Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

Completed

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT06779929

Run by

Brigham and Women's Hospital

People needed

70000

Starts

2024-11-01

Expected to finish

2026-03-01

Last updated by the study team

2026-05-15

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 calcitonin level within the last year to treatment initiation
• Previous exposure to GLP-1RA or pramlintide during the 180-days washout period and including treatment initiation date
• Patients with severe hypoglycemia within the last 6 months to treatment initiation
• Patients with hospitalization for heart failure within the last 60 days to treatment initiation
• Patient with acute coronary syndrome, ischemic stroke, peripheral arterial disease, or coronary or cerebrovascular procedure within the last 60 days to treatment initiation
• Patients with prescription dispensing for both tirzepatide and dulaglutide on treatment initiation date

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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