NCT00738153已完成不适用
Efficacy and Safety Study of Levemir® (Insulin Detemir) to Treat Type 1 and 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
- 798
- 主要终点
- The incidence of serious adverse drug reactions, including major hypoglycaemic events
研究概览
简要总结
This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 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 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician
排除标准
- •Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
- •Currently being treated with insulin detemir
- •Previously enrolled in this study
- •Hypersensitivity to insulin detemir or to any of the excipients
- •Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures.
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
结局指标
主要结局
The incidence of serious adverse drug reactions, including major hypoglycaemic events
时间窗: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
次要结局
- Number of all adverse events(From baseline to 12 and 24 weeks of Levemir® therapy, respectively)
- Number of all hypoglycaemic events(in the 4 weeks preceding the visits at 12 weeks and 24 weeks.)
- Weight changes(at the end of study)
- HbA1c(at the end of study)
- Sub -group analysis of hypo risk(From baseline to 12 and 24 weeks of Levemir® therapy, respectively)
- Number of serious adverse events(From baseline to 12 and 24 weeks of Levemir® therapy, respectively)
研究者
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