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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02181842

Enrollment

246

Registered

2014-07-04

Start date

2009-01-26

Completion date

2011-06-30

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Pharmacological therapy

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.

Interventions

DRUGPioglitazone

Pioglitazone tablets

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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%)

Design outcomes

Primary

Measure	Time frame	Description
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.
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 ≤.
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 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.

Secondary

Measure	Time frame	Description
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.

Participant flow

Recruitment details

Participants took part in the study at 68 investigative sites in Japan, from 29 January 2009 to 30 June 2011.

Pre-assignment details

Participants with a historical diagnosis of type 2 diabetes mellitus with presence of cerebral infarction as medical history were enrolled to receive pioglitazone 15 milligram (mg) - 30 mg tablet, orally, once daily for up to 48 weeks.

Participants by arm

Arm	Count
Pioglitazone Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.	244
Total	244

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Case Report Forms Uncollected	2

Baseline characteristics

Characteristic	Pioglitazone
Age, Continuous	68.0 Years STANDARD_DEVIATION 8.38
BMI	25.06 kg/m^2 STANDARD_DEVIATION 3.399
Drinking Habits Current Drinker	68 Participants
Drinking Habits Ex-Drinker	44 Participants
Drinking Habits Never Drank	130 Participants
Drinking Habits Unknown	2 Participants
Duration between Diagnosis of Cerebral Infarction and Start of Pioglitazone Therapy	1544.8 Days STANDARD_DEVIATION 1539.58
Duration of Impaired Glucose Tolerance (IGT) ≥ 10 years	60 Participants
Duration of Impaired Glucose Tolerance (IGT) 1 - < 5 years	63 Participants
Duration of Impaired Glucose Tolerance (IGT) < 1 year	32 Participants
Duration of Impaired Glucose Tolerance (IGT) 5 - < 10 years	55 Participants
Duration of Impaired Glucose Tolerance (IGT) Unknown	34 Participants
Height	159.43 centimete (cm) STANDARD_DEVIATION 8.835
Initial Disease Type of Cerebral Infarction Atherothrombotic Infarction	99 Participants
Initial Disease Type of Cerebral Infarction Cardioembolic Infarction	6 Participants
Initial Disease Type of Cerebral Infarction Lacunar Infarction	129 Participants
Initial Disease Type of Cerebral Infarction Other	7 Participants
Initial Disease Type of Cerebral Infarction Unknown	3 Participants
Medical Complications Had no Presence of Medical Complications	12 Participants
Medical Complications Had Presence of Medical Complications	232 Participants
Medical History Had no Presence of Medical History	176 Participants
Medical History Had Presence of Medical History	68 Participants
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy Grade 0	81 Participants
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy Grade 1	103 Participants
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy Grade 2	29 Participants
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy Grade 3	17 Participants
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy Grade 4	13 Participants
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy Grade 5	0 Participants
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy Unknown	1 Participants
Predisposition to Hypersensitivity Had no Predisposition to Hypersensitivity	238 Participants
Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity	5 Participants
Predisposition to Hypersensitivity Unknown	1 Participants
Region of Enrollment Japan	244 Participants
Severity of Initial Cerebral Infarction Moderate	52 Participants
Severity of Initial Cerebral Infarction Multiple Small to Moderate-Sized	31 Participants
Severity of Initial Cerebral Infarction Severe	3 Participants
Severity of Initial Cerebral Infarction Small	157 Participants
Severity of Initial Cerebral Infarction Unknown	1 Participants
Sex: Female, Male Female	81 Participants
Sex: Female, Male Male	163 Participants
Smoking Classification Current Smoker	43 Participants
Smoking Classification Ex-Smoker	52 Participants
Smoking Classification Never Smoked	146 Participants
Smoking Classification Unknown	3 Participants
Weight	63.831 kilograms (kg) STANDARD_DEVIATION 10.9416

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	7 / 244
serious Total, serious adverse events	16 / 244

Outcome results

Primary

Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point

Fasting blood glucose level at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.

Time frame: Baseline and 48 Week

Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.

Arm	Measure	Group	Value (MEAN)	Dispersion
Pioglitazone	Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point	Baseline	172.62 mg/dL	Standard Deviation 54.016
Pioglitazone	Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point	48 Week	147.32 mg/dL	Standard Deviation 43.102

Primary

Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point

HbA1c (NGSP) values at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.

Time frame: Baseline and 48 Week

Arm	Measure	Group	Value (MEAN)	Dispersion
Pioglitazone	Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point	Baseline	7.83 Percent	Standard Deviation 0.836
Pioglitazone	Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point	48 Week	7.09 Percent	Standard Deviation 0.777

Primary

Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone

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).