Samba-AC: A Randomized, Open-Label, Cross-Over Study to Investigate the PK and PD Profiles of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Healthy Subjects and Non-Diabetic Subjects With Mild to Moderate Asthma or COPD
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Area under the insulin curve (AUC)
研究概览
简要总结
This will be a randomized, open-label, active-controlled, single dose crossover study with either three or four treatment periods. Investigational treatment is with Dance 501 Human Insulin Inhalation Solution (Dance 501) and the comparator is Insulin Lispro (Humalog®).
Target population will be Non-Diabetic individuals with mild to moderate asthma or chronic obstructive pulmonary disease (COPD) and non-diabetic individuals without underlying lung disease (healthy subjects).
详细描述
The PK and PD profile of Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be compared to subcutaneous injection of insulin lispro.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non-diabetic subjects with asthma, or COPD. Non-smokers or smokers quit at least 6 months prior to enrollment. BMI <= 35 kg/m
- •Fasting blood glucose <= 125 mg/dL.
排除标准
- •pulmonary disorder other than asthma or COPD. Upper respiratory within previous 4 weeks. Significant exacerbation of asthma or COPD symptoms. Hospitalization for asthma or COPD within previous 3 months. Clinically significant medical condition. Current medications interfering with glucose metabolism.
研究组 & 干预措施
Dance 501
Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
干预措施: inhaled human insulin (Drug)
Insulin Lispro
Insulin Lispro (Humalog®) will be administered by subcutaneous injection
干预措施: Insulin Lispro (Humalog U-100) (Drug)
结局指标
主要结局
Area under the insulin curve (AUC)
时间窗: 10 hours
Area under the insulin curve (AUC)
Area under the glucose infusion rate curve (GIR)
时间窗: 10 hours
Area under the glucose infusion rate curve (GIR)
次要结局
- Area under the insulin curve following inhalation of salbutamol(10 hours)