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
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCT1080225091
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
The above-mentioned findings of the present SDUS did not reveal any new safety concerns for the long-term use of Zafatek 25 mg in patients with T2DM complicated by SRI or ESRF.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 83
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)
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method