NCT00411892终止3 期
Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 196
- 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 the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone.
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
- •Current treatment with oral antidiabetes drugs (OADs) for at least 2 months
- •HbA1c between 7.0-11.0% if on OAD monotherapy
- •HbA1c between 7.0-10.0% if on OAD combination therapy
- •BMI less than or equal to 40 kg/m2
排除标准
- •Current regular smoking or regular smoking within the last 6 months
- •Current acute or chronic pulmonary disease (except for asthma)
- •Proliferative retinopathy requiring treatment
- •Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity
- •Pregnancy
研究组 & 干预措施
A
Experimental
干预措施: pioglitazone (Drug)
A
Experimental
干预措施: inhaled human insulin (Drug)
B
Active Comparator
干预措施: pioglitazone (Drug)
结局指标
主要结局
HbA1c change from baseline
时间窗: After 26 weeks of treatment
次要结局
- Frequency of hypoglycaemic episodes(after 26 weeks of treatment)
- Change in body weight(after 26 weeks of treatment)
- Fasting plasma glucose(after 26 weeks of treatment)
- Lipid profiles(after 26 weeks of treatment)
- Glucose profiles(at pre- and post meals, bedtime and 3:00 am)
研究者
研究点 (1)
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