NCT00832182已完成3 期
An Open-labelled, Non-randomized, Multi-centre, Multinational Extension Trial Assessing the Safety of Insulin Aspart in Patients With Type I Diabetes Treated With a Basal-bolus Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of hypoglycemic episodes and adverse events
研究概览
简要总结
This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to the ANA/DCD/065 trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Signed informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
- •The subject must have completed the ANA/DCD/065 trial
排除标准
- •Impaired hepatic function
- •Impaired renal function
- •Total daily insulin requirements of more than 1.4 U/kg
- •Cardiac problems
- •Uncontrolled hypertension
- •Known or suspected allergy to trial product or related products
- •Current hypoglycaemic unawareness as judged by the investigator
- •Known or suspect abuse of alcohol or narcotics
- •Women breastfeeding or having the intention of becoming pregnant, or if judged not to be using adequate contraceptive measures (adequate measures are intrauterine device (IUD), oral contraception and barrier methods)
- •Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results
研究组 & 干预措施
Insulin aspart and neutral protamine Hagedorn insulin
Experimental
干预措施: insulin aspart (Drug)
Insulin aspart and neutral protamine Hagedorn insulin
Experimental
干预措施: insulin NPH (Drug)
结局指标
主要结局
Number of hypoglycemic episodes and adverse events
时间窗: at 3 and 6 months and at the end of the trial
次要结局
- 9-point blood glucose profile(at 3 and 6 months and at the end of the trial)
- HbA1c(at 3 and 6 months and at the end of the trial)
研究者
研究点 (1)
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