A Randomized, Open-Label, 6-Period Cross-Over Study to Investigate the Dose Response of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects With Type 2 Diabetes Mellitus (T2DM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Primary Pharmacokinetic Endpoint - PK 1
研究概览
简要总结
This will be a randomized, open-label, active-controlled, 6-period crossover study. Target population will be subjects with Type 2 Diabetes Mellitus (T2DM)
详细描述
To assess the dose-response and dose-exposure of Dance 501 (Human Insulin Inhalation Solution) administered with the Dance 501 Inhaler.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with T2DM.
- •BMI between 25.0 and 40.0 kg/m
- •Treated with metformin and/or at least 1 daily injection of insulin for at least 6 months.
- •Non-smoker for at least 5 years.
- •Forced vital capacity and forced expiratory volume in one second is at least 75% normal.
排除标准
- •Any condition affecting pulmonary drug absorption.
- •History or presence of cancer except basal cell skin cancer or squamous cell skin cancer.
- •Serious systemic infectious disease during four weeks prior to dosing.
- •Clinically significant abnormal lab values.
- •Proliferative retinopathy and/or severe neuropathy.
- •Recurrent severe hypoglycemia.
- •Current treatment with oral anti-diabetic drugs except metformin, glucagon-like peptide receptor agonists.
- •Current treatment with MAO inhibitors.
- •Unstable Thyroid hormones for at least 3 months.
- •Insufficient glycemic control with significant fluctuations of blood glucose.
研究组 & 干预措施
Dance 501
Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered using the Dance 501 Inhaler.
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
Primary Pharmacokinetic Endpoint - PK 1
时间窗: 0 - 10 hours
Area under the human insulin and insulin lispro concentrations time curves
Primary Pharmacokinetic Endpoint - PK 2
时间窗: 0 - 10 hours
Maximum observed concentration of human insulin and insulin lispro
Primary Pharmacodynamic Endpoint - PD 2
时间窗: 0 - 10 hours
Maximum observed glucose infusion rate
Primary Pharmacodynamic Endpoint - PD 1
时间窗: 0 - 10 hours
Area under the glucose infusion rate time curve
次要结局
- Secondary Pharmacokinetic Endpoint - PK 1(0 - 1 hour, 0 - 2 hours, 0 - 8 hours)
- Secondary Pharmacokinetic Endpoint - PK 2(0 - 10 hours)
- Secondary Pharmacokinetic Endpoint - PK 3(0 - 10 hours)
- Secondary Pharmacokinetic Endpoint - PK 4(0 - 10 hours)
- Secondary Pharmacokinetic Endpoint - PK 5(0 - 10 hours)
- Secondary Pharmacodynamic Endpoint - PD 1(0 - 1 hour, 0 - 2 hours, 0 - 8 hours)
- Secondary Pharmacodynamic Endpoint - PD2(0 - 10 hours)
- Secondary Pharmacodynamic Endpoint - PD3(0 - 10 hours)