Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
- Conditions
- Diabetes Mellitus, Type 2Renal Insufficiency
- Interventions
- Drug: BI 10773Drug: 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
Trial Locations
- Locations (127)
1245.36.10014 Boehringer Ingelheim Investigational Site
🇺🇸Anaheim, California, United States
1245.36.10012 Boehringer Ingelheim Investigational Site
🇺🇸Corpus Christi, Texas, United States
1245.36.31004 Boehringer Ingelheim Investigational Site
🇳🇱Den Haag, Netherlands
1245.36.31017 Boehringer Ingelheim Investigational Site
🇳🇱Hardenberg, Netherlands
1245.36.20053 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1245.36.10004 Boehringer Ingelheim Investigational Site
🇺🇸Greer, South Carolina, United States
1245.36.10017 Boehringer Ingelheim Investigational Site
🇺🇸Plantation, Florida, United States
1245.36.10008 Boehringer Ingelheim Investigational Site
🇺🇸Greenville, North Carolina, United States
1245.36.10002 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1245.36.10021 Boehringer Ingelheim Investigational Site
🇺🇸Endwell, New York, United States
1245.36.10003 Boehringer Ingelheim Investigational Site
🇺🇸Melrose Park, Pennsylvania, United States
1245.36.10007 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1245.36.10011 Boehringer Ingelheim Investigational Site
🇺🇸Spokane, Washington, United States
1245.36.10023 Boehringer Ingelheim Investigational Site
🇺🇸Renton, Washington, United States
1245.36.10006 Boehringer Ingelheim Investigational Site
🇺🇸Tacoma, Washington, United States
1245.36.20055 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1245.36.20051 Boehringer Ingelheim Investigational Site
🇨🇦Mississauga, Ontario, Canada
1245.36.20086 Boehringer Ingelheim Investigational Site
🇨🇦Thornhill, Ontario, Canada
1245.36.33001 Boehringer Ingelheim Investigational Site
🇫🇷Corbeil Essonnes, France
1245.36.33042 Boehringer Ingelheim Investigational Site
🇫🇷Nanterre Cedex, France
1245.36.33041 Boehringer Ingelheim Investigational Site
🇫🇷Nice, France
1245.36.85201 Boehringer Ingelheim Investigational Site
🇭🇰Hong Kong, Hong Kong
1245.36.33043 Boehringer Ingelheim Investigational Site
🇫🇷Rennes, France
1245.36.33044 Boehringer Ingelheim Investigational Site
🇫🇷Saint Mandé, France
1245.36.91209 Boehringer Ingelheim Investigational Site
🇮🇳Aligarh, Uttar Pradesh, India
1245.36.91205 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1245.36.91201 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1245.36.91204 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1245.36.91208 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1245.36.91213 Boehringer Ingelheim Investigational Site
🇮🇳Gurgaon, India
1245.36.91203 Boehringer Ingelheim Investigational Site
🇮🇳Hyderabad, India
1245.36.91211 Boehringer Ingelheim Investigational Site
🇮🇳Kolkata, India
1245.36.91207 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
1245.36.60004 Boehringer Ingelheim Investigational Site
🇲🇾Pahang, Malaysia
1245.36.60011 Boehringer Ingelheim Investigational Site
🇲🇾Perak, Malaysia
1245.36.60010 Boehringer Ingelheim Investigational Site
🇲🇾Pulau Piang, Malaysia
1245.36.44016 Boehringer Ingelheim Investigational Site
🇬🇧Blackpool, United Kingdom
1245.36.48005 Boehringer Ingelheim Investigational Site
🇵🇱Torun, Poland
1245.36.44012 Boehringer Ingelheim Investigational Site
🇬🇧Chesterfield, United Kingdom
1245.36.74008 Boehringer Ingelheim Investigational Site
🇸🇰Nove Mesto Nad Vahom, Slovakia
1245.36.74012 Boehringer Ingelheim Investigational Site
🇸🇰Presov, Slovakia
1245.36.34021 Boehringer Ingelheim Investigational Site
🇪🇸San Sebastian de los Reyes, Spain
1245.36.70008 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1245.36.70009 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1245.36.63010 Boehringer Ingelheim Investigational Site
🇵🇭Tacloban, Philippines
1245.36.31012 Boehringer Ingelheim Investigational Site
🇳🇱Geleen, Netherlands
1245.36.35003 Boehringer Ingelheim Investigational Site
🇵🇹Faro, Portugal
1245.36.48006 Boehringer Ingelheim Investigational Site
🇵🇱Gdansk, Poland
1245.36.48003 Boehringer Ingelheim Investigational Site
🇵🇱Lodz, Poland
1245.36.48004 Boehringer Ingelheim Investigational Site
🇵🇱Lodz, Poland
1245.36.48002 Boehringer Ingelheim Investigational Site
🇵🇱Poznan, Poland
1245.36.10013 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1245.36.20023 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1245.36.20048 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
1245.36.20056 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1245.36.33040 Boehringer Ingelheim Investigational Site
🇫🇷Poitiers, France
1245.36.33038 Boehringer Ingelheim Investigational Site
🇫🇷Reims Cedex, France
1245.36.85206 Boehringer Ingelheim Investigational Site
🇭🇰Hong Kong, Hong Kong
1245.36.85202 Boehringer Ingelheim Investigational Site
🇭🇰Kowloon, Hong Kong
1245.36.91202 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1245.36.10018 Boehringer Ingelheim Investigational Site
🇺🇸Honolulu, Hawaii, United States
1245.36.20052 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1245.36.91214 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1245.36.91210 Boehringer Ingelheim Investigational Site
🇮🇳Mangalore, India
1245.36.91215 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, Maharastra, India
1245.36.10005 Boehringer Ingelheim Investigational Site
🇺🇸Bethlehem, Pennsylvania, United States
1245.36.10015 Boehringer Ingelheim Investigational Site
🇺🇸Shreveport, Louisiana, United States
1245.36.91212 Boehringer Ingelheim Investigational Site
🇮🇳New Delhi, India
1245.36.91216 Boehringer Ingelheim Investigational Site
🇮🇳Nasik, India
1245.36.60006 Boehringer Ingelheim Investigational Site
🇲🇾Kelantan Kota Bahru, Malaysia
1245.36.60003 Boehringer Ingelheim Investigational Site
🇲🇾Johor Baru, Malaysia
1245.36.10009 Boehringer Ingelheim Investigational Site
🇺🇸West Palm Beach, Florida, United States
1245.36.44010 Boehringer Ingelheim Investigational Site
🇬🇧Birmingham, United Kingdom
1245.36.20054 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1245.36.33036 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1245.36.33037 Boehringer Ingelheim Investigational Site
🇫🇷Reims, France
1245.36.60009 Boehringer Ingelheim Investigational Site
🇲🇾Kuala Lumpur, Malaysia
1245.36.60005 Boehringer Ingelheim Investigational Site
🇲🇾Kuala Lumpur, Malaysia
1245.36.60007 Boehringer Ingelheim Investigational Site
🇲🇾Perak, Malaysia
1245.36.60008 Boehringer Ingelheim Investigational Site
🇲🇾Sabah, Malaysia
1245.36.31015 Boehringer Ingelheim Investigational Site
🇳🇱Amersfoort, Netherlands
1245.36.60001 Boehringer Ingelheim Investigational Site
🇲🇾Selangor Darul Ehsan, Malaysia
1245.36.31009 Boehringer Ingelheim Investigational Site
🇳🇱Maastricht, Netherlands
1245.36.31002 Boehringer Ingelheim Investigational Site
🇳🇱Utrecht, Netherlands
1245.36.31003 Boehringer Ingelheim Investigational Site
🇳🇱Zaandam, Netherlands
1245.36.63008 Boehringer Ingelheim Investigational Site
🇵🇭Cavite City, Philippines
1245.36.63006 Boehringer Ingelheim Investigational Site
🇵🇭Cebu, Philippines
1245.36.63005 Boehringer Ingelheim Investigational Site
🇵🇭Manila, Philippines
1245.36.63009 Boehringer Ingelheim Investigational Site
🇵🇭Marikina, Philippines
1245.36.63007 Boehringer Ingelheim Investigational Site
🇵🇭Manila, Philippines
1245.36.48007 Boehringer Ingelheim Investigational Site
🇵🇱Ruda Slaska, Poland
1245.36.48001 Boehringer Ingelheim Investigational Site
🇵🇱Lublin, Poland
1245.36.35004 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1245.36.35002 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1245.36.35001 Boehringer Ingelheim Investigational Site
🇵🇹Vila Nova de Gaia, Portugal
1245.36.70011 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1245.36.70004 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1245.36.70006 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1245.36.70002 Boehringer Ingelheim Investigational Site
🇷🇺Vsevolozhsk, Russian Federation
1245.36.74013 Boehringer Ingelheim Investigational Site
🇸🇰Nitra, Slovakia
1245.36.74011 Boehringer Ingelheim Investigational Site
🇸🇰Moldava nad Bodvou, Slovakia
1245.36.74007 Boehringer Ingelheim Investigational Site
🇸🇰Trencin, Slovakia
1245.36.74009 Boehringer Ingelheim Investigational Site
🇸🇰Zilina, Slovakia
1245.36.76020 Boehringer Ingelheim Investigational Site
🇿🇦Somerset West, South Africa
1245.36.76021 Boehringer Ingelheim Investigational Site
🇿🇦Plumstead, South Africa
1245.36.76022 Boehringer Ingelheim Investigational Site
🇿🇦Somerset West, South Africa
1245.36.34015 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1245.36.34009 Boehringer Ingelheim Investigational Site
🇪🇸Granada, Spain
1245.36.34014 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet de Llobregat, Spain
1245.36.34012 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1245.36.34013 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1245.36.34019 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1245.36.34020 Boehringer Ingelheim Investigational Site
🇪🇸Manresa, Spain
1245.36.34017 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1245.36.34016 Boehringer Ingelheim Investigational Site
🇪🇸Santiago de Compostela, Spain
1245.36.44013 Boehringer Ingelheim Investigational Site
🇬🇧Blackpool, United Kingdom
1245.36.44018 Boehringer Ingelheim Investigational Site
🇬🇧Bath, United Kingdom
1245.36.44025 Boehringer Ingelheim Investigational Site
🇬🇧Doncaster, United Kingdom
1245.36.44026 Boehringer Ingelheim Investigational Site
🇬🇧Chester, United Kingdom
1245.36.44036 Boehringer Ingelheim Investigational Site
🇬🇧Epsom, United Kingdom
1245.36.44001 Boehringer Ingelheim Investigational Site
🇬🇧Frome, United Kingdom
1245.36.44023 Boehringer Ingelheim Investigational Site
🇬🇧Nantwich, United Kingdom
1245.36.44007 Boehringer Ingelheim Investigational Site
🇬🇧Midsomer Norton, United Kingdom
1245.36.44024 Boehringer Ingelheim Investigational Site
🇬🇧Welwyn Garden City, United Kingdom
1245.36.10019 Boehringer Ingelheim Investigational Site
🇺🇸Lomita, California, United States
1245.36.85204 Boehringer Ingelheim Investigational Site
🇭🇰Hong Kong, Hong Kong
1245.36.85205 Boehringer Ingelheim Investigational Site
🇭🇰Hong Kong, Hong Kong