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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142445 | Registry Identifier | JapicCTI | |
| JapicCTI-R150762 | Registry Identifier | JapicCTI |
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The purpose of this study is to evaluate the safety and efficacy of long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) in the routine clinical setting.
This is a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day).
The usual adult dosage is one tablet (15 mg/1 mg of pioglitazone/glimepiride) administered orally once daily before or after breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone/glimepiride | Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone/glimepiride | Drug | Pioglitazone/glimepiride combination tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Drug Reactions | Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were tabulated by each symptom. 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. | 12 months |
| Frequency of Serious Adverse Drug Reactions | Frequency of serious adverse drug reactions is defined at the number of participants with serious adverse drug reactions. Frequency of serious adverse drug reactions were tabulated by each symptom. 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. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Tabulation of HbA1c values and 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 |
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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 diagnosis of type 2 diabetes mellitus receiving treatment with pioglitazone/glimepiride 15 mg/1 mg once daily in routine clinical practice, because pioglitazone alone was not considered effective, were enrolled in the study.
This observational study took part at 64 investigative sites in Japan from 15 June 2011 to 31 July 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone/Glimepiride | Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Change From Baseline in Fasting Blood Glucose Level |
Tabulation of fasting blood glucose level and 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 |
| Change From Baseline in Fasting Insulin Level | Tabulation of fasting insulin level and 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. A positive change from Baseline indicates a worsening. | Baseline, Months 3, 6, 9, 12 and at Final assessment |
| COMPLETED |
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| NOT COMPLETED |
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Baseline measures are based on the Safety Analysis Set (safety assessment population) that included all patients who received at least one dose of pioglitazone/glimepiride.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone/Glimepiride | Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast. |
| 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 | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Pregnancy Status (Females Only) | Data based on female participants only (N=117). | Number | participants |
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| Duration of Type 2 Diabetes | Duration of type 2 diabetes data was available for 207 participants. | Mean | Standard Deviation | years |
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| Duration of Type 2 Diabetes, Categorical | Number | participants |
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| Categories of Health Care | Number | participants |
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| History of Allergy | Number | participants |
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| Complications of Type 2 Diabetes | Number | participants |
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| Breakdown of Complications (Tabulated in Duplicate) | Tabulated in duplicate = participants may be accounted for in more than one category. | Number | participants |
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| Presence of Medical History | Number | participants |
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| Weight | Weight data was available for 250 participants. | Mean | Standard Deviation | kg |
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| Weight, Categorical | Number | participants |
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| Body Mass Index (BMI) | BMI data was available for 242 participants. | Mean | Standard Deviation | kg/m^2 |
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| BMI, Categorical | Number | participants |
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| History of Alcohol (Drinking Alcohol-Containing Beverages Nearly Every Day) | Number | participants |
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| Smoking Classification | Number | participants |
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| Compliance Rate with the Diet Regimen (at the Start of Treatment with Sonias Combination Tablets LD) | Number | participants |
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| Compliance Rate with the Exercise Regimen (at Start of Treatment with Sonias Combination Tablets LD) | Number | participants |
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| Glycosylated hemoglobin A1c (HbA1c) (at Start of Treatment with Sonias Combination Tablets LD) | HbA1c data was available for 264 participants. | Mean | Standard Deviation | % |
| |||||||||||||||||||||
| HbA1c, Categorical | Number | participants |
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| 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 | Frequency of Adverse Drug Reactions | Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were tabulated by each symptom. 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. | The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289). | Posted | Number | participants | 12 months |
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| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Tabulation of HbA1c values and 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. | The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point. | Posted | Mean | Standard Deviation | percent | Baseline, Months 3, 6, 9, 12 and at Final assessment |
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| Secondary | Change From Baseline in Fasting Blood Glucose Level | Tabulation of fasting blood glucose level and 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. | The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Months 3, 6, 9, 12 and at Final assessment |
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| Secondary | Change From Baseline in Fasting Insulin Level | Tabulation of fasting insulin level and 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. A positive change from Baseline indicates a worsening. | The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point. | Posted | Mean | Standard Deviation | μU/dL | Baseline, Months 3, 6, 9, 12 and at Final assessment |
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| Primary | Frequency of Serious Adverse Drug Reactions | Frequency of serious adverse drug reactions is defined at the number of participants with serious adverse drug reactions. Frequency of serious adverse drug reactions were tabulated by each symptom. 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. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289). | Posted | Number | participants | 12 months |
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12 Months
Safety Analysis Set included all patients who received at least one dose of pioglitazone/glimepiride. At each visit the investigator documented any occurrence of adverse events. Any event that occurred during the observation period 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, orally once daily before or after breakfast. | 2 | 289 | 0 | 289 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA version 17.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| ≥5 to <10 years |
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| ≥10 years |
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| Unknown |
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| Unknown |
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| Diabetic retinopathy |
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| Diabetic neuropathy |
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| Hypertension |
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| Dyslipidaemia |
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| Hyperuricaemia |
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| Liver disease |
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| Renal disease |
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| Heart disease |
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| Cerebrovascular disease |
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| Malignant tumor |
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| Other |
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| Unknown |
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| ≥50 to <60 kg |
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| ≥60 to <70 kg |
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| ≥70 kg |
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| Unmeasured |
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| ≥25 to <30 kg/m^2 |
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| ≥30 kg/m^2 |
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| Unknown |
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| Unknown |
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| Ex-smoker |
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| Unknown |
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| ≥ 50% |
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| < 50% |
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| Not performed or compliance status is unknown |
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| ≥ 50% |
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| < 50% |
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| Not performed or compliance status is unknown |
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| ≥ 7.0% to < 8.0% |
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| ≥ 8.0% |
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| Unknown |
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| Title | Measurements |
|---|---|
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| Oedema |
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| Weight increased |
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