Actos Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 主要终点
- Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%)
研究组 & 干预措施
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).
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL)
时间窗: 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.
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %)
时间窗: 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 %.
Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 48 Week
时间窗: 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.
Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 48 Week
时间窗: 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.
Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 48 Week
时间窗: 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.
Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 48 Week
时间窗: 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.
Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone
时间窗: 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).
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c
时间窗: 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).
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender
时间窗: 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.
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI
时间窗: 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 ≤.
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs
时间窗: 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.
Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point
时间窗: Baseline and 48 Week
Fasting blood glucose level at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point
时间窗: Baseline and 48 Week
HbA1c (NGSP) values at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
次要结局
- Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)(Up to 48 Weeks)