Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of TA-7284 in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Inclusion Criteria:

• Men or women age ≥20 years old
• Diagnosed with Type 2 diabetes mellitus at least 3 months before screening
• HbA1c of ≥7.0% and ≤10.0% (monotherapy group)
• HbA1c of ≥7.0% and ≤10.5% (combination therapy group)

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