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A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

2012年10月5日 更新者：Pfizer

A Phase 1B, Randomized, Double-Blind, Placebo-Controlled Trial To Assess The Efficacy And Safety Of 4-Week Administration Of Multiple Oral Doses Of PF-04620110 In Type 2 Diabetes Mellitus Subjects With Insufficient Glycemic Control On Metformin

PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

48

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

  • 美国
    • California
      • Chula Vista、California、美国、91911
        • Pfizer Investigational Site
    • Florida
      • DeLand、Florida、美国、32720
        • Pfizer Investigational Site
      • Miami Gardens、Florida、美国、33169
        • Pfizer Investigational Site

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

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Male and/or female subjects between the ages of 18 and 60 years;
  • Body Mass Index (BMI) of >25.0 kg/m2 and <40 kg/m2;
  • Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;
  • Subjects who have been on well-tolerated and stable doses of metformin

Exclusion Criteria:

  • Recent evidence (6 months prior to screening) or history of unstable major organ disease;
  • Diagnosis of Type 1 diabetes mellitus;
  • Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;
  • Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;

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：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：Placebo
Matching placebo giving for 4 weeks
实验性的：PF-04620110
药品：PF-04620110
5 mg of PF-04620110 given once daily
药品：PF-04620110
2.5 mg of PF-04620110 given twice daily

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
Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
大体时间：Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28
大体时间：Baseline (Day -1); 24 hours post-dose on Day 28
APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.
Baseline (Day -1); 24 hours post-dose on Day 28
Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
大体时间：Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
大体时间：Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
大体时间：Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
大体时间：Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
大体时间：Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
大体时间：Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Fasting Glucose at Day 28
大体时间：0 hour (pre-dose) on Day -1, Day 28
0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Fasting Insulin at Day 28
大体时间：0 hour (pre-dose) on Day -1, Day 28
0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Fasting Net Triglycerides at Day 28
大体时间：0 hour (pre-dose) on Day -1, Day 28
0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28
大体时间：Baseline (Day -1); 6 to 10 hours post-dose on Day 28
Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
Baseline (Day -1); 6 to 10 hours post-dose on Day 28
Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28
大体时间：Baseline (Day -1); 12 to 16 hours post-dose on Day 28
Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
Baseline (Day -1); 12 to 16 hours post-dose on Day 28
Maximum Observed Plasma Concentration (Cmax) of PF-04620110
大体时间：24 hours post-morning dose on Day 28
24 hours post-morning dose on Day 28
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110
大体时间：24 hours post-morning dose on Day 28
24 hours post-morning dose on Day 28
Time to Cmax (Tmax) of PF-04620110
大体时间：24 hours post-morning dose on Day 28
24 hours post-morning dose on Day 28
Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110
大体时间：24 hours post-morning dose on Day 28

Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours.

AUC (0-24) was computed using the linear trapezoidal method.
24 hours post-morning dose on Day 28

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

Pfizer

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

2011年2月1日

初级完成 (实际的)

2011年5月1日

研究完成 (实际的)

2011年5月1日

研究注册日期

首次提交

2011年1月28日

首先提交符合 QC 标准的

2011年2月16日

首次发布 (估计)

2011年2月17日

研究记录更新

最后更新发布 (估计)

2012年11月6日

上次提交的符合 QC 标准的更新

2012年10月5日

最后验证

2012年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • B0961007

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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