Use of Open-Flow Microperfusion to Measure LY2605541 and Human Insulin Concentrations in Adipose Tissue Interstitial Fluid
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)
研究概览
简要总结
LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, and to measure the quantity of LY2605541 in fat tissue. The study has two parts. It involves intravenous (IV) infusion of the investigational drug and a procedure to measure concentrations in the fat tissue. Both parts of the study will be conducted in participants with type 1 diabetes mellitus (T1DM). Part A and B of the study might take up to 7 weeks to complete.
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
- None
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
- •Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) based on medical history for at least 1 year prior to enrollment
- •Have a c-peptide value ≤0.3 nanomoles per liter (nmol/L) at screening
- •Have a serum creatinine value within normal limits at screening
- •Have a haemoglobin A1c (HbA1c) value ≤75 millimoles per mole (mmol/mol) (9.0%) at screening
- •Have a body mass index (BMI) of 20.0-30.0 kilograms per meter squared (kg/m^2), inclusive, at screening
排除标准
- •Have known or suspected allergies or hypersensitivities to LY2605541, human insulin, sinistrin, related compounds or any components of the formulations
- •Are women who are pregnant or lactating
- •Have an abnormal blood pressure for the population as determined by the investigator
- •Have renal insufficiency or major renal disorders
- •Have proliferative retinopathy or maculopathy
- •Have lipodystrophy
- •Have any wound healing disorder or are prone to keloid or hypertrophic scar formation
- •Have results of screening prothrombin time (PT) and international normalized ratio (INR) tests that are significantly prolonged
- •Have a fasting triglycerides value > 4.52 millimoles per liter (mmol/L) (400 milligrams/deciliter (mg/dL))
- •Are receiving chronic systemic or inhaled glucocorticoid or have received such therapy within the 4 weeks before dosing
- •Have a total daily insulin dose greater than 1.2 units per kilogram (U/kg)
- •Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
- •Regular use or intended use of non-selective beta blockers
- •Regular use or intended use of monoamine oxidase (MAO) inhibitors
- •Are currently participating in a weight loss program or plan to do so during the course of the study
- •Are unwilling to avoid excessive sun exposure, steam baths, saunas, and swimming during the study. Sun cream should be used during sun bathing for the 6-month period following the study
- •Are unwilling to avoid extensive consumption of food containing inulin during the study and in the 48-hour period leading up to the clamp
研究组 & 干预措施
Insulin Peglispro (LY2605541)
Part A Cohort 1: (low dose) priming dose (PD) of 2.00 units (U), 0.92 U/hour (U/h) constant infusion of insulin peglispro Part A Cohort 1: (high dose) PD of 8.00 U, 4.50 U/h constant IV infusion of insulin peglispro Part A Cohort 2: (intermediate dose 1) PD of 4.00 U, 1.84/h constant IV infusion of insulin peglispro Part A Cohort 2: (intermediate dose 2) PD of 6.0 U, 2.76 U/h constant IV infusion of insulin peglispro Part B Insulin Peglispro: PD of 6.00 U, 2.76 constant IV infusion of insulin peglispro and a constant infusion of 6 pico moles per kilogram per minute (pmol/kg/min). IV infusion of sinistrin (250 mg/mL, SOC to achieve a steady state for up to 16 hours).
干预措施: Insulin Peglispro (Drug)
Human Insulin
Constant IV infusion ( 6 pico moles per kilogram perminute [pmol/kg/min]) of human insulin for up to 36 hours. IV infusion of sinistrin (250 mg/mL, SOC to achieve a steady state for up to 16 hours).
干预措施: Human Insulin (Drug)
结局指标
主要结局
Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)
时间窗: 16, 20, 24, and 28 hours postdose
Part B: Pharmacokinetics: ISF-to-Serum Concentrations
时间窗: 16, 20, 24, and 28 hours postdose
Absolute concentration of ISF of insulin peglispro and human insulin.
次要结局
未报告次要终点