A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
2018年1月9日 更新者：Adocia
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.
研究概览
地位
完全的
条件
详细说明
This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.
Each subject will be randomly allocated to a sequence of four treatments, three single doses of BioChaperone® Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) and one single dose of Humalog® Mix25 at 0.8 U/kg on four separate dosing visits.
Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.
研究类型
介入性
注册 (实际的)
32
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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-
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Mainz、德国
- Profil Mainz GmbH & Co. KG
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Neuss、德国
- Profil Institut für Stoffwechselforschung GmbH
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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 70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:
- Male or female subject aged 18-70 years (both inclusive)
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- HbA1c level between 6.5% and 9.0 % (both inclusive)
- Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
- Body weight <= 125.0 kg at the screening visit
- Insulin-treated subjects. Total insulin dose of <= 1.2 (I)U/kg/day
Exclusion Criteria:
- Type 1 diabetes mellitus
- Known or suspected hypersensitivity to IMP(s) or related products
- Previous participation in this trial. Participation is defined as randomised.
- Receipt of any medicinal product in clinical development within 60 days before randomisation in this trial.
- Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator considering the underlying disease.
- Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-160 mmHg systolically or 50-95 mmHg diastolically (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial); symptoms of arterial hypotension and/or a heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.
- Women of child bearing potential not willing to use contraceptive methods.
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：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：BioChaperone® Combo 75/25 at 0.6 U/kg
Single subcutaneous injection of 0.6 U/kg
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Injection of BioChaperone® Combo 75/25 at 0.6 U/kg
|
|
实验性的：BioChaperone® Combo 75/25 at 0.8 U/kg
Single subcutaneous dose of 0.8 U/kg
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Injection of BioChaperone® Combo 75/25 at 0.8 U/kg
|
|
实验性的：BioChaperone® Combo 75/25 at 1.0 U/kg
Single subcutaneous dose of 1.0 U/kg
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Injection of BioChaperone® Combo 75/25 at 1.0 U/kg
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有源比较器：Humalog® Mix25 at 0.8 U/kg
Single subcutaneous dose of 0.8 U/kg
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Injection of Humalog® Mix25 at 0.8 U/kg
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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 |
|---|---|---|
|
AUC last_total
大体时间：From 0 to 30 hours
|
Area under the plasma insulin concentration-time curve from t=0 to the last measured total insulin plasma concentration above LLOQ.
The total insulin concentration is the sum of lispro and basal concentrations.
|
From 0 to 30 hours
|
|
Cmax_total
大体时间：From 0 to 30 hours
|
Maximum observed plasma insulin total concentration
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From 0 to 30 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
AUCGIR 0-last (mg/kg)
大体时间：From 0 to 30 hours
|
Area under the glucose infusion rate curve from 0 hours until the end of clamp
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From 0 to 30 hours
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GIRmax (mg/kg/min)
大体时间：From 0 to 30 hours
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Maximum glucose infusion rate
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From 0 to 30 hours
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tGIRmax
大体时间：From 0 to 30 hours
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Time to maximum glucose infusion rate
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From 0 to 30 hours
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Adverse Events
大体时间：Up to 102 days (maximum duration of subject's participation)
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Up to 102 days (maximum duration of subject's participation)
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Local tolerability: number of injection site reaction
大体时间：Up to 102 days (maximum duration of subject's participation)
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Frequency of injection site reaction in each arm.
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Up to 102 days (maximum duration of subject's participation)
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Number of hypoglycaemic events in each treatment arm
大体时间：Up to 102 days (maximum duration of subject's participation)
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Up to 102 days (maximum duration of subject's participation)
|
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。
赞助
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 (实际的)
2017年6月6日
初级完成 (实际的)
2017年8月28日
研究完成 (实际的)
2017年12月21日
研究注册日期
首次提交
2017年6月6日
首先提交符合 QC 标准的
2017年6月7日
首次发布 (实际的)
2017年6月8日
研究记录更新
最后更新发布 (实际的)
2018年1月10日
上次提交的符合 QC 标准的更新
2018年1月9日
最后验证
2018年1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.