Pharmacokinetic/Pharmacodynamic Study of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)
研究概览
简要总结
This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.
详细描述
The study is looking for patients that meet the following criteria:
- Duration of type diabetes greater than or equal to 10 years
- HbA1C less than or equal to 9.0%
- C-peptide negative
- Ages 18 - 65, male or female
- Body Mass Index (BMI) 18.5 - 32
- Non-smoker
- No advanced diabetes complications
- Not pregnant or breast feeding
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of type 1 diabetes greater than or equal to 10 years
- •HbA1c less than or equal to 9.0%
- •C-peptide negative
- •Ages 18 - 65, male or female
- •BMI 18.5 - 32
- •Non- smoker
- •No advance diabetes complications
- •Not pregnant or breast feeding
排除标准
- •Arm or leg rashes, open wounds, or skin conditions
- •Psychiatric disorders
- •Participation in a clinical research trial in last 3 months
- •Clinically significant acute illness
结局指标
主要结局
Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)
时间窗: Samples were collected at -1,-0.25, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 12.5, 13.0, 14.0, 15.0, 16.0 hours
Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PK was determined by analysis of serum insulin assay values. The mean Cmax was reported.
Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)
时间窗: Glucose infusion rates were adjusted every 10 minutes as necessary
Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PD was determined by analysis of glucose infusion rates required to maintain the glucose clamp level of 100 mg/dL. The mean GIRmax was reported.
次要结局
- Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients(Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal)