NCT00706017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
- 2,282
- 试验地点
- 1
- 主要终点
- Incidence of SADR (serious adverse drug reactions ) incl major hypo (hypoglycaemic events)
研究概览
简要总结
This observational study is conducted in North America. 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 2 diabetes
- •Including newly diagnosed not on insulin or insulin analogue treatment
- •Selection at the discretion of the physician
- •Adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older
排除标准
- •Current treatment with Levemir®
- •Previously enrolled in the study
- •Hypersensitivity to Levemir®
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 SADR (serious adverse drug reactions ) incl major hypo (hypoglycaemic events)
时间窗: during treatment
次要结局
- Glucose control measures(during treatment)
- Weight(during treatment)
研究者
研究点 (1)
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