Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- (Part B) PK: AUC of Insulin Lispro
研究概览
简要总结
The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes a test formulation of insulin lispro and the effect of the test formulation 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 65 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 1 diabetes mellitus (T1DM) 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- •Have previously completed or withdrawn from this study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
Part A:Insulin Lispro Test
Individualized doses of Insulin Lispro test formulation administered by injection under the skin once in each of 3 periods
干预措施: Insulin Lispro (Drug)
Part A:Insulin Lispro Reference
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)
Part B:Insulin Lispro Test
Individualized doses of Insulin Lispro test formulation administered by injection under the skin with each meal for 14 days
干预措施: Insulin Lispro (Drug)
Part B:Insulin Lispro Reference
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
(Part B) PK: AUC of Insulin Lispro
时间窗: Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment
(Part B) PK: AUC of Insulin Lispro
(Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro
时间窗: Time 0 to 5 hours post dose for each treatment on Day 1
(Part A) PK: AUC of Insulin Lispro
次要结局
- (Part A) Pharmacodynamics (PD): AUC of Glucose Following a Meal(Time 0 to 5 hours post meal for each treatment on Day 1)
- (Part B) PD: AUC of Glucose Following a Meal(Time 0 to 5 hours post meal on Day1 and Day14 of study treatment)