Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro (Humalog) Following Single Dose Administration in Japanese Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to 10 Hours (AUC 0-10h) Following Administration of Each Treatment Arm
研究概览
简要总结
This study will compare LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs will be given by injection under the skin of the abdomen. This study will be conducted in participants with type 1 diabetes to investigate how quickly and how much LY900014 is absorbed and the effect of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 3 to 6 weeks for each participant, not including screening.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are Japanese male or female participant with a diagnosis of T1DM, based on the World Health Organization classification, for at least 1 year prior to screening
- •Have a body mass index (BMI) of 18.5 to 30.0 kilograms per square meter (kg/m²)
- •Have a glycated hemoglobin <9.0% at screening
排除标准
- •Have, except for current regimen of insulin therapy and concomitant medication(s), regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing
- •Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations), or have received such therapy within the 4 weeks before screening
- •Have a history of renal impairment (exclusion only if estimated glomerular filtration rate [GFR] <60 milliliters/minute/1.73 square meters [GFR is estimated according to a formula recommended by the Japanese Society of Nephrology]), or have a serum creatinine level ≥126 micromoles per liter (μmol/L) (>1.42 milligrams per deciliter [mg/dL]) (male) or ≥111 μmol/L (>1.25 mg/dL) (female)
- •Have a history of deep vein thrombosis of the leg, or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children), as determined by the investigator
- •Have proliferative retinopathy or maculopathy and/or severe neuropathy; in particular, autonomic neuropathy, as determined by the investigator based on a recent (<1.5 years) ophthalmologic examination
- •Have had any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening, as determined by the investigator
- •Require daily insulin treatment >1.5 units per kilogram (U/kg)
研究组 & 干预措施
LY900014
Single, 15 units (U)LY900014 administered subcutaneously (SC) in one of two study periods in Japanese Patients With Type 1 Diabetes Mellitus (T1DM).
干预措施: LY900014 (Drug)
Insulin Lispro (Humalog)
Single, 15 U insulin lispro administered SC in one of two study periods in Japanese Patients With Type 1 Diabetes Mellitus.
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to 10 Hours (AUC 0-10h) Following Administration of Each Treatment Arm
时间窗: Predose, 5 minutes (min), 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min, 45 min, 50 min, 55 min, 60 min, 70 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min, 540 min, and 600 min postdose
PK: Insulin Lispro AUC from time zero to 10 hours
次要结局
- Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Treatment Arm(Predose, every minute from run-in and for the duration of the EC until up to 10 hours postdose)