AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT00279045

Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

A Phase 3 study testing Rosiglitazone, glyburide and metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 490 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Rosiglitazone, glyburide and metformin
How many people
4,426 participants
Where
490 sitesin 17 countries
Study dates
3 Jan 2000to 19 Jun 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

490 sites in 17 countries.

490 sites in 17 countries

United States178 sites

  • GSK Investigational Site

    Albany, New York, 12206

  • GSK Investigational Site

    Albuquerque, New Mexico, 87102

  • GSK Investigational Site

    Albuquerque, New Mexico, 87106

  • GSK Investigational Site

    Albuquerque, New Mexico, 87109

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109

  • GSK Investigational Site

    Anniston, Alabama, 36207

  • GSK Investigational Site

    Arlington, Texas, 76014

  • GSK Investigational Site

    Atlanta, Georgia, 30308

  • GSK Investigational Site

    Atlanta, Georgia, 30312

  • GSK Investigational Site

    Atlanta, Georgia, 30322

  • GSK Investigational Site

    Atlanta, Georgia, 30328

  • GSK Investigational Site

    Atlanta, Georgia, 30338

  • GSK Investigational Site

    Austin, Texas, 78745

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • GSK Investigational Site

    Baltimore, Maryland, 21204

  • GSK Investigational Site

    Baltimore, Maryland, 21205

  • GSK Investigational Site

    Baltimore, Maryland, 21208

  • GSK Investigational Site

    Bangor, Maine, 04401

  • GSK Investigational Site

    Beaumont, Texas, 77701

  • GSK Investigational Site

    Bend, Oregon, 97701

  • GSK Investigational Site

    Berkeley, California, 94705

  • GSK Investigational Site

    Billings, Montana, 59102

  • GSK Investigational Site

    Birmingham, Alabama, 35233

  • GSK Investigational Site

    Blue Ridge, Georgia, 30513

  • GSK Investigational Site

    Boise, Idaho, 83706

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Boulder, Colorado, 80304

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Charleston, South Carolina, 29403

  • GSK Investigational Site

    Charleston, West Virginia, 25304

  • GSK Investigational Site

    Charlottesville, Virginia, 22908

  • GSK Investigational Site

    Cherry Hill, New Jersey, 08034

  • GSK Investigational Site

    Cherry Hill, New Jersey, 8034

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Cleveland, Ohio, 44121

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Columbia, South Carolina, 29201

  • GSK Investigational Site

    Corona, California, 92879

  • GSK Investigational Site

    Corpus Christi, Texas, 78411

  • GSK Investigational Site

    Corpus Christi, Texas, 78412

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Dallas, Texas, 75390

  • GSK Investigational Site

    Denver, Colorado, 80209

  • GSK Investigational Site

    Denver, Colorado, 80220

  • GSK Investigational Site

    Detroit, Michigan, 48201

  • GSK Investigational Site

    Downingtown, Pennsylvania, 19335

  • GSK Investigational Site

    Dunwoody, Georgia, 30338

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Endwell, New York, 13760

  • GSK Investigational Site

    Englewood, Colorado, 80110

  • GSK Investigational Site

    Eugene, Oregon, 97401

  • GSK Investigational Site

    Evansville, Indiana, 47713

  • GSK Investigational Site

    Fair Oaks, California, 95628

  • GSK Investigational Site

    Fayetteville, Georgia, 30214

  • GSK Investigational Site

    Feasterville, Pennsylvania, 19053

  • GSK Investigational Site

    Federal Way, Washington, 98003

  • GSK Investigational Site

    Fleetwood, Pennsylvania, 19522

  • GSK Investigational Site

    Flushing, New York, 11365

  • GSK Investigational Site

    Fort Myers, Florida, 33907

  • GSK Investigational Site

    Fort Worth, Texas, 76107

  • GSK Investigational Site

    Fremont, California, 94538

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Fullerton, California, 92835

