Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01368081
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1162
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 10773 low dose BI 10773 BI 10773 low dose tablet once daily BI 10773 low dose Placebo (high dose) BI 10773 low dose tablet once daily BI 10773 high dose Placebo (low dose) BI 10773 high dose tablet once daily BI 10773 high dose BI 10773 BI 10773 high dose tablet once daily Metformin Metformin Metformin tablets 500-2250 mg a day (twice or three times per day)
- Primary Outcome Measures
Name Time Method Number of Patients With Drug Related Adverse Events After the first drug intake until 7 days after the last treatment administration, up to 383 days Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
- Secondary Outcome Measures
Name Time Method Change From Baseline in HbA1c Baseline and 52 weeks Change from baseline in HbA1c after 52 weeks of treatment
Trial Locations
- Locations (87)
1245.52.023 Boehringer Ingelheim Investigational Site
🇯🇵Adachi-ku, Tokyo, Japan
1245.52.048 Boehringer Ingelheim Investigational Site
🇯🇵Aki-gun, Hiroshima, Japan
1245.52.012 Boehringer Ingelheim Investigational Site
🇯🇵Annaka, Gunma, Japan
1245.52.087 Boehringer Ingelheim Investigational Site
🇯🇵Atami, Shizuoka, Japan
1245.52.008 Boehringer Ingelheim Investigational Site
🇯🇵Beppu, Oita, Japan
1245.52.073 Boehringer Ingelheim Investigational Site
🇯🇵Chiyoda-ku, Tokyo, Japan
1245.52.002 Boehringer Ingelheim Investigational Site
🇯🇵Chuo-ku, Tokyo, Japan
1245.52.020 Boehringer Ingelheim Investigational Site
🇯🇵Chuo-ku, Tokyo, Japan
1245.52.021 Boehringer Ingelheim Investigational Site
🇯🇵Chuo-ku, Tokyo, Japan
1245.52.031 Boehringer Ingelheim Investigational Site
🇯🇵Fujisawa, Kanagawa, Japan
Scroll for more (77 remaining)1245.52.023 Boehringer Ingelheim Investigational Site🇯🇵Adachi-ku, Tokyo, Japan