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Absorption of Insulin Following Subcutaneous Bolus Administration With Different Bolus Durations

2014年2月25日 更新者:Pieber Thomas, MD、Medical University of Graz

Subcutaneous Insulin Absorption Following Bolus Administrations With an Insulin Pump - Comparison of Bolus Administrations With Different Bolus Durations

To cover meal-related insulin requirements, insulin pumps allow insulin to be delivered at high rates over a short period of time (bolus delivery). The length of this period (bolus duration) usually depends on the chosen bolus size and on the used insulin pump model. This study will evaluate the impact of different bolus durations (i.e., durations commonly employed in commercially available insulin pumps: 2 and 40 seconds for delivering 1 Unit of insulin) on the pharmacokinetic and pharmacodynamic properties of an rapid-acting insulin analogue.

Objective: To evaluate in type 1 diabetic patients the pharmacodynamics and pharmacokinetics of rapid-acting insulin (insulin lispro) administered as subcutaneous boluses with different bolus durations.

Study design: Single-center, randomized, controlled, two-arm cross-over intervention study

Population: Twenty type 1 diabetic subjects

Intervention: The investigational treatment is the subcutaneous administration of insulin lispro either as one bolus of 15 IU over a period of 30s or as one bolus of 15 IU over a period of 10 min. Plasma samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an 8-hour clamp experiment. Patients will undergo both investigational treatments in a randomized order; between the two clamp visits there will be a wash-out period of 5-21 days.

Main study endpoint: Time to maximum glucose infusion rate

研究概览

地位

完全的

研究类型

介入性

注册 (实际的)

20

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

    • Styria
      • Graz、Styria、奥地利、A-8036
        • Medical University of Graz

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 60年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Informed consent obtained after being advised of the nature of the study
  • Male or female aged 18-60 years (both inclusive)
  • Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months
  • Fasting C-peptide < 0.3nmol/L
  • Body mass index 20.0-30.0 kg/m² (both inclusive)
  • HbA1c < 10%

Exclusion Criteria:

  • Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
  • Skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator
  • History of bleeding disorder
  • Current participation in another clinical study
  • Use of insulin lispro >2 weeks
  • Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator
  • Smoker (defined as >5 cigarettes/d)
  • Lipodystrophy
  • Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months
  • Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen

Study Day Exclusion Criteria:

  • Strenuous exercise within the last 24 hours prior to the clamp visit
  • Non-fasting (i.e. consumption of food or beverages, other than water, later than 22:00 hours the evening before the visit) except if slight intake of rapidly absorbable carbohydrates has been necessary in order to prevent hypoglycaemia
  • Injection of long-acting insulin (e.g. insulin glargine or insulin detemir) later than 12:00 hours (noon), 2 days before the clamp visit
  • Injection of NPH insulin or other intermediate-acting insulin products later than 12:00 hours (noon) on the day before the clamp visit
  • Injection of any short acting insulin (aspart, lispro, glulisine) or more than 6 IU of human insulin between 22:00 hours and 03:00 hours the night before the clamp visit
  • Injection of any insulin later than 03:00 hours the night before the clamp visit
  • Infusion of any insulin later than 03:00 hours the night before the clamp visit for subjects using continuous subcutaneous insulin infusion (CSII)
  • Positive result of alcohol breath test
  • Any medical condition that, in the opinion of the Investigator, could interfere with insulin pharmacokinetics and/or glucose metabolism

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
实验性的:1 bolus of insulin lispro with short bolus duration
Subcutaneous administration of insulin lispro as a bolus of 15 IU over a period of 30 seconds
Administration of 15 IU of insulin lispro over a period of 30 seconds
实验性的:1 bolus of insulin lispro with long bolus duration
Subcutaneous administration of insulin lispro as a bolus of 15 IU over a period of 10 minutes
Administration of 15 IU of insulin lispro over a period of 30 seconds

研究衡量的是什么?

主要结果指标

结果测量
大体时间
tmax(GIR); time to maximum glucose infusion rate
大体时间:8 hours
8 hours

次要结果测量

结果测量
大体时间
GIRmax, maximum glucose infusion rate
大体时间:8 hours
8 hours

其他结果措施

结果测量
大体时间
tmax(ins), time to maximum observed plasma insulin lispro concentration
大体时间:8 hours
8 hours

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。

调查人员

  • 首席研究员:Thomas R Pieber, MD、Medical University of Graz, Internal Medicine, Endocrinology and Metabolism

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2011年8月1日

初级完成 (实际的)

2011年11月1日

研究完成 (实际的)

2014年1月1日

研究注册日期

首次提交

2013年2月13日

首先提交符合 QC 标准的

2013年2月13日

首次发布 (估计)

2013年2月15日

研究记录更新

最后更新发布 (估计)

2014年2月26日

上次提交的符合 QC 标准的更新

2014年2月25日

最后验证

2014年2月1日

更多信息

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.

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