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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132329 | Registry Identifier | JapicCTI | |
| JapicCTI-R160828 | Registry Identifier | JapicCTI |
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To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos tablets) in combination with biguanides (for 12 months after the start of pioglitazone tablets treatment) in patients with type 2 diabetes mellitus.
This is a special drug use surveillance with an observation period of 12 months designed to investigate the safety and efficacy of pioglitazone (Actos) in the routine clinical setting in patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy (planned sample size, 1000).
The usual adult dosage is 15 to 30 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 45 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone 15 mg to 30 mg | administered orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Pioglitazone Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions | Adverse drug reactions 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. | Baseline up to 12 months |
| Number of Participants Reporting One or More Serious Adverse Drug Reactions | Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. | Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12) |
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Inclusion Criteria:
Exclusion Criteria:
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Type 2 diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Postmarketing Group Manager | Takeda | Study Chair |
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Participants with a historical diagnosis of type 2 diabetes mellitus who failed to respond adequately to treatment with biguanides were enrolled to receive pioglitazone 15 milligram (mg) - 30 mg for up to 12 months.
Participants took part in the study at 152 investigative sites in Japan from 23 February 2009 to 31 January 2012.
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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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Reporting One or More Adverse Drug Reactions | Adverse drug reactions 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 | Number | participants | Baseline up to 12 months |
|
Baseline up to 12 months
At each visit the investigator had to document any occurrence of adverse events 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 adverse drug reactions were collected in this study.
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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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema | General disorders | MedDRA (14.1) | 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 Blood Glucose | The change between the fasting blood glucose value collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. | Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12) |
| Change From Baseline in Body Weight | Change relative to baseline in participant's weight measured at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). | Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12) |
| Change From Baseline in Immunoreactive Insulin (IRI) | The change in the value of IRI (portion of insulin in blood measured by immunochemical methods for the hormone; presumed to represent the free [unbound] and biologically active fraction of total blood insulin) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. | Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12) |
| Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | The change between homeostasis model assessment of insulin resistance collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. Homeostasis Model assessment of insulin resistance Measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5). A higher score indicates higher insulin resistance. | Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12) |
| Investigator's transfer |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pregnancy status | The baseline characteristic was analyzed only in female participants. | Number | participants |
|
| Time from diagnosis of type 2 diabetes | Number | participants |
|
| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | Number | participants |
|
| Details Regarding Predisposition to Hypersensitivity | Predisposition to hypersensitivity was categorized as hypersensitivity due to drug, food, or other. The baseline characteristic was analyzed in only participants who had a liability or tendency to suffer from hypersensitivity. | Number | participants |
|
| Drinking Habits | Number | participants |
|
| Smoking Habits | Number | participants |
|
| Weight | Number | participants |
|
| Body Mass Index | Number | participants |
|
| Medical History | Number | participants |
|
| Breakdown of Medical History | Breakdown of medical history was categorized as liver disease, renal disease, heart disease, cerebrovascular disease, malignant tumor and any other disease from those mentioned above. The baseline characteristic was analyzed only in participants who had medical history. Participants could be counted in more than 1 category (including duplicates). | Number | participants |
|
| Medical Complications | Number | participants |
|
| Breakdown of Complications | Breakdown of medical complications was categorized as diabetic retinopathy,diabetic nephropathy,diabetic neuropathy,dyslipidaemia,hypertension,heart disease,liver disease(all types of liver disease),hepatic steatosis,alcoholic liver injury,viral liver injury,other liver disease,renal disease(other than diabetic nephropathy),renal disease(including diabetic nephropathy),malignant tumor,cerebrovascular disease,any other disease from those mentioned above.Baseline characteristic was analyzed only in participants who had medical complications. Participants could be counted in more than 1 category. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Number | participants | Baseline up to 12 months |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12) |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose | The change between the fasting blood glucose value collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12) |
|
|
|
| Secondary | Change From Baseline in Body Weight | Change relative to baseline in participant's weight measured at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | kg | Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12) |
|
|
|
| Secondary | Change From Baseline in Immunoreactive Insulin (IRI) | The change in the value of IRI (portion of insulin in blood measured by immunochemical methods for the hormone; presumed to represent the free [unbound] and biologically active fraction of total blood insulin) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | micro units per milliliter (mcU/mL) | Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12) |
|
|
|
| Secondary | Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | The change between homeostasis model assessment of insulin resistance collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. Homeostasis Model assessment of insulin resistance Measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5). A higher score indicates higher insulin resistance. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | HOMA-IR score | Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12) |
|
|
|
| 12 |
| 880 |
| 36 |
| 880 |
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Biliary cirrhosis primary | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Weight Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
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 |
| Title | Measurements |
|---|---|
|
| Change at Month 9 (n = 650) |
|
| Change at Month 12 (n = 624) |
|
| Change at Final Assessment (n = 824) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 9 (n = 143) |
|
| Change at Month 12 (n = 146) |
|
| Change at Final Assessment (n = 210) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 9 (n = 587) |
|
| Change at Month 12 (n = 582) |
|
| Change at Final Assessment (n = 788) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 9 (n = 20) |
|
| Change at Month 12 (n = 27) |
|
| Change at Final Assessment (n = 44) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 9 (n = 20) |
|
| Change at Month 12 (n = 26) |
|
| Change at Final Assessment (n = 43) |
|