pioglitazone
DrugPioglitazone tablets
Other names: Actos Tablets
NCT Number: NCT02181842
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.
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Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pioglitazone tablets
Other names: Actos Tablets
Time frame: 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.
Time frame: 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 %.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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 ≤.
Time frame: 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.
Time frame: Baseline and 48 Week
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
HbA1c (NGSP) values at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
Time frame: 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.
Takeda
Industry
Actos Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>
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