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Trial · Observational

CompletedPhase not statedRegistry data

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

Short name DUP-SURPASS

NCTNCT07088718 (opens ClinicalTrials.gov in a new tab)Other id2018P002966-DUP-SURPASSCVOT
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
44,671 participants (actual)
Sponsor
Brigham and Women's Hospital · Other
Design
Not stated
Countries
1 country

United States

Start
1 Oct 2024
Primary completion
30 Jul 2025
Completion
30 Jul 2025
First posted
28 Jul 2025
Last update posted
15 Oct 2025
Conditions
Type 2 Diabetes · Major Adverse Cardiac Events · Cardiovascular (CV) Risk

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph –

    DUP-SURPASS

    NCT07088718

    1 Oct 2024 to 30 Jul 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • DulaglutideDrug

Arms2

  • Other

    Tirzepatide

    Exposure group

  • Other

    Dulaglutide

    Reference group

Primary outcomes1

Outcomes the sponsor listed as primary.

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

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

    Registry description

    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.

Secondary outcomes(3)

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

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

    Registry description

    To evaluate the comparative effect of tirzepatide vs dulaglutide on the individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke 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.

  2. Hernia

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

    Registry description

    To evaluate the effect of tirzepatide vs dulaglutide on a negative control outcome of hernia 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.

  3. Lumbar radiculopathy

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

    Registry description

    To evaluate the effect of tirzepatide vs dulaglutide on a negative control outcome of lumbar radiculopathy 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2026

5 results

Cardiovascular outcomes of semaglutide and tirzepatide for patients with type 2 diabetes in clinical practice.

Krüger et al. 2026Nature medicinecited by 31

PMID 41207920PMC12823426DOI 10.1038/s41591-025-04102-xPUB-41207920

CC BY5 results
Download PDFSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
FOLLOWING ELIGIBILITY CIRTERIA OF THE SURPASS-CVOT TRIAL Inclusion Criteria: * 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 Exclusion Criteria: * 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

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