Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
- Conditions
- Diabetes Mellitus, Type 2Renal Insufficiency
- Interventions
- Drug: Placebo
- Registration Number
- NCT01164501
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 741
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 tablets once daily BI 10773 low dose Placebo BI 10773 tablets once daily BI 10773 high dose Placebo BI 10773 tablets once daily BI 10773 high dose BI 10773 BI 10773 tablets once daily Placebo Placebo Placebo tablets matching BI 10773
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment Baseline and 24 weeks Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment.
Note adjusted means are provided.HbA1c Change From Baseline in Patients With Mild Renal Impairment Baseline and 24 weeks Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment.
Note adjusted means are provided.HbA1c Change From Baseline in Patients With Moderate Renal Impairment Baseline and 24 weeks Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment.
Note adjusted means are provided.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (127)
1245.36.10014 Boehringer Ingelheim Investigational Site
🇺🇸Anaheim, California, United States
1245.36.10019 Boehringer Ingelheim Investigational Site
🇺🇸Lomita, California, United States
1245.36.10017 Boehringer Ingelheim Investigational Site
🇺🇸Plantation, Florida, United States
1245.36.10009 Boehringer Ingelheim Investigational Site
🇺🇸West Palm Beach, Florida, United States
1245.36.10018 Boehringer Ingelheim Investigational Site
🇺🇸Honolulu, Hawaii, United States
1245.36.10015 Boehringer Ingelheim Investigational Site
🇺🇸Shreveport, Louisiana, United States
1245.36.10021 Boehringer Ingelheim Investigational Site
🇺🇸Endwell, New York, United States
1245.36.10008 Boehringer Ingelheim Investigational Site
🇺🇸Greenville, North Carolina, United States
1245.36.10005 Boehringer Ingelheim Investigational Site
🇺🇸Bethlehem, Pennsylvania, United States
1245.36.10003 Boehringer Ingelheim Investigational Site
🇺🇸Melrose Park, Pennsylvania, United States
Scroll for more (117 remaining)1245.36.10014 Boehringer Ingelheim Investigational Site🇺🇸Anaheim, California, United States