A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT)
研究概览
简要总结
The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T1DM for at least 1 year
- •Fasting C-peptide ≤0.30 nanomoles per liter (nmol/L)
- •Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²)
- •Participants should have a glycated hemoglobin of ≤9.0% at screening
排除标准
- 未提供
研究组 & 干预措施
LY900027
LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods.
干预措施: LY900027 (Drug)
Insulin Lispro
Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods.
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT)
时间窗: Day 1 through Day 10 in each dosing period
PK: AUC after Bolus Administration Prior to a MMTT
PK: Maximum Observed Insulin Lispro Concentration (Cmax)
时间窗: Day 1 through Day 10 in each dosing period
PK: C PK: Cmax
次要结局
- Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion(Day 1 through Day 10 in each dosing period)
- Duration Until Catheter Failure(Day -1 through Day 10 in each dosing period)
- PD: Total Daily Insulin Dose(Day 1 through Day 10 in each dosing period)