NCT07203677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49,065

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

April 30, 2026

Status Verified

September 1, 2025

Enrollment Period

26 days

First QC Date

September 25, 2025

Last Update Submit

April 25, 2026

Conditions

Type2 Diabetes MellitusAtherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events

    To evaluate the comparative effect of tirzepatide vs sitagliptin on the composite of myocardial infarction, stroke, or all-cause mortality in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

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

Secondary Outcomes (10)

  • Composite of myocardial infarction or stroke

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

  • Myocardial infarction

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

  • Stroke

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

  • All-cause mortality

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

  • Infection-related mortality

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

  • +5 more secondary outcomes

Other Outcomes (1)

  • Hernia and lumbar radiculopathy

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

Study Arms (2)

Initiation of tirzepatide

Exposure group

Drug: Initiation of tirzepatide

Initiation of sitagliptin

Reference group

Drug: Initiation of sitagliptin

Interventions

Initiation of tirzepatideDRUG

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

Initiation of tirzepatide
Initiation of sitagliptinDRUG

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

Initiation of sitagliptin

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals aged 40 years or older with T2DM and and atherosclerotic cardiovascular disease.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

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

September 25, 2025

First Posted

October 2, 2025

Study Start

September 19, 2025

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

April 30, 2026

Record last verified: 2025-09

Locations

US(1)