Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TA-7284 as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.

This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.

Inclusion Criteria:

• Men or women age ≥20 years old
• Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period
• HbA1c of ≥7.0% and ≤10.0%

Exclusion Criteria:

• Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
• Past or current history of severe diabetic complications
• Fasting plasma glucose > 270 mg/dL before treatment start
• History of hereditary glucose-galactose malabsorption or primary renal glucosuria
• Patients requiring insulin therapy