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

January 17, 2006
April 11, 2013
January 2000
Not Provided
Time from randomization to the primary action point (monotherapy failure).
Time from randomization to the primary action point i.e.monotherapy failure.
Complete list of historical versions of study NCT00279045 on ClinicalTrials.gov Archive Site
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).
  • Compare effects of long-term treatment Rosiglitazone,Metformin,Glyburide:
  • - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP).
Not Provided
Not Provided
 
Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus

The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Rosiglitazone
  • Drug: glyburide
  • Drug: metformin
    Other Names:
    • metformin
    • Rosiglitazone
    • glyburide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4100
Not Provided
Not Provided

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.
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Czech Republic,   France,   Germany,   Netherlands,   Spain,   Sweden,   United Kingdom
 
NCT00279045
49653/048
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP