Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
NCT ID: NCT00279045
Last Updated: 2017-11-29
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
PHASE3
4426 participants
INTERVENTIONAL
2000-01-03
2006-06-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Interventions
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Rosiglitazone
glyburide
metformin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
* No previous treatment with oral or parenteral glucose-lowering therapy.
Exclusion Criteria
* Anemia (\<11g for males, \<10 g for females).
* Unstable or severe NY Heart Association-class 3 or 4.
* Any NY Heart Association congestive heart failure.
* Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.
30 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Doncaster, , United Kingdom
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Doncaster, , United Kingdom
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Gateshead, , United Kingdom
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Glasgow, , United Kingdom
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Glenrothes, , United Kingdom
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Irvine, , United Kingdom
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Kent, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Newtownabbey, , United Kingdom
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Peterborough, , United Kingdom
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Swansea, , United Kingdom
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Wakefield, , United Kingdom
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Wigan, , United Kingdom
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Nuneaton, Warwickshire, United Kingdom
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Rugby, Warwickshire, United Kingdom
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Livingston, West Lothian, United Kingdom
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Cardiff, , United Kingdom
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Co.Antrim, , United Kingdom
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Melksham, Wiltshire, United Kingdom
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Trowbridge, Wiltshire, United Kingdom
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Barnsley, , United Kingdom
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Mesa, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Berkeley, California, United States
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Corona, California, United States
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Fair Oaks, California, United States
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Fremont, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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Greenbrae, California, United States
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Harbor City, California, United States
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Healdsburg, California, United States
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La Jolla, California, United States
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Bath, , United Kingdom
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Loma Linda, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Modesto, California, United States
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Pasadena, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Rosa, California, United States
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Sunnyvale, California, United States
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Ukiah, California, United States
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Walnut Creek, California, United States
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Yorba Linda, California, United States
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Boulder, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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Longmont, Colorado, United States
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Wheat Ridge, Colorado, United States
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Wheat Ridge, Colorado, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Fort Myers, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Titusville, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Blue Ridge, Georgia, United States
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Dunwoody, Georgia, United States
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Fayetteville, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Springfield, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Lexington, Kentucky, United States
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Lake Charles, Louisiana, United States
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New Orleans, Louisiana, United States
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Slidell, Louisiana, United States
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Slidell, Louisiana, United States
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Bangor, Maine, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Lansing, Michigan, United States
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Royal Oak, Michigan, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Jackson, Mississippi, United States
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Olive Branch, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Cherry Hill, New Jersey, United States
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Cherry Hill, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Endwell, New York, United States
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Flushing, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Mogadore, Ohio, United States
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Westlake, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Bend, Oregon, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Downingtown, Pennsylvania, United States
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Feasterville, Pennsylvania, United States
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Fleetwood, Pennsylvania, United States
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Hermitage, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Jefferson Hills, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Warminster, Pennsylvania, United States
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West Chester, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Greer, South Carolina, United States
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Spartanburg, South Carolina, United States
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Bristol, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Corpus Christi, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Salem, Virginia, United States
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Federal Way, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Wenatchee, Washington, United States
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Charleston, West Virginia, United States
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Huntington, West Virginia, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Oregon, Wisconsin, United States
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Vienna, , Austria
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Vienna, , Austria
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Wiener Neustadt, , Austria
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Blankenberge, , Belgium
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Boechout, , Belgium
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Deurne, , Belgium
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Leuven, , Belgium
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Lubbeek (Linden), , Belgium
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Tielt, , Belgium
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Wezembeek-Oppem, , Belgium
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Wijnegem, , Belgium
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Zemst, , Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Red Deer, Alberta, Canada
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Coquitlam, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Winnipeg, Manitoba, Canada
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Cambellton, New Brunswick, Canada
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Moncton, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Antigonish, Nova Scotia, Canada
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Halifax, Nova Scotia, Canada
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Burlington, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Oakville, Ontario, Canada
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Ottawa, Ontario, Canada
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Thornhill, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Timmins, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Chicoutimi, Quebec, Canada
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La Malbaie, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Plessisville, Quebec, Canada
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Saint-Marc-des-Carrieres, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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St-Isidore de Dorchester, Quebec, Canada
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Ostrava, , Czechia
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Phaha 5, , Czechia
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Prague, , Czechia
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Ústí nad Labem, , Czechia
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Zlín, , Czechia
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Frederiksberg C, , Denmark
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Odense, , Denmark
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Hanko, , Finland
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Helsinki, , Finland
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Jyväskylä, , Finland
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Lmatra, , Finland
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Savitaipale, , Finland
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Alben, , France
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Bezier, , France
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Bourges, , France
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Brogile, , France
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Chartres, , France
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Denguin, , France
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Évreux, , France
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Gamarde-les-Bains, , France
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La Rochelle, , France
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Labarthe-sur-Lèze, , France
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Le Mans, , France
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Le Pian-Médoc, , France
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Lille, , France
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Mallemort, , France
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Marseille, , France
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Marseille, , France
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Marsillargues, , France
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Marssac-sur-Tarn, , France
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Mont de Marsen, , France
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Montignac, , France
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Moulon, , France
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Mûrs-Erigné, , France
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Nantes, , France
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Nantes, , France
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Nîmes, , France
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Orthez, , France
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Paris, , France
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Rennes, , France
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Roanna, , France
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Saint Genies Des Fontaines, , France
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Saint-Etienne, , France
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Saint-Julien-des-Landes, , France
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Saint-Martin-d'Hères, , France
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Saint-Pierre-de-Chandieu, , France
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Sisteron, , France
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Strasbourg, , France
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Tarare, , France
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Vieux-Condé, , France
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Vourey, , France
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Bad Rappenau, Baden-Wurttemberg, Germany
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Deggingen, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Trochtelfingen, Baden-Wurttemberg, Germany
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Unterschneidheim, Baden-Wurttemberg, Germany
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Wangen, Baden-Wurttemberg, Germany
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Weinheim, Baden-Wurttemberg, Germany
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Aschaffenburg, Bavaria, Germany
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Haag, Bavaria, Germany
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Höhenkirchen-Siegertsbrunn, Bavaria, Germany
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Ismaning, Bavaria, Germany
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Krummenaab, Bavaria, Germany
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Künzing, Bavaria, Germany
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Landshut, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Nuremberg, Bavaria, Germany
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Wallerfing, Bavaria, Germany
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Bad Kreuznach, Hesse, Germany
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Frankfurt am Main, Hesse, Germany
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Großalmerode, Hesse, Germany
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Lollar, Hesse, Germany
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Offenbach, Hesse, Germany
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Offenbach, Hesse, Germany
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Offenbach, Hesse, Germany
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Offenbach, Hesse, Germany
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Schaafheim, Hesse, Germany
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Vellmar, Hesse, Germany
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Damme, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Hildesheim, Lower Saxony, Germany
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Lüneburg, Lower Saxony, Germany
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Paderborn, Lower Saxony, Germany
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Winsen/Lohe, Lower Saxony, Germany
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Beckum, North Rhine-Westphalia, Germany
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Bergkamen, North Rhine-Westphalia, Germany
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Borken, North Rhine-Westphalia, Germany
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Dortmund, North Rhine-Westphalia, Germany
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Duisburg, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Euskirchen, North Rhine-Westphalia, Germany
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Goch, North Rhine-Westphalia, Germany
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Lüdenscheid, North Rhine-Westphalia, Germany
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Lünen, North Rhine-Westphalia, Germany
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Neuss, North Rhine-Westphalia, Germany
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Schwabenheim, North Rhine-Westphalia, Germany
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Siegen, North Rhine-Westphalia, Germany
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Warendorf, North Rhine-Westphalia, Germany
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Deidesheim, Rhineland-Palatinate, Germany
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Diez, Rhineland-Palatinate, Germany
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Lambrecht, Rhineland-Palatinate, Germany
