Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00279045 |
Recruitment Status :
Completed
First Posted : January 19, 2006
Last Update Posted : November 29, 2017
|
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
- Study Details
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- No Results Posted
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- How to Read a Study Record
Brief Summary:
The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: Rosiglitazone Drug: glyburide Drug: metformin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4426 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus |
Study Start Date : | January 3, 2000 |
Actual Primary Completion Date : | June 1, 2006 |
Actual Study Completion Date : | June 19, 2006 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Type 2 diabetes
Intervention Details:
- Drug: Rosiglitazone
- Drug: glyburide
- Drug: metformin
Other Names:
- glyburide
- Rosiglitazone
Primary Outcome Measures :
- Time from randomization to the primary action point (monotherapy failure).
Secondary Outcome Measures :
- Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP).
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Newly diagnosed patients (< 3years) with type 2 diabetes.
- Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
- No previous treatment with oral or parenteral glucose-lowering therapy.
Exclusion criteria:
- History of lactic acidosis.
- 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.
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279045
Locations


United States, Alabama | |
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Anniston, Alabama, United States, 36207 | |
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Birmingham, Alabama, United States, 35233 | |
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Mesa, Arizona, United States, 85206 | |
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Tucson, Arizona, United States, 85723 | |
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Little Rock, Arkansas, United States, 77205 | |
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Berkeley, California, United States, 94705 | |
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Corona, California, United States, 92879 | |
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Fair Oaks, California, United States, 95628 | |
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Fremont, California, United States, 94538 | |
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Fresno, California, United States, 93720 | |
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Fullerton, California, United States, 92835 | |
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Greenbrae, California, United States, 94904 | |
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Harbor City, California, United States, 90710 | |
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Healdsburg, California, United States, 95448 | |
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La Jolla, California, United States, 92037 | |
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Loma Linda, California, United States, 92354 | |
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Los Angeles, California, United States, 90059 | |
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Los Angeles, California, United States, 90095 | |
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Modesto, California, United States, 95355 | |
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Pasadena, California, United States, 91105 | |
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San Diego, California, United States, 92126 | |
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San Francisco, California, United States, 94143 | |
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Santa Rosa, California, United States, 95405 | |
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Sunnyvale, California, United States, 94086 | |
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Ukiah, California, United States, 95482 | |
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Walnut Creek, California, United States, 94598 | |
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Yorba Linda, California, United States, 92886 | |
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Boulder, Colorado, United States, 80304 | |
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Denver, Colorado, United States, 80209 | |
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Denver, Colorado, United States, 80220 | |
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Englewood, Colorado, United States, 80110 | |
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Longmont, Colorado, United States, 80501 | |
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Washington, District of Columbia, United States, 20003 | |
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Washington, District of Columbia, United States, 20037 | |
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Hollywood, Florida, United States, 33023 | |
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Jacksonville, Florida, United States, 32204 | |
