Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900014 in Patients With Type 2 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A)
研究概览
简要总结
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. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.
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) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
- •Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
- •Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study
- •Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
- •Have venous access sufficient to allow for blood sampling
- •Have provided written consent and are willing to follow study procedures and commit to the study duration
排除标准
- •Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
- •Have previously completed or withdrawn from this study
- •Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
- •Had blood loss of more than 500 milliliters (mL) within the last month
- •Are treated with a continuous subcutaneous insulin infusion (insulin pump)
研究组 & 干预措施
LY900014 (Part A)
Individualized doses of LY900014 administered by injection under the skin once in each of 3 periods
干预措施: LY900014 (Drug)
Insulin Lispro - Reference (Part A)
Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods
干预措施: Insulin Lispro (Drug)
LY900014 (Part B)
Individualized doses of LY900014 administered by injection under the skin with each meal for 14 days
干预措施: LY900014 (Drug)
Insulin Lispro - Reference (Part B)
Individualized doses of insulin lispro reference formulation administered by injection under the skin with each meal for 14 days
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A)
时间窗: Day 1: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment
PK: Insulin Lispro AUC(0-5h) (Part A)
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B)
时间窗: Days 1 and 14: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment
PK: Insulin Lispro AUC(0-5h) (Part B)
次要结局
- Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part B)(Days 1 and 14: Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes in each study period)
- Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part A)(Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes)