Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk
Registered observational trial (active not recruiting). 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.
Registered clinical trial record on ClinicalTrials.gov (NCT07619495). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results. Status: active not recruiting. Study type: observational. Sponsor: Brigham and Women's Hospital. Conditions: Type 2 Diabetes Mellitus, Obesity, Overweight. Interventions: Semaglutide, Dulaglutide. 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. 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. Primary outcome measures: Composite of all-cause mortality, myocardial infarction, or stroke.. Eligibility: 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
This is a registered clinical-trial record from ClinicalTrials.gov — a description of a planned, ongoing, or completed study, not peer-reviewed results. Listing on ClinicalTrials.gov does not mean the study has been evaluated by the U.S. Federal Government, nor does it imply endorsement or that the intervention is safe or effective.
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