EUCTR2006-000306-23-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 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere®/Insulin Versus Subcutaneous Basal Insulin and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow-up
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 590
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-tobacco smoking (urine cotinine = 100 ng/mL) males or females ages = 18 and = 80 years, with type 1 diabetes currently receiving sc basal/prandial insulin therapy at < 1.4 iu/kg/day, with a body mass index = 35 kg/m2 and a HbA1c of > 7.0% and = 11.0%, Forced Expiratory Volume in 1 Second (FEV1) = 70% predicted (NHANES III), DLco = 80% predicted (Miller) and Total Lung Capacity (TLC) = 80% predicted (ITS). Subjects must have a C-peptide level of = 0.20 pmol/mL.
- •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: history of active viral and/or cirrhotic hepatic disease and/or abnormal levels of liver enzymes aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 3 times the upper limit of normal (ULN), 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, PFTs or radiologic findings and, evidence of severe complications of diabetes.
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