Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
PIONEER 6: a cardiovascular outcomes trial (CVOT) for RYBELSUS®1,2
Confirm treatment with RYBELSUS® does not result in an unacceptable increase in CV risk compared to placebo (rule out 80% excess risk) in subjects with type 2 diabetes at high risk of CV events.
3183 with inadequately controlled type 2 diabetes and ASCVD.
Median observation time was 16 months.
Diagnosed with type 2 diabetes and ≥50 years of age and established CVD or CKD OR ≥60 years of age with at least 1 CV risk factora
ASCVD=atherosclerotic cardiovascular disease; CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; MACE=major adverse cardiovascular event; MI=myocardial infarction.
aCV risk factors included microalbuminuria or proteinuria, hypertension and left ventricular hypertrophy, left ventricular systolic or diastolic dysfunction, or ankle-brachial index of <0.9.2
bTreatment arms included patients taking either RYBELSUS® or placebo who were either treatment-naïve or taking oral antidiabetics (OADs) and/or insulin.2
RYBELSUS® demonstrated CV safety with no increased risk of MACE1
aTreatment arms included patients taking either RYBELSUS® or placebo who were either treatment-naïve or taking oral antidiabetics (OADs) and/or insulin.2