Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk
NCT ID: NCT07096063
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
887132 participants
OBSERVATIONAL
2024-10-01
2025-07-15
Brief Summary
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Detailed Description
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1. Tirzepatide vs dulaglutide,
2. Semaglutide vs sitagliptin,
3. Tirzepatide vs semaglutide
on cardiovascular outcomes in individuals typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes (T2DM) and overweight but might not meet the eligibility criteria of pivotal RCTs for each drug (SUSTAIN-6 and SURPASS-CVOT trials), used to support regulatory approval in patients at cardiovascular risk.Although many features of the target trials cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the target trial. Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice.
The three database studies will be new-user active-comparative studies, conducted using 3 national United States claims databases, where investigators compare the effect of semaglutide vs sitagliptin (used as an active comparator placebo proxy), tirzepatide vs dulaglutide, and tirzepatide vs semaglutide on the composite end point of all-cause mortality, myocardial infarction, or stroke. Clinical guidelines during the study period recommended both tirzepatide and semaglutide for the same indications of glucose lowering and weight reduction.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1
Tirzepatide vs dulaglutide
Tirzepatide
New use of tirzepatide dispensing claim is used as the exposure.
Dulaglutide
New use of dulaglutide dispensing claim is used as the comparator.
Cohort 2
Semaglutide vs sitagliptin
Semaglutide
New use of semaglutide dispensing claim is used as the exposure/comparator.
Sitagliptin
New use of sitagliptin dispensing claim is used as the comparator.
Cohort 3
Tirzepatide vs semaglutide
Tirzepatide
New use of tirzepatide dispensing claim is used as the exposure.
Semaglutide
New use of semaglutide dispensing claim is used as the exposure/comparator.
Interventions
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Tirzepatide
New use of tirzepatide dispensing claim is used as the exposure.
Dulaglutide
New use of dulaglutide dispensing claim is used as the comparator.
Semaglutide
New use of semaglutide dispensing claim is used as the exposure/comparator.
Sitagliptin
New use of sitagliptin dispensing claim is used as the comparator.
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes
* BMI ≥25.0kg/m2
* Age ≥18 years
* Male or female sex
* History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension
* Type 2 diabetes
* BMI ≥25.0kg/m2
* Age ≥18 years
* Male or female sex
* History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension
* Type 2 diabetes
* BMI ≥25.0kg/m2
* Age ≥18 years
* Male or female sex
Exclusion Criteria
* Malignancy
* Type 1 diabetes or secondary diabetes
* Chronic kidney disease or dialysis
* Uncontrolled diabetic retinopathy or maculopathy
* Pregnancy
* Prior use of pramlintide or any GLP-1-RA
ELIGIBILITY FOR SEMAGLUTIDE VS SITAGLIPTIN
* Medullary thyroid carcinoma, MEN syndrome type 2
* Malignancy
* Type 1 diabetes or secondary diabetes
* Chronic kidney disease or dialysis
* Uncontrolled diabetic retinopathy or maculopathy
* Pregnancy
* Prior use of pramlintide or any GLP-1-RA or DPP4i
ELIGIBILITY FOR TIRZEPATIDE VS SEMAGLUTIDE
* Medullary thyroid carcinoma, MEN syndrome type 2
* Malignancy
* Type 1 diabetes or secondary diabetes
* Chronic kidney disease or dialysis
* Uncontrolled diabetic retinopathy or maculopathy
* Pregnancy
* Prior use of pramlintide or any GLP-1-RA
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Shirley Vichy Wang
Associate Professor of Medicine
Principal Investigators
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Shirley Wang, PhD, ScM
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Nils Krüger, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan
Document Type: Study Protocol and Statistical Analysis Plan: Amendment to Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018P002966-DUP-TIRZSEMA-CVOT
Identifier Type: -
Identifier Source: org_study_id
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