Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardio… (NCT06779929) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
United States70,000 participantsStarted 2024-11-01
Plain-language summary
This cohort study was initiated to emulate the design of the SURPASS-CVOT trial using observational analogues of the trial design components in a study based on insurance claims data.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with T2D who were new users of tirzepatide or new users of dulaglutide
* AND established ASCVD defined as:
* History of Myocardial Infarction (MI) or MI sequela
* Unstable or stable angina
* Coronary atherosclerosis disease or procedures
* Ischemic stroke
* Peripheral arterial disease or procedures
* Atherosclerotic cerebrovascular disease or cerebrovascular procedures
* Lower-limb amputation
* Age \>= 40 years old
* Patients with at least 180 days of continuous health plan enrollment before and including the treatment initiation date
Exclusion Criteria:
* Patients with Type 1 diabetes mellitus
* Patients with missing age or sex information
* Patients with history of proliferative diabetic retinopathy, panretinal photocoagulation, vitreous hemorrhage, or intravitreal anti-VEGF injection
* Patient within history of left ventricular assisted device (LVAD) or heart transplant
* Patients with any previous organ transplants
* Patients with acute of chronic pancreatitis
* Patients with gastroparesis, bowel obstruction or bariatric surgery
* Patient with CKD Stage 5, end stage kidney disease, kidney transplant, or hemodialysis
* Patients with multiple endocrine neoplasm syndrome type 2 (MEN-2)
* Patient with cancer
* Pregnant women
* Patient with diabetic ketoacidosis or HONK within the last year to treatment initiation
* Patients with acute hepatitis within the last year to treatment initiation
* Patients with elevated serum calciton…
What they're measuring
1
Composite CV outcome
Timeframe: From treatment initiation to end of follow up, up to 48 months.