Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- Treatment difference in HbA1c
研究概览
简要总结
This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (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 OAD(s) for more than or equal to 2 months
- •Body mass index (BMI) less than or equal to 40.0 kg/m2
- •HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
- •HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy
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)
A
干预措施: glimepiride (Drug)
B
干预措施: rosiglitazone (Drug)
B
干预措施: glimepiride (Drug)
结局指标
主要结局
Treatment difference in HbA1c
时间窗: After 26 weeks
次要结局
- Adverse events(For the duration of the trial)
- Blood glucose(after 26 weeks of treatment)
- Lung function(after 26 weeks of treatment)
- Body weight(during treatment)
- Hypoglycaemia(from 12-26 weeks of treatment)