This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
547
Placebo tablets once a day
Placebo tablets once a day
Placebo tablets once a day
Change From Baseline in HbA1c After 12 Weeks of Treatment.
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
Time frame: baseline and 12 weeks
Occurrence of Treat to Target Efficacy Response
Occurrence of treat to target efficacy response, that is an HbA1c of \<7.0% after 12 weeks of treatment
Time frame: baseline and 12 weeks
Change From Baseline in FPG
Change from baseline in FPG after 12 weeks of treatment
Time frame: baseline and 12 weeks
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Placebo tablets once a day
BI 10773 tablets low dose once a day
Placebo tablets once a day
Placebo tablets once a day
Placebo tablets once a day
BI 10773 tablets mid-high dose once a day
BI 10773 tablets high dose once a day
Placebo tablets once a day
Placebo tablets once a day
Placebo tablets once a day
Placebo tablets once a day
BI 10773 tablets mid-low dose once a day
Placebo tablets once a day
1245.38.016 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1245.38.001 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1245.38.003 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1245.38.002 Boehringer Ingelheim Investigational Site
Hachioji, Tokyo, Japan
1245.38.010 Boehringer Ingelheim Investigational Site
Hanamaki, Iwate, Japan
1245.38.005 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa, Japan
1245.38.020 Boehringer Ingelheim Investigational Site
Kanazawa, Ishikawa, Japan
1245.38.013 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba, Japan
1245.38.019 Boehringer Ingelheim Investigational Site
Katsushika-ku, Tokyo, Japan
1245.38.021 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto, Japan
...and 22 more locations