Cardiometabolic & kidneyRandomised controlled trial
Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes
- Randomised controlled trial
- double-blind
- placebo-controlled
- event-driven
- superiority
Authors' conclusion
Among persons with type 2 diabetes and atherosclerotic cardiovascular disease, chronic kidney disease, or both, the use of oral semaglutide was associated with a significantly lower risk of major adverse cardiovascular events than placebo, without an increase in the incidence of serious adverse events.
Study context
- Population
- Persons ≥50 years with T2DM (glycated hemoglobin 6.5 to 10.0%) and atherosclerotic CVD, CKD, or bothmedian follow-up 49.5 months
- Participants
- 9,650 persons
- Comparison
- Oral semaglutide vs placebo, in addition to standard care
- Oral semaglutiden = 4,825
- Placebon = 4,825reference
- Primary endpoint
- MACE (CV death, nonfatal MI or nonfatal stroke), time-to-first-event analysis
Primary result
As reported in the abstract
Hazard ratio
0.86
95% CI 0.77–0.96
P = 0.006
Events by treatment group
Oral semaglutide vs Placebo
HR 0.86 (95% CI 0.77–0.96); P = 0.006
Secondary outcomes
Confirmatory secondary outcomes (incl. major kidney disease events)
- Did not differ significantly between the two groups
Safety
Serious adverse events
Gastrointestinal disorders
Original publication
Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes. N Engl J Med. Published 29 March 2025. doi:10.1056/nejmoa2501006
Summarised from the published abstract; every number is checked against it