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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
261
Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
Matching placebo for Dapagliflozin 5mg/10mg oral dose
Research Site
Noda, Chiba, Japan
Research Site
Fukuoka, Fukuoka, Japan
Adjusted Mean Change in HbA1c Levels
To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Time frame: From Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Time frame: From Baseline to Week 24
Adjusted Mean Change in Body Weight
To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Time frame: From Baseline to Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Yukuhashi, Fukuoka, Japan
Research Site
Hiroshima, Hiroshima, Japan
Research Site
Chitose-shi, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Takasago-shi, Hyōgo, Japan
Research Site
Hakusan-shi, Ishikawa-ken, Japan
Research Site
Sanuki-shi, Kagawa-ken, Japan
Research Site
Takamatsu, Kagawa-ken, Japan
...and 16 more locations