Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
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
1 other identifier
interventional
4,426
17 countries
490
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Jan 2000
Longer than P75 for phase_3 diabetes-mellitus-type-2
490 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2000
CompletedFirst Submitted
Initial submission to the registry
January 17, 2006
CompletedFirst Posted
Study publicly available on registry
January 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2006
CompletedNovember 29, 2017
November 1, 2017
6.4 years
January 17, 2006
November 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from randomization to the primary action point (monotherapy failure).
Secondary Outcomes (1)
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).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (490)
GSK Investigational Site
Anniston, Alabama, 36207, United States
GSK Investigational Site
Birmingham, Alabama, 35233, United States
GSK Investigational Site
Mesa, Arizona, 85206, United States
GSK Investigational Site
Tucson, Arizona, 85723, United States
GSK Investigational Site
Little Rock, Arkansas, 77205, United States
GSK Investigational Site
Berkeley, California, 94705, United States
GSK Investigational Site
Corona, California, 92879, United States
GSK Investigational Site
Fair Oaks, California, 95628, United States
GSK Investigational Site
Fremont, California, 94538, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Fullerton, California, 92835, United States
GSK Investigational Site
Greenbrae, California, 94904, United States
GSK Investigational Site
Harbor City, California, 90710, United States
GSK Investigational Site
Healdsburg, California, 95448, United States
GSK Investigational Site
La Jolla, California, 92037, United States
GSK Investigational Site
Loma Linda, California, 92354, United States
GSK Investigational Site
Los Angeles, California, 90059, United States
GSK Investigational Site
Los Angeles, California, 90095, United States
GSK Investigational Site
Modesto, California, 95355, United States
GSK Investigational Site
Pasadena, California, 91105, United States
GSK Investigational Site
San Diego, California, 92126, United States
GSK Investigational Site
San Francisco, California, 94143, United States
GSK Investigational Site
Santa Rosa, California, 95405, United States
GSK Investigational Site
Sunnyvale, California, 94086, United States
GSK Investigational Site
Ukiah, California, 95482, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Yorba Linda, California, 92886, United States
GSK Investigational Site
Boulder, Colorado, 80304, United States
GSK Investigational Site
Denver, Colorado, 80209, United States
GSK Investigational Site
Denver, Colorado, 80220, United States
GSK Investigational Site
Englewood, Colorado, 80110, United States
GSK Investigational Site
Longmont, Colorado, 80501, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80043, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20003, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Fort Myers, Florida, 33907, United States
GSK Investigational Site
Hollywood, Florida, 33023, United States
GSK Investigational Site
Jacksonville, Florida, 32204, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Melbourne, Florida, 32935, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Miami, Florida, 33176, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
Palm Harbor, Florida, 34683, United States
GSK Investigational Site
Sarasota, Florida, 34239, United States
GSK Investigational Site
St. Petersburg, Florida, 33702, United States
GSK Investigational Site
St. Petersburg, Florida, 33710, United States
GSK Investigational Site
Tampa, Florida, 33612, United States
GSK Investigational Site
Titusville, Florida, 32796, United States
GSK Investigational Site
West Palm Beach, Florida, 33401, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Atlanta, Georgia, 30312, United States
GSK Investigational Site
Atlanta, Georgia, 30322, United States
GSK Investigational Site
Atlanta, Georgia, 30328, United States
GSK Investigational Site
Atlanta, Georgia, 30338, United States
GSK Investigational Site
Blue Ridge, Georgia, 30513, United States
GSK Investigational Site
