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Active Not Recruiting
NCT07619495
Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk
Conditions: Type 2 Diabetes Mellitus, Obesity, Overweight
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 120000
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
Study Period:
Optum: Eligible cohort entry period between December 5, 2017 to November 30, 2025.
MarketScan: Eligible cohort entry period between December 5, 2017 to September 30, 2023.
Medicare: Eligible cohort entry period between December 5, 2017 to September 30, 2020.
Inclusion Criteria:
* Men or women aged 18 years or older
* History of myocardial infarction, stroke, any surgical or percutaneous revascularization procedure
* Use of antihypertensive or lipid-lowering drugs
* Coronary, carotid, or peripheral artery disease
* BMI greater than or equal to 25.0 mg/m2
* Type 2 diabetes
Exclusion Criteria:
* Medullary thyroid carcinoma
* MEN syndrome type 2
* Malignancy
* Type 1 diabetes
* Secondary diabetes
* End-stage renal disease or dialysis
* Uncontrolled diabetic retinopathy or maculopathy
* Pregnancy
* History of bariatric surgery
* Prior use of pramlintide or any GLP-1-RA, except semaglutide or dulaglutide
* Cardiovascular event or intervention in the last 7 days
Source: ClinicalTrials.gov (NCT07619495). StuddyBuddy aggregates publicly available trial information.