Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro Following Single Dose Administration in Elderly and Younger Adults With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm
研究概览
简要总结
The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus.
Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are male or female participants with Type 1 Diabetes Mellitus (T1DM)
- •Have a body mass index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m²)
- •Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)
- •Have had no episodes of severe hypoglycaemia in the last 6 months
排除标准
- •Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- •Have a history of renal impairment
- •Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives
- •Have proliferative retinopathy or maculopathy and/or severe neuropathy
研究组 & 干预措施
Elderly Adults LY900014
Single, subcutaneous (SC) 15-U dose of LY900014 in the elderly adult group.
干预措施: LY900014 (Drug)
Elderly Adults Insulin Lispro
Single, SC 15-U dose of insulin lispro (Humalog) in in the elderly adult group.
干预措施: Insulin Lispro (Drug)
Younger Adults LY900014
Single, SC 15-U dose of LY900014 in the younger adult group.
干预措施: LY900014 (Drug)
Younger Adults Insulin Lispro
Single, SC 15-U dose of insulin lispro (Humalog) in the younger adult group.
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm
时间窗: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose
Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose \[AUC(0-10h)\] for each treatment arm.
次要结局
- Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm(Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose)