A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT03914326

Run by

Novo Nordisk A/S

People needed

9651

Starts

2019-06-17

Expected to finish

2024-08-23

Last updated by the study team

2025-12-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
• Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
• Heart failure presently classified as being in New York Heart Association Class IV
• Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening

Where it is running

• Medical Investigations, Inc. — Little Rock, Arkansas, United States
• Unity Health-Searcy Medical Center — Searcy, Arkansas, United States
• B&K Medical Research Center — Fresno, California, United States
• University of Vermont Medical Center — Fullerton, California, United States
• Scripps Whittier Diabetes Inst — La Jolla, California, United States
• Diabetes & Endocrine Associates — La Mesa, California, United States
• First Valley Medical Group — Lancaster, California, United States
• Pacific Clinical Studies — Los Alamitos, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Monterey Endocrine & Diabetes Institute, Inc — Monterey, California, United States
• Desert Oasis Hlthcr Med Group — Palm Springs, California, United States
• San Diego Family Care — San Diego, California, United States
• Lundquist Inst-Biomed Innovtn — Torrance, California, United States
• Coastal Metabolic Research Center — Ventura, California, United States
• Rocky Mount Reg VA Med-DN — Aurora, Colorado, United States
• Creekside Endocrine Associates, PC — Denver, Colorado, United States
• New West Physicians,Inc. — Golden, Colorado, United States
• East Coast Medical Associates, Inc. — Boca Raton, Florida, United States
• Suncoast Clin Res Port Richey — New Port Richey, Florida, United States
• AdventHealth Diab Inst — Orlando, Florida, United States
• Ellipsis Group — Alpharetta, Georgia, United States
• Physicians Research Assoc. LLC — Lawrenceville, Georgia, United States
• Endo Res Solutions Inc — Roswell, Georgia, United States
• East West Med Res Inst — Honolulu, Hawaii, United States
• Chambliss Clinical Trials, LLC — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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