Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures
• Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization

Exclusion Criteria:

• Type 1 diabetes mellitus
• FPG >240 mg/dL before randomization
• Subjects who have history of unstable or rapidly progressing renal disease
• Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
• Significant cardiovascular history