NCT00670683已完成不适用
Safety and Efficacy of Insulin Detemir (Levemir® FlexPen®) in Patients With 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
- 797
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This study is conducted in Asia. This study is a prospective, open, uncontrolled, observational surveillance study with Levemir® FlexPen® conducted in Korea.
The aim of this observational study is to evaluate the short term and the long term safety and efficacy of Levemir® FlexPen®. The study is planned and conducted as per requirement from Korea Food and Drug Administration (KFDA).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus
排除标准
- •Contra-indication based on local label
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: for the duration of the trial
次要结局
- FBG (Fasting Blood Glucose)(for the duration of the trial)
- Adverse events(for the duration of the trial)
- Clinical laboratory abnormality(for the duration of the trial)
- Weight(for the duration of the trial)
- HbA1c(for the duration of the trial)
- 2hr-PPBG (2hr-Post Prandial Blood Glucose)(for the duration of the trial)
研究者
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