Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients with severe renal impairment or end-stage renal disease"

Specified Drug Use Surveillance on Zafatek Tablets 25 mg -Surveillance on Long-Term Use of Trelagliptin Tablets in Type 2 Diabetes Mellitus Patients with Severe Renal Impairment or End-Stage Renal Failure-

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080225091

Enrollment

Registered

2020-02-27

Start date

2020-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

investigational material(s) Generic name etc : Trelagliptin INN of investigational material : Trelagliptin Succinate Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: Participants with any of the following contraindications for trelagliptin will be excluded: a. Patient with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus b. Patient with severe infection, perioperative status, or serious trauma c. Patient with a history of hypersensitivity to any ingredients of this drug

Design outcomes

Primary

Measure	Time frame
1.Safety; Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) Timeframe: 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.. 2.Safety; Number of Participants Who Had One or More Serious ADRs Timeframe: 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. 3.Safety; Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs Timeframe: 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 r	—

Measure

Time frame

1.Safety; Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) Timeframe: 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.. 2.Safety; Number of Participants Who Had One or More Serious ADRs Timeframe: 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. 3.Safety; Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs Timeframe: 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 r

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026