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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT1080225091 | Registry Identifier | jRCT |
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The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.
The drug being tested in this study is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure.
This study is an observational (non-interventional) study and will look at the long-term safety of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 100.
This multi-center observational trial will be conducted in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trelagliptin 25 mg | Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trelagliptin | Drug | Trelagliptin tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | Up to Month 12 |
| Number of Participants Who Had One or More Serious ADRs | AE is 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 untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | Up to Month 12 |
| Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs | Number of participants who had one or more hypoglycemia of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is 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 untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | Up to Month 12 |
| Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs |
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Inclusion Criteria:
1. Participants must be type 2 diabetes mellitus patients meeting the following conditions: Have severe renal impairment or end-stage renal disease, with serum creatinine (mg/dL) or creatinine clearance (Ccr; mL/min) meeting the following criteria within 3 months before the start of treatment with this product
Serum creatinine (mg/dL)*: male: > 2.4, female: > 2.0
Ccr (mL/min): < 30 In patients with end-stage renal disease, this product may be administered irrespective of the time of hemodialysis.
Exclusion Criteria:
1. Participants with any of the following contraindications for trelagliptin will be excluded:
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Patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure as part of routine medical care.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a historical diagnosis of type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure were enrolled. Participants received trelagliptin as part of a routine medical care.
Participants took part in the survey at 12 investigative sites in Japan, from 1 March 2020 to 31 January 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trelagliptin 25 mg | Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | May 11, 2022 | Sep 19, 2023 |
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Number of participants who had one or more infection of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is 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 untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. |
| Up to Month 12 |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trelagliptin 25 mg | Trelagliptin 25 milligrams (mg) tablet, orally, once weekly 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 | Standard Deviation | 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 |
| |||||||||||||||||
| Duration of Type 2 Diabetes Mellitus | Mean duration between the first diagnosis of type 2 diabetes mellitus and the start of the study 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 | Kilogram (kg)/meter (m)^2] |
| |||||||||||||||
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
| ||||||||||||||||
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
| |||||||||||||||||
| Dialysis Treatment Status | Count of Participants | Participants |
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| Predisposition to Hypersensitivity | Number of participants who had or did not have a liability or tendency to suffer from hypersensitivity was reported. Unknown: Data could not be collected. | 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 |
| |||||||||||||||||
| 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. Unknown: Data could not be collected. | Count of Participants | Participants |
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| Smoking Classification | Unknown: Data could not be collected. | Count of Participants | Participants |
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| Alcohol Classification | Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported. Unknown: Data could not be collected. | Count of Participants | Participants |
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| Hepatic Impairment | Count of Participants | Participants |
| ||||||||||||||||||
| Glycated hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Percent |
| ||||||||||||||||
| Fasting Blood Glucose | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | milligram (mg)/deciliter (dL) |
| ||||||||||||||||
| Serum Creatinine Value Within 3 Months Before Start of Treatment with the Study Drug | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | mg/dL |
| ||||||||||||||||
| Creatinine Clearance Within 3 Months Before Start of Treatment with the Study Drug | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | milliliter (mL)/minute (min) |
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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 | Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants Who Had One or More Serious ADRs | AE is 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 untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to Month 12 |
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| |||||||||||||||||||||||||||
| Primary | Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs | Number of participants who had one or more hypoglycemia of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is 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 untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to Month 12 |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs | Number of participants who had one or more infection of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is 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 untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey 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 | Trelagliptin 25 mg | Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care. | 5 | 83 | 33 | 83 | 10 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA/J v25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA/J v25.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA/J v25.0 | Systematic Assessment |
| |
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA/J v25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA/J v25.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA/J v25.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA/J v25.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA/J v25.0 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA/J v25.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA/J v25.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Cholinergic syndrome | Nervous system disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Impaired gastric emptying | Gastrointestinal disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Erosive oesophagitis | Gastrointestinal disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Neurogenic bladder | Renal and urinary disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Death | General disorders | MedDRA/J v25.0 | 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/J v25.0 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA/J v25.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA/J v25.0 | Systematic Assessment |
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| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA/J v25.0 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA/J v25.0 | Systematic Assessment |
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| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA/J v25.0 | Systematic Assessment |
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| Device pacing issue | Product Issues | MedDRA/J v25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periodontitis | Infections and infestations | MedDRA/J v25.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA/J v25.0 | Systematic Assessment |
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| Hepatic function abnorma | Hepatobiliary disorders | MedDRA/J v25.0 | 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 | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 26, 2023 | Sep 19, 2023 | SAP_001.pdf |
| 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 |
|---|---|
| C000595449 | trelagliptin |
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| Inpatient |
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| Had Predisposition to Hypersensitivity |
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| Unknown |
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| Had Medical Complications |
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| Had Medical History |
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| Unknown |
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| Current Smoker |
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| Ex-Smoker |
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| Unknown |
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| Yes |
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| Unknown |
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