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Completed
NCT07390110
Comparative Effectiveness of Oral Semaglutide vs Sitagliptin Among Individuals With Heart Failure With Preserved Ejection Fraction (STEP-HFpEF DM ORAL)
Conditions: Type 2 Diabetes, Heart Failure
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 25664
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
Summary
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.
Eligibility Criteria
Eligible Cohort Entry Dates:
* Optum: Eligible cohort entry period from September 20, 2019 to November 30, 2025.
* Marketscan: Eligible cohort entry from September 20, 2019 to December 31, 2023.
* Medicare: Eligible cohort entry from September 20, 2019 to December 31, 2020.
Inclusion Criteria:
* Heart failure
* BMI \> 27.0kg/m2
* Type 2 diabetes mellitus
* LVEF \> 45%
* Age \> 18 years
* Sex: male or female
Exclusion Criteria:
* Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma, other malignancy
* Type 1 diabetes mellitus, uncontrolled diabetic retinopathy or maculopathy, bariatric surgery, end-stage renal disease or dialysis, nursing home admission
* Any use of GLP-1-RA including injectable semaglutide except oral semaglutide, pregnancy, treatment with continuous subcutaneous insulin infusion
* Concurrent use of both study drugs
Source: ClinicalTrials.gov (NCT07390110). StuddyBuddy aggregates publicly available trial information.