NCT00700765已完成不适用
Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or 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
- 1,531
- 试验地点
- 1
- 主要终点
- Major hypoglycaemic events
研究概览
简要总结
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.
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
- •Type 1 or type 2 diabetes mellitus
排除标准
- •Subjects who are unlikely to comply with the protocol
- •Subjects who are currently being treated with Levemir®
- •Subjects who previously were enrolled into the study
- •Subjects with hypersensitivity to Levemir® or any of its excipients
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
结局指标
主要结局
Major hypoglycaemic events
时间窗: during treatment
Incidence of serious adverse drug reactions (SADRs)
时间窗: during treatment
次要结局
- Weight changes(after 12 weeks)
- HbA1c(after 12 weeks and 26 weeks of treatment)
- Number of all hypoglycaemic events(the last 4 weeks of treatment)
- Variability in fasting blood glucose (FBG) and average plasma glucose level(after 12 weeks)
- Number of all adverse events(during treatment)
- Number of serious adverse events(during treatment)
研究者
研究点 (1)
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