Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics
NCT ID: NCT00698230
Last Updated: 2018-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
302 participants
INTERVENTIONAL
2008-05-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment A - INCB013739 & Metformin
INCB013739 5 mg QD and Metformin
INCB013739
INCB013739 5 mg QD tablet
Metformin
Treatment B - INCB013739 & Metformin
INCB013739 15 mg QD and Metformin
INCB013739
INCB013739 15 mg QD tablet
Metformin
Treatment C - INCB013739 & Metformin
INCB013739 50 mg QD and Metformin
INCB013739
INCB013739 50 mg QD tablet
Metformin
Treatment D - INCB013739 & Metformin
INCB013739 100 mg QD and Metformin
INCB013739
INCB013739 100 mg QD tablet
Metformin
Treatment E - INCB013739 & Metformin
INCB013739 200 mg QD and Metformin
INCB013739
INCB013739 200 mg QD
Metformin
Treatment F - Placebo
Matching placebo
Placebo comparator matching INCB013739
Orally once daily tablet
Interventions
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INCB013739
INCB013739 5 mg QD tablet
INCB013739
INCB013739 15 mg QD tablet
INCB013739
INCB013739 50 mg QD tablet
INCB013739
INCB013739 100 mg QD tablet
INCB013739
INCB013739 200 mg QD
Placebo comparator matching INCB013739
Orally once daily tablet
Metformin
Eligibility Criteria
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Inclusion Criteria
* Stable dose of metformin for more than 8 weeks
Exclusion Criteria
* Type 1 diabetes mellitus or secondary forms of diabetes
* Subjects with uncontrolled thyroid disease
* History of renal impairment
18 Years
75 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Bill Williams, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Birmingham, Alabama, United States
Artesia, California, United States
Calabasas, California, United States
Fresno, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
Santa Ana, California, United States
Colorado Springs, Colorado, United States
Chiefland, Florida, United States
Hollywood, Florida, United States
Longwood, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Dunwoody, Georgia, United States
Rome, Georgia, United States
Belleville, Illinois, United States
Shawnee Mission, Kansas, United States
Bangor, Maine, United States
Columbia, Maryland, United States
Sterling Heights, Michigan, United States
Florissant, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
New York, New York, United States
Springfield Gardens, New York, United States
West Seneca, New York, United States
Calabash, North Carolina, United States
Mooresville, North Carolina, United States
New Bern, North Carolina, United States
Winston-Salem, North Carolina, United States
Kettering, Ohio, United States
Norton, Ohio, United States
Norman, Oklahoma, United States
Altoona, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Greenville, South Carolina, United States
North Myrtle Beach, South Carolina, United States
Spartanburg, South Carolina, United States
Bristol, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Georgetown, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Midland, Texas, United States
North Richland Hills, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Waco, Texas, United States
Burke, Virginia, United States
Hampton, Virginia, United States
Milwaukee, Wisconsin, United States
Carolina, , Puerto Rico
Fajardo, , Puerto Rico
Ponce, , Puerto Rico
Río Grande, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Rosenstock J, Banarer S, Fonseca VA, Inzucchi SE, Sun W, Yao W, Hollis G, Flores R, Levy R, Williams WV, Seckl JR, Huber R; INCB13739-202 Principal Investigators. The 11-beta-hydroxysteroid dehydrogenase type 1 inhibitor INCB13739 improves hyperglycemia in patients with type 2 diabetes inadequately controlled by metformin monotherapy. Diabetes Care. 2010 Jul;33(7):1516-22. doi: 10.2337/dc09-2315. Epub 2010 Apr 22.
Other Identifiers
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INCB 13739-202
Identifier Type: -
Identifier Source: org_study_id
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