NCT00447213已完成2 期
A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the blood sugar level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus for at least 24 months
- •Injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months
- •HbA1c equal or less than 11 %
- •Nonsmokers, had not smoked for at least 6 months and agree not to smoke (cigars, cigarettes or pipes) or use smokeless tobacco for the duration of the study
- •Satisfactory lung function results to meet the requirement of the study
排除标准
- •Previously received any form of inhaled insulin
- •Require a daily total insulin dosage greater than 100 U
- •Have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
- •History or presence of liver disease
- •History or presence of kidney disease
研究组 & 干预措施
1
Experimental
干预措施: Insulin glargine (Drug)
1
Experimental
干预措施: Human Insulin Inhalation Powder (Drug)
1
Experimental
干预措施: Injectable Insulin (Drug)
2
Experimental
干预措施: Insulin glargine (Drug)
2
Experimental
干预措施: Human Insulin Inhalation Powder (Drug)
2
Experimental
干预措施: Injectable Insulin (Drug)
结局指标
主要结局
Change in HbA1c from baseline
时间窗: 12 and 24 weeks
次要结局
- Proportion of patients who achieve an HbA1c < 7% and <= 6.5%(12 and 24 weeks)
- Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses(at each visit)
- 8-point self monitoring blood glucose profiles(12 and 24 weeks)
- Two hour glucose excursions for the morning, midday, and evening meals(12 and 24 weeks)
- Inhaler reliability(throughout the study)
- Patient-reported treatment satisfaction and insulin delivery satisfaction(12 and 24 weeks)
- Preference for the study therapies(week 24)
研究者
研究点 (1)
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