Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised Extension) To Investigate Safety and Efficacy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 596
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes.
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 diabetes
- •HbA1c less than or equal to 11%
- •Body mass index (BMI) less than or equal to 40.0 kg/m2
排除标准
- •Total daily insulin dosage more than 100 IU or U/day.
- •Current smoking or smoking within the last 6 months
- •Impaired hepatic or renal function
- •Cardiac problems
- •Uncontrolled hypertension
- •Current proliferative retinopathy or maculopathy requiring acute treatment
研究组 & 干预措施
A
干预措施: inhaled human insulin (Drug)
A
干预措施: insulin detemir (Drug)
B
干预措施: insulin detemir (Drug)
B
干预措施: insulin aspart (Drug)
结局指标
主要结局
HbA1c
时间窗: After 52 weeks
次要结局
- Pulmonary Function(For the duration of the trial)
- Body weight(after 52 weeks)
- Antibodies(after 52 weeks)
- Insulin doses(For the duration of the trial)
- Fasting plasma glucose(after 52 weeks)
- Hypoglycemia(For the duration of the trial)