NCT00704574已完成不适用
Safety of Levemir® (Insulin Detemir) Treatment in Children and Adolescents With Type 1 Diabetes (PREDICTIVE™ - Youth)
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
- 159
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse drug reactions, including major hypoglycaemic events
研究概览
简要总结
This observational study is conducted in Europe. The trial aims to observe the incidence of serious adverse drug reactions in children and adolescents with type 1 diabetes during Levemir® treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained prior to any trial-related activities
- •Any patient with diabetes type 1 is eligible for the study, including newly
- •The selection of the patients will be at the discretion of the individual physician
排除标准
- •Type 2 diabetes
- •Currently treated with 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 serious adverse drug reactions, including major hypoglycaemic events
时间窗: after 6 month treatment
次要结局
- Number of all hypoglycaemic events(after 6 month treatment)
- Variability in FPG (Fasting Plasma Glucose)(after 6 month treatment)
- Number of adverse drug reactions(after 6 month treatment)
- BMI changes(after 6 month treatment)
- HbA1c(after 6 month treatment)
研究者
研究点 (1)
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