Efficacy and Safety In Poorly Controlled Type 2 Diabetics

A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus

The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.

Inclusion criteria:

• Type 2 diabetes
• Drug-naive.
• Laboratory test result for HbA1c of greater than or equal to 10%.
• Written informed consent.

Exclusion criteria:

• Prior use of antidiabetic medications within 3 months of screening.
• Fluid retention (edema).
• Significant liver disease.
• Low red blood cells (anemia).
• Severe or unstable angina (chest pain).
• Congestive heart failure.
• Severe high blood pressure.
• Alcohol or drug abuse.
• Other inclusion or exclusion criteria to be determined by the physician and study sponsor.