Pioglitazone Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>
26 de julio de 2018 actualizado por: Takeda
Actos Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>
The purpose of this survey is to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This survey was designed to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction.
For adults, 15-30 mg of pioglitazone is usually administered orally once daily before or after breakfast. The dose should be adjusted depending on sex, age, and symptoms; however, the maximum daily dose should not exceed 45 mg.
Tipo de estudio
De observación
Inscripción (Actual)
246
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
Type 2 diabetes mellitus
Descripción
Inclusion Criteria:
Type 2 diabetic patients with a prior history of cerebral infarction who meet all the following conditions, [1] to [3], at the time of enrollment in the survey:
- First onset of cerebral infarction was at least 24 weeks prior to enrollment
- HbA1c values ≥ 6.5% within 12 weeks prior to the start of treatment with Pioglitazone Tablets
- No prior history of treatment with Pioglitazone Tablets since the first onset of cerebral infarction
Exclusion Criteria:
Patients who meet any of the following conditions, [1] to [5], shall be excluded from the survey:
- Contraindication for Actos Tablets
- Prior history of recurrence of cerebral infarction
- Prior history of cerebral hemorrhage or subarachnoid hemorrhage
- Complications or prior history of myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease, atrial fibrillation, atrial flutter, or valvular disease
- Reduced cardiac function (defined as an ejection fraction [EF] ≤ 40%)
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 |
|---|---|
|
Pioglitazone
Pioglitazone 15-30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast (the dose can be adjusted; however, the maximum daily dose should not exceed 45 mg).
|
Tabletas de pioglitazona
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL)
Periodo de tiempo: 48 Week
|
The reported data were percentage of participants who achieved good glycemic control at 48 Week.
Good glycemic control was defined with fasting blood glucose level < 130 mg/dL.
|
48 Week
|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %)
Periodo de tiempo: 48 Week
|
The reported data were percentage of participants who achieved good glycemic control at 48 Week.
Good glycemic control was defined with HbA1c (NGSP) Values < 6.9 %.
|
48 Week
|
|
Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 48 Week
Periodo de tiempo: From Baseline, Up to 48 Week
|
Changes from baseline in laboratory parameter at 48 Week were reported.
The reported data on this outcome measure is SBP as a one of laboratory parameters.
|
From Baseline, Up to 48 Week
|
|
Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 48 Week
Periodo de tiempo: From Baseline, Up to 48 Week
|
Changes from baseline in laboratory parameter at 48 Week were reported.
The reported data on this outcome measure is DBP as a one of laboratory parameters.
|
From Baseline, Up to 48 Week
|
|
Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 48 Week
Periodo de tiempo: From Baseline, Up to 48 Week
|
Changes from baseline in laboratory parameter at 48 Week were reported.
The reported data on this outcome measure is HDL-Cholesterol as a one of laboratory parameters.
|
From Baseline, Up to 48 Week
|
|
Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 48 Week
Periodo de tiempo: From Baseline, Up to 48 Week
|
Changes from baseline in laboratory parameter at 48 Week were reported.
The reported data on this outcome measure is LDL-Cholesterol as a one of laboratory parameters.
|
From Baseline, Up to 48 Week
|
|
Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone
Periodo de tiempo: From Baseline, Up to 48 Week
|
The reported data were changes from baseline in laboratory parameter, that is HbA1c (National Glycohemoglobin Standardization Program Criteria; NGSP), at 48 Week in participants stratified by specific characteristics, mean daily dose of pioglitazone, at the time of enrollment.
Mean daily dose of pioglitazone at the time of enrollment were categorized into <15 mg, 15 to <30 mg, 30 <45 mg and 45 mg ≤ as planned (Note; final categorized number of participants was 0 in 45 mg ≤ group).
|
From Baseline, Up to 48 Week
|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c
Periodo de tiempo: From Baseline, Up to 48 Week
|
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of HbA1c, at the time of enrollment.
Levels of HbA1c at the time of enrollment were categorized into <6.2%,
6.2 to <6.9%, 6.9 <7.4%, 7.4 <8.4%, and 8.4% ≤ as planned (Note; final categorized number of participants was 0 in <6.2% and 6.2 to <6.9% group).
|
From Baseline, Up to 48 Week
|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender
Periodo de tiempo: From Baseline, Up to 48 Week
|
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Gender, at the time of enrollment.
Gender was categorized into male and female.
|
From Baseline, Up to 48 Week
|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI
Periodo de tiempo: From Baseline, Up to 48 Week
|
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of BMI, at the time of enrollment.
Levels of BMI at the time of enrollment were categorized into <18.5 kg/m^2, 18.5 to <25 kg/m^2, 25 <30 kg/m^2, and 30 kg/m^2 ≤.
|
From Baseline, Up to 48 Week
|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs
Periodo de tiempo: From Baseline, Up to 48 Week
|
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, presence of companion anti-diabetes drugs, at the time of enrollment.
Presence of companion anti-diabetes drugs at the time of enrollment were categorized into Had presence of companion anti-diabetes drugs and Had no presence of companion anti-diabetes drugs.
|
From Baseline, Up to 48 Week
|
|
Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point
Periodo de tiempo: Baseline and 48 Week
|
Fasting blood glucose level at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
|
Baseline and 48 Week
|
|
Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point
Periodo de tiempo: Baseline and 48 Week
|
HbA1c (NGSP) values at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
|
Baseline and 48 Week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Periodo de tiempo: Up to 48 Weeks
|
ADRs 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.
|
Up to 48 Weeks
|
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)
26 de enero de 2009
Finalización primaria (Actual)
30 de junio de 2011
Finalización del estudio (Actual)
30 de junio de 2011
Fechas de registro del estudio
Enviado por primera vez
2 de julio de 2014
Primero enviado que cumplió con los criterios de control de calidad
2 de julio de 2014
Publicado por primera vez (Estimar)
4 de julio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
26 de julio de 2018
Última verificación
1 de julio de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Isquemia
- Procesos Patológicos
- Necrosis
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema endocrino
- Diabetes mellitus
- Isquemia cerebral
- Carrera
- Infarto cerebral
- Infarto
- Diabetes Mellitus, Tipo 2
- Infarto cerebral
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Pioglitazona
Otros números de identificación del estudio
- 237-019
- JapicCTI-142568 (Identificador de registro: JapicCTI)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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