A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes
- Status
- CompletedResults posted
- Why it is watched
- non-weight indication: cardiovascular, cerebrovascular
- Who it enrolls
- age 50 Years to no upper limit; no BMI minimum stated; conditions: Diabetes Mellitus, Type 2
- Interventions
- Semaglutide; Placebo (semaglutide)
- Conditions
- Diabetes Mellitus, Type 2
- Phase and size
- Phase 3 · 9651 participants
- Dates
- Start 2019-06-17
Primary completion 2024-08-23 - Sponsor
- Novo Nordisk A/S (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Number of Participants From Randomization to First Occurrence of a Major Adverse Cardiovascular Event (MACE), a Composite Endpoint Consisting of: Cardiovascular (CV) Death/Non-fatal Myocardial Infarction/Non-fatal StrokeFrom randomisation (week 0) up to week 265
Published results in the collection
- Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 DiabetesRandomized trial · 2025 · Study tier 1 · Different population · Benefit · Industry funded
- Oral Semaglutide and Change in Cardiovascular Risk Factors in High-Risk Type 2 Diabetes: A Post Hoc Secondary Analysis of the SOUL Randomized Clinical TrialRandomized trial · 2026 · Study tier 1 · Different population · Benefit · Unreviewed automatic assessment
02Eligibility
Who can take part
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: * 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
03Change log
Registry changes
No changes recorded since the trial was added.