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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132250 | Registry Identifier | JapicCTI | |
| JapicCTI-R171018 | Other Identifier | JapicCTI |
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The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor.
In addition, examining the safety and efficacy of alogliptin in patients with renal impairment, information on the appropriate dosage of alogliptin according to the severity of impaired renal function should be collected.
A special drug use surveillance is planned to examine the safety and efficacy of long-term use of alogliptin in patients with type 2 diabetes mellitus under the daily clinical use conditions.
Participants of this surveillance will be patients with type 2 diabetes mellitus who failed to respond adequately to diet therapy and exercise therapy alone or to a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor. The planned sample size is 3,000 subjects.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily. Participants will receive the drug as part of routine medical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alogliptin 25mg, tablets, orally, once daily, up to 36 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin | Drug | Alogliptin tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Events | Up to Month 36 | |
| 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 month 36 relative to baseline. | Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Blood Glucose | The change in the value of fasting blood glucose collected at month 36 relative to baseline. | Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) |
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Inclusion Criteria:
Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies:
Exclusion Criteria:
Patients contraindicated for Nesina
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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 |
|---|---|---|---|---|---|---|
| Osaka | Japan |
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 type 2 diabetes mellitus who failed to respond adequately to diet and/or exercise therapy and α-glucosidase inhibitor were enrolled to receive Alogliptin as routine medical care. Treatments were not allocated at the start of the study. Thus, the Participant Flow cannot be presented "per Arm".
Participants took part in the study at 608 investigative sites in Japan, from 8-July-2010 to 31-October-2015. Data reports overall population, since data not collected separately per arm as specified in protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Population | Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 36 months along with an alpha-glucosidase inhibitor (α-GI), without an α-GI, or the other diabetic drugs from the start of administration of alogliptin and during the treatment period of alogliptin in routine medical care. |
| 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 | Alogliptin | Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received no diabetic drugs within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin. |
| BG001 | Alogliptin + αGI |
| 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 | Safety Analysis Set was defined as all participants who were enrolled and completed the study. | Posted | Count of Participants | Participants | Up to Month 36 |
|
Up to Month 36
Reported data on Serious Adverse Events were serious adverse drug reactions since only serious adverse drug reactions were collected in this study as specified protocol. 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 | Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received no diabetic drugs within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 19.0 | 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 |
|---|---|
| C520853 | alogliptin |
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Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received an α-GI within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin. |
| BG002 | Alogliptin + Other | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | All participants were enrolled in Japan. | Count of Participants | Participants |
|
| Time From Diagnosis of Type 2 Diabetes | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | years |
|
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | cm |
|
| Body Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | 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 |
|
| Waist Circumference (Female) | This baseline characteristic was analyzed only in female participants. | Count of Participants | Participants |
|
| Healthcare category | Participants were categorized as outpatient, inpatient, and In- to/from out-patient (participants who were both outpatient and inpatient at any time prior to enrollment). | Count of Participants | Participants |
|
| Pregnancy Status | This baseline characteristic was analyzed only in female participants. | Count of Participants | Participants |
|
| History of Allergy | Count of Participants | Participants |
|
| 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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| Hypertension Complications | Count of Participants | Participants |
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| Hyperlipidemia Complications | Count of Participants | Participants |
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| Hyperuricemia Complications | Count of Participants | Participants |
|
| Hepatic Dysfunction Complications | 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 |
|
| Renal Dysfunction Complications | 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 |
|
| Cardiac Disease Complications | Count of Participants | Participants |
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| Heart Failure Complications | 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 (Participants with cardiac disease resulting in slight limitation of physical activity), Class III (Participants with cardiac disease resulting in marked limitation of physical activity), Class IV (Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). | This baseline characteristic was analyzed only for Participants who had complications of heart failure. | Count of Participants | Participants |
|
| Stroke-Related Disorder Complications | Count of Participants | Participants |
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| Allergic Disease Complications | Count of Participants | Participants |
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| Malignancy Complications | 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 |
|
| Alcohol Consumption Classification | Count of Participants | Participants |
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| Smoking Classification | Count of Participants | Participants |
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| Glycosylated Hemoglobin A1c (HbA1c) | Count of Participants | Participants |
|
| OG002 | Alogliptin + Other | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin. |
|
|
| Primary | 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 month 36 relative to baseline. | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. Reported group were Alogliptin and Alogliptin + α-GI and data for Alogliptin + Other were not collected as specified in protocol. | Posted | Mean | Standard Deviation | Percent | Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose | The change in the value of fasting blood glucose collected at month 36 relative to baseline. | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. Reported group were Alogliptin and Alogliptin + α-GI and data for Alogliptin + Other were not collected as specified in protocol. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) |
|
|
|
| 1 |
| 1,560 |
| 2 |
| 1,560 |
| 26 |
| 1,560 |
| EG001 | Alogliptin + αGI | Alogliptin 25 mg, tablets, orally, once daily for up to 36 months in routine medical care. Participants in this group received an α-GI within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin. | 1 | 669 | 2 | 669 | 19 | 669 |
| EG002 | Alogliptin + Other | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in routine medical care. Participants in this group did not receive an α-GI within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin. | 2 | 989 | 8 | 989 | 23 | 989 |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 19.0 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
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| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 19.0 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.0 | 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.
| Male |
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| ≥ 85cm |
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| Unknown |
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| ≥ 90cm |
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