NCT00184639已完成3 期
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Semilente®MC in Children, Adolescents and Young Adults With Type 1 Diabetes on Basal-Bolus Regimen.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 3
- 主要终点
- Fasting plasma glucose
研究概览
简要总结
This trial is conducted in Europe.
A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Current intensified insulin treatment
- •Injection of insulin Semilente®MC at bedtime for at least 6 weeks
- •BMI maximum 32 kg/m^2
- •HbA1c > 5.5 % and < 12.0 %
排除标准
- •Current treatment with premixed insulin(s)
- •Impaired hepatic or renal function
- •Recurrent major hypoglycaemia
结局指标
主要结局
Fasting plasma glucose
时间窗: after 16 and 32 weeks, respectively
次要结局
- Hypoglycaemia
- HbA1c results at the end of each treatment period
- Blood glucose
- Standard Laboratory Safety Parameters
- Adverse events
研究者
研究点 (3)
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