Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus

This is a randomized, double-blind, double-dummy, placebo and active-controlled
(glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on
HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and
pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated
type 2 diabetic patients.

Inclusion Criteria:

- Males and females with type 2 diabetes, 18-70 years of age at Visit 1

- Managing diabetes with diet and exercise only or currently being treated with a
stable dose of metformin (at least 1500 mg/day)

- Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and
between 7.5% and 10.9%, if without treatment

- Body mass index (BMI) ≥ 23.0 kg/m^2 and ≤ 45.0 kg/m^2 at Visit 1

Exclusion Criteria:

- Females who are pregnant or breast-feeding

- Known medical history or presence of type 1 diabetes or acute metabolic diabetic
complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy

- Acute coronary syndrome or uncontrolled hypertension

- Does not meet all diet or previous/concomitant medication restriction criteria