Pioglitazone Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Actos Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Pioglitazone


Participation Criteria
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Eligibility Criteria
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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%)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pioglitazone<br>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). | Drug: Pioglitazone<br>* Pioglitazone tablets<br>* Other names: Actos Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 %. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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 ≤. | 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. | 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. | 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. | Baseline and 48 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 48 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacological therapy