  • GSK Investigational Site

    Greenbrae, California, 94904

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Gurnee, Illinois, 60031

  • GSK Investigational Site

    Harbor City, California, 90710

  • GSK Investigational Site

    Healdsburg, California, 95448

  • GSK Investigational Site

    Henderson, Nevada, 89014

  • GSK Investigational Site

    Hermitage, Pennsylvania, 16148

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033

  • GSK Investigational Site

    Hollywood, Florida, 33023

  • GSK Investigational Site

    Honolulu, Hawaii, 96813

  • GSK Investigational Site

    Houston, Texas, 77024

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Huntington, West Virginia, 25701

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Indianapolis, Indiana, 46250

  • GSK Investigational Site

    Irving, Texas, 75061

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Jacksonville, Florida, 32204

  • GSK Investigational Site

    Jacksonville, Florida, 32216

  • GSK Investigational Site

    Jefferson Hills, Pennsylvania, 15025

  • GSK Investigational Site

    Kansas City, Missouri, 64132

  • GSK Investigational Site

    La Jolla, California, 92037

  • GSK Investigational Site

    Lake Charles, Louisiana, 70601

  • GSK Investigational Site

    Lansing, Michigan, 48912

  • GSK Investigational Site

    Lexington, Kentucky, 40504-2681

  • GSK Investigational Site

    Little Rock, Arkansas, 77205

  • GSK Investigational Site

    Loma Linda, California, 92354

  • GSK Investigational Site

    Longmont, Colorado, 80501

  • GSK Investigational Site

    Los Angeles, California, 90059

  • GSK Investigational Site

    Los Angeles, California, 90095

  • GSK Investigational Site

    Madison, Wisconsin, 53717

  • GSK Investigational Site

    Melbourne, Florida, 32935

  • GSK Investigational Site

    Mesa, Arizona, 85206

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Miami, Florida, 33176

  • GSK Investigational Site

    Midland, Texas, 79705

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53209

  • GSK Investigational Site

    Minneapolis, Minnesota, 55404

  • GSK Investigational Site

    Minneapolis, Minnesota, 55407-3799

  • GSK Investigational Site

    Minneapolis, Minnesota, 55416

  • GSK Investigational Site

    Modesto, California, 95355

  • GSK Investigational Site

    Mogadore, Ohio, 44260

  • GSK Investigational Site

    Nashville, Tennessee, 37211

  • GSK Investigational Site

    New Orleans, Louisiana, 70119

  • GSK Investigational Site

    New York, New York, 10003

  • GSK Investigational Site

    New York, New York, 10010

  • GSK Investigational Site

    New York, New York, 10021

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Newport News, Virginia, 23606

  • GSK Investigational Site

    Ogden, Utah, 84403

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Olive Branch, Mississippi, 38654

  • GSK Investigational Site

    Omaha, Nebraska, 68105

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Oregon, Wisconsin, 53575

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Palm Harbor, Florida, 34683

  • GSK Investigational Site

    Pasadena, California, 91105

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19115

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19148

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15219

  • GSK Investigational Site

    Portland, Oregon, 97219

  • GSK Investigational Site

    Portland, Oregon, 97239

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Rochester, New York, 14609

  • GSK Investigational Site

    Rochester, New York, 14642

  • GSK Investigational Site

    Royal Oak, Michigan, 48073

  • GSK Investigational Site

    Salem, Virginia, 24153

  • GSK Investigational Site

    Salt Lake City, Utah, 84103

  • GSK Investigational Site

    Salt Lake City, Utah, 84108

  • GSK Investigational Site

    San Antonio, Texas, 78207

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92126

  • GSK Investigational Site

    San Francisco, California, 94143

  • GSK Investigational Site

    Santa Rosa, California, 95405

  • GSK Investigational Site

    Sarasota, Florida, 34239

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    Seattle, Washington, 98108

