Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacodynamics: Duration of Action of LY2963016 and Lantus
研究概览
简要总结
The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria
- •have had a duration of diabetes ≥1 year
- •have hemoglobin A1c ≤10.0%
- •have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L)
- •have a body mass index ≤29 kilograms per square meter (kg/m²)
- •have venous access sufficient to allow blood sampling and cannulation for clamp procedures
排除标准
- •are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device
- •have a total insulin requirement >1.2 units per kilogram per day (U/kg/day)
- •have a history of proliferative retinopathy
- •have known allergies to insulin glargine, insulin lispro, heparin, or related compounds
- •have an electrocardiogram (ECG) reading considered outside the normal limits
- •have an abnormal blood pressure
- •have abnormal clinical laboratory tests
- •have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- •history of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first-degree relatives
- •show evidence of significant active neuropsychiatric disease
- •regular use of known drugs of abuse and/or show positive findings on drug screening
- •show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
- •show evidence of hepatitis C and/or positive hepatitis C antibody
- •show evidence of hepatitis B and/or positive hepatitis B surface antigen
- •are women with a positive pregnancy test or women who are lactating
- •have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females)
- •had more than 1 episode of severe hypoglycemia within 6 months prior to study
- •undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer
- •had a blood transfusion or severe blood loss within 3 months; made a blood donation within 30 days prior to study entry; or have known hemoglobinopathy, haemolytic anemia, or sickle cell anemia
- •are receiving systemic glucocorticoid therapy
- •have irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night)
- •show a history of adverse reactions to heparin, including heparin-induced thrombocytopenia
- •smoke more than 10 cigarettes (or equivalent other tobacco products) per day
研究组 & 干预措施
LY2963016
A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days.
干预措施: LY2963016 (Drug)
Lantus
A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.
干预措施: Lantus (Drug)
结局指标
主要结局
Pharmacodynamics: Duration of Action of LY2963016 and Lantus
时间窗: Periods 1 and 2: Baseline up to 42 hours postdose
Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently \>150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.
次要结局
- Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus(Periods 1 and 2: Baseline up to 42 hours postdose)
- Maximum Glucose Infusion Rate (Rmax)(Periods 1 and 2: Baseline up to 42 hours postdose)
- Total Glucose Infused (Gtot)(Periods 1 and 2: Baseline up to 42 hours postdose)
- Time of Maximum Glucose Infusion Rate (tRmax)(Periods 1 and 2: Baseline up to 42 hours postdose)
- Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus(Periods 1 and 2: Baseline up to 42 hours postdose)