NCT00282971终止3 期
A Six Month, Open-label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 354
- 试验地点
- 63
- 主要终点
- Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
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
研究组 & 干预措施
Inhaled Insulin
Experimental
Inhaled insulin plus oral therapy
干预措施: Inhaled Insulin (Exubera) (Drug)
Standard of Care
Other
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
干预措施: Standard of Care (Other)
结局指标
主要结局
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
时间窗: 4, 12 and 24 weeks
\[(week 24 value - baseline value)/baseline value\]\*100%
次要结局
- Percentage of Participants Achieving Glycemic Control by Visit(4, 12 and 24 weeks)
- Change From Baseline in FEV1 at Week 24 LOCF(24 weeks)
研究者
研究点 (63)
Loading locations...
相似试验
已完成
3 期
A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose ControlDiabetes MellitusNCT00134147Pfizer1,100
已完成
4 期
This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT00418522Pfizer413
已完成
不适用
Long Acting Insulin Glargine Titration Web Tool (LTHome) vs Enhanced Usual Therapy of Glargine TitrationType 2 Diabetes MellitusNCT02540486LMC Diabetes & Endocrinology Ltd.139
终止
4 期
Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2)Type 2 DiabetesNCT00627471Sanofi9
已完成
不适用
Pilot Study Assessing Insulin Pump Therapy in Type 2 DiabetesType 2 DiabetesNCT00922649Animas Corporation58