ISRCTN81772352已完成不适用
Multicentre clinical study of the efficacy and safety of INHaled INSulin aerosol in the treatment of type 2 diabetes
Chuangxinhui Biotech Venture Capital Co., Ltd (China)0 个研究点目标入组 252 人开始时间: 2007年11月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 252
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Men and women (n = 253) diagnosed with type 2 diabetes were screened out at five centres in China. Inclusion criteria were:
- •1. Aged 18 to 65 years
- •2. Stable subcutaneous insulin schedule involving two to three injections daily for at least 2 months before study entry and not receiving any oral antidiabetic agents for at least 1 month
- •3. Screening and pre-randomisation fasting plasma glucose (FPG) values not more than 13mmol/L, body mass index (BMI) 18 - 28 kg/m^2
- •3. Written informed consent
排除标准
- •2. Chronic obstructive pulmonary disease or other significant respiratory disease
- •3. Smoking during the last 6 months
- •4. Abnormal screening chest X-ray
- •5. Abnormal pulmonary function at screening (carbon monoxide diffusing capacity [DLCO] less than 75%, total lung capacity [TLC] less than 80 or greater than 120%, and forced expiratory volume in one second [FEV1] less than 70% of predicted)
- •6. Major organ system disease
- •7. Clinically significant abnormalities on laboratory screening
- •8. Concomitant therapy with systemic glucocorticoids
- •9. Any inhaled insulin clinical trial previously
- •10. A daily insulin requirement of greater than 1.0 U/Kg
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