NCT01542489已完成不适用
An Observational 3 Months Study to Evaluate the Effect of Insulin Levemir® on 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
- 480
- 试验地点
- 1
- 主要终点
- Change in HbA1c (glycosylated haemoglobin)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.
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
- •Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (Levemir®) in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)
排除标准
- 未提供
研究组 & 干预措施
IDet + IAsp users
干预措施: insulin detemir (Drug)
IDet + IAsp users
干预措施: insulin aspart (Drug)
IDet + HI users
干预措施: insulin detemir (Drug)
IDet + HI users
干预措施: human soluble insulin (Drug)
结局指标
主要结局
Change in HbA1c (glycosylated haemoglobin)
次要结局
- Change in body weight
- Change in 7-point blood glucose variability
- Number of hypoglycaemic episodes
- Insulin dose
- Number of adverse events
- Number of injections
研究者
研究点 (1)
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