Clinical trial NCT02181842: Pioglitazone Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>
Official title: Actos Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-07-04
Enrollment: 246
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes mellitus

Brief 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.

Detailed 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.

Eligibility 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%)

Primary outcomes:
measure: Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL)
timeFrame: 48 Week
measure: Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %)
timeFrame: 48 Week
measure: Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 48 Week
timeFrame: From Baseline, Up to 48 Week
measure: Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 48 Week
timeFrame: From Baseline, Up to 48 Week
measure: Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 48 Week
timeFrame: From Baseline, Up to 48 Week
measure: Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 48 Week
timeFrame: From Baseline, Up to 48 Week
measure: Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone
timeFrame: From Baseline, Up to 48 Week
measure: Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c
timeFrame: From Baseline, Up to 48 Week
measure: Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender
timeFrame: From Baseline, Up to 48 Week
measure: Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI
timeFrame: From Baseline, Up to 48 Week
measure: Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs
timeFrame: From Baseline, Up to 48 Week
measure: Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point
timeFrame: Baseline and 48 Week
measure: Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point
timeFrame: Baseline and 48 Week
Secondary outcomes:
measure: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
timeFrame: Up to 48 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: