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

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 in the short-term period who
have an elevated blood sugar that requires additional medication for blood sugar control will
be eligible to enter the long-term treatment extension period where they will receive
metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c
(A1C) > 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible
to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label
saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the
long-term treatment extension period.Saxagliptin dose titration was not permitted.

Inclusion Criteria:

- Type 2 diabetes mellitus

- Drug naive

- Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)

- Fasting C-peptide >= 1 ng/mL

- Body mass index <= 40 kg/m2

Exclusion Criteria:

- Symptomatic poorly controlled diabetes

- Recent cardiac or cerebrovascular event

- Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for Women of Child Bearing
Potential