A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Placebo (semaglutide)
- Registration Number
- NCT04032197
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo (semaglutide) Placebo injected once-weekly. Standard dose escalations every 4 weeks will be applied, until the maximum dose of 1.0 mg placebo is reached. Semaglutide Semaglutide Semaglutide injected once-weekly. Standard dose escalations every 4 weeks will be applied, until the maximum dose of 1.0 mg semaglutide is reached.
- Primary Outcome Measures
Name Time Method Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries From baseline (from 41 days before randomisation) to week 26 Ratio
- Secondary Outcome Measures
Name Time Method Change in maximum target-to-background ratio (TBR) for 68Ga-DOTATATE in the carotid arteries From baseline (from 40 days before randomisation) to week 26 Ratio
Change in total wall volume of the most diseased carotid artery From baseline (from 41 days before randomisation) to week 52 mm3
Change in lipid rich necrotic core (LRNC) volume of the atherosclerotic plaque in the most diseased carotid artery From baseline (from 41 days before randomisation) to week 52 mm3
Change in average fibrous cap thickness (FCT) of the atherosclerotic plaque in the most diseased carotid artery From baseline (from 41 days before randomisation) to week 52 mm
Trial Locations
- Locations (4)
Clinical Trials Unit / Center for Medical Research
🇦🇹Graz, Austria
CTC Clinical Trial Consultants AB, Uppsala
🇸🇪Uppsala, Sweden
Steno Diabetes Center Copenhagen
🇩🇰Herlev, Denmark
Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl
🇸🇪Stockholm, Sweden