NCT07619495

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

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120,000

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
active not recruiting

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 20, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
Last Updated

June 9, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 23, 2026

Last Update Submit

June 5, 2026

Conditions

Type 2 Diabetes MellitusObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • Composite of all-cause mortality, myocardial infarction, or stroke.

    To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the composite of all-cause mortality, myocardial infarction, or stroke in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.

    1 day after cohort entry until outcome, disenrollment, end of study period, death, 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

Secondary Outcomes (5)

  • Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke

    1 day after cohort entry until outcome, disenrollment, end of study period, death, 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

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

    1 day after cohort entry until outcome, disenrollment, end of study period, death, 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

  • Hospitalization for heart failure

    1 day after cohort entry until outcome, disenrollment, end of study period, death, 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

  • Hospitalization for unstable angina

    1 day after cohort entry until outcome, disenrollment, end of study period, death, 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

  • Coronary revascularization

    1 day after cohort entry until outcome, disenrollment, end of study period, death, 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

Other Outcomes (5)

  • Urinary tract infections

    1 day after cohort entry until outcome, disenrollment, end of study period, death, 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

  • Serious infections

    1 day after cohort entry until outcome, disenrollment, end of study period, death, 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

  • Gastrointestinal adverse events

    1 day after cohort entry until outcome, disenrollment, end of study period, death, 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

  • +2 more other outcomes

Study Arms (2)

Injectable semaglutide

Exposure group

Drug: Semaglutide

Dulaglutide

Reference group

Drug: Dulaglutide

Interventions

SemaglutideDRUG

Initiation of injectable semaglutide described in electronic health records is used as the exposure.

Injectable semaglutide
DulaglutideDRUG

Initiation of dulaglutide described in electronic health records is used as the reference.

Dulaglutide

Eligibility Criteria

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

Individuals typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with T2DM and overweight.

You may qualify if:

  • Men or women aged 18 years or older
  • History of myocardial infarction, stroke, any surgical or percutaneous revascularization procedure
  • Use of antihypertensive or lipid-lowering drugs
  • Coronary, carotid, or peripheral artery disease
  • BMI greater than or equal to 25.0 mg/m2
  • Type 2 diabetes

You may not qualify if:

  • Medullary thyroid carcinoma
  • MEN syndrome type 2
  • Malignancy
  • Type 1 diabetes
  • Secondary diabetes
  • End-stage renal disease or dialysis
  • Uncontrolled diabetic retinopathy or maculopathy
  • Pregnancy
  • History of bariatric surgery
  • Prior use of pramlintide or any GLP-1-RA, except semaglutide or dulaglutide
  • Cardiovascular event or intervention in the last 7 days

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 2ObesityOverweight

Interventions

semaglutidedulaglutide

Condition Hierarchy (Ancestors)

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

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

May 23, 2026

First Posted

June 2, 2026

Study Start

January 20, 2026

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

June 9, 2026

Record last verified: 2026-05

Locations

US(1)