A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Mechanism of Action and Efficacy of Saxagliptin (BMS-477118) in the Treatment of Type 2 Diabetic Patients

The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

Inclusion Criteria:

• Type 2 diabetes mellitus
• Drug naive
• Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
• Fasting C-peptide ≥1.0 ng/mL
• Body mass index ≤40 kg/m²

Exclusion Criteria:

• Recent cardiac or cerebrovascular event
• Elevated serum creatinine