A Study of LY2605541 (Insulin Peglispro) and Human Insulin Concentrations in Fat Tissue
2018年11月6日 更新者:Eli Lilly and Company
Use of Open-Flow Microperfusion to Measure LY2605541 and Human Insulin Concentrations in Adipose Tissue Interstitial Fluid
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.
研究概览
研究类型
介入性
注册 (实际的)
24
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Graz、奥地利、8036
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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).
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Administered IV
其他名称:
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有源比较器: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).
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Administered IV
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)
大体时间:16, 20, 24, and 28 hours postdose
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16, 20, 24, and 28 hours postdose
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Part B: Pharmacokinetics: ISF-to-Serum Concentrations
大体时间:16, 20, 24, and 28 hours postdose
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Absolute concentration of ISF of insulin peglispro and human insulin.
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16, 20, 24, and 28 hours postdose
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年4月1日
初级完成 (实际的)
2015年3月1日
研究完成 (实际的)
2015年3月1日
研究注册日期
首次提交
2014年4月7日
首先提交符合 QC 标准的
2014年4月7日
首次发布 (估计)
2014年4月9日
研究记录更新
最后更新发布 (实际的)
2019年3月6日
上次提交的符合 QC 标准的更新
2018年11月6日
最后验证
2018年11月1日
更多信息
与本研究相关的术语
其他研究编号
- 14873
- I2R-MC-BIDP (其他标识符:Eli Lilly and Company)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com
This access is provided in a timely fashion after the primary publication is accepted.
Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com.
Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.