Dunwoody, Georgia, 30338, United States
GSK Investigational Site
Fayetteville, Georgia, 30214, United States
GSK Investigational Site
Honolulu, Hawaii, 96813, United States
GSK Investigational Site
Boise, Idaho, 83706, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Gurnee, Illinois, 60031, United States
GSK Investigational Site
Springfield, Illinois, 62704, United States
GSK Investigational Site
Evansville, Indiana, 47713, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Indianapolis, Indiana, 46250, United States
GSK Investigational Site
Lexington, Kentucky, 40504-2681, United States
GSK Investigational Site
Lake Charles, Louisiana, 70601, United States
GSK Investigational Site
New Orleans, Louisiana, 70119, United States
GSK Investigational Site
Slidell, Louisiana, 70458, United States
GSK Investigational Site
Slidell, Louisiana, 70461, United States
GSK Investigational Site
Bangor, Maine, 04401, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
GSK Investigational Site
Baltimore, Maryland, 21204, United States
GSK Investigational Site
Baltimore, Maryland, 21205, United States
GSK Investigational Site
Baltimore, Maryland, 21208, United States
GSK Investigational Site
Boston, Massachusetts, 02114, United States
GSK Investigational Site
Springfield, Massachusetts, 01199, United States
GSK Investigational Site
Ann Arbor, Michigan, 48109, United States
GSK Investigational Site
Detroit, Michigan, 48201, United States
GSK Investigational Site
Lansing, Michigan, 48912, United States
GSK Investigational Site
Royal Oak, Michigan, 48073, United States
GSK Investigational Site
Minneapolis, Minnesota, 55404, United States
GSK Investigational Site
Minneapolis, Minnesota, 55407-3799, United States
GSK Investigational Site
Minneapolis, Minnesota, 55416, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
Olive Branch, Mississippi, 38654, United States
GSK Investigational Site
Kansas City, Missouri, 64132, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
St Louis, Missouri, 63128, United States
GSK Investigational Site
Billings, Montana, 59102, United States
GSK Investigational Site
Omaha, Nebraska, 68105, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Henderson, Nevada, 89014, United States
GSK Investigational Site
Cherry Hill, New Jersey, 08034, United States
GSK Investigational Site
Cherry Hill, New Jersey, 8034, United States
GSK Investigational Site
Albuquerque, New Mexico, 87102, United States
GSK Investigational Site
Albuquerque, New Mexico, 87106, United States
GSK Investigational Site
Albuquerque, New Mexico, 87109, United States
GSK Investigational Site
Albany, New York, 12206, United States
GSK Investigational Site
Endwell, New York, 13760, United States
GSK Investigational Site
Flushing, New York, 11365, United States
GSK Investigational Site
New York, New York, 10003, United States
GSK Investigational Site
New York, New York, 10010, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
Rochester, New York, 14609, United States
GSK Investigational Site
Rochester, New York, 14642, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Cleveland, Ohio, 44121, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Mogadore, Ohio, 44260, United States
GSK Investigational Site
Westlake, Ohio, 44145, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Bend, Oregon, 97701, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Portland, Oregon, 97219, United States
GSK Investigational Site
Portland, Oregon, 97239, United States
GSK Investigational Site
Downingtown, Pennsylvania, 19335, United States
GSK Investigational Site
Feasterville, Pennsylvania, 19053, United States
GSK Investigational Site
Fleetwood, Pennsylvania, 19522, United States
GSK Investigational Site
Hermitage, Pennsylvania, 16148, United States
GSK Investigational Site
Hershey, Pennsylvania, 17033, United States
GSK Investigational Site
Jefferson Hills, Pennsylvania, 15025, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19104, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19115, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19148, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15219, United States
GSK Investigational Site
Upland, Pennsylvania, 19013, United States
GSK Investigational Site
Warminster, Pennsylvania, 18974, United States
