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

NCT07390110 · Active, not recruiting

Last updated 2026-05-28

This clinical trial compares the effects of the medication oral semaglutide to sitagliptin in adults with both type 2 diabetes and heart failure with preserved ejection fraction.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Type Observational

Participants 25,664 people

Who can join Ages 18+ · all sexes

Timeline Started 2026-01 · est. completion 2026-05

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT07390110 ↗

Description as written by the study sponsor.

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Treatments tested

Oral semaglutide Drug

Initiation of semaglutide dispensing claim is used as the exposure.
Sitagliptin Drug

Initiation of sitagliptin dispensing claim is used as the reference.

Main thing measured	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.
Sponsor	Brigham and Women's Hospital
Conditions studied	Type 2 Diabetes, Heart Failure
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07390110 ↗