EUCTR2006-000305-35-GB进行中（未招募）1 期
A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere®/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 668
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Key inclusion criteria include: non-smoking males and females >/= 18 and 7.0% and /= 70% predicted (NHANES III); DLco >/= 70% predicted (Miller) Total Lung Capacity >/= 80% predicted (ITS)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key exclusion criteria include: subjects receiving concomitant sulphonylureas, meglitinides, alpha glucosidase inhibitors, pramlintide acetate (Symlin®), and/or any incretins (eg, exenatides, such as Byetta®) within the preceding 8 weeks; history of viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >/= 3 times the upper limit of normal); history of chronic obstructive pulmonary disease (COPD), asthma (any history of bronchospasm or asthma after the age of 14),and/or any other clinically important pulmonary disease confirmed by documented history, pulmonary function testing, or radiologic findings; or evidence of severe complications of diabetes
研究者
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