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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
101
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).
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).
Clinical Trials Unit / Center for Medical Research
Graz, Austria
Steno Diabetes Center Copenhagen
Herlev, Denmark
Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl
Stockholm, Sweden
CTC Clinical Trial Consultants AB, Uppsala
Uppsala, Sweden
Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries
Ratio
Time frame: From baseline (from 41 days before randomisation) to week 26
Change in maximum target-to-background ratio (TBR) for 68Ga-DOTATATE in the carotid arteries
Ratio
Time frame: From baseline (from 40 days before randomisation) to week 26
Change in total wall volume of the most diseased carotid artery
mm3
Time frame: From baseline (from 41 days before randomisation) to week 52
Change in lipid rich necrotic core (LRNC) volume of the atherosclerotic plaque in the most diseased carotid artery
mm3
Time frame: From baseline (from 41 days before randomisation) to week 52
Change in average fibrous cap thickness (FCT) of the atherosclerotic plaque in the most diseased carotid artery
mm
Time frame: From baseline (from 41 days before randomisation) to week 52
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