Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
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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.
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 Start Date :
January 3, 2000
Actual Primary Completion Date :
June 1, 2006
Actual Study Completion Date :
June 19, 2006
Resource links provided by the National Library of Medicine
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).
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Ages Eligible for Study:
30 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.