Human evidence 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).

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Human evidence record

What this study tells us

Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.

Who was studied?

Adults >=50 with T2D and ASCVD, CKD, or both

How many?

n=9650

What happened?

MACE occurred in 12.0% with oral semaglutide versus 13.8% placebo (HR 0.86, 95% CI 0.77-0.96; P=0.006).

What stops us overclaiming?

High-risk T2D cardiovascular population; 14 mg regimen differs from the 25 mg obesity formulation.

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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

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