- Question
- Does oral semaglutide reduce major cardiovascular events in people with type 2 diabetes and atherosclerotic cardiovascular disease, chronic kidney disease, or both?
- Design
- Double-blind, placebo-controlled, event-driven superiority trial with 9650 randomized participants. Median follow-up was 49.5 months.
- Population
- Adults aged 50 years or older with type 2 diabetes, glycated hemoglobin between 6.5 and 10.0%, and established atherosclerotic cardiovascular disease, chronic kidney disease, or both.
- Intervention
- Once-daily oral semaglutide (maximal dose 14 mg) added to standard care.
- Control
- Once-daily placebo added to standard care.
- Primary outcome
- Major adverse cardiovascular events: a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, analyzed as time to first event.
- Results
- A primary-outcome event occurred in 579 of 4825 participants (12.0%) on oral semaglutide and 668 of 4825 (13.8%) on placebo (HR 0.86; 95% CI 0.77 to 0.96; P = 0.006). The confirmatory secondary outcomes, including major kidney disease events, did not differ significantly between groups.
- Safety
- Serious adverse events occurred in 47.9% with oral semaglutide and 50.3% with placebo; gastrointestinal disorders occurred in 5.0% and 4.4%, respectively.
- Conclusion
- In people with type 2 diabetes and atherosclerotic cardiovascular disease, chronic kidney disease, or both, oral semaglutide significantly lowered the risk of major adverse cardiovascular events versus placebo without increasing serious adverse events.
- Why it matters
- It showed that an oral GLP-1 receptor agonist provides cardiovascular benefit in high-risk patients with type 2 diabetes, broadening treatment options beyond injectable formulations.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026