  • GSK Investigational Site

    Seattle, Washington, 98195

  • GSK Investigational Site

    Slidell, Louisiana, 70458

  • GSK Investigational Site

    Slidell, Louisiana, 70461

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Spokane, Washington, 99207

  • GSK Investigational Site

    Spokane, Washington, 99208

  • GSK Investigational Site

    Springfield, Illinois, 62704

  • GSK Investigational Site

    Springfield, Massachusetts, 01199

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    St Louis, Missouri, 63128

  • GSK Investigational Site

    St. Petersburg, Florida, 33702

  • GSK Investigational Site

    St. Petersburg, Florida, 33710

  • GSK Investigational Site

    Sunnyvale, California, 94086

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Tampa, Florida, 33612

  • GSK Investigational Site

    The Bronx, New York, 10461

  • GSK Investigational Site

    Titusville, Florida, 32796

  • GSK Investigational Site

    Tucson, Arizona, 85723

  • GSK Investigational Site

    Ukiah, California, 95482

  • GSK Investigational Site

    Upland, Pennsylvania, 19013

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    Warminster, Pennsylvania, 18974

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20003

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20037

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    West Chester, Pennsylvania, 19380

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

  • GSK Investigational Site

    Westlake, Ohio, 44145

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80043

  • GSK Investigational Site

    Yorba Linda, California, 92886

Other trials in United States

Germany72 sites

  • GSK Investigational Site

    Aschaffenburg, Bavaria, 63739

  • GSK Investigational Site

    Bad Kreuznach, Hesse, 55545

  • GSK Investigational Site

    Bad Rappenau, Baden-Wurttemberg, 74906

  • GSK Investigational Site

    Beckum, North Rhine-Westphalia, 59269

  • GSK Investigational Site

    Bergkamen, North Rhine-Westphalia, 59192

  • GSK Investigational Site

    Berlin, 13057

  • GSK Investigational Site

    Berlin, 13355

  • GSK Investigational Site

    Borken, North Rhine-Westphalia, 46325

  • GSK Investigational Site

    Chemnitz, Saxony, 09130

  • GSK Investigational Site

    Damme, Lower Saxony, 49401

  • GSK Investigational Site

    Deggingen, Baden-Wurttemberg, 73326

  • GSK Investigational Site

    Deidesheim, Rhineland-Palatinate, 67146

  • GSK Investigational Site

    Diez, Rhineland-Palatinate, 65582

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44137

  • GSK Investigational Site

    Dresden, Saxony, 01129

  • GSK Investigational Site

    Dresden, Saxony, 01187

  • GSK Investigational Site

    Dresden, Saxony, 01309

  • GSK Investigational Site

    Duisburg, North Rhine-Westphalia, 47119

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45130

  • GSK Investigational Site

    Euskirchen, North Rhine-Westphalia, 53879

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60326

  • GSK Investigational Site

    Freital, Saxony, 01705

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Großalmerode, Hesse, 37247

  • GSK Investigational Site

    Haag, Bavaria, 83527

  • GSK Investigational Site

    Hamburg, 22041

  • GSK Investigational Site

    Hamburg, 22607

  • GSK Investigational Site

    Hanover, Lower Saxony, 30171

  • GSK Investigational Site

    Hanover, Lower Saxony, 30177

  • GSK Investigational Site

    Hildesheim, Lower Saxony, 31139

  • GSK Investigational Site

    Höhenkirchen-Siegertsbrunn, Bavaria, 85635

  • GSK Investigational Site

    Ismaning, Bavaria, 85737

