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

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Pioglitazone

• Registration Number: NCT02181842
• Lead Sponsor: Takeda

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.

Study Timeline

• Study Start: 2009-01-26
• Primary Completion: 2011-06-30
• Study Completion: 2011-06-30
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-04
• Results First Submitted: 2017-10-16
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-26
• Last Update Submitted: 2018-07-26
• Results First Posted: 2019-01-16
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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%)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pioglitazone	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).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL)	48 Week	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.
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %)	48 Week	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 %.
Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 48 Week	From Baseline, Up to 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.
Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 48 Week	From Baseline, Up to 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.
Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 48 Week	From Baseline, Up to 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.
Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 48 Week	From Baseline, Up to 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.
Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone	From Baseline, Up to 48 Week	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).
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c	From Baseline, Up to 48 Week	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).
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender	From Baseline, Up to 48 Week	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.
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI	From Baseline, Up to 48 Week	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 ≤.
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs	From Baseline, Up to 48 Week	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.
Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point	Baseline and 48 Week	Fasting blood glucose level at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point	Baseline and 48 Week	HbA1c (NGSP) values at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)	Up to 48 Weeks	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.