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Jacksonville, Florida, United States, 32216 | |
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Melbourne, Florida, United States, 32935 | |
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Miami, Florida, United States, 33176 | |
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Orlando, Florida, United States, 32806 | |
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Palm Harbor, Florida, United States, 34683 | |
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Saint Petersburg, Florida, United States, 33702 | |
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Saint Petersburg, Florida, United States, 33710 | |
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Sarasota, Florida, United States, 34239 | |
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Tampa, Florida, United States, 33612 | |
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Titusville, Florida, United States, 32796 | |
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West Palm Beach, Florida, United States, 33401 | |
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Atlanta, Georgia, United States, 30308 | |
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Atlanta, Georgia, United States, 30312 | |
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Atlanta, Georgia, United States, 30322 | |
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Atlanta, Georgia, United States, 30328 | |
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Atlanta, Georgia, United States, 30338 | |
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Blue Ridge, Georgia, United States, 30513 | |
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Dunwoody, Georgia, United States, 30338 | |
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Fayetteville, Georgia, United States, 30214 | |
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Honolulu, Hawaii, United States, 96813 | |
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Chicago, Illinois, United States, 60612 | |
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Gurnee, Illinois, United States, 60031 | |
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Evansville, Indiana, United States, 47713 | |
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Indianapolis, Indiana, United States, 46202 | |
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Indianapolis, Indiana, United States, 46250 | |
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Lexington, Kentucky, United States, 40504-2681 | |
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Lake Charles, Louisiana, United States, 70601 | |
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New Orleans, Louisiana, United States, 70119 | |
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Slidell, Louisiana, United States, 70458 | |
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Slidell, Louisiana, United States, 70461 | |
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Bangor, Maine, United States, 04401 | |
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Baltimore, Maryland, United States, 21201 | |
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Baltimore, Maryland, United States, 21205 | |
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Boston, Massachusetts, United States, 02114 | |
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Springfield, Massachusetts, United States, 01199 | |
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Ann Arbor, Michigan, United States, 48109 | |
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Detroit, Michigan, United States, 48201 | |
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Lansing, Michigan, United States, 48912 | |
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Royal Oak, Michigan, United States, 48073 | |
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Minneapolis, Minnesota, United States, 55404 | |
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Minneapolis, Minnesota, United States, 55407-3799 | |
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Minneapolis, Minnesota, United States, 55416 | |
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Jackson, Mississippi, United States, 39202 | |
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Olive Branch, Mississippi, United States, 38654 | |
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Kansas City, Missouri, United States, 64132 | |
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Saint Louis, Missouri, United States, 63110 | |
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Saint Louis, Missouri, United States, 63128 | |
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Billings, Montana, United States, 59102 | |
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Henderson, Nevada, United States, 89014 | |
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Cherry Hill, New Jersey, United States, 08034 | |
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Cherry Hill, New Jersey, United States, 8034 | |
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Albuquerque, New Mexico, United States, 87102 | |
