A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

An Open-Label, Randomized, 2 Way Crossover, Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.

This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients with type 2 diabetes mellitus who have normal renal function. The patients will receive both TA-7284-Low and TA-7284-High orally alone in either Period 1 or 2.

Inclusion Criteria:

• Patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment
• Body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening
• HbA1c of ≥6.5% and ≤10.5% at screening

Exclusion Criteria:

• Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
• Past or current history of severe diabetic complications
• Patients requiring insulin therapy
• History of hereditary glucose-galactose malabsorption or primary renal glucosuria