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Rhaunen, Rhineland-Palatinate, Germany
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Chemnitz, Saxony, Germany
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Dresden, Saxony, Germany
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Dresden, Saxony, Germany
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Dresden, Saxony, Germany
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Freital, Saxony, Germany
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Pirna, Saxony, Germany
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Schmiedeberg, Saxony, Germany
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Itzehoe, Schleswig-Holstein, Germany
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Ratzeburg, Schleswig-Holstein, Germany
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Wahlstedt, Schleswig-Holstein, Germany
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Wilster, Schleswig-Holstein, Germany
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Berlin, , Germany
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Berlin, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Budapest, , Hungary
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Miskolc, , Hungary
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Belfast, , Ireland
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Co. Tipperary, , Ireland
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Cork, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Gowran, , Ireland
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Kilkenny, , Ireland
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Acquaviva Delle Fonti (BA), Apulia, Italy
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Ferrara, Emilia-Romagna, Italy
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Ravenna, Emilia-Romagna, Italy
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Scandiano (RE), Emilia-Romagna, Italy
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Rozzano (MI), Lombardy, Italy
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Catania, Sicily, Italy
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Città Di Castello (PG), Umbria, Italy
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Florence, , Italy
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La Spezia, , Italy
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Lecce, , Italy
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Milan, , Italy
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Palermo, , Italy
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Parma, , Italy
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Perugia, , Italy
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Rovigo, , Italy
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S. Benedetto TR (AP), , Italy
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San Giovanni Rotondo FG, , Italy
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Sassari, , Italy
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Terni, , Italy
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Torino, , Italy
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Udine, , Italy
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Vicenza, , Italy
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's-Hertogenbosch, , Netherlands
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De Bilt, , Netherlands
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Geleen, , Netherlands
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Hengelo, , Netherlands
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Huizen, , Netherlands
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Losser, , Netherlands
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Losser, , Netherlands
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Rijswijk, , Netherlands
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Roelofarendsveen, , Netherlands
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Woerden, , Netherlands
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Hamar, , Norway
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Paradis, , Norway
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Skedsmokorset, , Norway
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Albaida (Valencia), , Spain
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Basurto/Bilbao, , Spain
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Benassal (Castellón), , Spain
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Benicasim (Castellón), , Spain
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Bilbao, , Spain
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Cartagena, , Spain
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Cáceres, , Spain
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El Palmar (Murcia), , Spain
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Elche (Alicante), , Spain
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Elda-Alicante, , Spain
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Figueras, , Spain
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Girona, , Spain
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Granollers (Barcelona), , Spain
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Jerez (Cadiz), , Spain
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Madrid, , Spain
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Madrid, , Spain
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Mataró, , Spain
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Málaga, , Spain
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Mérida, , Spain
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Olleria, Valencia, , Spain
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Onda/Castellón, , Spain
GSK Investigational Site
Orihuela (Alicante), , Spain
GSK Investigational Site
Plasencia, , Spain
GSK Investigational Site
Pontevedra, , Spain
GSK Investigational Site
Sagunto/Valencia, , Spain
GSK Investigational Site
San Juan (Alicante), , Spain
GSK Investigational Site
San Vincente Raspeig (Alicante), , Spain
GSK Investigational Site
Santa Coloma de Gramanet (Barcelona), , Spain
GSK Investigational Site
Santa Cruz de Tenerife, , Spain
GSK Investigational Site
Tereul, , Spain
GSK Investigational Site
Toledo, , Spain
GSK Investigational Site
Torrelavega/Santander, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valladolid, , Spain
GSK Investigational Site
Vallda (Valencia), , Spain
GSK Investigational Site
Villajoyosa - Alicante, , Spain
GSK Investigational Site
Zamora, , Spain
GSK Investigational Site
Zaragoza, , Spain
GSK Investigational Site
Älta, , Sweden
GSK Investigational Site
Degerberga, , Sweden
GSK Investigational Site
Gimo, , Sweden
GSK Investigational Site
Malmo, , Sweden
GSK Investigational Site
Stockholm, , Sweden
GSK Investigational Site
Aberdeen, Aberdeenshire, United Kingdom
GSK Investigational Site
Sandy, Bedfordshire, United Kingdom
GSK Investigational Site
Reading, Berkshire, United Kingdom
GSK Investigational Site
Llanelli, Carmarthenshire, United Kingdom
GSK Investigational Site
Warrington, Cheshire, United Kingdom
GSK Investigational Site
Bournemouth, Dorset, United Kingdom
GSK Investigational Site
Poole, Dorset, United Kingdom
GSK Investigational Site
Barry, Glamorgan, United Kingdom
GSK Investigational Site
Cardiff, Glamorgan, United Kingdom
GSK Investigational Site
Hemel Hempstead, Hertfordshire, United Kingdom
GSK Investigational Site
Stevenage, Hertfordshire, United Kingdom
GSK Investigational Site
Airdrie, Lanarkshire, United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom
GSK Investigational Site
Bolton, Lancashire, United Kingdom
GSK Investigational Site
Chorley, Lancashire, United Kingdom
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom
GSK Investigational Site
Wellingborough, Northamptonshire, United Kingdom
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom
GSK Investigational Site
Haverfordwest, Pembrokeshire, United Kingdom
GSK Investigational Site
Frome, Somerset, United Kingdom
GSK Investigational Site
Crawley, Sussex West, United Kingdom
GSK Investigational Site
Bradford, , United Kingdom
Countries
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References
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Viberti G, Kahn SE, Greene DA, Herman WH, Zinman B, Holman RR, Haffner SM, Levy D, Lachin JM, Berry RA, Heise MA, Jones NP, Freed MI. A diabetes outcome progression trial (ADOPT): an international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1737-43. doi: 10.2337/diacare.25.10.1737.