  • GSK Investigational Site

    Itzehoe, Schleswig-Holstein, 25524

  • GSK Investigational Site

    Krummenaab, Bavaria, 92703

  • GSK Investigational Site

    Künzing, Bavaria, 94550

  • GSK Investigational Site

    Lambrecht, Rhineland-Palatinate, 67466

  • GSK Investigational Site

    Landshut, Bavaria, 84028

  • GSK Investigational Site

    Lollar, Hesse, 35475

  • GSK Investigational Site

    Lüdenscheid, North Rhine-Westphalia, 58511

  • GSK Investigational Site

    Lüneburg, Lower Saxony, 21335

  • GSK Investigational Site

    Lünen, North Rhine-Westphalia, 44534

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68161

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Munich, Bavaria, 80469

  • GSK Investigational Site

    Munich, Bavaria, 80805

  • GSK Investigational Site

    Munich, Bavaria, 80807

  • GSK Investigational Site

    Munich, Bavaria, 80937

  • GSK Investigational Site

    Munich, Bavaria, 81379

  • GSK Investigational Site

    Neuss, North Rhine-Westphalia, 41460

  • GSK Investigational Site

    Nuremberg, Bavaria, 90427

  • GSK Investigational Site

    Offenbach, Hesse, 63065

  • GSK Investigational Site

    Offenbach, Hesse, 63067

  • GSK Investigational Site

    Offenbach, Hesse, 63071

  • GSK Investigational Site

    Offenbach, Hesse, 63073

  • GSK Investigational Site

    Paderborn, Lower Saxony, 33100

  • GSK Investigational Site

    Pirna, Saxony, 01796

  • GSK Investigational Site

    Ratzeburg, Schleswig-Holstein, 23909

  • GSK Investigational Site

    Rhaunen, Rhineland-Palatinate, 55624

  • GSK Investigational Site

    Schaafheim, Hesse, 64850

  • GSK Investigational Site

    Schmiedeberg, Saxony, 01762

  • GSK Investigational Site

    Schwabenheim, North Rhine-Westphalia, 55270

  • GSK Investigational Site

    Siegen, North Rhine-Westphalia, 57072

  • GSK Investigational Site

    Trochtelfingen, Baden-Wurttemberg, 72818

  • GSK Investigational Site

    Unterschneidheim, Baden-Wurttemberg, 73485

  • GSK Investigational Site

    Vellmar, Hesse, 34246

  • GSK Investigational Site

    Wahlstedt, Schleswig-Holstein, 23812

  • GSK Investigational Site

    Wallerfing, Bavaria, 94574

  • GSK Investigational Site

    Wangen, Baden-Wurttemberg, 88239

  • GSK Investigational Site

    Warendorf, North Rhine-Westphalia, 48231

  • GSK Investigational Site

    Weinheim, Baden-Wurttemberg, 69469

  • GSK Investigational Site

    Wilster, Schleswig-Holstein, 25554

  • GSK Investigational Site

    Winsen/Lohe, Lower Saxony, 21423

Other trials in Germany

United Kingdom46 sites

  • GSK Investigational Site

    Aberdeen, Aberdeenshire, AB25 2AY

  • GSK Investigational Site

    Airdrie, Lanarkshire, ML6 0JS

  • GSK Investigational Site

    Barnsley, S70 3RJ

  • GSK Investigational Site

    Barry, Glamorgan, CF63 4HP

  • GSK Investigational Site

    Bath, BA2 3HT

  • GSK Investigational Site

    Bolton, Lancashire

  • GSK Investigational Site

    Bournemouth, Dorset, BH7 7DW

  • GSK Investigational Site

    Bradford, BD7 3EE

  • GSK Investigational Site

    Cardiff, Glamorgan, CF14 9BB

  • GSK Investigational Site

    Cardiff, CF5 4AE

  • GSK Investigational Site

    Chorley, Lancashire, PR7 1NY

  • GSK Investigational Site

    Co.Antrim

  • GSK Investigational Site

    Crawley, Sussex West, RH10 1LL

  • GSK Investigational Site

    Doncaster, DN1 2EG

  • GSK Investigational Site

    Doncaster, DN9 1EP

  • GSK Investigational Site

    Edinburgh, Midlothian, EH3 9YW

  • GSK Investigational Site

    Frome, Somerset, BA11 1EZ

  • GSK Investigational Site

    Gateshead, NE9 6SX

  • GSK Investigational Site

