Un estudio de seguridad posterior a la autorización paneuropeo: riesgo de cáncer de páncreas entre pacientes con diabetes tipo 2 que iniciaron exenatida en comparación con aquellos que iniciaron otros fármacos hipoglucemiantes basados en agonistas del receptor del péptido 1 no similares al glucagón (EXCEED)
EXCEED: un estudio de seguridad paneuropeo posterior a la autorización: riesgo de cáncer de páncreas entre pacientes con diabetes tipo 2 que iniciaron tratamiento con exenatida en comparación con aquellos que iniciaron otros fármacos hipoglucemiantes basados en agonistas del receptor del péptido 1 no similares al glucagón
EXCEED is a non-interventional post-authorisation safety study aiming to assess the risk of developing pancreatic cancer among type 2 diabetes mellitus (T2DM) patients who initiated exenatide compared to those who initiated other non-glucagon like peptide 1 receptor agonists (GLP-1 RA) based glucose lowering drugs (GLDs). Study data will be collected from secondary data sources across 7 European countries. The study will be conducted as a multi-country, long-term, retrospective, observational database study. Initiators of exenatide will be matched to initiators of non-GLP-1 RA based GLDs (comparator group) based on propensity score and calendar period of study entry. All analyses for pancreatic cancer will be conducted in the matched study population using an "intention-to-treat" approach. The study will use information from 8 data sources in 7 European countries (France, Spain, The United Kingdom, Finland, Denmark, Norway, and Sweden). Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide or non-GLP-1 RA based GLDs during the study period, 2006 to 2023, will be included. Exposure to exenatide and non-GLP-1 RA based GLDs will be ascertained from recordings of prescriptions or insurance claims registrations as available in the different data sources. The outcome of pancreatic cancer will be defined as a primary diagnosis of pancreatic cancer during follow-up
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: AstraZeneca Clinical Study Information Center
- Número de teléfono: 1-877-240-9479
- Correo electrónico: information.center@astrazeneca.com
Ubicaciones de estudio
-
-
-
Copenhagen, Dinamarca
- Reclutamiento
- Research Site
-
-
-
-
-
Barcelona, España
- Reclutamiento
- Research Site
-
-
-
-
-
Helsinki, Finlandia
- Reclutamiento
- Research Site
-
-
-
-
-
Paris, Francia
- Reclutamiento
- Research Site
-
-
-
-
-
Bergen, Noruega
- Reclutamiento
- Research Site
-
-
-
-
-
Edinburgh, Reino Unido
- Reclutamiento
- Research Site
-
London, Reino Unido
- Reclutamiento
- Research Site
-
-
-
-
-
Vänersborg, Suecia
- Reclutamiento
- Research Site
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide or non-GLP-1 RA based GLDs during the study period, 2006 to 2023, will be included. Exposure to exenatide and non-GLP-1 RA based GLDs will be ascertained from recordings of prescriptions or insurance claims registrations as available in the different data sources.
Descripción
For inclusion in either exposure group, all of the following inclusion criteria must be fulfilled:
- Aged 18 years or older at the index date
- Individual level data on prescriptions, diagnoses and medical history is available for a minimum of 12 months prior to the index date
- A diagnosis of T2DM on index date or prior to index date
For inclusion in the overall exenatide exposure group, the following criterion must be fulfilled:
-
One incident prescription (or incident dispensed prescription) for exenatide (BYETTA or BYDUREON/ BYDUREON BCise) between the start and 12 months before the end of the study period. This incident prescription must have succeeded a prescription of a GLD of another drug class during the baseline period.
For inclusion in the BYDUREON/ BYDUREON BCise exposure group, for the analyses of the secondary objective, the criterion a) is substituted with criterion b):
-
One incident prescription (or incident dispensed prescription) for BYDUREON/ BYDUREON BCise between the start and 12 months before the end of the study period. This incident prescription must have succeeded a prescription of a GLD of another drug class during the baseline period.
For inclusion in the comparator group, the following criterion must be fulfilled:
-
One incident prescription (or incident dispensed prescription) of a GLD between the start and 12 months before the end of the study period. The GLD must not be a DPP-4i, a GLP-1 RA, or a combination with either a DPP-4i or a GLP-1 RA. This incident prescription must have succeeded a prescription of a GLD of another drug class during the baseline period.
Patients are not eligible for any of the study population groups if they fulfil any of the following exclusion criteria:
- A diagnosis of type 1 diabetes mellitus (T1DM) on index date or a diagnosis of T1DM during the baseline period that is not succeeded by a T2DM diagnosis during the remaining part of the baseline period.
- A diagnosis of gestational diabetes during the baseline period or on index date.
- A diagnosis of polycystic ovarian syndrome during the baseline period or on index date in combination with exposure to metformin (Anatomical Therapeutic Chemical Classification System (ATC) code of the World Health Organization (WHO): A10BA02) as the only GLD on index date or during the baseline period.
- History of any cancer on or prior to index date. The only exception is that nonmelanoma skin cancer does not lead to exclusion.
- History of any acute pancreatitis, other diseases of the pancreas, or disorders of the pancreas on or prior to index date.
- One or more prescriptions (or dispensed prescriptions) of a GLP-1 RA (incretin mimetics) other than exenatide on or prior to index date.
- One or more prescriptions (or dispensed prescriptions) of DPP-4i (incretin mimetics) on or prior to the index date.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Initiators of exenatide
Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide during the study period, 2006 to 2023 |
All patients initiating exenatide during the study period will be identified by ATC codes and be included in the exenatide group in a hierarchical manner, regardless of previous use of non-GLP-1 RA based glucose lowering drugs.
Otros nombres:
|
|
Initiators of non-GLP-1 RA based glucose lowering drugs
Patients with T2DM, aged 18 years or older, who initiated treatment with non-GLP-1 RA based glucose lowering drugs during the study period, 2006 to 2023 |
Initiators of non-GLP-1 RA based GLDs with no use of exenatide before or during the study period.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence rate of primary diagnosis of pancreatic cancer among exenatide exposed population
Periodo de tiempo: Follow-up starts from the index date to the study completion, an average of 1.5 years or less
|
To estimate the incidence rate (IR) for pancreatic cancer associated with exposure to exenatide, compared with exposure to non-GLP-1 RA based GLDs, among patients with T2DM. |
Follow-up starts from the index date to the study completion, an average of 1.5 years or less
|
|
Hazard ratio of primary diagnosis of pancreatic cancer among exenatide exposed population
Periodo de tiempo: Follow-up starts from thr index date to the study completion, an average of 1.5 years or less
|
To estimate the hazard ratio (HR) for pancreatic cancer associated with exposure to exenatide, compared with exposure to non-GLP-1 RA based GLDs, among patients with T2DM |
Follow-up starts from thr index date to the study completion, an average of 1.5 years or less
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Fabian Hoti, PhD, IQVIA Pty Ltd
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Neoplasias por sitio
- Neoplasias
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Neoplasias pancreáticas
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Hormonas peptídicas
- Péptidos
- Aminoácidos, péptidos y proteínas
- Compuestos de azufre
- Químicos orgánicos
- Factores biológicos
- Amidas
- Mezclas complejas
- Guanidinas
- Amidinos
- Sulfonas
- Insulina
- Hormonas pancreáticas
- Toxinas, biológicas
- Urea
- Proinsulina
- Veneno
- Exenatida
- Insulina
- Biguanidas
- 2,4-tiazolidinediona
- Compuestos de sulfonilurea
- Sulfonamidas
Otros números de identificación del estudio
- D5551R00015
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Marco de tiempo para compartir IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Criterios de acceso compartido de IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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. .