A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Trial Investigating the Effect of Semaglutide on Atherosclerosis in Patients With Cardiovascular Disease and Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032197
• Other study ID #: NN9535-4430
• Secondary ID: U1111-1215-40582
• Status: Completed
• Phase: Phase 1
• Start date: August 12, 2019
• Est. completion date: June 6, 2023

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study looks into how the type 2 diabetes medicine, semaglutide, can prevent risk of heart disease complications and stroke. Participants will either get semaglutide or placebo ("dummy" medicine) - which treatment is decided by chance. Semaglutide is a new medicine to treat type 2 diabetes and can be prescribed by doctors in some countries. The study medicine will be in a pen, and must be injected with a needle in the stomach, thigh or upper arm once a week. The study will last for 57-63 weeks. Participants will have 10 clinic visits with the study doctor, 5 visits to the specialised clinic for imaging and at least 1 phone contact. Participants' health will be monitored carefully and blood samples will therefore be taken at the clinic visits. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 6, 2023
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Male or female, age above or equal to 50 years at the time of signing informed consent

• Body mass index equal to or less than 39.9 kg/m^2

• Diagnosed with type 2 diabetes 180 daysor more prior to the day of the first screening visit

• HbA1c 6.0% - 9.0% (42-75 mmol/mol) (both inclusive)

• Established cardiovascular disease

Exclusion Criteria:

• Hospitalisation for unstable angina pectoris or transient ischaemic attack within 90 days prior to the day of the first screening visit

• Planned coronary, carotid or peripheral artery revascularisation.

• Presently classified as being in New York Heart Association (NYHA) equal to or above Class III

• Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or systemic anti-inflammatory drugs within 90 days prior to the first screening visit. Stable treatment with acetylsalicylic acid for prevention of cardiovascular events and occasional use of propionic acid derivatives drugs (e.g. ibuprofen) is allowed

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide
Subcutaneous (s.c., under the skin) injections for 52 weeks. Participants will remain on their pre-study standard of care treatment (antidiabetic medication and CV medication).
• Placebo (semaglutide)
Subcutaneous (s.c., under the skin) injections for 52 weeks. Participants will remain on their pre-study standard of care treatment (antidiabetic medication and CV medication).

Locations

Country	Name	City	State
Austria	Clinical Trials Unit / Center for Medical Research	Graz
Denmark	Steno Diabetes Center Copenhagen	Herlev
Sweden	Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl	Stockholm
Sweden	CTC Clinical Trial Consultants AB, Uppsala	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Austria,  Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries	Ratio	From baseline (from 41 days before randomisation) to week 26
Secondary	Change in maximum target-to-background ratio (TBR) for 68Ga-DOTATATE in the carotid arteries	Ratio	From baseline (from 40 days before randomisation) to week 26
Secondary	Change in total wall volume of the most diseased carotid artery	mm3	From baseline (from 41 days before randomisation) to week 52
Secondary	Change in lipid rich necrotic core (LRNC) volume of the atherosclerotic plaque in the most diseased carotid artery	mm3	From baseline (from 41 days before randomisation) to week 52
Secondary	Change in average fibrous cap thickness (FCT) of the atherosclerotic plaque in the most diseased carotid artery	mm	From baseline (from 41 days before randomisation) to week 52