NCT01575483已完成不适用
Korean Post-marketing Surveillance for Onglyza®
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
- 发起方
- AstraZeneca
- 入组人数
- 3,433
- 试验地点
- 1
- 主要终点
- Adverse events occurrence
研究概览
简要总结
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Onglyza® so that the regulatory authority can manage the marketing approval properly.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Female and male patients who are at least 18 years of age
- •Patients with diagnosis of T2DM initiating Onglyza® treatment within the approved indications in Korea
排除标准
- •Indication which is not approved for Onglyza® in Korea
- •Patients with contraindication for the use of Onglyza® (as clarified in Korean label)
研究组 & 干预措施
Patients with T2DM
Patients with diagnosis of type 2 diabetes mellitus (T2DM) initiating Onglyza® treatment within the approved indications will be enrolled
干预措施: No Intervention (subjects were previously treated with Onglyza®) (Drug)
结局指标
主要结局
Adverse events occurrence
时间窗: 30 days after last dose of study drug
次要结局
- Number of Adverse Events and Serious Adverse Events(30 days after last dose of study drug)
- Effectiveness of Onglyza® measured by Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and 2-hr post-prandial glucose (2-hr PPG) comparing baseline data(Baseline (Week 0), 12 weeks and 24 weeks of registration)
研究者
研究点 (1)
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