    Glasgow, Lanarkshire, G81 4SA

  • GSK Investigational Site

    Glasgow, G51 4TF

  • GSK Investigational Site

    Glenrothes

  • GSK Investigational Site

    Haverfordwest, Pembrokeshire, SA61 1RN

  • GSK Investigational Site

    Hemel Hempstead, Hertfordshire, HP2 4AD

  • GSK Investigational Site

    Irvine, KA12 OAY

  • GSK Investigational Site

    Kent, TN11 9HL

  • GSK Investigational Site

    Leicester, LE3 8GS

  • GSK Investigational Site

    Livingston, West Lothian, EH54 6PP

  • GSK Investigational Site

    Llanelli, Carmarthenshire, SA14 8QF

  • GSK Investigational Site

    London, SE1 9RT

  • GSK Investigational Site

    London, W1M 7AB

  • GSK Investigational Site

    Melksham, Wiltshire, SN12 6UN

  • GSK Investigational Site

    Newtownabbey, BT36 4PP

  • GSK Investigational Site

    Nottingham, Nottinghamshire, NG3 7DQ

  • GSK Investigational Site

    Nuneaton, Warwickshire, CV10 7DJ

  • GSK Investigational Site

    Peterborough, PE7 3JL

  • GSK Investigational Site

    Poole, Dorset

  • GSK Investigational Site

    Reading, Berkshire, RG2 7AG

  • GSK Investigational Site

    Rugby, Warwickshire, CV21 3SP

  • GSK Investigational Site

    Sandy, Bedfordshire, SG19 3JR

  • GSK Investigational Site

    Stevenage, Hertfordshire

  • GSK Investigational Site

    Swansea, SA4 4BY

  • GSK Investigational Site

    Trowbridge, Wiltshire, BA14 8TG

  • GSK Investigational Site

    Wakefield, WF1 4DG

  • GSK Investigational Site

    Warrington, Cheshire, WA5 1QC

  • GSK Investigational Site

    Wellingborough, Northamptonshire, NN8 4RW

  • GSK Investigational Site

    Wigan, WN1 1XX

Other trials in United Kingdom

Spain40 sites

  • GSK Investigational Site

    Albaida (Valencia)

  • GSK Investigational Site

    Basurto/Bilbao, 48013

  • GSK Investigational Site

    Benassal (Castellón), 12160

  • GSK Investigational Site

    Benicasim (Castellón)

  • GSK Investigational Site

    Bilbao, 48013

  • GSK Investigational Site

    Cáceres, 10005

  • GSK Investigational Site

    Cartagena, 30203

  • GSK Investigational Site

    El Palmar (Murcia), 30120

  • GSK Investigational Site

    Elche (Alicante), 03202

  • GSK Investigational Site

    Elda-Alicante, 03600

  • GSK Investigational Site

    Figueras, 17600

  • GSK Investigational Site

    Girona

  • GSK Investigational Site

    Granollers (Barcelona), 08400

  • GSK Investigational Site

    Jerez (Cadiz), 11047

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Málaga, 29009

  • GSK Investigational Site

    Mataró, 08034

  • GSK Investigational Site

    Mérida, 6800

  • GSK Investigational Site

    Olleria, Valencia, 46850

  • GSK Investigational Site

    Onda/Castellón, 12200

  • GSK Investigational Site

    Orihuela (Alicante), 03314

  • GSK Investigational Site

    Plasencia, 10600

  • GSK Investigational Site

    Pontevedra, 36071

  • GSK Investigational Site

    Sagunto/Valencia, 46520

  • GSK Investigational Site

    San Juan (Alicante), 03550

  • GSK Investigational Site

    San Vincente Raspeig (Alicante), 03690

  • GSK Investigational Site

    Santa Coloma de Gramanet (Barcelona), 08923

  • GSK Investigational Site

    Santa Cruz de Tenerife, 38010

  • GSK Investigational Site

    Tereul, 44002

  • GSK Investigational Site

    Toledo, 45004

  • GSK Investigational Site

    Torrelavega/Santander, 39300

  • GSK Investigational Site

    Valencia, 46017

  • GSK Investigational Site

    Valencia, 46830

  • GSK Investigational Site

    Valencia

  • GSK Investigational Site

    Valladolid, 47010

  • GSK Investigational Site

    Vallda (Valencia)

