Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279045
• Other study ID #: 49653/048
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2006
• Last updated: November 27, 2017
• Start date: January 3, 2000
• Est. completion date: June 19, 2006

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4426
• Est. completion date: June 19, 2006
• Est. primary completion date: June 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Rosiglitazone

• glyburide

• metformin

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Wiener Neustadt
Belgium	GSK Investigational Site	Blankenberge
Belgium	GSK Investigational Site	Boechout
Belgium	GSK Investigational Site	Deurne
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Lubbeek (Linden)
Belgium	GSK Investigational Site	Tielt
Belgium	GSK Investigational Site	Wezembeek-Oppem
Belgium	GSK Investigational Site	Wijnegem
Belgium	GSK Investigational Site	Zemst
Canada	GSK Investigational Site	Antigonish	Nova Scotia
Canada	GSK Investigational Site	Burlington	Ontario
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Cambellton	New Brunswick
Canada	GSK Investigational Site	Charlottetown	Prince Edward Island
Canada	GSK Investigational Site	Chicoutimi	Quebec
Canada	GSK Investigational Site	Coquitlam	British Columbia
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	La Malbaie	Quebec
Canada	GSK Investigational Site	Laval	Quebec
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Moncton	New Brunswick
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Oakville	Ontario
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Plessisville	Quebec
Canada	GSK Investigational Site	Red Deer	Alberta
Canada	GSK Investigational Site	Regina	Saskatchewan
Canada	GSK Investigational Site	Saint John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Saint Marc Des Carrieres	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Saskatoon	Saskatchewan
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	St-Isidore De Dorchester	Quebec
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Thornhill	Ontario
Canada	GSK Investigational Site	Thunder Bay	Ontario
Canada	GSK Investigational Site	Timmins	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Windsor	Ontario
Canada	GSK Investigational Site	Winnipeg	Manitoba
Canada	GSK Investigational Site	Winnipeg	Manitoba
Czechia	GSK Investigational Site	Ostrava
Czechia	GSK Investigational Site	Phaha 5
Czechia	GSK Investigational Site	Praha 4
Czechia	GSK Investigational Site	Usti Nad Labem
Czechia	GSK Investigational Site	Zlin
Denmark	GSK Investigational Site	Frederiksberg C
Denmark	GSK Investigational Site	Odense
Finland	GSK Investigational Site	Hanko
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jyvaskyla
Finland	GSK Investigational Site	Lmatra
Finland	GSK Investigational Site	Savitaipale
France	GSK Investigational Site	Alben
France	GSK Investigational Site	Bezier
France	GSK Investigational Site	Bourges
France	GSK Investigational Site	Brogile
France	GSK Investigational Site	Chartres
France	GSK Investigational Site	Denguin
France	GSK Investigational Site	Evreux
France	GSK Investigational Site	Gamarde Les Bains
France	GSK Investigational Site	La Rochelle
France	GSK Investigational Site	Labarthe Sur Leze
France	GSK Investigational Site	Le Mans
France	GSK Investigational Site	Le Pian Medoc
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Mallemort
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Marsillargues
France	GSK Investigational Site	Marssac
France	GSK Investigational Site	Mont De Marsen
France	GSK Investigational Site	Montignac
France	GSK Investigational Site	Moulon
France	GSK Investigational Site	Murs Erigne
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Nantes Cedex 01
France	GSK Investigational Site	Nimes
France	GSK Investigational Site	Orthez
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Rennes
France	GSK Investigational Site	Roanna
France	GSK Investigational Site	Saint Etienne
France	GSK Investigational Site	Saint Genies Des Fontaines
France	GSK Investigational Site	Sisteron
France	GSK Investigational Site	St Julien Des Landes
France	GSK Investigational Site	St Martin D'Heres
France	GSK Investigational Site	St Pierre de Chandieu
France	GSK Investigational Site	Strasbourg
France	GSK Investigational Site	Tarare
France	GSK Investigational Site	Vieux Conde
France	GSK Investigational Site	Vourey
Germany	GSK Investigational Site	Aschaffenburg	Bayern
Germany	GSK Investigational Site	Bad Kreuznach	Hessen
Germany	GSK Investigational Site	Bad Rappenau	Baden-Wuerttemberg
Germany	GSK Investigational Site	Beckum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bergkamen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Borken	Nordrhein-Westfalen
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Damme	Niedersachsen
Germany	GSK Investigational Site	Deggingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Deidesheim	Rheinland-Pfalz
Germany	GSK Investigational Site	Diez	Rheinland-Pfalz
Germany	GSK Investigational Site	Dortmund	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Duisburg	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Euskirchen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Freital	Sachsen
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Grossalmerode	Hessen
Germany	GSK Investigational Site	Haag	Bayern
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Hildesheim	Niedersachsen
Germany	GSK Investigational Site	Hoehenkirchen-Siegertsbrunn	Bayern
Germany	GSK Investigational Site	Ismaning	Bayern
Germany	GSK Investigational Site	Itzehoe	Schleswig-Holstein
Germany	GSK Investigational Site	Krummenaab	Bayern
Germany	GSK Investigational Site	Kuenzing	Bayern
Germany	GSK Investigational Site	Lambrecht	Rheinland-Pfalz
Germany	GSK Investigational Site	Landshut	Bayern
Germany	GSK Investigational Site	Lollar	Hessen
Germany	GSK Investigational Site	Luedenscheid	Nordrhein-Westfalen
Germany	GSK Investigational Site	Lueneburg	Niedersachsen
Germany	GSK Investigational Site	Luenen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Neuss	Nordrhein-Westfalen
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Offenbach	Hessen
Germany	GSK Investigational Site	Offenbach	Hessen
Germany	GSK Investigational Site	Offenbach	Hessen
Germany	GSK Investigational Site	Offenbach	Hessen
Germany	GSK Investigational Site	Paderborn	Niedersachsen
Germany	GSK Investigational Site	Pirna	Sachsen
Germany	GSK Investigational Site	Ratzeburg	Schleswig-Holstein
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Schaafheim	Hessen
Germany	GSK Investigational Site	Schmiedeberg	Sachsen
Germany	GSK Investigational Site	Schwabenheim	Nordrhein-Westfalen
Germany	GSK Investigational Site	Siegen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Trochtelfingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Unterschneidheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Vellmar	Hessen
Germany	GSK Investigational Site	Wahlstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Wallerfing	Bayern
Germany	GSK Investigational Site	Wangen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Warendorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wilster	Schleswig-Holstein
Germany	GSK Investigational Site	Winsen/Lohe	Niedersachsen
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Miskolc
Ireland	GSK Investigational Site	Belfast
Ireland	GSK Investigational Site	Co. Tipperary
Ireland	GSK Investigational Site	Cork
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Gowran
Ireland	GSK Investigational Site	Kilkenny
Italy	GSK Investigational Site	Acquaviva Delle Fonti (BA)	Puglia
Italy	GSK Investigational Site	Catania	Sicilia
Italy	GSK Investigational Site	Città Di Castello (PG)	Umbria
Italy	GSK Investigational Site	Ferrara	Emilia-Romagna
Italy	GSK Investigational Site	Firenze
Italy	GSK Investigational Site	La Spezia
Italy	GSK Investigational Site	Lecce
Italy	GSK Investigational Site	Milano
Italy	GSK Investigational Site	Palermo
Italy	GSK Investigational Site	Parma
Italy	GSK Investigational Site	Perugia
Italy	GSK Investigational Site	Ravenna	Emilia-Romagna
Italy	GSK Investigational Site	Rovigo
Italy	GSK Investigational Site	Rozzano (MI)	Lombardia
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	Scandiano (RE)	Emilia-Romagna
Italy	GSK Investigational Site	Terni
Italy	GSK Investigational Site	Torino
Italy	GSK Investigational Site	Udine
Italy	GSK Investigational Site	Vicenza
Netherlands	GSK Investigational Site	De Bilt
Netherlands	GSK Investigational Site	Den Bosch
Netherlands	GSK Investigational Site	Geleen
Netherlands	GSK Investigational Site	Hengelo
Netherlands	GSK Investigational Site	Huizen
Netherlands	GSK Investigational Site	Losser
Netherlands	GSK Investigational Site	Losser
Netherlands	GSK Investigational Site	Rijswijk
Netherlands	GSK Investigational Site	Roelofarendsveen
Netherlands	GSK Investigational Site	Woerden
Norway	GSK Investigational Site	Hamar
Norway	GSK Investigational Site	Paradis
Norway	GSK Investigational Site	Skedsmokorset
Spain	GSK Investigational Site	Albaida (Valencia)
Spain	GSK Investigational Site	Basurto/Bilbao
Spain	GSK Investigational Site	Benassal (Castellón)
Spain	GSK Investigational Site	Benicasim (Castellón)
Spain	GSK Investigational Site	Bilbao
Spain	GSK Investigational Site	Cáceres
Spain	GSK Investigational Site	Cartagena
Spain	GSK Investigational Site	El Palmar (Murcia)
Spain	GSK Investigational Site	Elche (Alicante)
Spain	GSK Investigational Site	Elda-Alicante
Spain	GSK Investigational Site	Figueras
Spain	GSK Investigational Site	Gerona
Spain	GSK Investigational Site	Granollers (Barcelona)
Spain	GSK Investigational Site	Jerez (Cadiz)
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Mataro
Spain	GSK Investigational Site	Merida
Spain	GSK Investigational Site	Olleria, Valencia
Spain	GSK Investigational Site	Onda/Castellón
Spain	GSK Investigational Site	Orihuela (Alicante)
Spain	GSK Investigational Site	Plasencia
Spain	GSK Investigational Site	Pontevedra
Spain	GSK Investigational Site	Sagunto/Valencia
Spain	GSK Investigational Site	San Juan (Alicante)
Spain	GSK Investigational Site	San Vincente Raspeig (Alicante)
Spain	GSK Investigational Site	Santa Coloma De Gramanet (Barcelona)
Spain	GSK Investigational Site	Tenerife
Spain	GSK Investigational Site	Tereul
Spain	GSK Investigational Site	Toledo
Spain	GSK Investigational Site	Torrelavega/Santander
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valladolid
Spain	GSK Investigational Site	Vallda (Valencia)
Spain	GSK Investigational Site	Villajoyosa - Alicante
Spain	GSK Investigational Site	Zamora
Spain	GSK Investigational Site	Zaragoza
Sweden	GSK Investigational Site	Alta
Sweden	GSK Investigational Site	Degerberga
Sweden	GSK Investigational Site	Gimo
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Stockholm
United Kingdom	GSK Investigational Site	Aberdeen	Aberdeenshire
United Kingdom	GSK Investigational Site	Airdrie	Lanarkshire
United Kingdom	GSK Investigational Site	Barnsley
United Kingdom	GSK Investigational Site	Barry	Glamorgan
United Kingdom	GSK Investigational Site	Bath
United Kingdom	GSK Investigational Site	Bolton	Lancashire
United Kingdom	GSK Investigational Site	Bournemouth	Dorset
United Kingdom	GSK Investigational Site	Bradford
United Kingdom	GSK Investigational Site	Cardiff
United Kingdom	GSK Investigational Site	Cardiff	Glamorgan
United Kingdom	GSK Investigational Site	Chorley	Lancashire
United Kingdom	GSK Investigational Site	Co.Antrim
United Kingdom	GSK Investigational Site	Crawley	Sussex West
United Kingdom	GSK Investigational Site	Doncaster
United Kingdom	GSK Investigational Site	Doncaster
United Kingdom	GSK Investigational Site	Edinburgh	Midlothian
United Kingdom	GSK Investigational Site	Frome	Somerset
United Kingdom	GSK Investigational Site	Gateshead
United Kingdom	GSK Investigational Site	Glasgow
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Glenrothes
United Kingdom	GSK Investigational Site	Haverfordwest	Pembrokeshire
United Kingdom	GSK Investigational Site	Hemel Hempstead	Hertfordshire
United Kingdom	GSK Investigational Site	Irvine
United Kingdom	GSK Investigational Site	Kent
United Kingdom	GSK Investigational Site	Leicester
United Kingdom	GSK Investigational Site	Livingston	West Lothian
United Kingdom	GSK Investigational Site	Llanelli	Carmarthenshire
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Melksham	Wiltshire
United Kingdom	GSK Investigational Site	Newtownabbey
United Kingdom	GSK Investigational Site	Nottingham	Nottinghamshire
United Kingdom	GSK Investigational Site	Nuneaton	Warwickshire
United Kingdom	GSK Investigational Site	Peterborough
United Kingdom	GSK Investigational Site	Poole	Dorset
United Kingdom	GSK Investigational Site	Reading	Berkshire
United Kingdom	GSK Investigational Site	Rugby	Warwickshire
United Kingdom	GSK Investigational Site	Sandy	Bedfordshire
United Kingdom	GSK Investigational Site	Stevenage	Hertfordshire
United Kingdom	GSK Investigational Site	Swansea
United Kingdom	GSK Investigational Site	Trowbridge	Wiltshire
United Kingdom	GSK Investigational Site	Wakefield
United Kingdom	GSK Investigational Site	Warrington	Cheshire
United Kingdom	GSK Investigational Site	Wellingborough	Northamptonshire
United Kingdom	GSK Investigational Site	Wigan
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Anniston	Alabama
United States	GSK Investigational Site	Arlington	Texas
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bangor	Maine
United States	GSK Investigational Site	Beaumont	Texas
United States	GSK Investigational Site	Bend	Oregon
United States	GSK Investigational Site	Berkeley	California
United States	GSK Investigational Site	Billings	Montana
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Blue Ridge	Georgia
United States	GSK Investigational Site	Boise	Idaho
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Boulder	Colorado
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charleston	West Virginia
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Cherry Hill	New Jersey
United States	GSK Investigational Site	Cherry Hill	New Jersey
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Corona	California
United States	GSK Investigational Site	Corpus Christi	Texas
United States	GSK Investigational Site	Corpus Christi	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Downingtown	Pennsylvania
United States	GSK Investigational Site	Dunwoody	Georgia
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Endwell	New York
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fair Oaks	California
United States	GSK Investigational Site	Fayetteville	Georgia
United States	GSK Investigational Site	Feasterville	Pennsylvania
United States	GSK Investigational Site	Federal Way	Washington
United States	GSK Investigational Site	Fleetwood	Pennsylvania
United States	GSK Investigational Site	Flushing	New York
United States	GSK Investigational Site	Fort Myers	Florida
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fremont	California
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Fullerton	California
United States	GSK Investigational Site	Greenbrae	California
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Gurnee	Illinois
United States	GSK Investigational Site	Harbor City	California
United States	GSK Investigational Site	Healdsburg	California
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Hermitage	Pennsylvania
United States	GSK Investigational Site	Hershey	Pennsylvania
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington	West Virginia
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Irving	Texas
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jefferson Hills	Pennsylvania
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	La Jolla	California
United States	GSK Investigational Site	Lake Charles	Louisiana
United States	GSK Investigational Site	Lansing	Michigan
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Loma Linda	California
United States	GSK Investigational Site	Longmont	Colorado
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Midland	Texas
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Modesto	California
United States	GSK Investigational Site	Mogadore	Ohio
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newport News	Virginia
United States	GSK Investigational Site	Ogden	Utah
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Olive Branch	Mississippi
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Oregon	Wisconsin
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Palm Harbor	Florida
United States	GSK Investigational Site	Pasadena	California
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Royal Oak	Michigan
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Saint Petersburg	Florida
United States	GSK Investigational Site	Saint Petersburg	Florida
United States	GSK Investigational Site	Salem	Virginia
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Santa Rosa	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Slidell	Louisiana
United States	GSK Investigational Site	Slidell	Louisiana
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	Springfield	Illinois
United States	GSK Investigational Site	Sunnyvale	California
United States	GSK Investigational Site	Syracuse	New York
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Titusville	Florida
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Ukiah	California
United States	GSK Investigational Site	Upland	Pennsylvania
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	Warminster	Pennsylvania
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	West Chester	Pennsylvania
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Westlake	Ohio
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Yorba Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Ireland,  Italy,  Netherlands,  Norway,  Spain,  Sweden,  United Kingdom, 

References & Publications (5)

A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care, Vol 25, No. 10, October, 2002.

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. — View Citation

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 t — View Citation

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 Ame — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from randomization to the primary action point (monotherapy failure).
Secondary	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).

External Links

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