DRUG
Semaglutide
Initiation of injectable semaglutide described in electronic health records is used as the exposure.
Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk
Status
Completed
Phase
Not applicable
Enrollment
120,000
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
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 semaglutide vs dulaglutide on cardiovascular outcomes in individuals typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes (T2DM) and overweight. 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 database study will be a new-user active-comparative study, conducted using 3 national United States claims databases, where the effect of semaglutide vs dulaglutide on the composite end point of all-cause mortality, myocardial infarction, or stroke will be assessed. Clinical guidelines during the study period recommended both injectable semaglutide and dulaglutide for the same indications of glucose lowering and cardiovascular risk reduction.
Interventions
Treatment arms and agents.
DRUG
Dulaglutide
Initiation of dulaglutide described in electronic health records is used as the reference.
Timeline
From registration to results.
First posted
Jun 2, 2026
Study start
Jan 20, 2026
Primary completion
Jun 1, 2026
Study completion
Jun 1, 2026
Results posted
Not reported
Registry updated
Jul 9, 2026
Outcomes
What the study measures.
Primary outcomes
Composite of all-cause mortality, myocardial infarction, or stroke.
Time frame · 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
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.
Secondary outcomes
Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke
Time frame · 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
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the individual components of the primary endpoint, i.e., 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.
Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure
Time frame · 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
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
Hospitalization for heart failure
Time frame · 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
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the occurrence of heart failure hospitalizations in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
Hospitalization for unstable angina
Time frame · 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
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on hospitalizations for unstable angina in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
Coronary revascularization
Time frame · 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
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the occurrence of coronary revascularization in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Study Period: Optum: Eligible cohort entry period between December 5, 2017 to November 30, 2025. MarketScan: Eligible cohort entry period between December 5, 2017 to September 30, 2023. Medicare: Eligible cohort entry period between December 5, 2017 to September 30, 2020. Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.