GSK Investigational Site
West Chester, Pennsylvania, 19380, United States
GSK Investigational Site
Charleston, South Carolina, 29403, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Nashville, Tennessee, 37211, United States
GSK Investigational Site
Arlington, Texas, 76014, United States
GSK Investigational Site
Austin, Texas, 78745, United States
GSK Investigational Site
Beaumont, Texas, 77701, United States
GSK Investigational Site
Corpus Christi, Texas, 78411, United States
GSK Investigational Site
Corpus Christi, Texas, 78412, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Dallas, Texas, 75390, United States
GSK Investigational Site
Fort Worth, Texas, 76107, United States
GSK Investigational Site
Houston, Texas, 77024, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Irving, Texas, 75061, United States
GSK Investigational Site
Midland, Texas, 79705, United States
GSK Investigational Site
San Antonio, Texas, 78207, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Ogden, Utah, 84403, United States
GSK Investigational Site
Salt Lake City, Utah, 84103, United States
GSK Investigational Site
Salt Lake City, Utah, 84108, United States
GSK Investigational Site
Charlottesville, Virginia, 22908, United States
GSK Investigational Site
Newport News, Virginia, 23606, United States
GSK Investigational Site
Richmond, Virginia, 23249, United States
GSK Investigational Site
Salem, Virginia, 24153, United States
GSK Investigational Site
Federal Way, Washington, 98003, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
GSK Investigational Site
Seattle, Washington, 98108, United States
GSK Investigational Site
Seattle, Washington, 98195, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Spokane, Washington, 99207, United States
GSK Investigational Site
Spokane, Washington, 99208, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Charleston, West Virginia, 25304, United States
GSK Investigational Site
Huntington, West Virginia, 25701, United States
GSK Investigational Site
Madison, Wisconsin, 53717, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53209, United States
GSK Investigational Site
Oregon, Wisconsin, 53575, United States
GSK Investigational Site
Vienna, A-1080, Austria
GSK Investigational Site
Vienna, A-1130, Austria
GSK Investigational Site
Wiener Neustadt, A-2700, Austria
GSK Investigational Site
Blankenberge, 8370, Belgium
GSK Investigational Site
Boechout, 2530, Belgium
GSK Investigational Site
Deurne, 2100, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Lubbeek (Linden), B-3210, Belgium
GSK Investigational Site
Tielt, 8700, Belgium
GSK Investigational Site
Wezembeek-Oppem, 1970, Belgium
GSK Investigational Site
Wijnegem, 2110, Belgium
GSK Investigational Site
Zemst, 1980, Belgium
GSK Investigational Site
Calgary, Alberta, T2R 0X7, Canada
GSK Investigational Site
Edmonton, Alberta, T5N 3Y6, Canada
GSK Investigational Site
Edmonton, Alberta, T6G 2C8, Canada
GSK Investigational Site
Red Deer, Alberta, T4N 6V7, Canada
GSK Investigational Site
Coquitlam, British Columbia, V3K 3P4, Canada
GSK Investigational Site
Vancouver, British Columbia, V5Z 1M9, Canada
GSK Investigational Site
Victoria, British Columbia, V8R 6T9, Canada
GSK Investigational Site
Winnipeg, Manitoba, R2H 2A6, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3E 3P4, Canada
GSK Investigational Site
Cambellton, New Brunswick, E3N 3S8, Canada
GSK Investigational Site
Moncton, New Brunswick, E1C 6Z8, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
GSK Investigational Site
Antigonish, Nova Scotia, B2G 2C2, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3H 1V7, Canada
GSK Investigational Site
Burlington, Ontario, L7M 4Y1, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3A 1Y8, Canada
GSK Investigational Site
Kingston, Ontario, K7L 2V7, Canada
GSK Investigational Site
London, Ontario, N6A 4V2, Canada
GSK Investigational Site
Mississauga, Ontario, L5M 2N1, Canada
GSK Investigational Site
Oakville, Ontario, L6H 3P1, Canada
GSK Investigational Site
Ottawa, Ontario, K1H 7W9, Canada
GSK Investigational Site
Thornhill, Ontario, L4J 1V8, Canada
GSK Investigational Site
Thunder Bay, Ontario, P7B 2Z3, Canada
GSK Investigational Site
Timmins, Ontario, P4N 8P2, Canada
GSK Investigational Site
Toronto, Ontario, M5C 2T2, Canada
