Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes
Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes
The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.
Inclusion Criteria:
Male or female, age equal to or above 50 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus
HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive) (latest available and no more than 30 days old local laboratory assessment based on medical records or point of care measurement)
At least one of the below conditions (a-d):
a) Coronary heart disease defined as at least one of the following: i. Prior myocardial infarction ii. Prior coronary revascularisation procedure iii. 50% or above stenosis in coronary artery documented by cardiac catheterisation, computerized tomography coronary angiography iv. Coronary heart disease with ischaemia documented by stress test with any imaging modality b) Cerebrovascular disease defined as at least one of the following: i. Prior stroke ii. Prior carotid artery revascularisation procedure iii.50% or above stenosis in carotid artery documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at rest ii. Intermittent claudication with a 50% or above stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound iii. Prior peripheral artery (excluding carotid) revascularization procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) d) Chronic kidney disease defined as: i. eGFR below 60 mL/min/1.73 m^2 (based on medical records using latest available and no more than 6 months old assessment)
Exclusion Criteria:
Capital Federal, C1056ABI, Argentina
Rosario, Santa Fe, S2000CVB, Argentina
Saint Stefan, 8511, Austria
Bucaramanga-piedecuesta, Valle Del Menzuli - Santander, Santander Department 681012, Colombia
Plzeň - Východní Předměstí, 32600, Czechia
Plzeň 3, 301 00, Czechia
Shatin, New Territories, Hong Kong
Hyderabad, Andhra Pradesh 500016, India
Hyderabad, Andhra Pradesh 500034, India
Hyderabad, Andhra Pradesh 500072, India
Goa, Maharashtra 403 202, India
New Dehli, New Delhi 110029, India
Thriruvananthapuram, 695 032, India
Lucca, LU 55100, Italy
Bunkyo-ku, Tokyo, 113-8655, Japan
Ehime, 790-0024, Japan
Ehime, 790-0024, Japan
Kyoto-shi, Kyoto, 606-8507, Japan
Saga-shi, Saga, 849-8501, Japan
Takamatsu-shi, Kagawa, 760-8557, Japan
Lembah Pantai, Kuala Lumpur 59100, Malaysia
Sarawak, 98000, Malaysia
Kragujevac, 34000, Serbia
Eskişehir, 26040, Turkey (Türkiye)
Yüreğir/Adana, 1370, Turkey (Türkiye)
Dnipro, 49005, Ukraine
Kyiv, 04053, Ukraine
Lviv, 79010, Ukraine
Uzhhorod, 88000, Ukraine
Norfolk, NR4 7UQ, United Kingdom