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Albuquerque, New Mexico, United States, 87106 | |
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Albuquerque, New Mexico, United States, 87109 | |
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Albany, New York, United States, 12206 | |
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Bronx, New York, United States, 10461 | |
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Endwell, New York, United States, 13760 | |
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Flushing, New York, United States, 11365 | |
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New York, New York, United States, 10003 | |
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New York, New York, United States, 10032 | |
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Rochester, New York, United States, 14609 | |
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Rochester, New York, United States, 14642 | |
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Syracuse, New York, United States, 13210 | |
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Durham, North Carolina, United States, 27710 | |
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Cincinnati, Ohio, United States, 45219 | |
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Cleveland, Ohio, United States, 44121 | |
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Cleveland, Ohio, United States, 44195 | |
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Mogadore, Ohio, United States, 44260 | |
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Westlake, Ohio, United States, 44145 | |
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Oklahoma City, Oklahoma, United States, 73104 | |
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Bend, Oregon, United States, 97701 | |
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Eugene, Oregon, United States, 97401 | |
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Portland, Oregon, United States, 97219 | |
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Portland, Oregon, United States, 97239 | |
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Downingtown, Pennsylvania, United States, 19335 | |
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Feasterville, Pennsylvania, United States, 19053 | |
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Fleetwood, Pennsylvania, United States, 19522 | |
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Hermitage, Pennsylvania, United States, 16148 | |
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Hershey, Pennsylvania, United States, 17033 | |
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Jefferson Hills, Pennsylvania, United States, 15025 | |
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Philadelphia, Pennsylvania, United States, 19104 | |
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Philadelphia, Pennsylvania, United States, 19107 | |
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Philadelphia, Pennsylvania, United States, 19115 | |
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Philadelphia, Pennsylvania, United States, 19148 | |
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Pittsburgh, Pennsylvania, United States, 15219 | |
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Upland, Pennsylvania, United States, 19013 | |
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Warminster, Pennsylvania, United States, 18974 | |
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Charleston, South Carolina, United States, 29403 | |
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Columbia, South Carolina, United States, 29201 | |
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Greer, South Carolina, United States, 29651 | |
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Spartanburg, South Carolina, United States, 29303 | |
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Bristol, Tennessee, United States, 37620 | |
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Nashville, Tennessee, United States, 37211 | |
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Arlington, Texas, United States, 76014 | |
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Austin, Texas, United States, 78745 | |
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Beaumont, Texas, United States, 77701 | |
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Corpus Christi, Texas, United States, 78411 | |
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Corpus Christi, Texas, United States, 78412 | |
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Dallas, Texas, United States, 75230 | |
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Dallas, Texas, United States, 75231 | |
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Dallas, Texas, United States, 75390 | |
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Fort Worth, Texas, United States, 76107 | |
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Houston, Texas, United States, 77024 | |
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Houston, Texas, United States, 77030 | |
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Irving, Texas, United States, 75061 | |
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Midland, Texas, United States, 79705 | |
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San Antonio, Texas, United States, 78207 | |
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San Antonio, Texas, United States, 78229 | |
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Ogden, Utah, United States, 84403 | |
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Salt Lake City, Utah, United States, 84103 | |
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Salt Lake City, Utah, United States, 84108 | |
United States, Virginia | |
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Charlottesville, Virginia, United States, 22908 | |
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Newport News, Virginia, United States, 23606 | |
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Richmond, Virginia, United States, 23249 | |
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Salem, Virginia, United States, 24153 | |
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Federal Way, Washington, United States, 98003 | |
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Seattle, Washington, United States, 98104 | |
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Seattle, Washington, United States, 98108 | |
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Seattle, Washington, United States, 98195 | |
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Spokane, Washington, United States, 99204 | |
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Spokane, Washington, United States, 99207 | |
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Spokane, Washington, United States, 99208 | |
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Wenatchee, Washington, United States, 98801 | |
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Charleston, West Virginia, United States, 25304 | |
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Huntington, West Virginia, United States, 25701 | |
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Madison, Wisconsin, United States, 53717 | |
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Milwaukee, Wisconsin, United States, 53209 | |
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Oregon, Wisconsin, United States, 53575 | |
Austria | |
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Vienna, Austria, A-1080 | |
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Vienna, Austria, A-1130 | |
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Wiener Neustadt, Austria, A-2700 | |
Belgium | |
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Blankenberge, Belgium, 8370 | |
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Boechout, Belgium, 2530 | |
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Deurne, Belgium, 2100 | |
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Leuven, Belgium, 3000 | |
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Lubbeek (Linden), Belgium, B-3210 | |
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Tielt, Belgium, 8700 | |
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Wezembeek-Oppem, Belgium, 1970 | |
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Wijnegem, Belgium, 2110 | |
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Zemst, Belgium, 1980 | |
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Calgary, Alberta, Canada, T2R 0X7 | |
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Edmonton, Alberta, Canada, T5N 3Y6 | |
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Edmonton, Alberta, Canada, T6G 2C8 | |
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Red Deer, Alberta, Canada, T4N 6V7 | |
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Coquitlam, British Columbia, Canada, V3K 3P4 | |
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Victoria, British Columbia, Canada, V8R 6T9 | |
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Winnipeg, Manitoba, Canada, R2H 2A6 | |
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Cambellton, New Brunswick, Canada, E3N 3S8 | |
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Moncton, New Brunswick, Canada, E1C 6Z8 | |
Canada, Newfoundland and Labrador | |
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Saint John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
Canada, Nova Scotia | |
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Antigonish, Nova Scotia, Canada, B2G 2C2 | |
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Halifax, Nova Scotia, Canada, B3H 1V7 | |
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Burlington, Ontario, Canada, L7M 4Y1 | |
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Kingston, Ontario, Canada, K7L 2V7 | |
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London, Ontario, Canada, N6A 4V2 | |
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Mississauga, Ontario, Canada, L5M 2N1 | |
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Oakville, Ontario, Canada, L6H 3P1 | |
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Ottawa, Ontario, Canada, K1H 7W9 | |
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Sudbury, Ontario, Canada, P3A 1Y8 | |