  • GSK Investigational Site

    Villajoyosa - Alicante, 03570

  • GSK Investigational Site

    Zamora, 49021

  • GSK Investigational Site

    Zaragoza, 50003

Other trials in Spain

Canada39 sites

  • GSK Investigational Site

    Antigonish Nova Scotia, Nova Scotia, B2G 2C2

  • GSK Investigational Site

    Burlington, Ontario, L7M 4Y1

  • GSK Investigational Site

    Calgary, Alberta, T2R 0X7

  • GSK Investigational Site

    Cambellton, New Brunswick, E3N 3S8

  • GSK Investigational Site

    Charlottetown, Prince Edward Island, C1A 1L2

  • GSK Investigational Site

    Chicoutimi, Quebec, G7H 5H6

  • GSK Investigational Site

    Coquitlam, British Columbia, V3K 3P4

  • GSK Investigational Site

    Edmonton, Alberta, T5N 3Y6

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2C8

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3A 1Y8

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • GSK Investigational Site

    Kingston, Ontario, K7L 2V7

  • GSK Investigational Site

    La Malbaie, Quebec, G5A 1W7

  • GSK Investigational Site

    Laval, Quebec, H7T 2P5

  • GSK Investigational Site

    London, Ontario, N6A 4V2

  • GSK Investigational Site

    Mississauga, Ontario, L5M 2N1

  • GSK Investigational Site

    Moncton, New Brunswick, E1C 6Z8

  • GSK Investigational Site

    Montreal, Quebec, H1T 2M4

  • GSK Investigational Site

    Montreal, Quebec, H2W 1T8

  • GSK Investigational Site

    Oakville, Ontario, L6H 3P1

  • GSK Investigational Site

    Ottawa, Ontario, K1H 7W9

  • GSK Investigational Site

    Plessisville, Quebec, G6L 3J1

  • GSK Investigational Site

    Red Deer, Alberta, T4N 6V7

  • GSK Investigational Site

    Regina, Saskatchewan, S4P 0W5

  • GSK Investigational Site

    Saint-Marc-des-Carrieres, Quebec, G0A 4B0

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G5

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7N 0W8

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    St-Isidore de Dorchester, Quebec, G0S 2S0

