Absorption of Insulin Following Subcutaneous Bolus Administration With Different Bolus Durations
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
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Styria
-
Graz、Styria、奥地利、A-8036
- Medical University of Graz
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
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
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.
1 型糖尿病的临床试验
-
Oxford Brookes UniversityUniversity of Oxford完全的体力活动 | 心理健康 1 | 认知功能 1,社交 | Academic Attainment | Fitness Testing英国
-
Merck Sharp & Dohme LLC招聘中非小细胞肺癌 | 实体瘤 | 程序性细胞死亡-1(PD1、PD-1) | 程序性细胞死亡 1 配体 1(PDL1, PD-L1) | 程序性细胞死亡 1 配体 2(PDL2、PD-L2)日本
-
Amsterdam UMC, location VUmcRadboud University Medical Center; Maastricht University Medical Center; GGZ inGeest; Neurocare; M... 和其他合作者招聘中
-
Calliditas Therapeutics ABEurofins Optimed; York Bioanalytical Solution完全的
Insulin LISPRO的临床试验
-
Diasome Pharmaceuticlas, Inc.招聘中
-
Julphar Gulf Pharmaceutical IndustriesParexel; Profil Institut für Stoffwechselforschung GmbH完全的
-
Mannkind Corporation完全的