Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- HbA1c change from baseline
研究概览
简要总结
This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).
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 2 diabetes
- •Treated with OADs for more than or equal to 3 months
- •HbA1c greater than or equal to 8.0% and less than or equal to 11.0%
- •Body Mass Index (BMI) less than or equal to 40.0 kg/m2
排除标准
- •Recurrent major hypoglycaemia
- •Current smoking or smoking within the last 6 months
- •Impaired hepatic or renal function
- •Cardiac problems
- •Uncontrolled hypertension
- •Proliferative retinopathy or maculopathy
研究组 & 干预措施
A
干预措施: inhaled human insulin (Drug)
B
干预措施: inhaled human insulin (Drug)
C
干预措施: metformin (Drug)
C
干预措施: glimepiride (Drug)
结局指标
主要结局
HbA1c change from baseline
时间窗: After 18 weeks of treatment
次要结局
- Lung function(after 18 weeks of treatment)
- Adverse events(For the duration of the trial)
- Body weight(after 18 weeks of treatment)
- Blood glucose(after 18 weeks of treatment)
- Hypoglycaemia(after 18 weeks of treatment)