A Mixed Meal Tolerance Test Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LY900014 Compared to Humalog Following a Single Dose in Adults With Type 1 Diabetes
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 (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm
研究概览
简要总结
Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. The safety and tolerability of LY900014 will also be assessed. Screening is required within 14 days prior to the lead in. For each participant, the study will last up to 91 days.
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
- 是
入选标准
- •Are male or female participants with Type 1 Diabetes Mellitus (T1DM) 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 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
研究组 & 干预措施
LY900014
T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014.
干预措施: LY900014 (Drug)
Insulin Lispro (Humalog®)
T1DM participants received a single, individualized, SC dose of insulin lispro.
干预措施: Insulin Lispro (Drug)
Insulin Aspart (NovoRapid®)
T1DM participants received a single, individualized, SC dose of insulin aspart.
干预措施: Insulin Aspart (Drug)
Insulin Aspart (Fiasp®)
T1DM participants received a single, individualized, SC dose of insulin aspart.
干预措施: Insulin Aspart (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm
时间窗: 0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose
PK: Insulin Lispro or Insulin Aspart AUC(0-7h)
次要结局
- Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)(Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdose)