NCT00604656已完成3 期
A Six Months, Multi-centre, Open, Randomised, Parallel Safety and Efficacy Comparison of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process in Subjects With Type 1 Diabetes on a 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
- 241
- 试验地点
- 35
- 主要终点
- Insulin aspart antibodies
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 diabetes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 1 diabetes
- •Duration of diabetes for at least 12 months
- •Treatment with insulin aspart for at least 3 months before trial start
- •Body Mass Index (BMI) below 35.0 kg/m2
- •HbA1c below 12.0%
排除标准
- •Total insulin dosage more than 1.4 IU/kg/day
- •Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
- •Known hypoglycaemia unawareness as judged by the investigator
- •Known hypersensitivity or allergy
结局指标
主要结局
Insulin aspart antibodies
时间窗: After 6 months treatment
次要结局
- Incidence of hypoglycaemic episodes
- Occurrence of adverse events
- HbA1c
研究者
研究点 (35)
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