A 16-week Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Japanese Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin

INTERVENTION: investigational material(s) Generic name etc : Dapagliflozin 5 mg INN of investigational material : dapagliflozin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Dapagliflozin, a blood glucose lowering drug Oral dose control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : Placebo tablet Oral dose CONDITION: Type 2 Diabetes Mellitus INCLUSION CRITERIA: ‐Provision of informed consent prior to any study specific procedures ‐Diagnosis of Type 2 Diabetes according the criteria specified by the Japan Diabetes Society ‐Japanese Men or women age 20 years or more at time of consenting. ‐Stable (unless adjustment is required based on Fasting Plasma Glucose values) dose insulin mono‐therapy with the mean insulin [up to two types of insulin within authorized indication in Japan] dose of 0.2 IU/kg/day or more AND 15 IU/body/day or more over the past 8 weeks prior to enrolment. ‐HbA1c 7.2% or more and < 11% from the blood samples collected at Visit 1 (enrolment) and Visit 3, observed from the central laboratory