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

Takeda

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Pioglitazone

Study type: Observational

Funder types: Industry

Identifiers

NCT02181842

237-019

JapicCTI-142568 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 246 patients

Sex: All

Volunteers: No Healthy Volunteers

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%)

Trial design

246 participants in 1 patient group

Pioglitazone

Description:

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).

Treatment:

Drug: Pioglitazone