Status:
COMPLETED
Comparative Effectiveness of Tirzepatide Versus Sitagliptin in Individuals at Cardiovascular Risk (TIRZSITA-CVOT)
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Type2 Diabetes Mellitus
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
40+ years
Brief 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 clin...
Detailed Description
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT...
Eligibility Criteria
Inclusion
- History of MI or stroke, surgical or percutaneous coronary/carotid peripheral artery revascularization, amputation, diagnosis of coronary/carotid/peripheral artery disease
- BMI ≥25.0kg/m2
- Type 2 diabetes
- Age ≥40 years
- Male or female sex
Exclusion
- Medullary thyroid carcinoma, MEN syndrome type 2, malignancy
- Treatment for diabetic retinopathy/macular edema, heart failure NYHA IV, gastric emptying abnormality/bariatric surgery, end-stage renal disease or dialysis, pregnancy
- Prior use of pramlintide or any GLP-1-RA except tirzepatide,
- Pancreatitis, liver disease
- Cardiovascular event or intervention, hospitalization for heart failure
- Concurrent use of both drugs i.e. tirzepatide and sitagliptin
Key Trial Info
Start Date :
September 19 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 15 2025
Estimated Enrollment :
49065 Patients enrolled
Trial Details
Trial ID
NCT07203677
Start Date
September 19 2025
End Date
October 15 2025
Last Update
October 31 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120