NCT00539396已完成2 期
A Phase 2 Randomized, Open Label, Multi-Center Study of the Use of Prandial Inhaled Technosphere Insulin in Combination With Basal Subcutaneous Lantus as Basal Insulin Versus Prandial Subcutaneous NovoRapid in Combination With Basal Subcutaneous Lantus Insulin in Subjects With Type 1 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- Change in blood glucose following a standard meal
研究概览
简要总结
A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes currently receiving SC insulin at mealtimes for at least 3 months
- •BMI <40 kg/m squared
- •HbA1c greater than or equal to 7% and less than or equal to 11.5%
- •Serum creatinine less than 2 for males and less than 1.8 for females
- •Acceptable pulmonary function
排除标准
- •Significant hepatic disease
- •Previously diagnosed pulmonary disease, ketoacidosis of evidence of severe secondary complications of diabetes
结局指标
主要结局
Change in blood glucose following a standard meal
时间窗: 0-300 minutes
次要结局
- Mean change from baseline HbA1c(week 12)
研究者
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