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • GSK Investigational Site

    Thornhill, Ontario, L4J 1V8

  • GSK Investigational Site

    Thunder Bay, Ontario, P7B 2Z3

  • GSK Investigational Site

    Timmins, Ontario, P4N 8P2

  • GSK Investigational Site

    Toronto, Ontario, M5C 2T2

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • GSK Investigational Site

    Victoria, British Columbia, V8R 6T9

  • GSK Investigational Site

    Windsor, Ontario, N8X 1K4

  • GSK Investigational Site

    Winnipeg, Manitoba, R2H 2A6

  • GSK Investigational Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

France39 sites

  • GSK Investigational Site

    Alben, 73410

  • GSK Investigational Site

    Bezier, 34500

  • GSK Investigational Site

    Bourges, 18000

  • GSK Investigational Site

    Brogile, 27270

  • GSK Investigational Site

    Chartres, 28000

  • GSK Investigational Site

    Denguin, 64230

  • GSK Investigational Site

    Évreux, 27000

  • GSK Investigational Site

    Gamarde-les-Bains, 40380

  • GSK Investigational Site

    La Rochelle, 17000

  • GSK Investigational Site

    Labarthe-sur-Lèze, 31860

  • GSK Investigational Site

    Le Mans, 72000

  • GSK Investigational Site

    Le Pian-Médoc, 33290

  • GSK Investigational Site

    Lille, 59000

  • GSK Investigational Site

    Mallemort, 13370

  • GSK Investigational Site

    Marseille, 13001

  • GSK Investigational Site

    Marseille, 13008

  • GSK Investigational Site

    Marsillargues, 34590

  • GSK Investigational Site

    Marssac-sur-Tarn, 81150

  • GSK Investigational Site

    Mont de Marsen, 40000

  • GSK Investigational Site

    Montignac, 24290

  • GSK Investigational Site

    Moulon, 33420

  • GSK Investigational Site

    Mûrs-Erigné, 49610

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Nantes, 44300

  • GSK Investigational Site

    Nîmes, 30900

  • GSK Investigational Site

    Orthez, 64300

  • GSK Investigational Site

    Paris, 75015

  • GSK Investigational Site

    Rennes, 35200

  • GSK Investigational Site

    Roanna, 42300

  • GSK Investigational Site

    Saint Genies Des Fontaines, 66740

  • GSK Investigational Site

    Saint-Etienne, 42000

  • GSK Investigational Site

    Saint-Julien-des-Landes, 85150

  • GSK Investigational Site

    Saint-Martin-d'Hères, 38400

  • GSK Investigational Site

    Saint-Pierre-de-Chandieu, 69780

  • GSK Investigational Site

    Sisteron, 04200

  • GSK Investigational Site

    Strasbourg, 67000

  • GSK Investigational Site

    Tarare, 69170

  • GSK Investigational Site

    Vieux-Condé, 59690

  • GSK Investigational Site

    Vourey, 38210

Other trials in France

Italy22 sites

  • GSK Investigational Site

    Acquaviva Delle Fonti (BA), Apulia, 70021

  • GSK Investigational Site

    Catania, Sicily, 95100

  • GSK Investigational Site

    Città Di Castello (PG), Umbria, 06012

  • GSK Investigational Site

    Ferrara, Emilia-Romagna, 44100

  • GSK Investigational Site

    Florence, 50134

  • GSK Investigational Site

    La Spezia, 19100

  • GSK Investigational Site

    Lecce, 73100

  • GSK Investigational Site

    Milan, 20132

  • GSK Investigational Site

    Palermo, 90127

  • GSK Investigational Site

    Parma, 43100

  • GSK Investigational Site

    Perugia, 06126

  • GSK Investigational Site

    Ravenna, Emilia-Romagna, 48100

  • GSK Investigational Site

    Rovigo, 45100

  • GSK Investigational Site

    Rozzano (MI), Lombardy, 20089

  • GSK Investigational Site

    S. Benedetto TR (AP)

  • GSK Investigational Site

    San Giovanni Rotondo FG

  • GSK Investigational Site

    Sassari

  • GSK Investigational Site

    Scandiano (RE), Emilia-Romagna, 42019

  • GSK Investigational Site

    Terni, 05100

  • GSK Investigational Site

    Torino, 10126

  • GSK Investigational Site

    Udine, 33100

  • GSK Investigational Site

    Vicenza, 36100

Other trials in Italy

Ireland10 sites

  • GSK Investigational Site

    Belfast, BT16 ORH

  • GSK Investigational Site

    Co. Tipperary

  • GSK Investigational Site

    Cork

  • GSK Investigational Site

    Dublin, 15

  • GSK Investigational Site

    Dublin, 24

  • GSK Investigational Site

    Dublin, 4

  • GSK Investigational Site

    Dublin, 7

  • GSK Investigational Site

    Dublin, 8

  • GSK Investigational Site

    Gowran

  • GSK Investigational Site

    Kilkenny

Other trials in Ireland

Netherlands10 sites

  • GSK Investigational Site

    's-Hertogenbosch, 5223 GV

  • GSK Investigational Site

    De Bilt, 3731 DN

