NCT00687063已完成不适用
An Observational, Safety and Efficacy Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of 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
- 10,008
- 主要终点
- Weight change from baseline
研究概览
简要总结
The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any subject with type 2 diabetes
排除标准
- •Subjects with a hypersensitivity to insulin detemir or any of its excipient
- •Children below 6 years
- •Subjects who are pregnant, lactating or planning to become pregnant
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
结局指标
主要结局
Weight change from baseline
时间窗: after 26 weeks
次要结局
- Insulin dose and frequency at the end of the study(after 26 weeks)
- FBG (Fasting Blood Glucose) change from baseline(after 26 weeks)
- Number of serious adverse events(after 26 weeks)
- Number of all hypoglycemic episodes (24 hr, daytime and nocturnal)(after 26 weeks)
- HbA1c change from baseline(after 26 weeks)
- Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 %(after 26 weeks)
- Number of all adverse events(after 26 weeks)
研究者
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