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

NCT06779929 | Active Not Recruiting FDA Drug

• 1 other identifier: 2024P001317
• Study Type: observational
• Target: 70,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Tirzepatide; Dulaglutide; Type 2 diabetes; Cardiovascular disease; Myocardial infarction; Stroke; Mortality

Outcome Measures

Primary Outcomes (1)

• Composite CV outcome

  Composite CV outcome includes myocardial infarction, stroke, and all-cause mortality.

  From treatment initiation to end of follow up, up to 48 months.

Study Arms (3)

Tirzepatide

Patients who initiated tirzepatide with no use in the prior 180 days

Drug: Tirzepatide

Dulaglutide

Patients who initiate dulaglutide with no use in the prior 180 days

Drug: Dulaglutide

Semaglutide

Patients who initiate semaglutide with no use in the prior 180 days

Drug: Semaglutide

Interventions

Tirzepatide DRUG

Tirzepatide

Tirzepatide

Dulaglutide DRUG

Dulaglutide

Dulaglutide

Semaglutide DRUG

Semaglutide

Semaglutide

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients \> 40 years old with T2D and established atherosclerotic cardiovascular disease.

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (1)

• Nicholls SJ, Bhatt DL, Buse JB, Prato SD, Kahn SE, Lincoff AM, McGuire DK, Nauck MA, Nissen SE, Sattar N, Zinman B, Zoungas S, Basile J, Bartee A, Miller D, Nishiyama H, Pavo I, Weerakkody G, Wiese RJ, D'Alessio D; SURPASS-CVOT investigators. Comparison of tirzepatide and dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes and atherosclerotic cardiovascular disease: SURPASS-CVOT design and baseline characteristics. Am Heart J. 2024 Jan;267:1-11. doi: 10.1016/j.ahj.2023.09.007. Epub 2023 Sep 25.

  PMID: 37758044 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Myocardial Infarction; Stroke

Interventions

Tirzepatide; dulaglutide; semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DrPH

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 17, 2025
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)