Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
2014年6月17日 更新者：Boehringer Ingelheim
An Open Label, Phase I Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Linagliptin (BI 1356) 5 mg After Single and Multiple Oral Administration in Patients With Type 2 Diabetes Mellitus of African American Origin for 7 Days
The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of African American origin.
研究概览
研究类型
介入性
注册 (实际的)
41
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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California
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Cypress、California、美国
- 1218.55.0006 Boehringer Ingelheim Investigational Site
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Florida
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Deland、Florida、美国
- 1218.55.0008 Boehringer Ingelheim Investigational Site
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Miami、Florida、美国
- 1218.55.0004 Boehringer Ingelheim Investigational Site
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Maryland
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Baltimore、Maryland、美国
- 1218.55.0005 Boehringer Ingelheim Investigational Site
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New York
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New York、New York、美国
- 1218.55.0003 Boehringer Ingelheim Investigational Site
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Texas
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Dallas、Texas、美国
- 1218.55.0001 Boehringer Ingelheim Investigational Site
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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
21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:
- Glycosylated haemoglobin >=7 and <= 10%
- Age >=21 and <= 65
- Body Mass Index >=18.5 and <=38 kg/m2
- African American origin
- Signed and dated informed consent prior to admission to the study
Exclusion criteria:
- Any finding of the medical examination considered clinically relevant by the Investigator
- Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular disease including hypertension >160-100 mmHg (under current treatment), stroke and transient ischemic attack (TIA).
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes
- Clinically relevant diseases of central nervous system or psychiatric disorders or relevant neurological disorders besides polyneuropathy
- Diagnosis of sickle cell anemia or known chronic anemia
- History of chronic or relevant infections (for example human immunodeficieny virus (HIV), Hepatitis B)
- History of relevant allergy/hypersensitivity
- Intake of drugs with a long half life (>24hours) within at least one month or less than 10 half lives of the respective drug prior to administration except allowed co medication
- Alcohol abuse, drug abuse
- Any laboratory value of clinical relevance that is outside an acceptable range
- Change of drug dosing of allowed co medication
- Any (electrocardiogram) ECG value outside the reference range and of clinical relevance.
- Fasted glucose >270 mg/dl or randomly determined blood glucose >400 mg/dl on two consecutive days during screening or wash out
- Serum creatinine above upper limit normal at screening
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：非随机化
- 介入模型：单组作业
- 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：linagliptin
Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation
|
dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration
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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 |
|---|---|---|
|
Linagliptin: AUC_τ,ss
大体时间：24 hours
|
area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval
|
24 hours
|
|
Linagliptin: C_max,ss
大体时间：24 hours
|
maximum concentration of linagliptin in plasma at steady state
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24 hours
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DPP-4 Inhibition: E_24,ss
大体时间：One single measurement 24 h after drug administration under steady state conditions
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Plasma DPP-4 inhibition at trough under steady state conditions.
Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.
|
One single measurement 24 h after drug administration under steady state conditions
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment Emergent Adverse Events
大体时间：21 days
|
Frequency of patients with AEs
|
21 days
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Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
大体时间：21 days
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12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities
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21 days
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Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event
大体时间：21 days
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Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event
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21 days
|
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Linagliptin: AUC_0-24
大体时间：24 hours
|
area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose
|
24 hours
|
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Linagliptin: C_max
大体时间：24h
|
maximum concentration of linagliptin in plasma on Day 1
|
24h
|
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DPP-4 Inhibition: E_24
大体时间：One single measurement 24 h after drug administration
|
Plasma DPP-4 inhibition 24 hours after first dose.
Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.
|
One single measurement 24 h after drug administration
|
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。
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。
有用的网址
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
2009年6月1日
初级完成 (实际的)
2010年8月1日
研究注册日期
首次提交
2009年7月1日
首先提交符合 QC 标准的
2009年7月7日
首次发布 (估计)
2009年7月8日
研究记录更新
最后更新发布 (估计)
2014年6月27日
上次提交的符合 QC 标准的更新
2014年6月17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.