Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides
27 de febrero de 2017 actualizado por: Takeda
Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides
To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and biguanides in participants with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and biguanides in participants with type 2 diabetes mellitus in the routine clinical setting.
Participants diagnosed with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy will be enrolled. The planned sample size is 1,000.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.
Tipo de estudio
De observación
Inscripción (Actual)
1096
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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Tokyo, Japón
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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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Participants with type 2 diabetes mellitus who have been examined at a medical institution
Descripción
Inclusion Criteria:
- Participants who did not adequately respond to the following treatment • Treatment with biguanides in addition to diet therapy and exercise therapy
Exclusion Criteria:
Participants contraindicated for Nesina
- Participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus [these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate].
- Participants with severe infection, pre- or post-operative patients, or patients with serious traumatic injury [blood glucose control by insulin injection is desirable for these participants, and hence use of Nesina is not appropriate].
- Participants with a history of hypersensitivity to any ingredient of Nesina.
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 |
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Alogliptin + Biguanides
All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with biguanide or without biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants Reporting One or More Adverse Drug Reactions
Periodo de tiempo: Baseline up to 12 months
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Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.
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Baseline up to 12 months
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Number of Participants Reporting One or More Serious Adverse Drug Reactions
Periodo de tiempo: Baseline up to 12 months
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Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.
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Baseline up to 12 months
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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)
Periodo de tiempo: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
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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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.
The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.
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Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
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Percentage of Participants of Achieving Objective Glycemic Control
Periodo de tiempo: Baseline and final assessment (up to Month 12)
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The rate of achieving objective glycemic control in HbA1c level, was calculated at 12 month or final visit (last visit for a participant in the study, up to Month 12).
Glycemic control was measured as <8.0%, <7.0%, and <6.0% of glycosylated hemoglobin.
The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.
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Baseline and final assessment (up to Month 12)
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Change From Baseline in Fasting Blood Glucose
Periodo de tiempo: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
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The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.
The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the biguanide treatment.
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Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
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Change From Baseline in Fasting Insulin Level
Periodo de tiempo: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
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The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.
The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.
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Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
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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
1 de julio de 2011
Finalización primaria (Actual)
1 de diciembre de 2014
Finalización del estudio (Actual)
1 de diciembre de 2014
Fechas de registro del estudio
Enviado por primera vez
15 de octubre de 2013
Primero enviado que cumplió con los criterios de control de calidad
15 de octubre de 2013
Publicado por primera vez (Estimar)
17 de octubre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
27 de febrero de 2017
Última verificación
1 de febrero de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 121-014
- JapicCTI-132282 (Identificador de registro: JapicCTI)
- JapicCTI-R150790 (Identificador de registro: JapicCTI)
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. .