NCT00523042终止3 期
Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in lung function, chest X-rays, or asthma exacerbation frequency
研究概览
简要总结
This trial is conducted in Europe, Asia, Oceania and the United States of America (USA).
This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.
详细描述
The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.
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
- •Type 1 or type 2 diabetes
- •Treatment with insulin and/or oral anti-diabetic drugs
- •Asthma for at least 6 months
- •Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years
- •HbA1C less than or equal to 11.0 %
- •Body Mass Index (BMI) less than or equal to 40.0 kg/m2
排除标准
- •Current smoking or smoking within the last 6 months
- •Other current acute or chronic pulmonary disease excluding asthma
- •Recurrent severe hypoglycaemia
- •Proliferative retinopathy or maculopathy
研究组 & 干预措施
A
Experimental
干预措施: inhaled human insulin (Drug)
B
Active Comparator
干预措施: insulin aspart (Drug)
结局指标
主要结局
Changes in lung function, chest X-rays, or asthma exacerbation frequency
时间窗: after 52 weeks of treatment
次要结局
- Preprandial insulin doses(for the duration of the trial)
- Diabetes control measured by change in HbA1c(from baseline to end of treatment)
- Laboratory assessments (biochemistry, insulin antibodies, blood count)(from baseline to end of treatment)
研究者
研究点 (1)
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