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Thornhill, Ontario, Canada, L4J 1V8 | |
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Thunder Bay, Ontario, Canada, P7B 2Z3 | |
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Timmins, Ontario, Canada, P4N 8P2 | |
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Toronto, Ontario, Canada, M5C 2T2 | |
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Windsor, Ontario, Canada, N8X 1K4 | |
Canada, Prince Edward Island | |
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Charlottetown, Prince Edward Island, Canada, C1A 1L2 | |
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Chicoutimi, Quebec, Canada, G7H 5H6 | |
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La Malbaie, Quebec, Canada, G5A 1W7 | |
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Laval, Quebec, Canada, H7T 2P5 | |
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Montreal, Quebec, Canada, H1T 2M4 | |
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Montreal, Quebec, Canada, H2W 1T8 | |
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Plessisville, Quebec, Canada, G6L 3J1 | |
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Saint Marc Des Carrieres, Quebec, Canada, G0A 4B0 | |
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Sainte-Foy, Quebec, Canada, G1V 4G5 | |
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Sherbrooke, Quebec, Canada, J1H 5N4 | |
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St-Isidore De Dorchester, Quebec, Canada, G0S 2S0 | |
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Regina, Saskatchewan, Canada, S4P 0W5 | |
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Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
Czechia | |
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Ostrava, Czechia, 703 52 | |
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Phaha 5, Czechia, 150 06 | |
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Praha 4, Czechia, 142 00 | |
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Usti Nad Labem, Czechia, 401 13 | |
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Zlin, Czechia, 762 75 | |
Denmark | |
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Frederiksberg C, Denmark, 1900 | |
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Odense, Denmark, 5000 | |
Finland | |
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Hanko, Finland, 10900 | |
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Helsinki, Finland, 00150 | |
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Jyvaskyla, Finland, 40100 | |
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Lmatra, Finland, 55800 | |
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Savitaipale, Finland, 54800 | |
France | |
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Alben, France, 73410 | |
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Bezier, France, 34500 | |
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Bourges, France, 18000 | |
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Brogile, France, 27270 | |
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Chartres, France, 28000 | |
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Denguin, France, 64230 | |
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Evreux, France, 27000 | |
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Gamarde Les Bains, France, 40380 | |
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La Rochelle, France, 17000 | |
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Labarthe Sur Leze, France, 31860 | |
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Le Mans, France, 72000 | |
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Le Pian Medoc, France, 33290 | |
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Lille, France, 59000 | |
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Mallemort, France, 13370 | |
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Marseille, France, 13001 | |
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Marseille, France, 13008 | |
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Marsillargues, France, 34590 | |
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Marssac, France, 81150 | |
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Mont De Marsen, France, 40000 | |
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Montignac, France, 24290 | |
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Moulon, France, 33420 | |
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Nantes Cedex 01, France, 44093 | |
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Orthez, France, 64300 | |
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Paris, France, 75015 | |
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Rennes, France, 35200 | |
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Saint Etienne, France, 42000 | |
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Saint Genies Des Fontaines, France, 66740 | |
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St Martin D'Heres, France, 38400 | |
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Strasbourg, France, 67000 | |
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Tarare, France, 69170 | |
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Vieux Conde, France, 59690 | |
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Vourey, France, 38210 | |
Germany | |
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Bad Rappenau, Baden-Wuerttemberg, Germany, 74906 | |
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Deggingen, Baden-Wuerttemberg, Germany, 73326 | |
GSK Investigational Site | |
Mannheim, Baden-Wuerttemberg, Germany, 68161 | |
GSK Investigational Site | |
Trochtelfingen, Baden-Wuerttemberg, Germany, 72818 | |
GSK Investigational Site | |
Unterschneidheim, Baden-Wuerttemberg, Germany, 73485 | |
GSK Investigational Site | |
Wangen, Baden-Wuerttemberg, Germany, 88239 | |
GSK Investigational Site | |
Weinheim, Baden-Wuerttemberg, Germany, 69469 | |
GSK Investigational Site | |
Aschaffenburg, Bayern, Germany, 63739 | |
GSK Investigational Site | |
Haag, Bayern, Germany, 83527 | |
GSK Investigational Site | |
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635 | |
GSK Investigational Site | |
Ismaning, Bayern, Germany, 85737 | |
GSK Investigational Site | |
Krummenaab, Bayern, Germany, 92703 | |
GSK Investigational Site | |
Kuenzing, Bayern, Germany, 94550 | |
GSK Investigational Site | |
Landshut, Bayern, Germany, 84028 | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 80339 | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 80469 | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 80805 | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 80807 | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 80937 | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 81379 | |
GSK Investigational Site | |
Nuernberg, Bayern, Germany, 90427 | |
GSK Investigational Site | |
Wallerfing, Bayern, Germany, 94574 | |
GSK Investigational Site | |
Bad Kreuznach, Hessen, Germany, 55545 | |
GSK Investigational Site | |
Frankfurt, Hessen, Germany, 60326 | |
GSK Investigational Site | |
Grossalmerode, Hessen, Germany, 37247 | |
GSK Investigational Site | |
Lollar, Hessen, Germany, 35475 | |
GSK Investigational Site | |
Offenbach, Hessen, Germany, 63065 | |
GSK Investigational Site | |
Offenbach, Hessen, Germany, 63067 | |
GSK Investigational Site | |
Offenbach, Hessen, Germany, 63071 | |
GSK Investigational Site | |
Offenbach, Hessen, Germany, 63073 | |
GSK Investigational Site | |
Schaafheim, Hessen, Germany, 64850 | |
GSK Investigational Site | |
Vellmar, Hessen, Germany, 34246 | |
GSK Investigational Site | |
Damme, Niedersachsen, Germany, 49401 | |
GSK Investigational Site | |
Hannover, Niedersachsen, Germany, 30171 | |
GSK Investigational Site | |
Hannover, Niedersachsen, Germany, 30177 | |
GSK Investigational Site | |
Hildesheim, Niedersachsen, Germany, 31139 | |
GSK Investigational Site | |
Lueneburg, Niedersachsen, Germany, 21335 | |
GSK Investigational Site | |
Paderborn, Niedersachsen, Germany, 33100 | |
GSK Investigational Site | |
Winsen/Lohe, Niedersachsen, Germany, 21423 | |
GSK Investigational Site | |
Beckum, Nordrhein-Westfalen, Germany, 59269 | |
GSK Investigational Site | |
Bergkamen, Nordrhein-Westfalen, Germany, 59192 | |
GSK Investigational Site | |
Borken, Nordrhein-Westfalen, Germany, 46325 | |
GSK Investigational Site | |
Dortmund, Nordrhein-Westfalen, Germany, 44137 | |
GSK Investigational Site | |
Duisburg, Nordrhein-Westfalen, Germany, 47119 | |
GSK Investigational Site | |
Essen, Nordrhein-Westfalen, Germany, 45130 | |
GSK Investigational Site | |
Euskirchen, Nordrhein-Westfalen, Germany, 53879 | |
GSK Investigational Site | |
Goch, Nordrhein-Westfalen, Germany, 47574 | |
GSK Investigational Site | |
Luedenscheid, Nordrhein-Westfalen, Germany, 58511 | |
GSK Investigational Site | |
Luenen, Nordrhein-Westfalen, Germany, 44534 | |
GSK Investigational Site | |
Neuss, Nordrhein-Westfalen, Germany, 41460 | |
GSK Investigational Site | |
Schwabenheim, Nordrhein-Westfalen, Germany, 55270 | |
GSK Investigational Site | |
Siegen, Nordrhein-Westfalen, Germany, 57072 | |
GSK Investigational Site | |
Warendorf, Nordrhein-Westfalen, Germany, 48231 | |
GSK Investigational Site | |
Deidesheim, Rheinland-Pfalz, Germany, 67146 | |
GSK Investigational Site | |
Diez, Rheinland-Pfalz, Germany, 65582 | |
GSK Investigational Site | |
Lambrecht, Rheinland-Pfalz, Germany, 67466 | |
GSK Investigational Site | |
Rhaunen, Rheinland-Pfalz, Germany, 55624 | |
GSK Investigational Site | |
Chemnitz, Sachsen, Germany, 09130 | |
GSK Investigational Site | |
Dresden, Sachsen, Germany, 01129 | |
GSK Investigational Site | |
Dresden, Sachsen, Germany, 01187 | |
GSK Investigational Site | |
Dresden, Sachsen, Germany, 01309 | |
GSK Investigational Site | |
Freital, Sachsen, Germany, 01705 | |
GSK Investigational Site | |
Pirna, Sachsen, Germany, 01796 | |
GSK Investigational Site | |
Schmiedeberg, Sachsen, Germany, 01762 | |
GSK Investigational Site | |
Itzehoe, Schleswig-Holstein, Germany, 25524 | |
GSK Investigational Site | |
Ratzeburg, Schleswig-Holstein, Germany, 23909 | |
GSK Investigational Site | |
Wahlstedt, Schleswig-Holstein, Germany, 23812 | |
GSK Investigational Site | |
