact: Maria Lytrivi
UZ Brussel
Brussel, Belgium
Contact: Nancy Van Wilder
AZ Groeninge Kortrijk
Kortrijk, Belgium
Contact: Gertjan Vereecke
UZ Leuven
Leuven, Belgium
Contact: Katrien Benhalima
CHU de Liège
Liège, Belgium
Contact: JC Philips
Centre Hospitalier Mouscron
Mouscron, Belgium
Contact: Philippe Oriot
AZ Delta Roeselare
Roeselare, Belgium
Contact: Xavier-Philippe Aers
Vitaz
Sint-Niklaas, Belgium
Contact: Peter Coremans

Sponsors and Collaborators