  • GSK Investigational Site

    Geleen, 6166 GR

  • GSK Investigational Site

    Hengelo, 7555 DL

  • GSK Investigational Site

    Huizen, 1271 BB

  • GSK Investigational Site

    Losser, 7581 BV

  • GSK Investigational Site

    Losser, 7582 BD

  • GSK Investigational Site

    Rijswijk, 2281 AK

  • GSK Investigational Site

    Roelofarendsveen, 2371 RB

  • GSK Investigational Site

    Woerden, 3443 GG

Other trials in Netherlands

Belgium9 sites

  • GSK Investigational Site

    Blankenberge, 8370

  • GSK Investigational Site

    Boechout, 2530

  • GSK Investigational Site

    Deurne, 2100

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Lubbeek (Linden), B-3210

  • GSK Investigational Site

    Tielt, 8700

  • GSK Investigational Site

    Wezembeek-Oppem, 1970

  • GSK Investigational Site

    Wijnegem, 2110

  • GSK Investigational Site

    Zemst, 1980

Other trials in Belgium

Czechia5 sites

  • GSK Investigational Site

    Ostrava, 703 52

  • GSK Investigational Site

    Phaha 5, 150 06

  • GSK Investigational Site

    Prague, 142 00

  • GSK Investigational Site

    Ústí nad Labem, 401 13

  • GSK Investigational Site

    Zlín, 762 75

Other trials in Czechia

Finland5 sites

  • GSK Investigational Site

    Hanko, 10900

  • GSK Investigational Site

    Helsinki, 00150

  • GSK Investigational Site

    Jyväskylä, 40100

  • GSK Investigational Site

    Lmatra, 55800

  • GSK Investigational Site

    Savitaipale, 54800

Other trials in Finland

Sweden5 sites

  • GSK Investigational Site

    Älta, 138 21

  • GSK Investigational Site

    Degerberga, 297 31

  • GSK Investigational Site

    Gimo, SE-747 43

  • GSK Investigational Site

    Malmö, SE-214 26

  • GSK Investigational Site

    Stockholm, SE-114 35

Other trials in Sweden

Austria3 sites

  • GSK Investigational Site

    Vienna, A-1080

  • GSK Investigational Site

    Vienna, A-1130

  • GSK Investigational Site

    Wiener Neustadt, A-2700

Other trials in Austria

Norway3 sites

  • GSK Investigational Site

    Hamar, 2317

  • GSK Investigational Site

    Paradis, 5231

  • GSK Investigational Site

    Skedsmokorset, N-2020

Other trials in Norway

Denmark2 sites

  • GSK Investigational Site

    Frederiksberg C, 1900

  • GSK Investigational Site

    Odense, 5000

Other trials in Denmark

Hungary2 sites

  • GSK Investigational Site

    Budapest, 1076

  • GSK Investigational Site

    Miskolc, 3526

Other trials in Hungary

About this study

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

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.

Being tested
Rosiglitazone, glyburide, metformin
Keywords
type 2 diabetes monotherapy treatment naive
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RosiglitazoneDrug

  • glyburideDrug

  • metforminDrug

    Also called glyburide, Rosiglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

  1. Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2006 (estimated)
  2. Study start3 Jan 2000
  3. Primary completion1 Jun 2006
  4. Study completion19 Jun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
4,426 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00279045
Sponsor's protocol ID
49653/048
Status last verified
Nov 2017
First submitted
17 Jan 2006
Last updated
29 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 12351470

  • 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.

    PubMed 17116177

  • 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.

    PubMed 17145742

  • 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.

    PubMed 16873701

  • 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.

    PubMed 15561950

  • El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.

    PubMed 38837240

  • 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.

    PubMed 32501595

  • 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.

    PubMed 21454723

  • 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.

    PubMed 19808911

  • 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.

    PubMed 18223031

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosiglitazone, glyburide and metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 490 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 490 sites in United States, Germany, United Kingdom, Spain, Canada and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from randomization to the primary action point (monotherapy failure).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00279045, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in