A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog Following a Single Dose in Patients With T2DM
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve Zero to 10 Hours (AUC[0-10) Following 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 participants with type 2 diabetes mellitus. The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).
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 and 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 70 Years（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 2 Diabetes Mellitus (T2DM) for at least 1 year
- •Have a body mass index (BMI) of 18.5 to 35.0 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 T2DM), 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
LY900014
Single, subcutaneous (SC) dose of 15 Units (U) LY900014 in one of two study periods
干预措施: LY900014 (Drug)
Insulin Lispro (Humalog)
Single SC dose of 15 U insulin lispro (Humalog) in one of two study periods
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve Zero to 10 Hours (AUC[0-10) Following Each Treatment Arm
时间窗: Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn,45 mn,50mn, 55mn, 60mn, 70mn, 90mn, 120mn, 150mn, 180mn, 240mn, 300mn, 360mn, 420mn, 480mn, 540mn, and 600 minutes(10 hours) postdose
Pharmacokinetics(PK): Insulin Lispro AUC from zero to 10 hours postdose \[AUC(0-10)\] following each treatment arm
次要结局
- Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm(Predose, every minute starting from run-in and throughout the duration of the 10 hours)