Effects of LY900014 on Recovery From Hyperglycemia Compared to Humalog in Subjects With Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension
研究概览
简要总结
The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating. For each participant, the study will last about two to nine 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants with type 1 diabetes
- •Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive
- •Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
- •Using CSII and stable insulin regimen for at least 3 months prior to inclusion into the trial
排除标准
- •Known or suspected hypersensitivity to investigational medical product(s) or related products
- •Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial
- •Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption
- •Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (less than 1.5 years) ophthalmologic examination
- •Widespread subcutaneous lipodystrophy in the abdomen
- •Current use of any glucose-lowering agents other than insulin within 3 months prior to screening
- •Chronic or recent use of corticosteroids
研究组 & 干预措施
100 U/mL LY900014
100 units per milliliter (U/mL) LY900014 administered by continuous subcutaneous insulin infusion (CSII) in one of two study periods.
干预措施: LY900014 (Drug)
100 U/mL Insulin Lispro (Humalog)
100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods.
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension
时间窗: Day 2: Baseline up to 5 hours after pump suspension
Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL.
Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus
时间窗: Day 1: Baseline up to 5 hours after missed meal bolus
Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL).
次要结局
- Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog)(Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension)
- Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog)(Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension)