Status:
ACTIVE_NOT_RECRUITING
Comparative Effectiveness of Tirzepatide vs Semaglutide in Participants With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Type 2 Diabetes
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
This cohort study aims to assess the comparative effectiveness of tirzepatide versus semaglutide with respect to cardiovascular events in patients with type 2 diabetes and heart failure with preserved...
Detailed Description
Both semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), and tirzepatide, a glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RA, are currently approved treatments to control bloo...
Eligibility Criteria
Inclusion
- Patients who are new users of tirzepatide or new users of semaglutide
- Patients with diagnosis of T2D and HFpEF, i.e., EF \>= 45%.
- Age \>= 18 years old
- Patients with continuous health plan enrollment before and including the treatment initiation date
Exclusion
- Patients with missing age or sex information
- Patients with type 1 diabetes mellitus, secondary or gestational diabetes
- History of diabetes related complications
- Patients with related chronic diseases.
- History of gastrointestinal conditions.
- Previous exposure to other GLP-1RA and pramlintide
- Patients with prescription dispensing for both tirzepatide and semaglutide on cohort entry date
Key Trial Info
Start Date :
January 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
26000 Patients enrolled
Trial Details
Trial ID
NCT06980623
Start Date
January 1 2025
End Date
March 1 2026
Last Update
December 12 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120