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

StatusCompleted
PhaseNot specified
Started2026-01-24
View on ClinicalTrials.gov ↗

Amendment history

2026-09-22
Trial completed
2026-06-27
Study Status, Document Section v4
Primary completion pushed: 2026-05-30 → 2026-06-30
Completion pushed: 2026-05-30 → 2026-06-30
2026-05-23
Study Status, Document Section v3
Primary completion date2026-05-11→2026-05-30
Completion date2026-05-11→2026-05-30
2026-03-10
Study Status v2
Primary completion date2026-02-11→2026-05-11
Completion date2026-02-11→2026-05-11
2026-02-06
Study Status, Study Design, Arms and Interventions, Eligibility, Document Section v1
Enrollment targetestimated 20000→confirmed 25664
Eligibility criteria+25 characters
Eligible Cohort Entry Dates: Optum: StudyEligible cohort entry period betweenfrom September 20, 2019 to AugustNovember 3130, 2025. Marketscan: StudyEligible periodcohort betweenentry from September 20, 2019 to SeptemberDecember 3031, 2023. Medicare: StudyEligible periodcohort betweenentry from September 20, 2019 to SeptemberDecember 3031, 2020. Inclusion Criteria: Heart failure BMI > 27.0kg/m2 Ty [...]
2026-01-29
Original filing
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.
Trial Details
NCT Number NCT07390110
Lead Sponsor Brigham and Women's Hospital
Conditions Type 2 Diabetes, Heart Failure
Enrollment 25,664 participants
Start Date 2026-01-24
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-21