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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132283 | Registry Identifier | JapicCTI (Japan) |
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The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.
This is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting.
Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alogliptin | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin | Drug | Alogliptin tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More 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 final assessment point (up to Month 36) relative to baseline. | Baseline, and final assessment point (up to Month 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Blood Glucose | The change in the value of fasting blood glucose level collected at final assessment point (up to Month 36) relative to baseline. | Baseline, and final assessment point (up to Month 36) |
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Inclusion Criteria:
-Patients with Haemoglobin A1c (HbA1c) [Japan Diabetes Society (JDS) value] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.
Exclusion Criteria:
-Patients contraindicated for alogliptin.
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Patients with mild 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 |
|---|---|---|---|---|---|---|
| Tokyo | 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 a historical diagnosis of mild type 2 diabetes mellitus were enrolled. Participants received interventions as part of routine medical care.
Participants took part in the study at 1406 investigative sites in Japan, from 03 August 2011 to 31 July 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alogliptin 25 mg | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. 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 completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alogliptin 25 mg | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. 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 | Percentage of Participants Who Had One or More Adverse Events | Safety Analysis Set; The safety analysis set was defined as all participants who completed the study. | Posted | Number | Percentage of Participants | Up to Month 36 |
|
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Up to Month 36
At each visit the investigator had to document any occurrence of adverse events (AEs) 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 (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the 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 | Alogliptin 25 mg | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 2, 2017 | Feb 7, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2019 | Nov 12, 2019 | SAP_002.pdf |
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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 |
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| 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 | Number | Participants |
|
| Number of Females who were not Pregnant | This baseline characteristic was analyzed only in female participants. | Count of Participants | Participants |
|
| Duration of Diagnosis 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 |
|
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
|
| 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/meter (m)^2 |
|
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
|
| Degree of Renal Dysfunction | Degree of renal dysfunction was determined by investigator for each participant. | 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 |
|
| Concomitant Diabetes Mellitus | Count of Participants | Participants |
|
| Concomitant Hypertension | Count of Participants | Participants |
|
| Concomitant Hyperlipidemia | Count of Participants | Participants |
|
| Concomitant Hyperuricaemia | Count of Participants | Participants |
|
| Concomitant Hepatic Disorder | Count of Participants | Participants |
|
| Concomitant Renal Disorder | 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 (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 |
|
| Concomitant Stroke-Related Disease | Count of Participants | Participants |
|
| 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 | Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported. | Count of Participants | Participants |
|
| Smoking Classification | Count of Participants | Participants |
|
| Hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP) Value] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Percentage of HbA1c |
|
| Dietary Instruction | Reported data was number of participants who received dietary instruction from health care professional at the start of this study as routine medical care. | Count of Participants | Participants |
|
| Exercise Instruction | Reported data was number of participants who received exercise instruction from health care professional at the start of this study as routine medical care. | Count of Participants | Participants |
|
|
| 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 final assessment point (up to 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. 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 final assessment point (up to Month 36) |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose | The change in the value of fasting blood glucose level collected at final assessment point (up to 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. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | Milligram (mg)/ deciliter (dL) | Baseline, and final assessment point (up to Month 36) |
|
|
|
| 20 |
| 18,249 |
| 65 |
| 18,249 |
| 41 |
| 18,249 |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Intraductal papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Hepatic cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Marasmus | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Cerebellar haemorrhage | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Subdural hygroma | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Anal fistula | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 20.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 20.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| C-reactive protein increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | 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 |