N/A
Completed N=89
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"
Source: ClinicalTrials.gov NCT04285983 ↗Enrolled (actual)
89
Serious AEs
39.8%
Results posted
Aug 2024
Primary outcomePrimary: Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) — 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) |
6 | — |
| PRIMARY Number of Participants Who Had One or More Serious ADRs |
2 | — |
| PRIMARY Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs |
0; 1 | — |
| PRIMARY Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs |
0; 0 | — |
Eligibility 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
- Participants with any of the following contraindications for trelagliptin will be excluded:
- Patient with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes mellitus
- Patient with severe infection, perioperative status, or serious trauma
- Patient with a history of hypersensitivity to any ingredients of trelagliptin
Data sourced from ClinicalTrials.gov (NCT04285983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.