GSK Investigational Site
Windsor, Ontario, N8X 1K4, Canada
GSK Investigational Site
Charlottetown, Prince Edward Island, C1A 1L2, Canada
GSK Investigational Site
Chicoutimi, Quebec, G7H 5H6, Canada
GSK Investigational Site
La Malbaie, Quebec, G5A 1W7, Canada
GSK Investigational Site
Laval, Quebec, H7T 2P5, Canada
GSK Investigational Site
Montreal, Quebec, H1T 2M4, Canada
GSK Investigational Site
Montreal, Quebec, H2W 1T8, Canada
GSK Investigational Site
Plessisville, Quebec, G6L 3J1, Canada
GSK Investigational Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 5N4, Canada
GSK Investigational Site
St-Isidore de Dorchester, Quebec, G0S 2S0, Canada
GSK Investigational Site
Regina, Saskatchewan, S4P 0W5, Canada
GSK Investigational Site
Saskatoon, Saskatchewan, S7N 0W8, Canada
GSK Investigational Site
Ostrava, 703 52, Czechia
GSK Investigational Site
Phaha 5, 150 06, Czechia
GSK Investigational Site
Prague, 142 00, Czechia
GSK Investigational Site
Ústí nad Labem, 401 13, Czechia
GSK Investigational Site
Zlín, 762 75, Czechia
GSK Investigational Site
Frederiksberg C, 1900, Denmark
GSK Investigational Site
Odense, 5000, Denmark
GSK Investigational Site
Hanko, 10900, Finland
GSK Investigational Site
Helsinki, 00150, Finland
GSK Investigational Site
Jyväskylä, 40100, Finland
GSK Investigational Site
Lmatra, 55800, Finland
GSK Investigational Site
Savitaipale, 54800, Finland
GSK Investigational Site
Alben, 73410, France
GSK Investigational Site
Bezier, 34500, France
GSK Investigational Site
Bourges, 18000, France
GSK Investigational Site
Brogile, 27270, France
GSK Investigational Site
Chartres, 28000, France
GSK Investigational Site
Denguin, 64230, France
GSK Investigational Site
Évreux, 27000, France
GSK Investigational Site
Gamarde-les-Bains, 40380, France
GSK Investigational Site
La Rochelle, 17000, France
GSK Investigational Site
Labarthe-sur-Lèze, 31860, France
GSK Investigational Site
Le Mans, 72000, France
GSK Investigational Site
Le Pian-Médoc, 33290, France
GSK Investigational Site
Lille, 59000, France
GSK Investigational Site
Mallemort, 13370, France
GSK Investigational Site
Marseille, 13001, France
GSK Investigational Site
Marseille, 13008, France
GSK Investigational Site
Marsillargues, 34590, France
GSK Investigational Site
Marssac-sur-Tarn, 81150, France
GSK Investigational Site
Mont de Marsen, 40000, France
GSK Investigational Site
Montignac, 24290, France
GSK Investigational Site
Moulon, 33420, France
GSK Investigational Site
Mûrs-Erigné, 49610, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Nantes, 44300, France
GSK Investigational Site
Nîmes, 30900, France
GSK Investigational Site
Orthez, 64300, France
GSK Investigational Site
Paris, 75015, France
GSK Investigational Site
Rennes, 35200, France
GSK Investigational Site
Roanna, 42300, France
GSK Investigational Site
Saint Genies Des Fontaines, 66740, France
GSK Investigational Site
Saint-Etienne, 42000, France
GSK Investigational Site
Saint-Julien-des-Landes, 85150, France
GSK Investigational Site
Saint-Martin-d'Hères, 38400, France
GSK Investigational Site
Saint-Pierre-de-Chandieu, 69780, France
GSK Investigational Site
Sisteron, 04200, France
GSK Investigational Site
Strasbourg, 67000, France
GSK Investigational Site
Tarare, 69170, France
GSK Investigational Site
Vieux-Condé, 59690, France
GSK Investigational Site
Vourey, 38210, France
GSK Investigational Site
Bad Rappenau, Baden-Wurttemberg, 74906, Germany
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Trochtelfingen, Baden-Wurttemberg, 72818, Germany
GSK Investigational Site
Unterschneidheim, Baden-Wurttemberg, 73485, Germany
GSK Investigational Site
Wangen, Baden-Wurttemberg, 88239, Germany
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469, Germany
GSK Investigational Site
Aschaffenburg, Bavaria, 63739, Germany
GSK Investigational Site
Haag, Bavaria, 83527, Germany
GSK Investigational Site
Höhenkirchen-Siegertsbrunn, Bavaria, 85635, Germany
GSK Investigational Site
Ismaning, Bavaria, 85737, Germany
GSK Investigational Site
Krummenaab, Bavaria, 92703, Germany
GSK Investigational Site
Künzing, Bavaria, 94550, Germany
GSK Investigational Site
Landshut, Bavaria, 84028, Germany
GSK Investigational Site
Munich, Bavaria, 80339, Germany
GSK Investigational Site
Munich, Bavaria, 80469, Germany
