The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
417
once daily, 12 weeks
once daily, 12 weeks
Research Site
Anjyo, Japan
Research Site
Bunkyō City, Japan
Research Site
Chūōku, Japan
Adjusted Mean Change in HbA1c Levels
The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.
Time frame: Baseline to Week 12
Adjusted Mean Change in Fasting Plasma Glucose
Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.
Time frame: Baseline to Week 12
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin \<7%, after 12 weeks of double-blind therapy
Time frame: At Week 12
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Research Site
Daitō, Japan
Research Site
Kamagaya, Japan
Research Site
Kashiwara, Japan
Research Site
Matsuyama, Japan
Research Site
Nagoya, Japan
Research Site
Naka, Japan
Research Site
Nakano, Japan
...and 10 more locations