Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

GlaxoSmithKline4,426 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

4,426

Conditions

Diabetes Mellitus, Type 2

Interventions

RosiglitazoneDRUG

glyburideDRUG

metforminDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (490)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Berkeley, California, United States

GSK Investigational Site

Corona, California, United States

GSK Investigational Site

Fair Oaks, California, United States

GSK Investigational Site

Fremont, California, United States

GSK Investigational Site

Fresno, California, United States

...and 480 more locations