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.
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.
Study Type
OBSERVATIONAL
Enrollment
246
Pioglitazone tablets
Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL)
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.
Time frame: 48 Week
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %)
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 %.
Time frame: 48 Week
Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 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.
Time frame: From Baseline, Up to 48 Week
Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 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.
Time frame: From Baseline, Up to 48 Week
Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 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.
Time frame: From Baseline, Up to 48 Week
Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 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.
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Time frame: From Baseline, Up to 48 Week
Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone
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).
Time frame: From Baseline, Up to 48 Week
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c
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).
Time frame: From Baseline, Up to 48 Week
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender
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.
Time frame: From Baseline, Up to 48 Week
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI
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 ≤.
Time frame: From Baseline, Up to 48 Week
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs
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.
Time frame: From Baseline, Up to 48 Week
Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point
Fasting blood glucose level at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
Time frame: Baseline and 48 Week
Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point
HbA1c (NGSP) values at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
Time frame: Baseline and 48 Week
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
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.
Time frame: Up to 48 Weeks