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Clinical Trial Details

Trial ID: L3846
Source ID: NCT01167881
Associated Drug: Bi 10773
Title: Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01167881/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BI 10773|DRUG: Glimepiride|DRUG: Placebo|DRUG: Placebo
Outcome Measures: Primary: The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment., Baseline and 104 weeks | Secondary: The Change in Body Weight From Baseline After 104 Weeks of Treatment., baseline and 104 weeks|The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment., baseline and 104 weeks|The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment., baseline and 104 weeks|The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment., baseline and 104 weeks|The Change From Baseline in HbA1c After 52 Weeks of Treatment., baseline and 52 weeks|The Change in Body Weight From Baseline After 52 Weeks of Treatment., baseline and 52 weeks|The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment., baseline and 52 weeks|The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment., baseline and 52 weeks|The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment., baseline and 52 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1549
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2010-08
Completion Date: 2015-08
Results First Posted: 2014-08-08
Last Update Posted: 2016-09-02
Locations: 1245.28.10005 Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States|1245.28.10012 Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States|1245.28.10016 Boehringer Ingelheim Investigational Site, Hot Springs, Arkansas, United States|1245.28.10003 Boehringer Ingelheim Investigational Site, Sacramento, California, United States|1245.28.10021 Boehringer Ingelheim Investigational Site, West Hills, California, United States|1245.28.10009 Boehringer Ingelheim Investigational Site, Bradednton, Florida, United States|1245.28.10015 Boehringer Ingelheim Investigational Site, Tampa, Florida, United States|1245.28.10033 Boehringer Ingelheim Investigational Site, Blue Ridge, Georgia, United States|1245.28.10026 Boehringer Ingelheim Investigational Site, Boise, Idaho, United States|1245.28.10007 Boehringer Ingelheim Investigational Site, Omaha, Nebraska, United States|1245.28.10027 Boehringer Ingelheim Investigational Site, Henderson, Nevada, United States|1245.28.10014 Boehringer Ingelheim Investigational Site, Rochester, New York, United States|1245.28.10006 Boehringer Ingelheim Investigational Site, Shelby, North Carolina, United States|1245.28.10011 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States|1245.28.10019 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States|1245.28.10004 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States|1245.28.10008 Boehringer Ingelheim Investigational Site, Perrysburg, Ohio, United States|1245.28.10020 Boehringer Ingelheim Investigational Site, Medford, Oregon, United States|1245.28.10017 Boehringer Ingelheim Investigational Site, Portland, Oregon, United States|1245.28.10031 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1245.28.10032 Boehringer Ingelheim Investigational Site, Longview, Texas, United States|1245.28.10022 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1245.28.10030 Boehringer Ingelheim Investigational Site, Draper, Utah, United States|1245.28.10023 Boehringer Ingelheim Investigational Site, Salt Lake City, Utah, United States|1245.28.10013 Boehringer Ingelheim Investigational Site, Kenosha, Wisconsin, United States|1245.28.54010 Boehringer Ingelheim Investigational Site, Buenos Aires, Argentina|1245.28.54001 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1245.28.54002 Boehringer Ingelheim Investigational Site, Córdoba, Argentina|1245.28.54003 Boehringer Ingelheim Investigational Site, Córdoba, Argentina|1245.28.43006 Boehringer Ingelheim Investigational Site, Graz, Austria|1245.28.43005 Boehringer Ingelheim Investigational Site, Salzburg, Austria|1245.28.43001 Boehringer Ingelheim Investigational Site, Wien, Austria|1245.28.43002 Boehringer Ingelheim Investigational Site, Wien, Austria|1245.28.43003 Boehringer Ingelheim Investigational Site, Wien, Austria|1245.28.43004 Boehringer Ingelheim Investigational Site, Wien, Austria|1245.28.20074 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1245.28.20077 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1245.28.20075 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada|1245.28.20084 Boehringer Ingelheim Investigational Site, Langley, British Columbia, Canada|1245.28.20082 Boehringer Ingelheim Investigational Site, Grand Falls-Windsor, Newfoundland and Labrador, Canada|1245.28.20016 Boehringer Ingelheim Investigational Site, Mount Pearl, Newfoundland and Labrador, Canada|1245.28.20079 Boehringer Ingelheim Investigational Site, St. John's, Newfoundland and Labrador, Canada|1245.28.20071 Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, Canada|1245.28.20080 Boehringer Ingelheim