NCT01707147已完成不适用
A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus(SELINA Study)
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
- 3,219
- 主要终点
- Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta
研究概览
简要总结
The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.
详细描述
Study Design:
Post Marketing 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
- 19 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 Type 2 Diabetes Mellitus
干预措施: Trajenta tablet (Drug)
结局指标
主要结局
Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta
时间窗: Up to 26 weeks (long-term surveillance)
Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.
次要结局
- Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)(Baseline and Week 24)
- Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment(24 Weeks)
- Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)(24 Weeks)
- Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)(Baseline and Week 24)
研究者
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