Study S000261

Comparative Effectiveness of Oral Semaglutide vs Sitagliptin Among Individuals With Heart Failure With Preserved Ejection Fraction (STEP-HFpEF DM ORAL)

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan: Study Protocol with Statistical Analysis Plan Amendment 1 (PDF)Study Protocol: Study Protocol with Statistical Analysis Plan (PDF)Study Protocol: Study Protocol with Statistical Analysis Plan Amendment 2 (PDF)

Registration

Registration: NCT07390110
Study type: OBSERVATIONAL
Status: COMPLETED
Enrollment: 25664
Start: 2026-01-24
Primary completion: 2026-06-30
Lead sponsor: Brigham and Women's Hospital
Conditions: Type 2 Diabetes; Heart Failure
Interventions: DRUG:Oral semaglutide; DRUG:Sitagliptin
Results posted: FALSE

Registered primary outcomes

Composite of worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting) or all-cause mortality. [Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between the arms, start of any other GLP-1-RA including injectable semaglutide.]
Worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting). [Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between the arms, start of any other GLP-1-RA including injectable semaglutide.]

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