Type 2 Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTrelagliptin
Trelagliptin tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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. * Estimated values corresponding to the Ccr (for persons aged 60 years weighing 65 kg)
Exclusion criteria
1\. Participants with any of the following contraindications for trelagliptin will be excluded: 1. Patient with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes mellitus 2. Patient with severe infection, perioperative status, or serious trauma 3. Patient with a history of hypersensitivity to any ingredients of trelagliptin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | Up to Month 12 | 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. |
| Number of Participants Who Had One or More Serious ADRs | Up to Month 12 | 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. |
| Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs | Up to Month 12 | 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. |
| Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs | Up to Month 12 | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 12 investigative sites in Japan, from 1 March 2020 to 31 January 2023.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 6 |
Baseline characteristics
| Characteristic | Trelagliptin 25 mg | — |
|---|---|---|
| Age, Continuous | 77.5 Years STANDARD_DEVIATION 9.21 | — |
| Alcohol Classification No | 16 Participants | — |
| Alcohol Classification Unknown | 7 Participants | — |
| Alcohol Classification Yes | 60 Participants | — |
| BMI | 23.04 Kilogram (kg)/meter (m)^2] STANDARD_DEVIATION 3.625 | — |
| Creatinine Clearance Within 3 Months Before Start of Treatment with the Study Drug | 22.915 milliliter (mL)/minute (min) STANDARD_DEVIATION 5.2967 | — |
| Dialysis Treatment Status Had Dialysis Treatment | 20 Participants | — |
| Dialysis Treatment Status Had No Dialysis Treatment | 63 Participants | — |
| Duration of Type 2 Diabetes Mellitus | 17.4 Years STANDARD_DEVIATION 10.08 | — |
| Fasting Blood Glucose | 124.5 milligram (mg)/deciliter (dL) STANDARD_DEVIATION 40.48 | — |
| Glycated hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)] | 6.71 Percent STANDARD_DEVIATION 0.956 | — |
| Healthcare Category Inpatient | 0 Participants | — |
| Healthcare Category Outpatient | 83 Participants | — |
| Height | 159.2 Centimeters (cm) STANDARD_DEVIATION 9.88 | — |
| Hepatic Impairment Had Hepatic Impairment | 14 Participants | — |
| Hepatic Impairment Had No Hepatic Impairment | 69 Participants | — |
| Medical Complications Had Medical Complications | 83 Participants | — |
| Medical Complications Had No Medical Complications | 0 Participants | — |
| Medical History Had Medical History | 60 Participants | — |
| Medical History Had No Medical History | 18 Participants | — |
| Medical History Unknown | 5 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 63 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 18 Participants | — |
| Predisposition to Hypersensitivity Unknown | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 83 Participants | — |
| Serum Creatinine Value Within 3 Months Before Start of Treatment with the Study Drug | 2.399 mg/dL STANDARD_DEVIATION 1.1757 | — |
| Sex: Female, Male Female | 31 Participants | — |
| Sex: Female, Male Male | 52 Participants | — |
| Smoking Classification Current Smoker | 10 Participants | — |
| Smoking Classification Ex-Smoker | 22 Participants | — |
| Smoking Classification Never Smoked | 43 Participants | — |
| Smoking Classification Unknown | 8 Participants | — |
| Weight | 58.42 Kilograms (kg) STANDARD_DEVIATION 11.611 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 83 |
| other Total, other adverse events | 10 / 83 |
| serious Total, serious adverse events | 33 / 83 |
Outcome results
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.
Time frame: Up to Month 12
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trelagliptin 25 mg | Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | 6 Participants |
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.
Time frame: Up to Month 12
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Trelagliptin 25 mg | Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs | Serious ADRs | 0 Participants |
| Trelagliptin 25 mg | Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs | Other ADRs | 1 Participants |
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.
Time frame: Up to Month 12
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Trelagliptin 25 mg | Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs | Serious ADRs | 0 Participants |
| Trelagliptin 25 mg | Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs | Other ADRs | 0 Participants |
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.
Time frame: Up to Month 12
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trelagliptin 25 mg | Number of Participants Who Had One or More Serious ADRs | 2 Participants |