Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardio… (NCT06779929) | Clinical Trial Compass
CompletedNot 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 range
40 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite CV outcome
Timeframe: From treatment initiation to end of follow up, up to 48 months.