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Comparative Effectiveness of Tirzepatide Versus Sitagliptin in Individuals at Cardiovascular Risk (TIRZSITA-CVOT)

NCT ID: NCT07203677

Last Updated: 2025-10-31

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

49065 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-19

Study Completion Date

2025-10-15

Brief Summary

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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.

Detailed Description

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This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT-DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to assess the comparative effectiveness of tirzepatide vs sitagliptin as a placebo proxy, after the pivotal RCT SURPASS-CVOT (NCT04255433) and its emulation (NCT07088718) demonstrated non-inferiority, leaving both regulators and clinical guideline committees uncertain whether to approve and recommend tirzepatide for a cardiovascular indication. This comparative effectiveness target trial described below draws from eligibility criteria from the SURPASS-CVOT trial and its emulation. Although many features of the target trial 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 purpose of this protocol is to specify the target trial assessing the comparative effectiveness of the dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1-RA) tirzepatide vs the dipeptidyl peptidase-4 inhibitors (DPP4i) sitagliptin on atherosclerotic cardiovascular end points in patients with type 2 diabetes and atherosclerotic cardiovascular disease.

The database study will be a new-user active-comparative study, conducted using 2 national United States claims databases, where we compare the effect of tirzepatide vs sitagliptin in preventing atherosclerotic cardiovascular events. Clinical guidelines during the study period recommended both agents under investigation as second-line options for glucose lowering and were similarly costly.

Conditions

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Type2 Diabetes Mellitus Atherosclerotic Cardiovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Initiation of tirzepatide

Exposure group

Initiation of tirzepatide

Intervention Type DRUG

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

Initiation of sitagliptin

Reference group

Initiation of sitagliptin

Intervention Type DRUG

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

Interventions

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Initiation of tirzepatide

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

Intervention Type DRUG

Initiation of sitagliptin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shirley Vichy Wang

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: Amendment 2 to Study Protocol with Statistical Analysis Plan

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Amendment to Study Protocol with Statistical Analysis Plan

View Document

Document Type: Study Protocol: Study Protocol with Statistical Analysis Plan

View Document

Other Identifiers

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2018P002966-DUP-TIRZSITA

Identifier Type: -

Identifier Source: org_study_id