Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
23 de enero de 2019 actualizado por: Takeda
A Prospective, Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or alogliptin FDCs, in standard clinical practice.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The drug being studied in this study is called alogliptin and alogliptin FDCs. Alogliptin and alogliptin FDCs is being researched to treat people who have diabetes mellitus type 2. This study will look at the glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2.
The study enrolled 593 patients. Alogliptin and alogliptin FDCs will be prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study).
This multi-center study will be conducted in China. The overall duration of study for observation will be approximately 6 months, or up to loss to follow-up or death, whichever occurs first. Participants will make multiple visits to the clinic as per regular doctor's appointments.
Tipo de estudio
De observación
Inscripción (Actual)
593
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
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Sai Ying Pun, Hong Kong
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Sha Tin, Hong Kong
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Beijing
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Beijing, Beijing, Porcelana
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Hubei
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Wuhan, Hubei, Porcelana
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Liaoning
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Dalian, Liaoning, Porcelana
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Shenyang, Liaoning, Porcelana
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Shandong
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Jinan, Shandong, Porcelana
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Qingdao, Shandong, Porcelana
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Tai'an, Shandong, Porcelana
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Taian, Shandong, Porcelana
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Tianjin
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Tianjin, Tianjin, Porcelana
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.
Descripción
Inclusion Criteria:
- Has a diagnosis of T2DM.
- Has made the decision, along with his/her treating physician, to begin treatment with alogliptin or alogliptin fixed-dose combinations (FDCs).
- Has an glycated hemoglobin (HbA1c) value recorded at most 3 months before initiation of treatment with alogliptin or alogliptin FDCs.
- Alogliptin or alogliptin FDCs is prescribed according to the approved label for China and Hong Kong.
Exclusion Criteria:
- Has gestational diabetes or type 1 diabetes mellitus.
- Has used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of alogliptin or alogliptin FDCs treatment.
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
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
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Tabletas de alogliptina
Alogliptin FDC with pioglitazone tablets
Alogliptin FDC with metformin tablets
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cambio desde el inicio en el nivel de hemoglobina glicosilada (HbA1c) en el mes 6
Periodo de tiempo: Línea de base y Mes 6
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El cambio en el valor de la hemoglobina glicosilada (la concentración de glucosa unida a la hemoglobina como porcentaje del máximo absoluto que se puede unir) recopilada en el Mes 6 en relación con la línea de base.
La hemoglobina glicosilada (HbA1c) como criterio diagnóstico de diabetes mellitus es ≥6,5%.
Un cambio negativo desde la línea de base indica una mejora.
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Línea de base y Mes 6
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics
Periodo de tiempo: Baseline and Month 6
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The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline.
Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%.
Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control.
A negative change from Baseline indicates improvement.
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Baseline and Month 6
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Percentage of Participants With a Decrease in HbA1c Level by <7.0%
Periodo de tiempo: Baseline and Month 6
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Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported.
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Baseline and Month 6
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Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings
Periodo de tiempo: Baseline and Month 6
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Percentage of participants with a decrease of >0.3% from baseline in HbA1c along with no tolerability findings were reported.
Tolerability findings included hypoglycemic event, or weight gain ≥5%.
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Baseline and Month 6
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Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time
Periodo de tiempo: Baseline and Months 3 and 6
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The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline.
A negative change from Baseline indicates improvement.
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Baseline and Months 3 and 6
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Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time
Periodo de tiempo: Baseline and Months 3 and 6
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The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline.
A negative change from Baseline indicates improvement.
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Baseline and Months 3 and 6
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Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Periodo de tiempo: Baseline up to Month 6
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An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function.
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI.
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Baseline up to Month 6
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Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs
Periodo de tiempo: Months 3 and 6
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Months 3 and 6
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Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction
Periodo de tiempo: Months 3 and 6
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Months 3 and 6
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
22 de diciembre de 2016
Finalización primaria (Actual)
26 de enero de 2018
Finalización del estudio (Actual)
26 de enero de 2018
Fechas de registro del estudio
Enviado por primera vez
8 de diciembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
8 de diciembre de 2016
Publicado por primera vez (Estimar)
12 de diciembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
23 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades del sistema endocrino
- Diabetes mellitus
- Diabetes Mellitus, Tipo 2
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Inhibidores de la proteasa
- Incretinas
- Inhibidores de la dipeptidil-peptidasa IV
- Metformina
- Pioglitazona
- Alogliptina
Otros números de identificación del estudio
- Alogliptin-5009
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach
for details).
To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias.
Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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. .