Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy

Based on the unmet clinical need for more safe and effective type 2 diabetes mellitus
therapies, together with the nonclinical efficacy and safety profile of S-707106, Shionogi
USA, Inc. is initiating studies to further assess the efficacy, clinical pharmacology and
safety profile of S-707106 in preparation for full clinical development as a novel treatment
for type 2 diabetes mellitus. It is anticipated that S-707106 will provide clinicians and
patients with a new therapeutic option to treat type 2 diabetes mellitus with potential
advantages over existing therapy.

Main Inclusion Criteria:

- Subjects with type 2 diabetes mellitus receiving a stable dose of metformin for the
past 3 months (with no other medication for glycemic control) and who are clinically
stable as determined by medical history

- Body mass index (BMI) ≥25.0 and <45.0 (kg/m2) using http://www.bmicalculator.org/ as
the BMI calculator

- No clinically significant abnormal laboratory tests as determined by the investigator
except Hemoglobin A1c level ≥7.5% and ≤11.0% and C peptide level >1.0 ng/mL

Main Exclusion Criteria:

- Type 1 diabetes mellitus or gestational diabetes mellitus within last 6 months

- Use of any medication for glycemic control other than metformin during the past 3
months or thiazolidinediones within the past year

- Congestive heart failure as defined by New York Heart Association class III or IV

- Fasting glucose >270 mg/dL

- Creatinine clearance is <60 mL/minute

- History of myocardial infarction within the past 3 months, history of clinically
significant cardiac arrhythmia, clinically significant hypotension or hypertension, or
clinically significant abnormal electrocardiogram as determined by the investigator