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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: metformin; Drug: Rosiglitazone; Drug: glyburide

• Study Type: Interventional
• Enrollment (Actual): 4426
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1130
    • GSK Investigational Site
  • Vienna, Austria, A-1080
    • GSK Investigational Site
  • Wiener Neustadt, Austria, A-2700
    • GSK Investigational Site
• Belgium
  • Blankenberge, Belgium, 8370
    • GSK Investigational Site
  • Boechout, Belgium, 2530
    • GSK Investigational Site
  • Deurne, Belgium, 2100
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
  • Lubbeek (Linden), Belgium, B-3210
    • GSK Investigational Site
  • Tielt, Belgium, 8700
    • GSK Investigational Site
  • Wezembeek-Oppem, Belgium, 1970
    • GSK Investigational Site
  • Wijnegem, Belgium, 2110
    • GSK Investigational Site
  • Zemst, Belgium, 1980
    • GSK Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2R 0X7
      • GSK Investigational Site
    • Edmonton, Alberta, Canada, T6G 2C8
      • GSK Investigational Site
    • Edmonton, Alberta, Canada, T5N 3Y6
      • GSK Investigational Site
    • Red Deer, Alberta, Canada, T4N 6V7
      • GSK Investigational Site
  • British Columbia
    • Coquitlam, British Columbia, Canada, V3K 3P4
      • GSK Investigational Site
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • GSK Investigational Site
    • Victoria, British Columbia, Canada, V8R 6T9
      • GSK Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • GSK Investigational Site
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • GSK Investigational Site
  • New Brunswick
    • Cambellton, New Brunswick, Canada, E3N 3S8
      • GSK Investigational Site
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • GSK Investigational Site
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
      • GSK Investigational Site
  • Nova Scotia
    • Antigonish, Nova Scotia, Canada, B2G 2C2
      • GSK Investigational Site
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • GSK Investigational Site
  • Ontario
    • Burlington, Ontario, Canada, L7M 4Y1
      • GSK Investigational Site
    • Kingston, Ontario, Canada, K7L 2V7
      • GSK Investigational Site
    • London, Ontario, Canada, N6A 4V2
      • GSK Investigational Site
    • Mississauga, Ontario, Canada, L5M 2N1
      • GSK Investigational Site
    • Oakville, Ontario, Canada, L6H 3P1
      • GSK Investigational Site
    • Ottawa, Ontario, Canada, K1H 7W9
      • GSK Investigational Site
    • Sudbury, Ontario, Canada, P3A 1Y8
      • GSK Investigational Site
    • Thornhill, Ontario, Canada, L4J 1V8
      • GSK Investigational Site
    • Thunder Bay, Ontario, Canada, P7B 2Z3
      • GSK Investigational Site
    • Timmins, Ontario, Canada, P4N 8P2
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5C 2T2
      • GSK Investigational Site
    • Windsor, Ontario, Canada, N8X 1K4
      • GSK Investigational Site
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 1L2
      • GSK Investigational Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • GSK Investigational Site
    • La Malbaie, Quebec, Canada, G5A 1W7
      • GSK Investigational Site
    • Laval, Quebec, Canada, H7T 2P5
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H1T 2M4
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H2W 1T8
      • GSK Investigational Site
    • Plessisville, Quebec, Canada, G6L 3J1
      • GSK Investigational Site
    • Saint Marc Des Carrieres, Quebec, Canada, G0A 4B0
      • GSK Investigational Site
    • Sainte-Foy, Quebec, Canada, G1V 4G5
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • GSK Investigational Site
    • St-Isidore De Dorchester, Quebec, Canada, G0S 2S0
      • GSK Investigational Site
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
      • GSK Investigational Site
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • GSK Investigational Site
• Czechia
  • Ostrava, Czechia, 703 52
    • GSK Investigational Site
  • Phaha 5, Czechia, 150 06
    • GSK Investigational Site
  • Praha 4, Czechia, 142 00
    • GSK Investigational Site
  • Usti Nad Labem, Czechia, 401 13
    • GSK Investigational Site
  • Zlin, Czechia, 762 75
    • GSK Investigational Site
• Denmark
  • Frederiksberg C, Denmark, 1900
    • GSK Investigational Site
  • Odense, Denmark, 5000
    • GSK Investigational Site
• Finland
  • Hanko, Finland, 10900
    • GSK Investigational Site
  • Helsinki, Finland, 00150
    • GSK Investigational Site
  • Jyvaskyla, Finland, 40100
    • GSK Investigational Site
  • Lmatra, Finland, 55800
    • GSK Investigational Site
  • Savitaipale, Finland, 54800
    • GSK Investigational Site
• France
  • Alben, France, 73410
    • GSK Investigational Site
  • Bezier, France, 34500
    • GSK Investigational Site
  • Bourges, France, 18000
    • GSK Investigational Site
  • Brogile, France, 27270
    • GSK Investigational Site
  • Chartres, France, 28000
    • GSK Investigational Site
  • Denguin, France, 64230
    • GSK Investigational Site
  • Evreux, France, 27000
    • GSK Investigational Site
  • Gamarde Les Bains, France, 40380
    • GSK Investigational Site
  • La Rochelle, France, 17000
    • GSK Investigational Site
  • Labarthe Sur Leze, France, 31860
    • GSK Investigational Site
  • Le Mans, France, 72000
    • GSK Investigational Site
  • Le Pian Medoc, France, 33290
    • GSK Investigational Site
  • Lille, France, 59000
    • GSK Investigational Site
  • Mallemort, France, 13370
    • GSK Investigational Site
  • Marseille, France, 13008
    • GSK Investigational Site
  • Marseille, France, 13001
    • GSK Investigational Site
  • Marsillargues, France, 34590
    • GSK Investigational Site
  • Marssac, France, 81150
    • GSK Investigational Site
  • Mont De Marsen, France, 40000
    • GSK Investigational Site
  • Montignac, France, 24290
    • GSK Investigational Site
  • Moulon, France, 33420
    • GSK Investigational Site
  • Murs Erigne, France, 49610
    • GSK Investigational Site
  • Nantes, France, 44300
    • GSK Investigational Site
  • Nantes Cedex 01, France, 44093
    • GSK Investigational Site
  • Nimes, France, 30900
    • GSK Investigational Site
  • Orthez, France, 64300
    • GSK Investigational Site
  • Paris, France, 75015
    • GSK Investigational Site
  • Rennes, France, 35200
    • GSK Investigational Site
  • Roanna, France, 42300
    • GSK Investigational Site
  • Saint Etienne, France, 42000
    • GSK Investigational Site
  • Saint Genies Des Fontaines, France, 66740
    • GSK Investigational Site
  • Sisteron, France, 04200
    • GSK Investigational Site
  • St Julien Des Landes, France, 85150
    • GSK Investigational Site
  • St Martin D'Heres, France, 38400
    • GSK Investigational Site
  • St Pierre de Chandieu, France, 69780
    • GSK Investigational Site
  • Strasbourg, France, 67000
    • GSK Investigational Site
  • Tarare, France, 69170
    • GSK Investigational Site
  • Vieux Conde, France, 59690
    • GSK Investigational Site
  • Vourey, France, 38210
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13355
    • GSK Investigational Site
  • Berlin, Germany, 13057
    • GSK Investigational Site
  • Hamburg, Germany, 22041
    • GSK Investigational Site
  • Hamburg, Germany, 22607
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Bad Rappenau, Baden-Wuerttemberg, Germany, 74906
      • GSK Investigational Site
    • 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
  • Bayern
    • 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, 80805
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80469
      • 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
  • Hessen
    • 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, 63071
      • GSK Investigational Site
    • Offenbach, Hessen, Germany, 63067
      • GSK Investigational Site
    • Offenbach, Hessen, Germany, 63065
      • GSK Investigational Site
    • Offenbach, Hessen, Germany, 63073
      • GSK Investigational Site
    • Schaafheim, Hessen, Germany, 64850
      • GSK Investigational Site
    • Vellmar, Hessen, Germany, 34246
      • GSK Investigational Site
  • Niedersachsen
    • 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
  • Nordrhein-Westfalen
    • 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
  • Rheinland-Pfalz
    • 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
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09130
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01309
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01129
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01187
      • GSK Investigational Site
    • Freital, Sachsen, Germany, 01705
      • GSK Investigational Site
    • Pirna, Sachsen, Germany, 01796
      • GSK Investigational Site
    • Schmiedeberg, Sachsen, Germany, 01762
      • GSK Investigational Site
  • Schleswig-Holstein
    • 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
• Hungary
  • Budapest, Hungary, 1076
    • GSK Investigational Site
  • Miskolc, Hungary, 3526
    • GSK Investigational Site
• Ireland
  • Belfast, Ireland, BT16 ORH
    • GSK Investigational Site
  • Co. Tipperary, Ireland
    • GSK Investigational Site
  • Cork, Ireland
    • GSK Investigational Site
  • Dublin, Ireland, 8
    • GSK Investigational Site
  • Dublin, Ireland, 4
    • GSK Investigational Site
  • Dublin, Ireland, 7
    • GSK Investigational Site
  • Dublin, Ireland, 15
    • GSK Investigational Site
  • Dublin, Ireland, 24
    • GSK Investigational Site
  • Gowran, Ireland
    • GSK Investigational Site
  • Kilkenny, Ireland
    • GSK Investigational Site
• Italy
  • 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
    • GSK Investigational Site
  • Emilia-Romagna
    • 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
  • Lombardia
    • Rozzano (MI), Lombardia, Italy, 20089
      • GSK Investigational Site
  • Puglia
    • Acquaviva Delle Fonti (BA), Puglia, Italy, 70021
      • GSK Investigational Site
  • Sicilia
    • Catania, Sicilia, Italy, 95100
      • GSK Investigational Site
  • Umbria
    • Città Di Castello (PG), Umbria, Italy, 06012
      • GSK Investigational Site
• Netherlands
  • 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
    • GSK Investigational Site
• Norway
  • Hamar, Norway, 2317
    • GSK Investigational Site
  • Paradis, Norway, 5231
    • GSK Investigational Site
  • Skedsmokorset, Norway, N-2020
    • GSK Investigational Site
• Spain
  • 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
    • GSK Investigational Site
  • Valencia, Spain, 46830
    • 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
    • GSK Investigational Site
• Sweden
  • 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
    • GSK Investigational Site
• United Kingdom
  • 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
    • GSK Investigational Site
  • Aberdeenshire
    • Aberdeen, Aberdeenshire, United Kingdom, AB25 2AY
      • GSK Investigational Site
  • Bedfordshire
    • Sandy, Bedfordshire, United Kingdom, SG19 3JR
      • GSK Investigational Site
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG2 7AG
      • GSK Investigational Site
  • Carmarthenshire
    • Llanelli, Carmarthenshire, United Kingdom, SA14 8QF
      • GSK Investigational Site
  • Cheshire
    • Warrington, Cheshire, United Kingdom, WA5 1QC
      • GSK Investigational Site
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • GSK Investigational Site
    • Poole, Dorset, United Kingdom
      • GSK Investigational Site
  • Glamorgan
    • Barry, Glamorgan, United Kingdom, CF63 4HP
      • GSK Investigational Site
    • Cardiff, Glamorgan, United Kingdom, CF14 9BB
      • GSK Investigational Site
  • Hertfordshire
    • Hemel Hempstead, Hertfordshire, United Kingdom, HP2 4AD
      • GSK Investigational Site
    • Stevenage, Hertfordshire, United Kingdom
      • GSK Investigational Site
  • Lanarkshire
    • Airdrie, Lanarkshire, United Kingdom, ML6 0JS
      • GSK Investigational Site
    • Glasgow, Lanarkshire, United Kingdom, G81 4SA
      • GSK Investigational Site
  • Lancashire
    • Bolton, Lancashire, United Kingdom
      • GSK Investigational Site
    • Chorley, Lancashire, United Kingdom, PR7 1NY
      • GSK Investigational Site
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH3 9YW
      • GSK Investigational Site
  • Northamptonshire
    • Wellingborough, Northamptonshire, United Kingdom, NN8 4RW
      • GSK Investigational Site
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG3 7DQ
      • GSK Investigational Site
  • Pembrokeshire
    • Haverfordwest, Pembrokeshire, United Kingdom, SA61 1RN
      • GSK Investigational Site
  • Somerset
    • Frome, Somerset, United Kingdom, BA11 1EZ
      • GSK Investigational Site
  • Sussex West
    • Crawley, Sussex West, United Kingdom, RH10 1LL
      • GSK Investigational Site
  • Warwickshire
    • Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
      • GSK Investigational Site
    • Rugby, Warwickshire, United Kingdom, CV21 3SP
      • GSK Investigational Site
  • West Lothian
    • Livingston, West Lothian, United Kingdom, EH54 6PP
      • GSK Investigational Site
  • Wiltshire
    • Melksham, Wiltshire, United Kingdom, SN12 6UN
      • GSK Investigational Site
    • Trowbridge, Wiltshire, United Kingdom, BA14 8TG
      • GSK Investigational Site
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35233
      • GSK Investigational Site
  • Arizona
    • Mesa, Arizona, United States, 85206
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85723
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 77205
      • GSK Investigational Site
  • California
    • Berkeley, California, United States, 94705
      • GSK Investigational Site
    • Corona, California, United States, 92879
      • GSK Investigational Site
    • Fair Oaks, California, United States, 95628
      • GSK Investigational Site
    • Fremont, California, United States, 94538
      • GSK Investigational Site
    • Fresno, California, United States, 93720
      • GSK Investigational Site
    • Fullerton, California, United States, 92835
      • GSK Investigational Site
    • Greenbrae, California, United States, 94904
      • GSK Investigational Site
    • Harbor City, California, United States, 90710
      • GSK Investigational Site
    • Healdsburg, California, United States, 95448
      • GSK Investigational Site
    • La Jolla, California, United States, 92037
      • GSK Investigational Site
    • Loma Linda, California, United States, 92354
      • GSK Investigational Site
    • Los Angeles, California, United States, 90095
      • GSK Investigational Site
    • Los Angeles, California, United States, 90059
      • GSK Investigational Site
    • Modesto, California, United States, 95355
      • GSK Investigational Site
    • Pasadena, California, United States, 91105
      • GSK Investigational Site
    • San Diego, California, United States, 92126
      • GSK Investigational Site
    • San Francisco, California, United States, 94143
      • GSK Investigational Site
    • Santa Rosa, California, United States, 95405
      • GSK Investigational Site
    • Sunnyvale, California, United States, 94086
      • GSK Investigational Site
    • Ukiah, California, United States, 95482
      • GSK Investigational Site
    • Walnut Creek, California, United States, 94598
      • GSK Investigational Site
    • Yorba Linda, California, United States, 92886
      • GSK Investigational Site
  • Colorado
    • Boulder, Colorado, United States, 80304
      • GSK Investigational Site
    • Denver, Colorado, United States, 80209
      • GSK Investigational Site
    • Denver, Colorado, United States, 80220
      • GSK Investigational Site
    • Englewood, Colorado, United States, 80110
      • GSK Investigational Site
    • Longmont, Colorado, United States, 80501
      • GSK Investigational Site
    • Wheat Ridge, Colorado, United States, 80033
      • GSK Investigational Site
    • Wheat Ridge, Colorado, United States, 80043
      • GSK Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • GSK Investigational Site
    • Washington, District of Columbia, United States, 20003
      • GSK Investigational Site
  • Florida
    • Fort Myers, Florida, United States, 33907
      • GSK Investigational Site
    • Hollywood, Florida, United States, 33023
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32216
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32204
      • GSK Investigational Site
    • Melbourne, Florida, United States, 32935
      • GSK Investigational Site
    • Miami, Florida, United States, 33136
      • GSK Investigational Site
    • Miami, Florida, United States, 33176
      • GSK Investigational Site
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
    • Palm Harbor, Florida, United States, 34683
      • GSK Investigational Site
    • Saint Petersburg, Florida, United States, 33710
      • GSK Investigational Site
    • Saint Petersburg, Florida, United States, 33702
      • GSK Investigational Site
    • Sarasota, Florida, United States, 34239
      • GSK Investigational Site
    • Tampa, Florida, United States, 33612
      • GSK Investigational Site
    • Titusville, Florida, United States, 32796
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33401
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30312
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30308
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30338
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30328
      • GSK Investigational Site
    • Blue Ridge, Georgia, United States, 30513
      • GSK Investigational Site
    • Dunwoody, Georgia, United States, 30338
      • GSK Investigational Site
    • Fayetteville, Georgia, United States, 30214
      • GSK Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • GSK Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83706
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • GSK Investigational Site
    • Gurnee, Illinois, United States, 60031
      • GSK Investigational Site
    • Springfield, Illinois, United States, 62704
      • GSK Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47713
      • GSK Investigational Site
    • Indianapolis, Indiana, United States, 46202
      • GSK Investigational Site
    • Indianapolis, Indiana, United States, 46250
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40504-2681
      • GSK Investigational Site
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • GSK Investigational Site
    • New Orleans, Louisiana, United States, 70119
      • GSK Investigational Site
    • Slidell, Louisiana, United States, 70461
      • GSK Investigational Site
    • Slidell, Louisiana, United States, 70458
      • GSK Investigational Site
  • Maine
    • Bangor, Maine, United States, 04401
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • GSK Investigational Site
    • Baltimore, Maryland, United States, 21208
      • GSK Investigational Site
    • Baltimore, Maryland, United States, 21204
      • GSK Investigational Site
    • Baltimore, Maryland, United States, 21205
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • GSK Investigational Site
    • Springfield, Massachusetts, United States, 01199
      • GSK Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • GSK Investigational Site
    • Detroit, Michigan, United States, 48201
      • GSK Investigational Site
    • Lansing, Michigan, United States, 48912
      • GSK Investigational Site
    • Royal Oak, Michigan, United States, 48073
      • GSK Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • GSK Investigational Site
    • Minneapolis, Minnesota, United States, 55407-3799
      • GSK Investigational Site
    • Minneapolis, Minnesota, United States, 55416
      • GSK Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • GSK Investigational Site
    • Olive Branch, Mississippi, United States, 38654
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63110
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63128
      • GSK Investigational Site
  • Montana
    • Billings, Montana, United States, 59102
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68105
      • GSK Investigational Site
  • Nevada
    • Henderson, Nevada, United States, 89014
      • GSK Investigational Site
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • GSK Investigational Site
    • Cherry Hill, New Jersey, United States, 8034
      • GSK Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • GSK Investigational Site
    • Albuquerque, New Mexico, United States, 87102
      • GSK Investigational Site
    • Albuquerque, New Mexico, United States, 87109
      • GSK Investigational Site
  • New York
    • Albany, New York, United States, 12206
      • GSK Investigational Site
    • Bronx, New York, United States, 10461
      • GSK Investigational Site
    • Endwell, New York, United States, 13760
      • GSK Investigational Site
    • Flushing, New York, United States, 11365
      • GSK Investigational Site
    • New York, New York, United States, 10032
      • GSK Investigational Site
    • New York, New York, United States, 10021
      • GSK Investigational Site
    • New York, New York, United States, 10029
      • GSK Investigational Site
    • New York, New York, United States, 10003
      • GSK Investigational Site
    • New York, New York, United States, 10010
      • GSK Investigational Site
    • Rochester, New York, United States, 14642
      • GSK Investigational Site
    • Rochester, New York, United States, 14609
      • GSK Investigational Site
    • Syracuse, New York, United States, 13210
      • GSK Investigational Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44195
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44121
      • GSK Investigational Site
    • Mogadore, Ohio, United States, 44260
      • GSK Investigational Site
    • Westlake, Ohio, United States, 44145
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • GSK Investigational Site
  • Oregon
    • Bend, Oregon, United States, 97701
      • GSK Investigational Site
    • Eugene, Oregon, United States, 97401
      • GSK Investigational Site
    • Portland, Oregon, United States, 97239
      • GSK Investigational Site
    • Portland, Oregon, United States, 97219
      • GSK Investigational Site
  • Pennsylvania
    • Downingtown, Pennsylvania, United States, 19335
      • GSK Investigational Site
    • Feasterville, Pennsylvania, United States, 19053
      • GSK Investigational Site
    • Fleetwood, Pennsylvania, United States, 19522
      • GSK Investigational Site
    • Hermitage, Pennsylvania, United States, 16148
      • GSK Investigational Site
    • Hershey, Pennsylvania, United States, 17033
      • GSK Investigational Site
    • Jefferson Hills, Pennsylvania, United States, 15025
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19107
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19104
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19115
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19148
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15219
      • GSK Investigational Site
    • Upland, Pennsylvania, United States, 19013
      • GSK Investigational Site
    • Warminster, Pennsylvania, United States, 18974
      • GSK Investigational Site
    • West Chester, Pennsylvania, United States, 19380
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • GSK Investigational Site
    • Columbia, South Carolina, United States, 29201
      • GSK Investigational Site
    • Greer, South Carolina, United States, 29651
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • GSK Investigational Site
    • Nashville, Tennessee, United States, 37211
      • GSK Investigational Site
  • Texas
    • Arlington, Texas, United States, 76014
      • GSK Investigational Site
    • Austin, Texas, United States, 78745
      • GSK Investigational Site
    • Beaumont, Texas, United States, 77701
      • GSK Investigational Site
    • Corpus Christi, Texas, United States, 78412
      • GSK Investigational Site
    • Corpus Christi, Texas, United States, 78411
      • GSK Investigational Site
    • Dallas, Texas, United States, 75230
      • GSK Investigational Site
    • Dallas, Texas, United States, 75231
      • GSK Investigational Site
    • Dallas, Texas, United States, 75390
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76107
      • GSK Investigational Site
    • Houston, Texas, United States, 77030
      • GSK Investigational Site
    • Houston, Texas, United States, 77024
      • GSK Investigational Site
    • Irving, Texas, United States, 75061
      • GSK Investigational Site
    • Midland, Texas, United States, 79705
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78207
      • GSK Investigational Site
  • Utah
    • Ogden, Utah, United States, 84403
      • GSK Investigational Site
    • Salt Lake City, Utah, United States, 84103
      • GSK Investigational Site
    • Salt Lake City, Utah, United States, 84108
      • GSK Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • GSK Investigational Site
    • Newport News, Virginia, United States, 23606
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23249
      • GSK Investigational Site
    • Salem, Virginia, United States, 24153
      • GSK Investigational Site
  • Washington
    • Federal Way, Washington, United States, 98003
      • GSK Investigational Site
    • Seattle, Washington, United States, 98195
      • GSK Investigational Site
    • Seattle, Washington, United States, 98108
      • GSK Investigational Site
    • Seattle, Washington, United States, 98104
      • GSK Investigational Site
    • Spokane, Washington, United States, 99204
      • GSK Investigational Site
    • Spokane, Washington, United States, 99208
      • GSK Investigational Site
    • Spokane, Washington, United States, 99207
      • GSK Investigational Site
    • Wenatchee, Washington, United States, 98801
      • GSK Investigational Site
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • GSK Investigational Site
    • Huntington, West Virginia, United States, 25701
      • GSK Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53717
      • GSK Investigational Site
    • Milwaukee, Wisconsin, United States, 53209
      • GSK Investigational Site
    • Oregon, Wisconsin, United States, 53575
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time from randomization to the primary action point (monotherapy failure).

Secondary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: N Engl J Med. 2007 Mar 29;356(13):1387-8.
• 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.
• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: January 3, 2000
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 19, 2006

Study Registration Dates

• First Submitted: January 17, 2006
• First Submitted That Met QC Criteria: January 17, 2006
• First Posted (Estimate): January 19, 2006

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: type 2 diabetes monotherapy treatment naive
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Rosiglitazone; Glyburide
• Other Study ID Numbers: 49653/048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 49653/048
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 49653/048
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: 49653/048
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 49653/048
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 49653/048
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Dataset Specification
   Information identifier: 49653/048
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Annotated Case Report Form
   Information identifier: 49653/048
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register