NCT01548248已完成不适用
An Observational 3-months Study to Evaluate Efficacy and Safety of Insulin Levemir® Used as Basal Insulin on the Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes
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
- 631
- 试验地点
- 1
- 主要终点
- Change in HbA1c (glycosylated haemoglobin)
研究概览
简要总结
This study is conducted in Europe. The aim of this study is to evaluate efficacy and safety of insulin detemir (Levemir®) used as basal insulin on the glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes treated with insulin NPH under normal clinical practice conditions in Slovakia.
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 type 2 diabetes treated with insulin NPH
排除标准
- 未提供
研究组 & 干预措施
Levemir® users
干预措施: insulin detemir (Drug)
Levemir® users
干预措施: insulin aspart (Drug)
结局指标
主要结局
Change in HbA1c (glycosylated haemoglobin)
次要结局
- Change in fasting plasma glucose (FPG)
- Change in 4-points glucose profiles
- Change in lipid profile
- Number of hypoglycaemic events
- Number of adverse events
- Change in weight
研究者
研究点 (1)
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