Pioglitazone Tablets Specified Drug-use Survey

• Status: Completed
• Trial end date: 2011-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Pioglitazone

Criteria

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%)