Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.

This is a 72 months long randomized clinical trial longitudinally evaluating beta-cell function, as well as glycemic control and inflammatory markers in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.

Inclusion Criteria:

• type 2 diabetes mellitus diagnosed within the prior 2 months
• HbA1c > 7% at the time of inclusion
• willing to perform intensive diabetes management
• able to comply with treatment and follow-up regimen

Exclusion Criteria:

• HbA1c > 8% at time of randomization
• creatinine > 1.5 mg/dl
• liver function tests > 3 times the upper limit of normal
• severe anemia
• severe proliferative retinopathy
• NYHA class III or IV heart failure
• active CAD or recent (within 6 months) MI
• pregnant, willing to get pregnant, or not willing to practice any contraceptive method
• non-english speaking
• active heavy alcohol or illicit drug users (within past 6 months)
• history of lactic acidosis