Wilster, Schleswig-Holstein, Germany, 25554 | |
GSK Investigational Site | |
Berlin, Germany, 13057 | |
GSK Investigational Site | |
Berlin, Germany, 13355 | |
GSK Investigational Site | |
Hamburg, Germany, 22041 | |
GSK Investigational Site | |
Hamburg, Germany, 22607 | |
Hungary | |
GSK Investigational Site | |
Budapest, Hungary, 1076 | |
GSK Investigational Site | |
Miskolc, Hungary, 3526 | |
Ireland | |
GSK Investigational Site | |
Belfast, Ireland, BT16 ORH | |
GSK Investigational Site | |
Co. Tipperary, Ireland | |
GSK Investigational Site | |
Cork, Ireland | |
GSK Investigational Site | |
Dublin, Ireland, 15 | |
GSK Investigational Site | |
Dublin, Ireland, 24 | |
GSK Investigational Site | |
Dublin, Ireland, 4 | |
GSK Investigational Site | |
Dublin, Ireland, 7 | |
GSK Investigational Site | |
Dublin, Ireland, 8 | |
GSK Investigational Site | |
Gowran, Ireland | |
GSK Investigational Site | |
Kilkenny, Ireland | |
Italy | |
GSK Investigational Site | |
Ferrara, Emilia-Romagna, Italy, 44100 | |
GSK Investigational Site | |
Ravenna, Emilia-Romagna, Italy, 48100 | |
GSK Investigational Site | |
Scandiano (RE), Emilia-Romagna, Italy, 42019 | |
GSK Investigational Site | |
Rozzano (MI), Lombardia, Italy, 20089 | |
GSK Investigational Site | |
Acquaviva Delle Fonti (BA), Puglia, Italy, 70021 | |
GSK Investigational Site | |
Catania, Sicilia, Italy, 95100 | |
GSK Investigational Site | |
Città Di Castello (PG), Umbria, Italy, 06012 | |
GSK Investigational Site | |
Firenze, Italy, 50134 | |
GSK Investigational Site | |
La Spezia, Italy, 19100 | |
GSK Investigational Site | |
Lecce, Italy, 73100 | |
GSK Investigational Site | |
Milano, Italy, 20132 | |
GSK Investigational Site | |
Palermo, Italy, 90127 | |
GSK Investigational Site | |
Parma, Italy, 43100 | |
GSK Investigational Site | |
Perugia, Italy, 06126 | |
GSK Investigational Site | |
Rovigo, Italy, 45100 | |
GSK Investigational Site | |
S. Benedetto TR (AP), Italy | |
GSK Investigational Site | |
San Giovanni Rotondo FG, Italy | |
GSK Investigational Site | |
Sassari, Italy | |
GSK Investigational Site | |
Terni, Italy, 05100 | |
GSK Investigational Site | |
Torino, Italy, 10126 | |
GSK Investigational Site | |
Udine, Italy, 33100 | |
GSK Investigational Site | |
Vicenza, Italy, 36100 | |
Netherlands | |
GSK Investigational Site | |
De Bilt, Netherlands, 3731 DN | |
GSK Investigational Site | |
Den Bosch, Netherlands, 5223 GV | |
GSK Investigational Site | |
Geleen, Netherlands, 6166 GR | |
GSK Investigational Site | |
Hengelo, Netherlands, 7555 DL | |
GSK Investigational Site | |
Huizen, Netherlands, 1271 BB | |
GSK Investigational Site | |
Losser, Netherlands, 7581 BV | |
GSK Investigational Site | |
Losser, Netherlands, 7582 BD | |
GSK Investigational Site | |
Rijswijk, Netherlands, 2281 AK | |
GSK Investigational Site | |
Roelofarendsveen, Netherlands, 2371 RB | |
GSK Investigational Site | |
Woerden, Netherlands, 3443 GG | |
Norway | |
GSK Investigational Site | |
Hamar, Norway, 2317 | |
GSK Investigational Site | |
Paradis, Norway, 5231 | |
GSK Investigational Site | |
Skedsmokorset, Norway, N-2020 | |
Spain | |
GSK Investigational Site | |
Albaida (Valencia), Spain | |
GSK Investigational Site | |
Basurto/Bilbao, Spain, 48013 | |
GSK Investigational Site | |
Benassal (Castellón), Spain, 12160 | |
GSK Investigational Site | |
Benicasim (Castellón), Spain | |
GSK Investigational Site | |
Bilbao, Spain, 48013 | |
GSK Investigational Site | |
Cartagena, Spain, 30203 | |
GSK Investigational Site | |
Cáceres, Spain, 10005 | |
GSK Investigational Site | |
El Palmar (Murcia), Spain, 30120 | |
GSK Investigational Site | |
Elche (Alicante), Spain, 03202 | |
GSK Investigational Site | |
Elda-Alicante, Spain, 03600 | |
GSK Investigational Site | |
Figueras, Spain, 17600 | |
GSK Investigational Site | |
Gerona, Spain | |
GSK Investigational Site | |
Granollers (Barcelona), Spain, 08400 | |
GSK Investigational Site | |
Jerez (Cadiz), Spain, 11047 | |
GSK Investigational Site | |
Madrid, Spain, 28006 | |
GSK Investigational Site | |
Madrid, Spain, 28046 | |
GSK Investigational Site | |
Malaga, Spain, 29009 | |
GSK Investigational Site | |
Mataro, Spain, 08034 | |
GSK Investigational Site | |
Merida, Spain, 6800 | |
GSK Investigational Site | |
Olleria, Valencia, Spain, 46850 | |
GSK Investigational Site | |
Onda/Castellón, Spain, 12200 | |
GSK Investigational Site | |
Orihuela (Alicante), Spain, 03314 | |
GSK Investigational Site | |
Plasencia, Spain, 10600 | |
GSK Investigational Site | |
Pontevedra, Spain, 36071 | |
GSK Investigational Site | |
Sagunto/Valencia, Spain, 46520 | |
GSK Investigational Site | |
San Juan (Alicante), Spain, 03550 | |
GSK Investigational Site | |
San Vincente Raspeig (Alicante), Spain, 03690 | |
GSK Investigational Site | |
Santa Coloma De Gramanet (Barcelona), Spain, 08923 | |
GSK Investigational Site | |
Tenerife, Spain, 38010 | |
GSK Investigational Site | |
Tereul, Spain, 44002 | |
GSK Investigational Site | |
Toledo, Spain, 45004 | |
GSK Investigational Site | |
Torrelavega/Santander, Spain, 39300 | |
GSK Investigational Site | |
Valencia, Spain, 46017 | |
GSK Investigational Site | |
Valencia, Spain, 46830 | |
