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"

Launched by TAKEDA · Feb 24, 2020

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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