Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Pharmacokinetics (PK): Area under the Concentration Curve (AUC) of Insulin Lispro
研究概览
简要总结
This study evaluates a new test formulation of a glucose lowering drug, insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test formulation and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks, including screening, lead-in and follow up. Screening is required within 28 days prior to entering the study.
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
- •Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump
- •Have a body mass index (BMI) of 18.5 to 33 kilogram per square meter (kg/m²), inclusive, at screening
- •Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are 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 participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
- •Have previously participated or withdrawn from this study
- •Have or used to have health problems, laboratory test results, blood pressure or ECG readings 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
研究组 & 干预措施
Insulin Lispro - Test Formulation
Novel formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods
干预措施: Insulin Lispro (Drug)
Insulin Lispro - Reference Formulation
Marketed formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area under the Concentration Curve (AUC) of Insulin Lispro
时间窗: Time 0 to 5 hours post dose on Day 1 and Day 3 of each study period
PK: AUC of Insulin Lispro
次要结局
- Pharmacodynamics (PD): AUC of Glucose Following a Meal(Time 0 to 5 hours post meal on Day 1 and Day 3 of each of study period)