Study record · Semaglutide (oral)
Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes
MACE occurred in 12.0% with oral semaglutide versus 13.8% placebo (HR 0.86, 95% CI 0.77-0.96; P=0.006).
Key result
MACE occurred in 12.0% with oral semaglutide versus 13.8% placebo (HR 0.86, 95% CI 0.77-0.96; P=0.006).
Study details
Study designRandomized, double-blind, placebo-controlled event-driven superiority trial
PhasePhase III / CV outcomes
PopulationAdults >=50 with T2D and ASCVD, CKD, or both
Sample size9650
RouteOral
Regimen / exposureOral semaglutide up to 14 mg once daily in addition to standard care
DurationMean follow-up 47.5 months
ComparatorPlacebo
Primary endpoint / questionMajor adverse cardiovascular events
Safety resultSerious adverse events were 47.9% versus 50.3%; GI disorders were reported somewhat more often with semaglutide.
Key limitationsHigh-risk T2D cardiovascular population; 14 mg regimen differs from the 25 mg obesity formulation.
Registry / identifierPMID 40162642 / NCT03914326