NCT00427154终止3 期
Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride on HbA1c in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Change in HbA1c
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 or rosiglitazone treatment, both in combination with metformin and glimepiride.
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
- •Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months
- •HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy
- •BMI less than or equal to 40 kg/m2
排除标准
- •Current smoking or smoking within the last 6 months
- •Current acute or chronic pulmonary disease (except for asthma)
- •Proliferative retinopathy requiring acute treatment
- •Clinically significant disease history including kidney or liver disease
- •Heart disease which limits physical activity or results in discomfort with physical activity
- •Pregnancy
研究组 & 干预措施
A
Active Comparator
干预措施: inhaled human insulin (Drug)
A
Active Comparator
干预措施: metformin (Drug)
A
Active Comparator
干预措施: glimepiride (Drug)
B
Active Comparator
干预措施: rosiglitazone (Drug)
B
Active Comparator
干预措施: metformin (Drug)
B
Active Comparator
干预措施: glimepiride (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: After 26 weeks
次要结局
- Lipid profiles(For the duration of the trial)
- Change in body weight(For the duration of the trial)
- Fasting plasma glucose(For the duration of the trial)
- Hypoglycaemic episodes(For the duration of the trial)
- Glucose profiles(For the duration of the trial)
研究者
研究点 (1)
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