Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk
8 de julio de 2026 actualizado por: Shirley Vichy Wang, Brigham and Women's Hospital
Comparative Effectiveness of Semaglutide and Dulaglutide in Patients at Low, Moderate, and High Cardiovascular Risk With Type 2 Diabetes and Overweight
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
120000
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02120
- Brigham and Women's Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Individuals typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with T2DM and overweight.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Dulaglutida
Grupo de referencia
|
Initiation of dulaglutide described in electronic health records is used as the reference.
|
|
Injectable semaglutide
Exposure group
|
Initiation of injectable semaglutide described in electronic health records is used as the exposure.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Composite of all-cause mortality, myocardial infarction, or stroke.
Periodo de tiempo: 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.
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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.
|
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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Urinary tract infections
Periodo de tiempo: 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 safety outcome of urinary tract infections 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
|
|
Serious infections
Periodo de tiempo: 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 safety outcome of serious infections 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
|
|
Gastrointestinal adverse events
Periodo de tiempo: 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 safety outcome of gastrointestinal adverse events 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
|
|
Hernia
Periodo de tiempo: 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 effect of injectable semaglutide vs dulaglutide on the negative control outcome of hernia 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
|
|
Lumbar radiculopathy
Periodo de tiempo: 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 effect of injectable semaglutide vs dulaglutide on the negative control outcome of lumbar radiculopathy 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
- Investigador principal: Nils Krüger, MD, Brigham and Women's Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de enero de 2026
Finalización primaria (Actual)
1 de junio de 2026
Finalización del estudio (Actual)
1 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
23 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de mayo de 2026
Publicado por primera vez (Actual)
2 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de julio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Diabetes Mellitus, Tipo 2
- semaglutida
- dulaglutida
Otros números de identificación del estudio
- 2018P002966-SEMADULA-CVOT
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .