NCT00117780已完成4 期
Comparison of Efficacy and Safety of Insulin Detemir Once or Twice Daily in a Basal-Bolus Regimen With Insulin Aspart in Patients With Type 1 Diabetes
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 4
- 主要终点
- Mean HbA1c
研究概览
简要总结
This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for more than 1 year
- •Subject treated by any kind of insulin regimen and whatever the number of injections
- •HbA1c = 7.5% and = 10%
排除标准
- •Type 2 diabetes
- •Treatment by oral anti-diabetic drugs
- •Severe medical conditions
结局指标
主要结局
Mean HbA1c
时间窗: after 4 months of insulin detemir treatment
次要结局
- HbA1c
- Adverse events
- Weight
- Hypoglycaemia
- Blood glucose
- Insulin dose requirements during initial 4 months of treatment and during 3 months extension
研究者
研究点 (4)
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