NCT00134147已完成3 期
A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,100
- 试验地点
- 122
- 主要终点
- Glycosylated hemoglobin
研究概览
简要总结
To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents
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
- 35 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus Type 2
- •Failing two or more oral anti-diabetic agents
排除标准
- •Asthma, COPD
结局指标
主要结局
Glycosylated hemoglobin
次要结局
- Percent of patients achieving good control of fasting glucose and lipids
- Rate of hypoglycemia
- Changes in body weight
- Patient satisfaction
- Safety based on adverse events reported and laboratory tests
研究者
研究点 (122)
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