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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132376 | Registry Identifier | JapicCTI | |
| JapicCTI-R171012 | Other Identifier | JapicCTI |
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The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in the routine clinical setting in combination with an insulin product in patients with type 2 diabetes mellitus who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy.
This is a special drug use surveillance on long-term use of newly co-administered pioglitazone tablets (Actos Tablets) as part of routine medical care in patients with type 2 diabetes mellitus who have poorly controlled blood glucose when using an insulin product in addition to diet therapy and exercise therapy; this survey is designed to determine the safety and efficacy of long-term use of pioglitazone tablets (Actos Tablets) in the routine clinical setting in combination with an insulin product (the planned sample size, 1000.) The usual adult dosage is 15 mg of pioglitazone administered orally once daily before or after breakfast. Dose adjustment will be made according to gender, age, and symptoms with an upper limit of 30 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Pioglitazone 15 mg to 30 mg, orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Pioglitazone Tablets |
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| 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. | Up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Blood Glucose | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) | |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) |
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Inclusion Criteria:
Participants with type 2 diabetes mellitus assumed to have insulin resistance who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy who meet the following criteria at enrollment.
Exclusion Criteria:
Participants with contraindications to Actos Tables and insulin products treatment
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Type 2 diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
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Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Participants with a historical diagnosis of type 2 diabetes mellitus who failed to respond adequately to treatment with insulin therapy were enrolled to receive pioglitazone 15 milligram (mg) - 30 mg for up to 12 months. Participants received interventions as part of routine medical care.
Participants took part in the study at 169 investigative sites in Japan, from 30-July-2009 to 30-June-2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone | Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months 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 12 months 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 | 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. | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Count of Participants | Participants | Up to Week 52 |
|
Baseline up to Week 52
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 12 months 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 |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | 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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| Change From Baseline in Fasting Triglycerides | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) |
| Change From Baseline in HDL Cholesterol | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) |
| Change From Baseline in LDL Cholesterol | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) |
| Number of Participants Who Received Specific Daily Dose of Insulin Product at Each Time Points | Number of participants who received study drug and specific daily dose of insulin product during the survey was reported. Daily dose of insulin was categorized by < 30 units, >= 30 and < 60 units, >= 60 and < 90 units, >= 90 units at each time points. | Baseline, Week 52, and final assessment (up to Week 52) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | All participants were enrolled in Japan. | Number | Participants |
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| Pregnancy Status | This baseline characteristic was analyzed only in female participants. | Count of Participants | Participants |
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| Duration of type 2 diabetes mellitus | Mean Duration between start of study and first time of diagnosis of type 2 diabetes mellitus was reported. | Count of Participants | Participants |
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| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | Count of Participants | Participants |
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| Drinking Habits | Count of Participants | Participants |
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| Smoking Habits | Count of Participants | Participants |
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| Body Weight | Mean | Standard Deviation | 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. Participants may be represented in more than 1 category. | 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. Participants may be represented in more than 1 category. | Count of Participants | Participants |
|
| Concomitant Hepatic Disease | Count of Participants | Participants |
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| Concomitant Renal Disease | Count of Participants | Participants |
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| Concomitant Cardiac Disease | Count of Participants | Participants |
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| Diabetic Complications | Number of Participants with Any of Diabetic Retinopathy, Diabetic Nephropathy, and Diabetic Neuropathy at Start of Study Treatment was reported. | Count of Participants | Participants |
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| Diet Therapy | Count of Participants | Participants |
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| Exercise Therapy | Count of Participants | Participants |
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| Fasting Blood Glucose | Mean | Standard Deviation | mg/dL |
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| Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)] | Mean | Standard Deviation | Percent |
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| Fasting Triglyceride | Mean | Standard Deviation | mg/dL |
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| HDL Cholesterol | Mean | Standard Deviation | mg/dL |
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| LDL Cholesterol | Mean | Standard Deviation | mg/dL |
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| Serum creatinine (Enzymatic method) | Mean | Standard Deviation | mg/dL |
|
| Urine protein (Qualitative) | Data of urine protein tests were reported, The test detect and/or measure protein being released into the urine. The stages of reported data were "- = absent", "± = 15 mg/dL", "+ = 30 mg/dL", "2+ = 100 mg/dL", "3+ = 300 mg/dL" respectively. | Count of Participants | Participants |
|
| Urine albumin/Creatinine ratio | Mean | Standard Deviation | mg/gCR |
|
| Systolic Blood Pressure (SBP) | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure (DBP) | Mean | Standard Deviation | mmHg |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Change From Baseline in Fasting Blood Glucose | 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 was evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | 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 was evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) |
|
|
|
| Secondary | Change From Baseline in Fasting Triglycerides | 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 was evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) |
|
|
|
| Secondary | Change From Baseline in HDL Cholesterol | 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 was evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) |
|
|
|
| Secondary | Change From Baseline in LDL Cholesterol | 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 was evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) |
|
|
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| Secondary | Number of Participants Who Received Specific Daily Dose of Insulin Product at Each Time Points | Number of participants who received study drug and specific daily dose of insulin product during the survey was reported. Daily dose of insulin was categorized by < 30 units, >= 30 and < 60 units, >= 60 and < 90 units, >= 90 units at each time points. | 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 was evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline, Week 52, and final assessment (up to Week 52) |
|
|
|
| 11 |
| 1,035 |
| 303 |
| 1,035 |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Generalised oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Face oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 17.1 | 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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| Change at Week 36 |
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| Change at Week 52 |
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| Change at Final Assessment |
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| Change at Week 36 |
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| Change at Week 52 |
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| Change at Final Assessment |
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| Change at Week 36 |
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| Change at Week 52 |
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| Change at Final Assessment |
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| Change at Week 36 |
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| Change at Week 52 |
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| Change at Final Assessment |
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| Change at Week 36 |
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| Change at Week 52 |
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| Change at Final Assessment |
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| >= 60 and < 90 units of insulin product |
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| >= 90 units of insulin product |
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| Week 52 |
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| Final Assessment |
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