Japanese male and female patients with Type 2 Diabetes and aged ≥ 20 years old, with inadequate glycemic control on insulin defined as Haemoglobin A1c ≥ 7.2% and \< 11% will be enrolled into the wash-out phase or directly into the lead-in phase depending on whether the patient has been receiving an Oral antidiabetic drug (including Glucagon-Like Peptide-1 agonists and excluding Thiazolidinedions) other than a Dipeptidyl Peptidase-4 inhibitor as part of the baseline treatment. Additional treatment with a concomitant Dipeptidyl Peptidase-4 inhibitor is allowed. And around 180 eligible patients in total will be randomized into the study with a 2:1 randomization scheme (i.e.120 patients into the dapagliflozin treatment group and 60 patients into the placebo treatment group. All subjects who completed a 16 weeks double-blind treatment period will shift to a 36 weeks open extension treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
266
Dapagliflozin, a blood glucose lowering drug. Oral dose
Placebo tablet. Oral dose
Research Site
Adachi-ku, Japan
Research Site
Chitose-shi, Japan
Research Site
Chiyoda-ku, Japan
Research Site
Chūōku, Japan
Research Site
Fukuoka, Japan
Research Site
Hirosaki-shi, Japan
Research Site
Kamakura-shi, Japan
Research Site
Koriyama-shi, Japan
Research Site
Mitaka-shi, Japan
Research Site
Osaka, Japan
...and 4 more locations
Adjusted Mean Change in HbA1c Levels
Mean change in HbA1c levels from baseline to Week 16 between dapagliflozin 5 mg versus placebo
Time frame: Baseline to Week 16
Fasting Plasma Glucose
Mean change in fasting plasma glucose from baseline to Week 16 between dapagliflozin 5 mg versus placebo
Time frame: Baseline to Week 16
Total Body Weight
Mean change in total body weight from baseline to Week 16 between dapagliflozin 5 mg versus placebo
Time frame: Baseline to Week 16
Total Mean Daily Insulin Dose
Mean change in calculated mean daily insulin dose from baseline to Week 16 between dapagliflozin 5 mg versus placebo
Time frame: Baseline to Week 16
Proportion of Participants With Mean Daily Insulin Dose Reduction of Greater Than or Equal 10%
Proportion of participants with mean daily insulin dose reduction greater than or equal 10% from baseline to week 16 (LOCF) between dapagliflozin 5 mg versus placebo
Time frame: Baseline to Week 16
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