An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
2006年7月18日 更新者：Eli Lilly and Company
The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.
研究概览
研究类型
介入性
阶段
- 阶段2
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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Alabama
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Birmingham、Alabama、美国
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Huntsville、Alabama、美国
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Arizona
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Peoria、Arizona、美国
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Tucson、Arizona、美国
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Arkansas
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Little Rock、Arkansas、美国
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California
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Santa Ana、California、美国
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Colorado
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Denver、Colorado、美国
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Connecticut
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Waterbury、Connecticut、美国
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West Hartford、Connecticut、美国
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Florida
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Clearwater、Florida、美国
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Kissimmee、Florida、美国
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St Petersburg、Florida、美国
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Georgia
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Decatur、Georgia、美国
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Hawaii
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Honolulu、Hawaii、美国
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Illinois
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Orland Park、Illinois、美国
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Peoria、Illinois、美国
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Indiana
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Evansville、Indiana、美国
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Kansas
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Wichita、Kansas、美国
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Kentucky
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Louisville、Kentucky、美国
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Maryland
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Baltimore、Maryland、美国
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Minnesota
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Edina、Minnesota、美国
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Minneapolis、Minnesota、美国
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New York
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Endwell、New York、美国
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Great Neck、New York、美国
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North Carolina
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Charlotte、North Carolina、美国
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Fayetteville、North Carolina、美国
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Oklahoma
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Oklahoma City、Oklahoma、美国
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Oregon
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Eugene、Oregon、美国
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Pennsylvania
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Allentown、Pennsylvania、美国
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Fleetwood、Pennsylvania、美国
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Philadelphia、Pennsylvania、美国
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South Carolina
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MT Pleasant、South Carolina、美国
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Texas
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San Antonio、Texas、美国
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Utah
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Salt Lake City、Utah、美国
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Virginia
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Lebanon、Virginia、美国
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Washington
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Renton、Washington、美国
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Spokane、Washington、美国
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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:
- Diagnosis of Type 2 Diabetes for at least 3 months.
- Diabetes managed with diet and exercise alone or with either metformin or sulfonylurea alone as an adjunct to diet and exercise.
- Diabetes therapy must be unchanged for at least 3 months prior to screening.
- Females must be of non-childbearing potential (surgically sterilized or at least 1 year post-menopausal, as defined by cessation of menses). Female patients who are not surgically sterilized and who are less than or equal to 45 years should have their post-menopausal status confirmed by FSH greater that 30ng/mL at screening.
Exclusion Criteria:
- Current use of insulin or any antidiabetic agent other than a sulfonylurea agent or metformin.
- Current use of metformin or a sulfonylurea agent in combination.
- History of liver disease.
- History of unstable angina (as defined by the Braunwald system), myocardial infarction, or a coronary revascularization procedure within the past 6 months.
- Currently suspected carcinoma or history of carcinoma in the last 5 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
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
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。
研究注册日期
首次提交
2003年7月21日
首先提交符合 QC 标准的
2003年7月21日
首次发布 (估计)
2003年7月22日
研究记录更新
最后更新发布 (估计)
2006年7月19日
上次提交的符合 QC 标准的更新
2006年7月18日
最后验证
2006年7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.