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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142438 | Registry Identifier | Japic CTI | |
| JapicCTI-R150734 | Registry Identifier | JapicCTI |
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The purpose of this study is to evaluate the safety and efficacy of long-term use of Sonias Combination Tablets in patients with type 2 diabetes mellitus in the routine clinical setting.
This a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus in the routine clinical setting.
The usual adult dosage is one tablet of Sonias administered orally once daily before or after breakfast (15 mg/1 mg or 30 mg/3 mg of pioglitazone/glimepiride).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone/glimepiride | Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone/glimepiride | Drug | Pioglitazone/glimepiride combination tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | For 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. | Baseline, and Months 3, 6, 9, 12 and at Final Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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Type 2 diabetes
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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 for whom therapy with pioglitazone combined with glimepiride is suitable and long-term treatment is considered necessary were enrolled in one treatment group to receive pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
Participants took part in the study at 182 investigative sites in Japan from 15 June 2011 to 31 May 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone/Glimepiride | Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants with available data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone/Glimepiride | Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast. |
| 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 With Adverse Drug Reactions | Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | All enrolled participants with available data. | Posted | Number | participants | For 12 months |
|
|
For 12 months
At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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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/Glimepiride | Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | 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 |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Glycosylated Hemoglobin (HbA1c) | Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline. | Baseline, and Months 3, 6, 9, 12 and at Final Assessment |
| Change From Baseline in Fasting Blood Glucose Level | Tabulated the changes from baseline in fasting blood glucose level at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. | Baseline, Months 3, 6, 9, 12 and at Final Assessment |
| Fasting Blood Glucose Level | Tabulated fasting blood glucose level from baseline at each test time point. | Baseline, Months 3, 6, 9, 12 and at Final Assessment |
| Change From Baseline in Fasting Insulin Level | Tabulated the changes from baseline at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. | Baseline, Months 3, 6, 9, 12 and at Final Assessment |
| Fasting Insulin Level | Tabulated fasting insulin level at each test time point. | Baseline, Months 3, 6, 9, 12 and at Final Assessment |
| years |
|
| Age, Customized | Number | participants |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pregnancy Status <Females> | Female participants only (n=439) | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Weight Categorical | Number | participants |
|
| Body Mass Index (BMI) | BMI data was available for 1011 participants. | Mean | Standard Deviation | kg/m^2 |
|
| BMI Categorical | Number | participants |
|
| Duration of Type 2 Diabetes | Duration of type 2 diabetes data was available for 788 participants. | Mean | Standard Deviation | years |
|
| Duration of Type 2 Diabetes, Categorical | Number | participants |
|
| Healthcare Category | Number | participants |
|
| History of Allergies | Number | participants |
|
| Presence of Complications | Number | participants |
|
| Breakdown of Complications | Participants may be accounted for in more than 1 category. | Number | participants |
|
| Presence of Medical History | Number | participants |
|
| Alcohol History (Drinking Alcohol-Containing Beverages Most Days) | Number | participants |
|
| Smoking Classification | Number | participants |
|
| Compliance Rate with the Diet Regimen (At the Start of Treatment) | Number | participants |
|
| Compliance rate with the Exercise Regimen (At the Start of Treatment) | Number | participants |
|
| Timing of Initiation of Pioglitazone Before the Start of Study Treatment | Data is only available for participants who were administered pioglitazone alone prior to beginning study treatment (n=189). | Number | participants |
|
| Timing of Initiation of Glimepiride Before the Start of Study Treatment | Data is only available for participants who were administered glimepiride alone prior to beginning study treatment (n=338). | Number | participants |
|
| Timing of Initiation of Pioglitazone and Glimepiride Before the Start of Study Treatment | Data is only available for participants who were administered both pioglitazone and glimepiride prior to beginning study treatment (n=558). | Number | participants |
|
| Glycosylated Haemoglobin (HbA1c) at the Start of Study Treatment | Number | participants |
|
| HbA1c at the Start of Study Treatment | HbA1c data was available for 1091 participants. | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. | All enrolled participants with data available. | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Baseline, and Months 3, 6, 9, 12 and at Final Assessment |
|
|
|
| Secondary | Glycosylated Hemoglobin (HbA1c) | Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline. | All enrolled participants with data available. | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Baseline, and Months 3, 6, 9, 12 and at Final Assessment |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose Level | Tabulated the changes from baseline in fasting blood glucose level at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. | All enrolled participants with data available. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Months 3, 6, 9, 12 and at Final Assessment |
|
|
|
| Secondary | Fasting Blood Glucose Level | Tabulated fasting blood glucose level from baseline at each test time point. | All enrolled participants with data available. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Months 3, 6, 9, 12 and at Final Assessment |
|
|
|
| Secondary | Change From Baseline in Fasting Insulin Level | Tabulated the changes from baseline at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. | All enrolled participants with data available. | Posted | Mean | Standard Deviation | μU/dL | Baseline, Months 3, 6, 9, 12 and at Final Assessment |
|
|
|
| Secondary | Fasting Insulin Level | Tabulated fasting insulin level at each test time point. | All enrolled participants with data available. | Posted | Mean | Standard Deviation | μU/dL | Baseline, Months 3, 6, 9, 12 and at Final Assessment |
|
|
|
| 23 |
| 1,158 |
| 0 |
| 1,158 |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Drowning | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | 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 |
|---|---|
|
| Month 12 (n=462) |
|
| Final Assessment (n=1,054) |
|
| Title | Measurements |
|---|---|
|
| Month 9 (n=831) |
|
| Month 12 (n=462) |
|
| Final Assessment (n=1054) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (n=462) |
|
| Final Assessment (n=369) |
|
| Title | Measurements |
|---|
|
| Month 9 (n=273) |
|
| Month 12 (n=462) |
|
| Final Assessment (n=369) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (n=18) |
|
| Final Assessment (n=46) |
|
|
| Month 9 (n=30) |
|
| Month 12 (n=18) |
|
| Final Assessment (n=46) |
|