NCT07417618

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
60,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2026

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

January 27, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2026

Completed
Last Updated

July 9, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 11, 2026

Last Update Submit

July 8, 2026

Conditions

Type 2 DiabetesOverweightASCVD

Outcome Measures

Primary Outcomes (4)

  • Composite of myocardial infarction, stroke, or all-cause mortality (with ASCVD)

    Hazard ratio of the composite of myocardial infarction, stroke, or all-cause mortality in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

  • Composite of myocardial infarction, or stroke (with ASCVD)

    Hazard ratio of the composite of myocardial infarction or stroke in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

  • Composite of myocardial infarction, stroke, or all-cause mortality (without ASCVD)

    Hazard ratio of the composite of myocardial infarction, stroke, or all-cause mortality in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

  • Composite of myocardial infarction, or stroke (without ASCVD)

    Hazard ratio of the composite of myocardial infarction or stroke in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

Secondary Outcomes (24)

  • Myocardial infarction (with ASCVD)

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

  • Stroke (with ASCVD)

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

  • All-cause mortality (with ASCVD)

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

  • Composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization (with ASCVD)

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

  • Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure (with ASCVD)

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

  • +19 more secondary outcomes

Other Outcomes (4)

  • Hernia (with ASCVD)

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

  • Lumbar radiculopathy (with ASCVD)

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

  • Hernia (without ASCVD)

    Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i

  • +1 more other outcomes

Study Arms (2)

Initiation of dulaglutide, semaglutide or tirzepatide

Exposure group.

Drug: DulaglutideDrug: SemaglutideDrug: Tirzepatide

Initiation of sitagliptin

Reference group.

Drug: Sitagliptin

Interventions

DulaglutideDRUG

Initiation of dulaglutide dispensing claim is used as the exposure.

Initiation of dulaglutide, semaglutide or tirzepatide
SemaglutideDRUG

Initiation of semaglutide dispensing claim is used as the exposure.

Initiation of dulaglutide, semaglutide or tirzepatide
TirzepatideDRUG

Initiation of tirzepatide dispensing claim is used as the exposure.

Initiation of dulaglutide, semaglutide or tirzepatide
SitagliptinDRUG

Initiation of sitagliptin dispensing claim is used as the reference.

Initiation of sitagliptin

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with T2DM and overweight with (or without) ASCVD.

You may qualify if:

  • History of ASCVD (defined as MI, ACS, stable/unstable angina surgical or percutaneous coronary/other arterial revascularization procedure, ischemic stroke, TIA, aortic aneurysm, peripheral artery disease)
  • BMI \>= 25.0kg/m2
  • Type 2 Diabetes

You may not qualify if:

  • Medullary thyroid carcinoma
  • MEN syndrome type 2
  • Malignancy
  • Type 1 diabetes or secondary diabetes
  • End-stage renal disease or dialysis
  • Uncontrolled diabetic retinopathy or maculopathy
  • Pregnancy
  • Bariatric surgery
  • Prior use of pramlintide, or any GLP-1RA except injectable semaglutide/tirzepatide/dulaglutide, or any DPP4i except sitagliptin
  • CV-event or intervention
  • Concurrent use of both study drugs
  • POPULATION WITHOUT ASCVD
  • BMI \>=25.0kg/m2
  • Type 2 diabetes
  • History of ASCVD (defined as MI, ACS, stable/unstable angina surgical or percutaneous coronary/other arterial revascularization procedure, ischemic stroke, TIA, aortic aneurysm, peripheral artery disease)
  • +10 more criteria

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

Diabetes Mellitus, Type 2Overweight

Interventions

dulaglutidesemaglutideTirzepatideSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, PeptideTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

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

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

January 27, 2026

Primary Completion

June 19, 2026

Study Completion

June 19, 2026

Last Updated

July 9, 2026

Record last verified: 2026-02

Locations

US(1)