GSK Investigational Site
Munich, Bavaria, 80805, Germany
GSK Investigational Site
Munich, Bavaria, 80807, Germany
GSK Investigational Site
Munich, Bavaria, 80937, Germany
GSK Investigational Site
Munich, Bavaria, 81379, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90427, Germany
GSK Investigational Site
Wallerfing, Bavaria, 94574, Germany
GSK Investigational Site
Bad Kreuznach, Hesse, 55545, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60326, Germany
GSK Investigational Site
Großalmerode, Hesse, 37247, Germany
GSK Investigational Site
Lollar, Hesse, 35475, Germany
GSK Investigational Site
Offenbach, Hesse, 63065, Germany
GSK Investigational Site
Offenbach, Hesse, 63067, Germany
GSK Investigational Site
Offenbach, Hesse, 63071, Germany
GSK Investigational Site
Offenbach, Hesse, 63073, Germany
GSK Investigational Site
Schaafheim, Hesse, 64850, Germany
GSK Investigational Site
Vellmar, Hesse, 34246, Germany
GSK Investigational Site
Damme, Lower Saxony, 49401, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30171, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30177, Germany
GSK Investigational Site
Hildesheim, Lower Saxony, 31139, Germany
GSK Investigational Site
Lüneburg, Lower Saxony, 21335, Germany
GSK Investigational Site
Paderborn, Lower Saxony, 33100, Germany
GSK Investigational Site
Winsen/Lohe, Lower Saxony, 21423, Germany
GSK Investigational Site
Beckum, North Rhine-Westphalia, 59269, Germany
GSK Investigational Site
Bergkamen, North Rhine-Westphalia, 59192, Germany
GSK Investigational Site
Borken, North Rhine-Westphalia, 46325, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137, Germany
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47119, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45130, Germany
GSK Investigational Site
Euskirchen, North Rhine-Westphalia, 53879, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574, Germany
GSK Investigational Site
Lüdenscheid, North Rhine-Westphalia, 58511, Germany
GSK Investigational Site
Lünen, North Rhine-Westphalia, 44534, Germany
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41460, Germany
GSK Investigational Site
Schwabenheim, North Rhine-Westphalia, 55270, Germany
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Siegen, North Rhine-Westphalia, 57072, Germany
GSK Investigational Site
Warendorf, North Rhine-Westphalia, 48231, Germany
GSK Investigational Site
Deidesheim, Rhineland-Palatinate, 67146, Germany
GSK Investigational Site
Diez, Rhineland-Palatinate, 65582, Germany
GSK Investigational Site
Lambrecht, Rhineland-Palatinate, 67466, Germany
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624, Germany
GSK Investigational Site
Chemnitz, Saxony, 09130, Germany
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Dresden, Saxony, 01129, Germany
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Dresden, Saxony, 01187, Germany
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Dresden, Saxony, 01309, Germany
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Freital, Saxony, 01705, Germany
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Pirna, Saxony, 01796, Germany
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Schmiedeberg, Saxony, 01762, Germany
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Itzehoe, Schleswig-Holstein, 25524, Germany
GSK Investigational Site
Ratzeburg, Schleswig-Holstein, 23909, Germany
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Wahlstedt, Schleswig-Holstein, 23812, Germany
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Wilster, Schleswig-Holstein, 25554, Germany
GSK Investigational Site
Berlin, 13057, Germany
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Berlin, 13355, Germany
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Hamburg, 22041, Germany
GSK Investigational Site
Hamburg, 22607, Germany
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Budapest, 1076, Hungary
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Miskolc, 3526, Hungary
GSK Investigational Site
Belfast, BT16 ORH, Ireland
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Co. Tipperary, Ireland
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Cork, Ireland
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Dublin, 15, Ireland
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Dublin, 24, Ireland
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Dublin, 4, Ireland
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Dublin, 7, Ireland
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Dublin, 8, Ireland
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Gowran, Ireland
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Kilkenny, Ireland
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Acquaviva Delle Fonti (BA), Apulia, 70021, Italy
GSK Investigational Site
Ferrara, Emilia-Romagna, 44100, Italy
GSK Investigational Site
Ravenna, Emilia-Romagna, 48100, Italy
GSK Investigational Site
Scandiano (RE), Emilia-Romagna, 42019, Italy
GSK Investigational Site
Rozzano (MI), Lombardy, 20089, Italy
GSK Investigational Site
Catania, Sicily, 95100, Italy
GSK Investigational Site
Città Di Castello (PG), Umbria, 06012, Italy
GSK Investigational Site
Florence, 50134, Italy
GSK Investigational Site
La Spezia, 19100, Italy
GSK Investigational Site
Lecce, 73100, Italy
GSK Investigational Site
Milan, 20132, Italy
GSK Investigational Site
Palermo, 90127, Italy
GSK Investigational Site
Parma, 43100, Italy
GSK Investigational Site
Perugia, 06126, Italy
GSK Investigational Site
Rovigo, 45100, Italy
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, 05100, Italy
GSK Investigational Site
Torino, 10126, Italy
GSK Investigational Site
Udine, 33100, Italy
GSK Investigational Site
Vicenza, 36100, Italy
GSK Investigational Site
's-Hertogenbosch, 5223 GV, Netherlands
GSK Investigational Site
De Bilt, 3731 DN, Netherlands
GSK Investigational Site
Geleen, 6166 GR, Netherlands
GSK Investigational Site
Hengelo, 7555 DL, Netherlands
GSK Investigational Site
Huizen, 1271 BB, Netherlands
GSK Investigational Site
Losser, 7581 BV, Netherlands
GSK Investigational Site
Losser, 7582 BD, Netherlands
GSK Investigational Site
Rijswijk, 2281 AK, Netherlands
GSK Investigational Site
Roelofarendsveen, 2371 RB, Netherlands
GSK Investigational Site
Woerden, 3443 GG, Netherlands
GSK Investigational Site
Hamar, 2317, Norway
GSK Investigational Site
Paradis, 5231, Norway
GSK Investigational Site
Skedsmokorset, N-2020, Norway
GSK Investigational Site
Albaida (Valencia), Spain
GSK Investigational Site
Basurto/Bilbao, 48013, Spain
GSK Investigational Site
Benassal (Castellón), 12160, Spain
GSK Investigational Site
Benicasim (Castellón), Spain
GSK Investigational Site
Bilbao, 48013, Spain
GSK Investigational Site
Cartagena, 30203, Spain
GSK Investigational Site
Cáceres, 10005, Spain
GSK Investigational Site
El Palmar (Murcia), 30120, Spain
GSK Investigational Site
Elche (Alicante), 03202, Spain
GSK Investigational Site
Elda-Alicante, 03600, Spain
GSK Investigational Site
Figueras, 17600, Spain
GSK Investigational Site
Girona, Spain
GSK Investigational Site
Granollers (Barcelona), 08400, Spain
GSK Investigational Site
Jerez (Cadiz), 11047, Spain
GSK Investigational Site
Madrid, 28006, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Mataró, 08034, Spain
GSK Investigational Site
Málaga, 29009, Spain
GSK Investigational Site
Mérida, 6800, Spain
GSK Investigational Site
Olleria, Valencia, 46850, Spain
GSK Investigational Site
Onda/Castellón, 12200, Spain
GSK Investigational Site
Orihuela (Alicante), 03314, Spain
GSK Investigational Site
Plasencia, 10600, Spain
GSK Investigational Site
Pontevedra, 36071, Spain
GSK Investigational Site
Sagunto/Valencia, 46520, Spain
GSK Investigational Site
San Juan (Alicante), 03550, Spain
GSK Investigational Site
San Vincente Raspeig (Alicante), 03690, Spain
GSK Investigational Site
Santa Coloma de Gramanet (Barcelona), 08923, Spain
GSK Investigational Site
Santa Cruz de Tenerife, 38010, Spain
GSK Investigational Site
Tereul, 44002, Spain
GSK Investigational Site
Toledo, 45004, Spain
GSK Investigational Site
Torrelavega/Santander, 39300, Spain
GSK Investigational Site
Valencia, 46017, Spain
GSK Investigational Site
Valencia, 46830, Spain
GSK Investigational Site
Valencia, Spain
GSK Investigational Site
Valladolid, 47010, Spain
GSK Investigational Site
Vallda (Valencia), Spain
GSK Investigational Site
Villajoyosa - Alicante, 03570, Spain
GSK Investigational Site
Zamora, 49021, Spain
GSK Investigational Site
Zaragoza, 50003, Spain
GSK Investigational Site
Älta, 138 21, Sweden
GSK Investigational Site
Degerberga, 297 31, Sweden
GSK Investigational Site
Gimo, SE-747 43, Sweden
GSK Investigational Site
Malmo, SE-214 26, Sweden
GSK Investigational Site
Stockholm, SE-114 35, Sweden
GSK Investigational Site
Aberdeen, Aberdeenshire, AB25 2AY, United Kingdom
GSK Investigational Site
Sandy, Bedfordshire, SG19 3JR, United Kingdom
GSK Investigational Site
Reading, Berkshire, RG2 7AG, United Kingdom
GSK Investigational Site
Llanelli, Carmarthenshire, SA14 8QF, United Kingdom
GSK Investigational Site
Warrington, Cheshire, WA5 1QC, United Kingdom
GSK Investigational Site
Bournemouth, Dorset, BH7 7DW, United Kingdom
GSK Investigational Site
Poole, Dorset, United Kingdom
GSK Investigational Site
Barry, Glamorgan, CF63 4HP, United Kingdom
GSK Investigational Site
Cardiff, Glamorgan, CF14 9BB, United Kingdom
GSK Investigational Site
Hemel Hempstead, Hertfordshire, HP2 4AD, United Kingdom
GSK Investigational Site
Stevenage, Hertfordshire, United Kingdom
GSK Investigational Site
Airdrie, Lanarkshire, ML6 0JS, United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, G81 4SA, United Kingdom
GSK Investigational Site
Bolton, Lancashire, United Kingdom
GSK Investigational Site
Chorley, Lancashire, PR7 1NY, United Kingdom
GSK Investigational Site
Edinburgh, Midlothian, EH3 9YW, United Kingdom
GSK Investigational Site
Wellingborough, Northamptonshire, NN8 4RW, United Kingdom
GSK Investigational Site
Nottingham, Nottinghamshire, NG3 7DQ, United Kingdom
GSK Investigational Site
Haverfordwest, Pembrokeshire, SA61 1RN, United Kingdom
GSK Investigational Site
Frome, Somerset, BA11 1EZ, United Kingdom
GSK Investigational Site
Crawley, Sussex West, RH10 1LL, United Kingdom
GSK Investigational Site
Nuneaton, Warwickshire, CV10 7DJ, United Kingdom
GSK Investigational Site
Rugby, Warwickshire, CV21 3SP, United Kingdom
GSK Investigational Site
Livingston, West Lothian, EH54 6PP, United Kingdom
GSK Investigational Site
Melksham, Wiltshire, SN12 6UN, United Kingdom
GSK Investigational Site
Trowbridge, Wiltshire, BA14 8TG, United Kingdom
GSK Investigational Site
Barnsley, S70 3RJ, United Kingdom
GSK Investigational Site
Bath, BA2 3HT, United Kingdom
GSK Investigational Site
Bradford, BD7 3EE, United Kingdom
GSK Investigational Site
Cardiff, CF5 4AE, United Kingdom
GSK Investigational Site
Co.Antrim, United Kingdom
GSK Investigational Site
Doncaster, DN1 2EG, United Kingdom
GSK Investigational Site
Doncaster, DN9 1EP, United Kingdom
GSK Investigational Site
Gateshead, NE9 6SX, United Kingdom
GSK Investigational Site
Glasgow, G51 4TF, United Kingdom
GSK Investigational Site
Glenrothes, United Kingdom
GSK Investigational Site
Irvine, KA12 OAY, United Kingdom
GSK Investigational Site
Kent, TN11 9HL, United Kingdom
GSK Investigational Site
Leicester, LE3 8GS, United Kingdom
GSK Investigational Site
London, SE1 9RT, United Kingdom
GSK Investigational Site
London, W1M 7AB, United Kingdom
GSK Investigational Site
Newtownabbey, BT36 4PP, United Kingdom
GSK Investigational Site
Peterborough, PE7 3JL, United Kingdom
GSK Investigational Site
Swansea, SA4 4BY, United Kingdom
GSK Investigational Site
Wakefield, WF1 4DG, United Kingdom
GSK Investigational Site
Wigan, WN1 1XX, United Kingdom
Related Publications (10)
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.
PMID: 12351470RESULTViberti 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.
PMID: 17116177RESULTKahn 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.
PMID: 17145742RESULTKahn 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.
PMID: 16873701RESULTZinman 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.
PMID: 15561950RESULTEl-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.
PMID: 38837240DERIVEDGnesin 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.
PMID: 32501595DERIVEDLachin 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.
PMID: 21454723DERIVEDKahn 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.
PMID: 19808911DERIVEDKahn 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.
PMID: 18223031DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2006
First Posted
January 19, 2006
Study Start
January 3, 2000
Primary Completion
June 1, 2006
Study Completion
June 19, 2006
Last Updated
November 29, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.