Samba-02: An Investigation of the Dose-Response and Subject Variability of Inhaled Insulin in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Area under the curve for glucose infusion rate from 0-12 hours (AUGgir0-12h)
研究概览
简要总结
Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501 inhaled human insulin
详细描述
This study investigated the pharmacokinetic (PK) and pharmacodynamic (PD) properties of Dance-501, a novel inhaled human insulin liquid formulation (INH) and device. Twenty-four subjects with type 2 diabetes (T2DM) received 3 INH doses: low (69 units), medium (139 units) and high (208 units) and 1 equivalent medium dose (18 units) of subcutaneous insulin lispro (LIS).
The medium dose was repeated to determine within subject variability. PD was investigated during a 12 hour euglycemic clamp.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus treated with insulin injections at a total daily dose less than 1.2 U/kg/day.
- •Body mass index 25-40 kg/m2
- •Hemoglobin A1c 6.5-9.5%
- •Forced vital capacity and forced expiratory volume in 1 second at least 75% of predicted normal values.
- •Fasting c-peptide less than 1 nmol/L
排除标准
- •Any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung function or subjects taking bronchodilators or subjects who smoke.
- •Active or chronic pulmonary disease.
- •Any major disorder other than type 2 diabetes.
- •Decompensated heart failure or myocardial infarction at any time or angina pectoris within the last 12 months.
- •Proliferative retinopathy or maculopathy or severe neuropathy.
研究组 & 干预措施
INH 69 U (low)
single 69 U dose administration of Dance inhaled human insulin using a low-concentration formulation (300 U/mL)
干预措施: INH 69 U (low) (Drug)
INH 69 U (high)
single 69 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL)
干预措施: INH 69 U (high) (Drug)
INH 139 U
single 139 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL) This arm was repeated in order to evaluate intra-subject variability.
干预措施: INH 139 U (Drug)
INH 208 U
single 208 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL)
干预措施: INH 208 U (Drug)
LIS 18 U
single 18 U dose administration of subcutaneous insulin lispro using a 100 U/mL formulation This arm was repeated in order to evaluate intra-subject variability.
干预措施: LIS 18 U (Drug)
结局指标
主要结局
Area under the curve for glucose infusion rate from 0-12 hours (AUGgir0-12h)
时间窗: 0 to 8 hours following each dose
Assessment of the linearity of the dose-response curves
Maximum glucose infusion rate (GIRmax)
时间窗: up to 12 hours following each dose
Assessment of the linearity of the dose-response curves
Area under the curve for insulin from 0-8 hours (AUCins0-8h)
时间窗: 0 to 8 hours following each dose
Assessment of the linearity of the dose-response curves
Maximum concentration of insulin (CMaxIns)
时间窗: up to 12 hours following each dose
Assessment of the linearity of the dose-response curves
次要结局
- Bioavailability(0 to 8 hours following each dose)