Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data

NCT07088718 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-SURPASSCVOT
• Study Type: observational
• Target: 44,671
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Major Adverse Cardiac Events; Cardiovascular (CV) Risk

Outcome Measures

Primary Outcomes (1)

• First occurence of MACE (all-cause mortailty, myocardial infarction, or death)

  To evaluate the comparative effect of tirzepatide vs dulaglutide on time to first occurrence of MACE (all-cause mortailty, myocardial infarction, or death) in patients with T2DM and an established CVD when following the eligibility criteria of the SURPASS-CVOT trial: Individuals aged 40 years or older with T2DM and an established CVD.

  1 day after cohort entry date until the first of outcome or censoring, up to 365 days

Secondary Outcomes (3)

• Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Tirzepatide vs dulaglutide)

  1 day after cohort entry date until the first of outcome or censoring, up to 365 days

• Hernia

  1 day after cohort entry date until the first of outcome or censoring, up to 365 days

• Lumbar radiculopathy

  1 day after cohort entry date until the first of outcome or censoring, up to 365 days

Study Arms (2)

Tirzepatide

Exposure group

Drug: Tirzepatide

Dulaglutide

Reference group

Drug: Dulaglutide

Interventions

Tirzepatide DRUG

New use of tirzepatide dispensing claim is used as the exposure.

Tirzepatide

Dulaglutide DRUG

New use of dulaglutide dispensing claim is used as the reference.

Dulaglutide

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 40 years or older with T2DM and an established CVD

You may qualify if:

• History of MI, surgical or percutaneous coronary/carotid peripheral artery revascularization
• BMI ≥25.0kg/m2
• Type 2 diabetes, diagnosis of coronary/carotid/peripheral artery disease
• Age ≥40 years
• Male or female sex

You may not qualify if:

• Medullary thyroid carcinoma, MEN syndrome type 2, malignancy
• Treatment for diabetic retinopathy//macular edema, pancreatitis, gastric emptying abnormality/bariatric surgery, liver disease, end-stage renal disease or dialysis, pregnancy
• Prior use of pramlintide or any GLP-1-RA except tirzepatide or dulaglutide
• Cardiovascular event, hospitalization for heart failure
• Concurrent use of both drugs i.e. tirzepatide and dulaglutide

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)

• Kruger N, Schneeweiss S, Desai RJ, Sreedhara SK, Kehoe AR, Fuse K, Hahn G, Schunkert H, Wang SV. Cardiovascular outcomes of semaglutide and tirzepatide for patients with type 2 diabetes in clinical practice. Nat Med. 2025 Nov 9. doi: 10.1038/s41591-025-04102-x. Online ahead of print.

  PMID: 41207920 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

Tirzepatide; dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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 Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Nils Krüger, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: October 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-08

Locations

US (1)