Effect of Different Doses of Inhaled Technosphere Insulin on Glucose Infusion Rates During Euglycemic Clamps in Comparison to a Subcutaneous Injection of Regular Human Insulin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Dose-corrected area-under-the serum insulin concentration vs. time curve for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment
研究概览
简要总结
A prospective, single center, open randomized, six way crossover study comparing the dose response effect of four different doses of Technosphere Insulin after pulmonary function delivery in comparison to s.c. injection of two different doses of regular human insulin.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be in good health, as judge by brief history and physical examination.
- •Sex: both, male and female.
- •Age: 18-40 years.
- •Body mass index: 18-27 kg/m
- •Capability to reach peak inspiratory flow of >41/sec measured by a computer assisted spirometry.
- •FEV1 equal to or greater than 80% of predicted normal.
排除标准
- •Diabetes Mellitus type 1 or type
- •Human insulin antibodies.
- •Anamnestic history of hypersensitivity to the study medication or to drugs with similar chemical structures.
- •Having a history of severe or multiple allergies.
- •Treatment with any other investigational drug in the last three months before study entry.
- •Progressive fatal disease.
- •History of significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and /or hematological disease.
- •Having ongoing respiratory tract infection.
- •Smoker defined as subjects with evidence or history of tobacco or nicotine use in the last year prior to entry in the study.
- •Blood donation within the last 30 days.
- •A woman who is lactating.
- •Pregnant women or women intending to become pregnant during the study.
- •A sexually active woman of childbearing age not actively practicing birth control or using medically accepted device or therapy.
- •A lack of compliance or other reasons, which prevent to the opinion of the investigator the participation of the subject in the study.
研究组 & 干预措施
Technosphere insulin inhalation system, 25 units
干预措施: Technosphere insulin (Drug)
Technosphere insulin inhalation system, 50 units
干预措施: Technosphere insulin (Drug)
Technosphere insulin inhalation system, 100 units
干预措施: Technosphere insulin (Drug)
Subcutaneous regular human insulin
干预措施: Regular human insulin (Drug)
结局指标
主要结局
Dose-corrected area-under-the serum insulin concentration vs. time curve for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment
时间窗: crossover every 3-28 days for up to 20 weeks
Area under the glucose infusion rate for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment
时间窗: crossover every 3-28 days for up to 20 weeks
次要结局
- Safety variables included adverse events (AEs), clinical laboratory tests, HbA1c, pulmonary function tests, vital signs, physical examinations, and diabetes-specific signs (ie, hypoglycemia)(crossover every 3-28 days for up to 20 weeks)