Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00279045

Run by

GlaxoSmithKline

People needed

4426

Starts

2000-01-03

Expected to finish

2006-06-19

Last updated by the study team

2017-11-29

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• GSK Investigational Site — Fullerton, California, United States
• GSK Investigational Site — Greenbrae, California, United States
• GSK Investigational Site — Harbor City, California, United States
• GSK Investigational Site — Healdsburg, California, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — Loma Linda, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Modesto, California, United States
• GSK Investigational Site — Pasadena, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Santa Rosa, California, United States
• GSK Investigational Site — Sunnyvale, California, United States
• GSK Investigational Site — Ukiah, California, United States
• GSK Investigational Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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