NCT00725036已完成3 期
A 24-month Multicentre, Open-label, Randomised, Parallel Group, Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With Insulin Aspart Administered s.c., Both in Combination With NPH, in Subjects With Type 1 Diabetes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 19
- 主要终点
- Long term pulmonary safety profiles
研究概览
简要总结
This trial is conducted in Oceania.
The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 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
- •Type 1 diabetes
- •Current treatment with any insulin in any regimen
- •Body mass index (BMI) below 38.0 kg/m2
- •HbA1c below or equal to 13.0%
排除标准
- •Total daily insulin dosage more than 100 IU/day
- •Current acute or chronic pulmonary disease (excluding asthma)
- •Recurrent major hypoglycaemia
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Chest X-ray with clinically significant abnormalities
结局指标
主要结局
Long term pulmonary safety profiles
时间窗: during treatment
次要结局
- Incidence of hypoglycaemic episodes
- Glycaemic control as measured by HbA1c
- Physical examination and body weight and vital signs
- Adverse events
- Treatment satisfaction
- Long-term safety profiles (laboratory, ECG, insulin antibodies)
研究者
研究点 (19)
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