Viberti G, Lachin J, Holman R, Zinman B, Haffner S, Kravitz B, Heise MA, Jones NP, O'Neill MC, Freed MI, Kahn SE, Herman WH; ADOPT Study Group. A Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of Type 2 diabetic patients in North America and Europe. Diabet Med. 2006 Dec;23(12):1289-94. doi: 10.1111/j.1464-5491.2006.02022.x.
Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006 Dec 7;355(23):2427-43. doi: 10.1056/NEJMoa066224. Epub 2006 Dec 4.
Kahn SE, Zinman B, Haffner SM, O'Neill MC, Kravitz BG, Yu D, Freed MI, Herman WH, Holman RR, Jones NP, Lachin JM, Viberti GC; ADOPT Study Group. Obesity is a major determinant of the association of C-reactive protein levels and the metabolic syndrome in type 2 diabetes. Diabetes. 2006 Aug;55(8):2357-64. doi: 10.2337/db06-0116.
Zinman B, Kahn SE, Haffner SM, O'Neill MC, Heise MA, Freed MI; ADOPT Study Group. Phenotypic characteristics of GAD antibody-positive recently diagnosed patients with type 2 diabetes in North America and Europe. Diabetes. 2004 Dec;53(12):3193-200. doi: 10.2337/diabetes.53.12.3193.
El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
Lachin JM, Viberti G, Zinman B, Haffner SM, Aftring RP, Paul G, Kravitz BG, Herman WH, Holman RR, Kahn SE; ADOPT Study Group. Renal function in type 2 diabetes with rosiglitazone, metformin, and glyburide monotherapy. Clin J Am Soc Nephrol. 2011 May;6(5):1032-40. doi: 10.2215/CJN.09291010. Epub 2011 Mar 31.
Kahn SE, Haffner SM, Viberti G, Herman WH, Lachin JM, Kravitz BG, Yu D, Paul G, Holman RR, Zinman B; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone decreases C-reactive protein to a greater extent relative to glyburide and metformin over 4 years despite greater weight gain: observations from a Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2010 Jan;33(1):177-83. doi: 10.2337/dc09-1661. Epub 2009 Oct 6.
Kahn SE, Zinman B, Lachin JM, Haffner SM, Herman WH, Holman RR, Kravitz BG, Yu D, Heise MA, Aftring RP, Viberti G; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone-associated fractures in type 2 diabetes: an Analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2008 May;31(5):845-51. doi: 10.2337/dc07-2270. Epub 2008 Jan 25.
Study Documents
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Document Type: Informed Consent Form
View DocumentDocument Type: Statistical Analysis Plan
View DocumentDocument Type: Study Protocol
View DocumentDocument Type: Clinical Study Report
View DocumentDocument Type: Individual Participant Data Set
View DocumentDocument Type: Dataset Specification
View DocumentDocument Type: Annotated Case Report Form
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Other Identifiers
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49653/048
Identifier Type: -
Identifier Source: org_study_id