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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142568 | Registry Identifier | JapicCTI |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Pioglitazone tablets |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL) | 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. | 48 Week |
| Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %) | 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 %. | 48 Week |
| Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 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. | From Baseline, Up to 48 Week |
| Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 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. | From Baseline, Up to 48 Week |
| Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 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. | From Baseline, Up to 48 Week |
| Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 48 Week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | 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. |
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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:
Exclusion Criteria:
Patients who meet any of the following conditions, [1] to [5], shall be excluded from the survey:
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Type 2 diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
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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 took part in the study at 68 investigative sites in Japan, from 29 January 2009 to 30 June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The safety analysis set was defined as all participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL) | 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. | 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 'Number of Participants Analyzed ' is number of participants analyzed at the given populations. | Posted | Number | Percentage of Participants | 48 Week |
|
Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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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. |
| From Baseline, Up to 48 Week |
| 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). | From Baseline, Up to 48 Week |
| Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c | 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). | From Baseline, Up to 48 Week |
| Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender | 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. | From Baseline, Up to 48 Week |
| Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI | 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 ≤. | From Baseline, Up to 48 Week |
| Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs | 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. | From Baseline, Up to 48 Week |
| 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. | Baseline and 48 Week |
| 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. | Baseline and 48 Week |
| Up to 48 Weeks |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | All participants were enrolled in Japan. | Number | Participants |
|
| Duration between Diagnosis of Cerebral Infarction and Start of Pioglitazone Therapy | Duration between the first time of diagnosis of cerebral infarction and the start of Pioglitazone therapy was reported. | Mean | Standard Deviation | Days |
|
| Duration of Impaired Glucose Tolerance (IGT) | Mean duration between start of study and first time of diagnosis of Impaired Glucose Tolerance (IGT) was reported. | Count of Participants | Participants |
|
| Predisposition to Hypersensitivity | Count of Participants | Participants |
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| Smoking Classification | Count of Participants | Participants |
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| Drinking Habits | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimete (cm) |
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| Weight | Mean | Standard Deviation | kilograms (kg) |
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| BMI | Body Mass Index = weight (kg)/[height (m)^2] | Mean | Standard Deviation | kg/m^2 |
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| Medical History | Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
|
| Initial Disease Type of Cerebral Infarction | Count of Participants | Participants |
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| Severity of Initial Cerebral Infarction | Count of Participants | Participants |
|
| Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy | Modified Rankin Scale(mRS) is a scale for measuring the degree of disability or dependence in the daily activities and attributes the severity of cerebral infarction graded on a 7 point scale (0= No symptoms; 1= No significant disability; 2= Slight disability; 3= Moderate disability; 4= Moderately severe disability; 5= Severe disability; 6=Death). Higher scores indicate greater severity of neurological disability. | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %) | 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 %. | 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 ' Number of Participants Analyzed ' is number of participants analyzed at the given populations. | Posted | Number | Percent age of Participants | 48 Week |
|
|
|
| Primary | Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 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. | 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 'Number of Participants Analyzed' is number of participants analyzed at the given populations. | Posted | Mean | Standard Deviation | mmHg | From Baseline, Up to 48 Week |
|
|
|
| Primary | Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 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. | 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 'Number of Participants Analyzed' is number of participants analyzed at the given populations. | Posted | Mean | Standard Deviation | mmHg | From Baseline, Up to 48 Week |
|
|
|
| Primary | Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 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. | 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 'Number of Participants Analyzed' is number of participants analyzed at the given populations. | Posted | Mean | Standard Deviation | mg/dL | From Baseline, Up to 48 Week |
|
|
|
| Primary | Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 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. | 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 'Number of Participants Analyzed' is number of participants analyzed at the given populations. | Posted | Mean | Standard Deviation | mg/dL | From Baseline, Up to 48 Week |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | Percent HbA1c | From Baseline, Up to 48 Week |
|
|
|
| Primary | Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c | 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). | 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. | Posted | Mean | Standard Deviation | Percent HbA1c | From Baseline, Up to 48 Week |
|
|
|
| Primary | Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender | 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. | 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. | Posted | Mean | Standard Deviation | Percent HbA1c | From Baseline, Up to 48 Week |
|
|
|
| Primary | Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI | 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 ≤. | 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. | Posted | Mean | Standard Deviation | Percent HbA1c | From Baseline, Up to 48 Week |
|
|
|
| Primary | Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs | 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. | 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. | Posted | Mean | Standard Deviation | Percent HbA1c | From Baseline, Up to 48 Week |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 48 Week |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Percent | Baseline and 48 Week |
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| Secondary | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | 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. | Safety Analysis Set; The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Count of Participants | Participants | Up to 48 Weeks |
|
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| 16 |
| 244 |
| 7 |
| 244 |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Cerebellar infarction | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Intraventricular haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 30 <45 mg |
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| 8.4% ≤ |
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| 25 <30 kg/m^2 |
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| 30 kg/m^2 ≤ |
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