An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
2 other identifiers
interventional
N/A
1 country
42
Brief Summary
The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2003
CompletedFirst Posted
Study publicly available on registry
July 22, 2003
CompletedJuly 19, 2006
July 1, 2006
July 21, 2003
July 18, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Peoria, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Pico Rivera, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Denver, Colorado, United States
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Waterbury, Connecticut, United States
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West Hartford, Connecticut, United States
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Clearwater, Florida, United States
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Kissimmee, Florida, United States
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Ocala, Florida, United States
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St. Petersburg, Florida, United States
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Decatur, Georgia, United States
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Honolulu, Hawaii, United States
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Orland Park, Illinois, United States
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Peoria, Illinois, United States
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Evansville, Indiana, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Edina, Minnesota, United States
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Minneapolis, Minnesota, United States
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Endwell, New York, United States
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Great Neck, New York, United States
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Charlotte, North Carolina, United States
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Fayetteville, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Allentown, Pennsylvania, United States
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Fleetwood, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Mt. Pleasant, South Carolina, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Lebanon, Virginia, United States
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Renton, Washington, United States
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Spokane, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 21, 2003
First Posted
July 22, 2003
Last Updated
July 19, 2006
Record last verified: 2006-07