- Male and female subjects between the ages of 30 and 65 years, inclusive, with a
historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American
Diabetes Association guidelines.
- Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight >50 kg (110 lbs).
- HbA1c >7% and not to exceed 10.5%.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Diagnosis of Type 1 diabetes mellitus
- Evidence of diabetic complications with significant end organ damage.