JPRN-jRCT1080225091已完成Unknown
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
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 83
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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