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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Specified Drug-Use Survey of Zafatek Tablets Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Trelagliptin


Participation Criteria
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Eligibility Criteria
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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. 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: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trelagliptin 25 mg<br>Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care. | Drug: Trelagliptin<br>* Trelagliptin tablets<br>* Other names: Zafatek tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who had One or More Adverse Reactions | Adverse reactions are defined as adverse events that are considered as having a causal relationship with pharmaceutical product. Timeframe is defined as a duration from the first dose of trelagliptin up to 12 months (or up to discontinuation of drug administration). | Up to Month 12 |