A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
2019年3月27日 更新者：Eli Lilly and Company
Evaluation of the Counter-Regulatory Response to Hypoglycaemia Following LY2605541 Administration Compared to Insulin Glargine in Patients With Type 1 Diabetes Mellitus
This study has 2 parts.
Each participant will receive a daily injection of LY2605541 during one treatment period and a daily injection of insulin glargine during one treatment period.
Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar levels to see how the body recovers after each treatment.
研究概览
研究类型
介入性
注册 (实际的)
25
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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Neuss、德国、41460
- 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:
- Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) less than 9%
- Otherwise fit and healthy
- Nonsmoker
Exclusion Criteria:
- Taking medication or supplements other than insulin to control diabetes
- Suffered a hypoglycemic event in the last 12 months that required hospitalization or has poor awareness of hypoglycemia
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：其他
- 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：LY2605541
Stable dose of LY2605541 (0.2 to 0.6 units per kilogram [U/kg]) administered subcutaneously (SQ) once daily for at least 14 days in 1 of 2 treatment periods.
Dose based on prestudy basal insulin dosing regimen.
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有源比较器：Insulin Glargine
Stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in 1 of 2 treatment periods.
Dose based on prestudy basal insulin dosing regimen.
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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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Concentration of Epinephrine
大体时间：30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Epinephrine levels are presented.
Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL
大体时间：30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Amount of Glucose Required to Maintain BG of 72 mg/dL
大体时间：30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Cortisol
大体时间：30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Cortisol levels are presented.
Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Glucagon
大体时间：30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Glucagon levels are presented.
Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Growth Hormone
大体时间：30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Growth hormone levels are presented.
Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Concentration of Norepinephrine
大体时间：30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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Norepinephrine values are presented.
Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.
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30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
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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
2013年2月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2013年1月14日
首先提交符合 QC 标准的
2013年1月14日
首次发布 (估计)
2013年1月16日
研究记录更新
最后更新发布 (实际的)
2019年6月24日
上次提交的符合 QC 标准的更新
2019年3月27日
最后验证
2019年3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.