Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus

Safety will be evaluated by monitoring of treatment-emergent adverse events, clinical
laboratory evaluations, vital signs, 12-lead electrocardiograms, 24-hour telemetry
monitoring, and physical exams. Specific study withdrawal criteria during washout periods of
metformin have been established for loss of glycemic control, i.e., glucose monitoring.
Pharmacokinetic assessments of monotherapy cohort versus add-on therapy will be performed

Inclusion Criteria:

- Body mass index range (25.0-38 kg/m2) with type 2 diabetes mellitus receiving stable
dose of metformin BID for the previous 60 days for glucose control

- Patients sterile or agree to use approved method of contraception

- No clinically significant abnormal tests

- Hemoglobin A1c level ≤10.5%

Exclusion Criteria:

- History of clinical manifestations of significant metabolic, hepatic, renal, and
hematological pulmonary, cardiovascular, gastrointestinal, urological, neurological,
or psychiatric disorders other than type 2 diabetes mellitus

- Uncontrolled diabetes

- Exclusionary labs - fasting blood sugar, low hemoglobin, elevated liver function
tests, positive result for human immunodeficiency virus, hepatitis B surface antigen,
and anti-hepatitis C virus

- Low creatinine clearance

- History of myocardial infarction within past 90 days or other cardiovascular
conditions

- Prior exposure to S-707106

- Treatment with investigational study drug within 30 days of study admission day