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
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had One or More Serious ADRs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
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:
- •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
研究组 & 干预措施
Trelagliptin 25 mg
Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.
干预措施: Trelagliptin (Drug)
结局指标
主要结局
Number of Participants Who Had One or More Serious ADRs
时间窗: Up to Month 12
AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs
时间窗: Up to Month 12
Number of participants who had one or more hypoglycemia of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs
时间窗: Up to Month 12
Number of participants who had one or more infection of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
时间窗: Up to Month 12
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
次要结局
未报告次要终点