Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01193218
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 547
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 10773 mid-high dose QD BI 10773 BI 10773 tablets mid-high dose once a day BI 10773 low dose QD Placebo (mid dose) BI 10773 tablets low dose once a day BI 10773 low dose QD Placebo (high dose) BI 10773 tablets low dose once a day BI 10773 low dose QD BI 10773 BI 10773 tablets low dose once a day BI 10773 mid-low dose QD Placebo (high dose) BI 10773 tablets mid-low dose once a day BI 10773 mid-high dose QD Placebo (high dose) BI 10773 tablets mid-high dose once a day BI 10773 mid-low dose QD BI 10773 BI 10773 tablets mid-low dose once a day BI 10773 mid-low dose QD Placebo (low dose) BI 10773 tablets mid-low dose once a day BI 10773 mid-high dose QD Placebo (low dose) BI 10773 tablets mid-high dose once a day Placebo Placebo (mid dose) Placebo tablets once a day BI 10773 mid-high dose QD Placebo (mid dose) BI 10773 tablets mid-high dose once a day BI 10773 high dose QD Placebo (low dose) BI 10773 tablets high dose once a day BI 10773 high dose QD Placebo (mid dose) BI 10773 tablets high dose once a day Placebo Placebo (low dose) Placebo tablets once a day Placebo Placebo (high dose) Placebo tablets once a day BI 10773 high dose QD BI 10773 BI 10773 tablets high dose once a day
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c After 12 Weeks of Treatment. baseline and 12 weeks The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
- Secondary Outcome Measures
Name Time Method Occurrence of Treat to Target Efficacy Response baseline and 12 weeks Occurrence of treat to target efficacy response, that is an HbA1c of \<7.0% after 12 weeks of treatment
Change From Baseline in FPG baseline and 12 weeks Change from baseline in FPG after 12 weeks of treatment
Related Research Topics
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Trial Locations
- Locations (32)
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
Scroll for more (22 remaining)1245.38.016 Boehringer Ingelheim Investigational Site🇯🇵Chiyoda-ku, Tokyo, Japan