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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-26

Study Completion Date

2011-06-30

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.

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Pioglitazone

Intervention Type DRUG

Pioglitazone tablets

Interventions

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Pioglitazone

Pioglitazone tablets

Intervention Type DRUG

Other Intervention Names

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Actos Tablets

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:

1. First onset of cerebral infarction was at least 24 weeks prior to enrollment
2. HbA1c values ≥ 6.5% within 12 weeks prior to the start of treatment with Pioglitazone Tablets
3. 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:

1. Contraindication for Actos Tablets
2. Prior history of recurrence of cerebral infarction
3. Prior history of cerebral hemorrhage or subarachnoid hemorrhage
4. Complications or prior history of myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease, atrial fibrillation, atrial flutter, or valvular disease
5. Reduced cardiac function (defined as an ejection fraction \[EF\] ≤ 40%)

Eligible Sex

ALL

Accepts Healthy Volunteers

No