NCT01903356已完成不适用
A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta Duo® (Linagliptin/Metformin HCl, 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg, b.i.d) in Korean Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 724
- 主要终点
- Incidence Rate of Adverse Events (AE)
研究概览
简要总结
The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.
详细描述
Study Design:
Post Marketed Study- Observational study
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients with T2DM
干预措施: Trajenta duo (Drug)
结局指标
主要结局
Incidence Rate of Adverse Events (AE)
时间窗: Up to 26 weeks
The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo
次要结局
- Relative Effectiveness Response Rate(24 Weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.(24 Weeks)
- Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.(Baseline and Week 24)
- Target Effectiveness Response Rate(24 Weeks)
研究者
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