Semaglutide for the treatment of glucose intolerance in women with prior gestational diabetes

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

14 Sep 2023 → ongoing

Decision date (initial)

2023-05-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

monetary support by FWO-TBM grant No T001522N and study medication provided by Novo Nordisk

External identifiers

EU CT number

2022-502082-22-00

ClinicalTrials.gov

NCT05569772

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To compare the development of type 2 diabetes by 160 weeks (based on the fasting glycaemia, OGTT and/or HbA1c) between the semaglutide and placebo group.

Secondary objectives 1

1. Secondary objectives are to determine between the semaglutide and placebo group by 160 weeks (end of treatment) and by 172-184 weeks (3-6 months after stop medication): need for therapy for diabetes; prediabetes based on the OGTT [fasting 100-125mg/dl and/or 2h value 140-199mg/dl and/or HbA1c (5.7-6.4% according to ADA criteria1)]; regression to normoglycaemia (normal OGTT fasting <100mg/dl and 2h value <140mg/dl and HbA1c <5.7% according to ADA criteria1); to evaluate novel biomarkers such as glycated CD59 and metabolomics to predict cardio-metabolic risk and beneficial response to semaglutide; Mean BMI; Mean waist circumference; Weight loss ≥5%, ≥10% and ≥15%; Insulin resistance; Beta-cell function; Metabolic syndrome; Hypertension; Lipid profile; Patient reported outcomes such as treatment satisfaction and quality of life.

Conditions and MedDRA coding

prediabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Participants eligible for inclusion in this Trial must meet all of the following criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. 3. History of GDM (diagnosed with 2013 WHO criteria 24-32 weeks of pregnancy) and glucose intolerance 6-24 weeks postpartum [based on ADA criteria1 (fasting 100-125mg/dl and or 2h value on the 75g OGTT 140-199mg/dl and/or HbA1c 5.7-6.4%), the OGTT needs to be performed after stop breastfeeding to avoid any interaction with result of the OGTT. 4. Needs to be able to understand and speak Dutch, French or English

Exclusion criteria 1

1. 1. Participant has a history of any type of diabetes or auto-antibodies for type 1 diabetes (GADA, ICA, IA-2, insulin, Znc), history of pancreatitis, family or personal history of medullary or personal history of any other type of thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-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 (IMP) 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The development of type 2 diabetes (T2DM) by 160 weeks defined by fasting glycaemia, OGTT and/or HbA1c according to the ADA criteria1

Secondary endpoints 1

1. Secondary outcomes by 160 weeks (end of treatment) and by 172-184 weeks (3-6 months after stop medication): such as need for rescue therapy for diabetes, prediabe, regression to normoglycaemia, mean BMI, waist circumference, waist/hip circumference, weight loss ≥5%, ≥10% and ≥15%, body fat percentage measured by bioelectrical impedance analysis and Beta-cell function

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Katrien Benhalima

Public contact point

Organisation

UZ Leuven

Contact name

Katrien Benhalima

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications