Clinical trial NCT00279045: Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
Official title: A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes monotherapy treatment naive
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-01-19
Enrollment: 4426
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* Newly diagnosed patients (\< 3years) with type 2 diabetes.
* Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
* No previous treatment with oral or parenteral glucose-lowering therapy.

Exclusion criteria:

* History of lactic acidosis.
* Anemia (\<11g for males, \<10 g for females).
* Unstable or severe NY Heart Association-class 3 or 4.
* Any NY Heart Association congestive heart failure.
* Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.

Primary outcomes:
measure: Time from randomization to the primary action point (monotherapy failure).
Secondary outcomes:
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).
Other outcomes:
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city: Anniston
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
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country: United States
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state: Arizona
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state: California
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facility: GSK Investigational Site
state: Bayern
city: Wallerfing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bad Kreuznach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Grossalmerode
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Lollar
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Offenbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Offenbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Offenbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Offenbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Schaafheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Vellmar
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Damme
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hildesheim
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Lueneburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Paderborn
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Winsen/Lohe
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Beckum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bergkamen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Borken
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duisburg
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Euskirchen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Luedenscheid
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Luenen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Neuss
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Schwabenheim
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Siegen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Warendorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Deidesheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Diez
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Lambrecht
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freital
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Pirna
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Schmiedeberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Itzehoe
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Ratzeburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Wahlstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Wilster
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Belfast
country: Ireland
facility: GSK Investigational Site
city: Co. Tipperary
country: Ireland
facility: GSK Investigational Site
city: Cork
country: Ireland
facility: GSK Investigational Site
city: Dublin
country: Ireland
facility: GSK Investigational Site
city: Dublin
country: Ireland
facility: GSK Investigational Site
city: Dublin
country: Ireland
facility: GSK Investigational Site
city: Dublin
country: Ireland
facility: GSK Investigational Site
city: Dublin
country: Ireland
facility: GSK Investigational Site
city: Gowran
country: Ireland
facility: GSK Investigational Site
city: Kilkenny
country: Ireland
facility: GSK Investigational Site
city: Ferrara
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Scandiano (RE)
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Rozzano (MI)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Acquaviva Delle Fonti (BA)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Catania
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Città Di Castello (PG)
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Firenze
country: Italy
facility: GSK Investigational Site
city: La Spezia
country: Italy
facility: GSK Investigational Site
city: Lecce
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Palermo
country: Italy
facility: GSK Investigational Site
city: Parma
country: Italy
facility: GSK Investigational Site
city: Perugia
country: Italy
facility: GSK Investigational Site
city: Rovigo
country: Italy
facility: GSK Investigational Site
city: S. Benedetto TR (AP)
country: Italy
facility: GSK Investigational Site
city: San Giovanni Rotondo FG
country: Italy
facility: GSK Investigational Site
city: Sassari
country: Italy
facility: GSK Investigational Site
city: Terni
country: Italy
facility: GSK Investigational Site
city: Torino
country: Italy
facility: GSK Investigational Site
city: Udine
country: Italy
facility: GSK Investigational Site
city: Vicenza
country: Italy
facility: GSK Investigational Site
city: De Bilt
country: Netherlands
facility: GSK Investigational Site
city: Den Bosch
country: Netherlands
facility: GSK Investigational Site
city: Geleen
country: Netherlands
facility: GSK Investigational Site
city: Hengelo
country: Netherlands
facility: GSK Investigational Site
city: Huizen
country: Netherlands
facility: GSK Investigational Site
city: Losser
country: Netherlands
facility: GSK Investigational Site
city: Losser
country: Netherlands
facility: GSK Investigational Site
city: Rijswijk
country: Netherlands
facility: GSK Investigational Site
city: Roelofarendsveen
country: Netherlands
facility: GSK Investigational Site
city: Woerden
country: Netherlands
facility: GSK Investigational Site
city: Hamar
country: Norway
facility: GSK Investigational Site
city: Paradis
country: Norway
facility: GSK Investigational Site
city: Skedsmokorset
country: Norway
facility: GSK Investigational Site
city: Albaida (Valencia)
country: Spain
facility: GSK Investigational Site
city: Basurto/Bilbao
country: Spain
facility: GSK Investigational Site
city: Benassal (Castellón)
country: Spain
facility: GSK Investigational Site
city: Benicasim (Castellón)
country: Spain
facility: GSK Investigational Site
city: Bilbao
country: Spain
facility: GSK Investigational Site
city: Cartagena
country: Spain
facility: GSK Investigational Site
city: Cáceres
country: Spain
facility: GSK Investigational Site
city: El Palmar (Murcia)
country: Spain
facility: GSK Investigational Site
city: Elche (Alicante)
country: Spain
facility: GSK Investigational Site
city: Elda-Alicante
country: Spain
facility: GSK Investigational Site
city: Figueras
country: Spain
facility: GSK Investigational Site
city: Gerona
country: Spain
facility: GSK Investigational Site
city: Granollers (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Jerez (Cadiz)
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Mataro
country: Spain
facility: GSK Investigational Site
city: Merida
country: Spain
facility: GSK Investigational Site
city: Olleria, Valencia
country: Spain
facility: GSK Investigational Site
city: Onda/Castellón
country: Spain
facility: GSK Investigational Site
city: Orihuela (Alicante)
country: Spain
facility: GSK Investigational Site
city: Plasencia
country: Spain
facility: GSK Investigational Site
city: Pontevedra
country: Spain
facility: GSK Investigational Site
city: Sagunto/Valencia
country: Spain
facility: GSK Investigational Site
city: San Juan (Alicante)
country: Spain
facility: GSK Investigational Site
city: San Vincente Raspeig (Alicante)
country: Spain
facility: GSK Investigational Site
city: Santa Coloma De Gramanet (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Tenerife
country: Spain
facility: GSK Investigational Site
city: Tereul
country: Spain
facility: GSK Investigational Site
city: Toledo
country: Spain
facility: GSK Investigational Site
city: Torrelavega/Santander
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valladolid
country: Spain
facility: GSK Investigational Site
city: Vallda (Valencia)
country: Spain
facility: GSK Investigational Site
city: Villajoyosa - Alicante
country: Spain
facility: GSK Investigational Site
city: Zamora
country: Spain
facility: GSK Investigational Site
city: Zaragoza
country: Spain
facility: GSK Investigational Site
city: Alta
country: Sweden
facility: GSK Investigational Site
city: Degerberga
country: Sweden
facility: GSK Investigational Site
city: Gimo
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Aberdeen
country: United Kingdom
facility: GSK Investigational Site
state: Aberdeenshire
city: Sandy
country: United Kingdom
facility: GSK Investigational Site
state: Bedfordshire
city: Reading
country: United Kingdom
facility: GSK Investigational Site
state: Berkshire
city: Llanelli
country: United Kingdom
facility: GSK Investigational Site
state: Carmarthenshire
city: Warrington
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Bournemouth
country: United Kingdom
facility: GSK Investigational Site
state: Dorset
city: Poole
country: United Kingdom
facility: GSK Investigational Site
state: Dorset
city: Barry
country: United Kingdom
facility: GSK Investigational Site
state: Glamorgan
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
state: Glamorgan
city: Hemel Hempstead
country: United Kingdom
facility: GSK Investigational Site
state: Hertfordshire
city: Stevenage
country: United Kingdom
facility: GSK Investigational Site
state: Hertfordshire
city: Airdrie
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Bolton
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Chorley
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
state: Midlothian
city: Wellingborough
country: United Kingdom
facility: GSK Investigational Site
state: Northamptonshire
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
state: Nottinghamshire
city: Haverfordwest
country: United Kingdom
facility: GSK Investigational Site
state: Pembrokeshire
city: Frome
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Crawley
country: United Kingdom
facility: GSK Investigational Site
state: Sussex West
city: Nuneaton
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Rugby
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Livingston
country: United Kingdom
facility: GSK Investigational Site
state: West Lothian
city: Melksham
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Trowbridge
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Barnsley
country: United Kingdom
facility: GSK Investigational Site
city: Bath
country: United Kingdom
facility: GSK Investigational Site
city: Bradford
country: United Kingdom
facility: GSK Investigational Site
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
city: Co.Antrim
country: United Kingdom
facility: GSK Investigational Site
city: Doncaster
country: United Kingdom
facility: GSK Investigational Site
city: Doncaster
country: United Kingdom
facility: GSK Investigational Site
city: Gateshead
country: United Kingdom
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Glenrothes
country: United Kingdom
facility: GSK Investigational Site
city: Irvine
country: United Kingdom
facility: GSK Investigational Site
city: Kent
country: United Kingdom
facility: GSK Investigational Site
city: Leicester
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Newtownabbey
country: United Kingdom
facility: GSK Investigational Site
city: Peterborough
country: United Kingdom
facility: GSK Investigational Site
city: Swansea
country: United Kingdom
facility: GSK Investigational Site
city: Wakefield
country: United Kingdom
facility: GSK Investigational Site
city: Wigan
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
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 America and Europe. Diabet Med. 2006 Dec;23(12):1289-94. doi: 10.1111/j.1464-5491.2006.02022.x.
citation: 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.
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 type 2 diabetes. Diabetes. 2006 Aug;55(8):2357-64. doi: 10.2337/db06-0116.
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. doi: 10.2337/diabetes.53.12.3193.
citation: 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.
citation: 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.
citation: 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.
citation: 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.