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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132302 | Registry Identifier | JapicCTI |
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The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride
This is a special drug use surveillance on long-term use of alogliptin/pioglitazone combination tablets. This study is designed to investigate the safety and efficacy of long-term use of alogliptin/pioglitazone combination tablet in patients with type 2 diabetes mellitus in the routine clinical setting.
Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000.
The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alogliptin/Pioglitazone combination tablets | Alogliptin/Pioglitazone combination tablets, taken orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin/Pioglitazone | Drug | Alogliptin/Pioglitazone combination tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Events | Up to 12 Months | |
| Changes From Baseline in Glycosylated Hemoglobin (HbA1c) | Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months). | Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Fasting Blood Glucose (FBG) | Reported data are changes in fasting blood glucose level from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months). | Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months) |
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Inclusion Criteria:
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded:
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Patients with type 2 diabetes mellitus who have been examined at a medical institution
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Someplace | Japan |
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Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled to receive Alogliptin/Pioglitazone 25 milligram (mg)/ 15 mg or 25 mg / 30 mg combination tablet orally, once daily for up to 12 months.
Participants took part in the study at 445 investigative sites in Japan, from 28 November 2011 to 31 March 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alogliptin/Pioglitazone | Alogliptin/Pioglitazone 25 mg/ 15 mg or 25 mg/ 30 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set; The safety analysis set was defined as all participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alogliptin/Pioglitazone | Alogliptin/Pioglitazone 25 mg/ 15 mg or 25 mg/ 30 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care. |
| 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 Who Experience at Least One Adverse Events | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Count of Participants | Participants | Up to 12 Months |
|
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Up to Month 12
At each visit the investigator had to document any occurrence of adverse drug reactions (ADRs). Any events reported by the participant or observed by the investigator were 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 | Alogliptin/Pioglitazone | Alogliptin/Pioglitazone 25 mg/ 15 mg or 25 mg/ 30 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda (Note: This product was divested to Teijin Pharma Limited in 2023) | +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 |
|---|---|
| C520853 | alogliptin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Years |
|
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | kilograms (kg) |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference (Male) | This baseline characteristic was analyzed only in male participants. | Count of Participants | Participants |
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| Waist Circumference (Female) | This baseline characteristic was analyzed only in female participants. | Count of Participants | Participants |
|
| Healthcare Category | Count of Participants | Participants |
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| Pregnancy Status (Not Pregnant) | This baseline characteristic was analyzed only in female participants. | 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 |
|
| Diabetic Complications | Count of Participants | Participants |
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| Concomitant Lifestyle-Related Disease | Count of Participants | Participants |
|
| Concomitant Hepatic Disorder | Count of Participants | Participants |
|
| Degree of Hepatic Dysfunction | Severity was determined using aspartate aminotransferase (AST) or alanine transaminase (ALT) values at the start of treatment with alogliptin. For the assessment of severity, the following categories were used and higher grades of serum AST or ALT were adopted. Normal: <50 international units per liter (IU/L) Grade 1: >=50 to <100 IU/L Grade 2: >=100 to <500 IU/L Grade 3: >=500 IU/L | Count of Participants | Participants |
|
| Concomitant Renal Disorder | Count of Participants | Participants |
|
| Degree of Renal Dysfunction (eGFR) | Estimated glomerular filtration rate (eGFR) was calculated using variables of gender, age at the start of treatment, and serum creatinine values, and severity was determined based on the following categories. If the serum creatinine value at the start of treatment was not listed, the severity was reported as "unknown." Normal: >=90 milliliter per min (mL/min)/1.73^2, Mild: >=60 mL/min/1.73^2 to <90 mL/min/1.73^2, Moderate: >=30 mL/min/1.73^2 to <60 mL/min/1.73^2, Severe: <30 mL/min/1.73^2 eGFR = 194 * Cr^-1.094 * (age)^-0.287 (* 0.739 if female) where Cr is creatinine value. | Count of Participants | Participants |
|
| Degree of Renal Dysfunction (Cr) | Normal or Mild: =< 1.4 mg/dL (for male) or =< 1.2 mg/dL (for female), Moderate: >1.4 mg/dL to =< 2.4 mg/dL (for male) or >1.2 mg/dL to =< 2.0 mg/dL (for female), Severe: > 2.4 mg/dL (for male), > 2.0 mg/dL (for female). If the serum creatinine value (Cr) at the start of treatment was not listed, the severity was reported as "unknown." | Count of Participants | Participants |
|
| Concomitant Cardiac Disease | Count of Participants | Participants |
|
| Concomitant Heart Failure | Count of Participants | Participants |
|
| New York Heart Association (NYHA) Heart Failure Classification | NYHA functional classification ranges from Class I (Participants with cardiac disease but without resulting limitations of physical activity), Class II (Cardiac disease resulting in slight limitation of physical activity), Class III (Cardiac disease resulting in marked limitation of physical activity), Class IV (Cardiac disease resulting in inability to carry on any physical activity without discomfort). | The baseline measure was analyzed only for participants who had complications of heart failure. Data of one participant was not collected throughout this study. | Count of Participants | Participants |
|
| Concomitant Stroke-Related Disease | Count of Participants | Participants |
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| Concomitant Allergic Condition | Count of Participants | Participants |
|
| Concomitant Malignant Tumor | Count of Participants | Participants |
|
| 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 |
|
| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | Count of Participants | Participants |
|
| Drinking Habits | Count of Participants | Participants |
|
| Smoking Classification | Count of Participants | Participants |
|
| Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Percent HbA1c |
|
| Alogliptin Status | Count of Participants | Participants |
|
| Pioglitazone Status | Count of Participants | Participants |
|
|
| Primary | Changes From Baseline in Glycosylated Hemoglobin (HbA1c) | Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | Percent HbA1c | Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months) |
|
|
|
| Secondary | Changes From Baseline in Fasting Blood Glucose (FBG) | Reported data are changes in fasting blood glucose level from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months) |
|
|
|
| 4 |
| 3,139 |
| 56 |
| 3,139 |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 19.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 19.1 | 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 |
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| Change in HbA1c at Month 6 |
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| Change in HbA1c at Month 12 |
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| Change in HbA1c at Final Assessment |
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| Change in FBG at Month 6 |
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| Change in FBG at Month 12 |
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| Change in FBG at Final Assessment |
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