Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00279045
First received: January 17, 2006
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Rosiglitazone
Drug: glyburide
Drug: metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time from randomization to the primary action point (monotherapy failure).

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 4100
Study Start Date: January 2000
Intervention Details:
    Drug: Rosiglitazone Drug: glyburide Drug: metformin
    Other Names:
    • metformin
    • Rosiglitazone
    • glyburide
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279045

  Hide Study Locations
Locations
Austria
GSK Investigational Site
Vienna, Austria, 1130 Wien
GSK Investigational Site
Vienna, Austria, A-1080
GSK Investigational Site
Wiener Neustadt, Austria, A-2700
Belgium
GSK Investigational Site
Blankenberge, Belgium, 8370
GSK Investigational Site
Boechout, Belgium, 2530
GSK Investigational Site
Deurne, Belgium, 2100
GSK Investigational Site
Leuven, Belgium, B-3000
GSK Investigational Site
Lubbeek (Linden), Belgium, B-3210
GSK Investigational Site
Tielt, Belgium, 8700
GSK Investigational Site
Wezembeek-Oppem, Belgium, B-1970
GSK Investigational Site
Wijnegem, Belgium, 2110
GSK Investigational Site
Zernst, Belgium, 1980
Czech Republic
GSK Investigational Site
Ostrava, Czech Republic, 703 52
GSK Investigational Site
Phaha 5, Czech Republic, 150 06
GSK Investigational Site
Praha 4, Czech Republic, 142 00
GSK Investigational Site
Usti Nad Labem, Czech Republic, 401 13
GSK Investigational Site
Zlin, Czech Republic, 762 75
France
GSK Investigational Site
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
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
Sisteron, France, 04200
GSK Investigational Site
St Genies Des Fontaines, France, 66740
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
Germany
GSK Investigational Site
Ismaning, Bayern, Germany, 85737
GSK Investigational Site
Muenchen, Bayern, Germany, 81379
GSK Investigational Site
Offenbach, Hessen, Germany, 63065
GSK Investigational Site
Paderborn, Niedersachsen, Germany, 33100
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Berlin, Germany, 13355
Netherlands
GSK Investigational Site
Geleen, Netherlands, 6166 GR
GSK Investigational Site
Huizen, Netherlands, 1271 BB
GSK Investigational Site
Losser, Netherlands, 7582 BD
Spain
GSK Investigational Site
Albaida (Valencia), Spain
GSK Investigational Site
Cartagena, Spain, 30203
GSK Investigational Site
Cáceres, Spain, 10005
GSK Investigational Site
Madrid, Spain, 28006
GSK Investigational Site
Olleria, Valencia, Spain, 46850
GSK Investigational Site
Sagunto/Valencia, Spain, 46520
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
Villajoyosa - Alicante, Spain, 03570
Sweden
GSK Investigational Site
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
United Kingdom
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG2 7AG
GSK Investigational Site
Airdrie, Lanarkshire, United Kingdom, ML6 0JS
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH3 9YW
GSK Investigational Site
Livingston, West Lothian, United Kingdom, EH54 6PP
GSK Investigational Site
Glasgow, United Kingdom, G51 4TF
GSK Investigational Site
Glenrothes, United Kingdom
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00279045     History of Changes
Other Study ID Numbers: 49653/048
Study First Received: January 17, 2006
Last Updated: April 11, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
type 2 diabetes monotherapy treatment naive

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Glyburide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014