GSK Investigational Site | |
Valencia, Spain | |
GSK Investigational Site | |
Valladolid, Spain, 47010 | |
GSK Investigational Site | |
Vallda (Valencia), Spain | |
GSK Investigational Site | |
Villajoyosa - Alicante, Spain, 03570 | |
GSK Investigational Site | |
Zamora, Spain, 49021 | |
GSK Investigational Site | |
Zaragoza, Spain, 50003 | |
Sweden | |
GSK Investigational Site | |
Alta, Sweden, 138 21 | |
GSK Investigational Site | |
Degerberga, Sweden, 297 31 | |
GSK Investigational Site | |
Gimo, Sweden, SE-747 43 | |
GSK Investigational Site | |
Malmö, Sweden, SE-214 26 | |
GSK Investigational Site | |
Stockholm, Sweden, SE-114 35 | |
United Kingdom | |
GSK Investigational Site | |
Aberdeen, Aberdeenshire, United Kingdom, AB25 2AY | |
GSK Investigational Site | |
Sandy, Bedfordshire, United Kingdom, SG19 3JR | |
GSK Investigational Site | |
Reading, Berkshire, United Kingdom, RG2 7AG | |
GSK Investigational Site | |
Llanelli, Carmarthenshire, United Kingdom, SA14 8QF | |
GSK Investigational Site | |
Warrington, Cheshire, United Kingdom, WA5 1QC | |
GSK Investigational Site | |
Bournemouth, Dorset, United Kingdom, BH7 7DW | |
GSK Investigational Site | |
Poole, Dorset, United Kingdom | |
GSK Investigational Site | |
Barry, Glamorgan, United Kingdom, CF63 4HP | |
GSK Investigational Site | |
Cardiff, Glamorgan, United Kingdom, CF14 9BB | |
GSK Investigational Site | |
Hemel Hempstead, Hertfordshire, United Kingdom, HP2 4AD | |
GSK Investigational Site | |
Stevenage, Hertfordshire, United Kingdom | |
GSK Investigational Site | |
Airdrie, Lanarkshire, United Kingdom, ML6 0JS | |
GSK Investigational Site | |
Glasgow, Lanarkshire, United Kingdom, G81 4SA | |
GSK Investigational Site | |
Bolton, Lancashire, United Kingdom | |
GSK Investigational Site | |
Chorley, Lancashire, United Kingdom, PR7 1NY | |
GSK Investigational Site | |
Edinburgh, Midlothian, United Kingdom, EH3 9YW | |
GSK Investigational Site | |
Wellingborough, Northamptonshire, United Kingdom, NN8 4RW | |
GSK Investigational Site | |
Nottingham, Nottinghamshire, United Kingdom, NG3 7DQ | |
GSK Investigational Site | |
Haverfordwest, Pembrokeshire, United Kingdom, SA61 1RN | |
GSK Investigational Site | |
Frome, Somerset, United Kingdom, BA11 1EZ | |
GSK Investigational Site | |
Crawley, Sussex West, United Kingdom, RH10 1LL | |
GSK Investigational Site | |
Nuneaton, Warwickshire, United Kingdom, CV10 7DJ | |
GSK Investigational Site | |
Rugby, Warwickshire, United Kingdom, CV21 3SP | |
GSK Investigational Site | |
Livingston, West Lothian, United Kingdom, EH54 6PP | |
GSK Investigational Site | |
Melksham, Wiltshire, United Kingdom, SN12 6UN | |
GSK Investigational Site | |
Trowbridge, Wiltshire, United Kingdom, BA14 8TG | |
GSK Investigational Site | |
Barnsley, United Kingdom, S70 3RJ | |
GSK Investigational Site | |
Bath, United Kingdom, BA2 3HT | |
GSK Investigational Site | |
Bradford, United Kingdom, BD7 3EE | |
GSK Investigational Site | |
Cardiff, United Kingdom, CF5 4AE | |
GSK Investigational Site | |
Co.Antrim, United Kingdom | |
GSK Investigational Site | |
Doncaster, United Kingdom, DN1 2EG | |
GSK Investigational Site | |
Doncaster, United Kingdom, DN9 1EP | |
GSK Investigational Site | |
Gateshead, United Kingdom, NE9 6SX | |
GSK Investigational Site | |
Glasgow, United Kingdom, G51 4TF | |
GSK Investigational Site | |
Glenrothes, United Kingdom | |
GSK Investigational Site | |
Irvine, United Kingdom, KA12 OAY | |
GSK Investigational Site | |
Kent, United Kingdom, TN11 9HL | |
GSK Investigational Site | |
Leicester, United Kingdom, LE3 8GS | |
GSK Investigational Site | |
London, United Kingdom, SE1 9RT | |
GSK Investigational Site | |
London, United Kingdom, W1M 7AB | |
GSK Investigational Site | |
Newtownabbey, United Kingdom, BT36 4PP | |
GSK Investigational Site | |
Peterborough, United Kingdom, PE7 3JL | |
GSK Investigational Site | |
Swansea, United Kingdom, SA4 4BY | |
GSK Investigational Site | |
Wakefield, United Kingdom, WF1 4DG | |
GSK Investigational Site | |
Wigan, United Kingdom, WN1 1XX |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Informed Consent Form
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Study Data/Documents: Informed Consent Form

Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan


Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol


Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report


Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set


Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification


Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form


Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Publications of Results:
A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care, Vol 25, No. 10, October, 2002.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00279045 |
Other Study ID Numbers: |
49653/048 |
First Posted: | January 19, 2006 Key Record Dates |
Last Update Posted: | November 29, 2017 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
Keywords provided by GlaxoSmithKline:
type 2 diabetes monotherapy treatment naive |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Rosiglitazone Glyburide Hypoglycemic Agents Physiological Effects of Drugs |