Investigational Site, Collingwood, Ontario, Canada|1245.28.20078 Boehringer Ingelheim Investigational Site, Stayner, Ontario, Canada|1245.28.20005 Boehringer Ingelheim Investigational Site, Strathroy, Ontario, Canada|1245.28.20083 Boehringer Ingelheim Investigational Site, Sudbury, Ontario, Canada|1245.28.20072 Boehringer Ingelheim Investigational Site, Chicoutimi, Quebec, Canada|1245.28.20081 Boehringer Ingelheim Investigational Site, Chicoutimi, Quebec, Canada|1245.28.20085 Boehringer Ingelheim Investigational Site, Gatineau, Quebec, Canada|1245.28.20043 Boehringer Ingelheim Investigational Site, Longueuil, Quebec, Canada|1245.28.20070 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada|1245.28.20073 Boehringer Ingelheim Investigational Site, Sherbrooke, Quebec, Canada|1245.28.20021 Boehringer Ingelheim Investigational Site, Trois Rivieres, Quebec, Canada|1245.28.20076 Boehringer Ingelheim Investigational Site, Quebec, Canada|1245.28.57007 Boehringer Ingelheim Investigational Site, Barranquilla, Colombia|1245.28.57005 Boehringer Ingelheim Investigational Site, Bogota, Colombia|1245.28.57003 Boehringer Ingelheim Investigational Site, Bogotá, Colombia|1245.28.57006 Boehringer Ingelheim Investigational Site, Floridablanca, Colombia|1245.28.42003 Boehringer Ingelheim Investigational Site, Brno, Czech Republic|1245.28.42005 Boehringer Ingelheim Investigational Site, Holice, Czech Republic|1245.28.42002 Boehringer Ingelheim Investigational Site, Mlada Boleslav, Czech Republic|1245.28.42008 Boehringer Ingelheim Investigational Site, Praha 1, Czech Republic|1245.28.42001 Boehringer Ingelheim Investigational Site, Slany, Czech Republic|1245.28.42007 Boehringer Ingelheim Investigational Site, Slany, Czech Republic|1245.28.42004 Boehringer Ingelheim Investigational Site, Uherske Hradiste, Czech Republic|1245.28.42006 Boehringer Ingelheim Investigational Site, Zlin, Czech Republic|1245.28.72001 Boehringer Ingelheim Investigational Site, Helsinki, Finland|1245.28.72004 Boehringer Ingelheim Investigational Site, Joensuu, Finland|1245.28.72003 Boehringer Ingelheim Investigational Site, Oulu, Finland|1245.28.72002 Boehringer Ingelheim Investigational Site, Pori, Finland|1245.28.85201 Boehringer Ingelheim Investigational Site, Hong Kong, Hong Kong|1245.28.85207 Boehringer Ingelheim Investigational Site, Hong Kong, Hong Kong|1245.28.85202 Boehringer Ingelheim Investigational Site, Kowloon, Hong Kong|1245.28.91206 Boehringer Ingelheim Investigational Site, Ahmedabad, India|1245.28.91202 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.28.91204 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.28.91205 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.28.91208 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.28.91201 Boehringer Ingelheim Investigational Site, Chennai, India|1245.28.91213 Boehringer Ingelheim Investigational Site, Chennai, India|1245.28.91203 Boehringer Ingelheim Investigational Site, Hyderabad, India|1245.28.91211 Boehringer Ingelheim Investigational Site, Kolkata, India|1245.28.91210 Boehringer Ingelheim Investigational Site, Mangalore, India|1245.28.91212 Boehringer Ingelheim Investigational Site, New Delhi, India|1245.28.91207 Boehringer Ingelheim Investigational Site, Pune, India|1245.28.91209 Boehringer Ingelheim Investigational Site, Uttar Pradesh, India|1245.28.39021 Boehringer Ingelheim Investigational Site, Cagliari, Italy|1245.28.39022 Boehringer Ingelheim Investigational Site, Chieri (to), Italy|1245.28.39016 Boehringer Ingelheim Investigational Site, Lucca, Italy|1245.28.39018 Boehringer Ingelheim Investigational Site, Milano, Italy|1245.28.39019 Boehringer Ingelheim Investigational Site, Milano, Italy|1245.28.39017 Boehringer Ingelheim Investigational Site, Monserrato (ca), Italy|1245.28.39023 Boehringer Ingelheim Investigational Site, Rimini, Italy|1245.28.39020 Boehringer Ingelheim Investigational Site, Salerno, Italy|1245.28.60003 Boehringer Ingelheim Investigational Site, Johor Bahru, Malaysia|1245.28.60006 Boehringer Ingelheim Investigational Site, Kelantan, Malaysia|1245.28.60005 Boehringer Ingelheim Investigational Site, Kuala Lumpur, Malaysia|1245.28.60009 Boehringer Ingelheim Investigational Site, Kuala Lumpur, Malaysia|1245.28.60004 Boehringer Ingelheim Investigational Site, Pahang, Malaysia|1245.28.60007 Boehringer Ingelheim Investigational Site, Perak, Malaysia|1245.28.60010 Boehringer Ingelheim Investigational Site, Pulau Pinang, Malaysia|1245.28.60001 Boehringer Ingelheim Investigational Site, Selangor Darul Ehsan, Malaysia|1245.28.52006 Boehringer Ingelheim Investigational Site, Aguascalientes, Mexico|1245.28.52008 Boehringer Ingelheim Investigational Site, Cuautla, Mexico|1245.28.52009 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1245.28.52007 Boehringer Ingelheim Investigational Site, Mexico, Mexico|1245.28.31008 Boehringer Ingelheim Investigational Site, 's HERTOGENBOSCH, Netherlands|1245.28.31020 Boehringer Ingelheim Investigational Site, Losser, Netherlands|1245.28.31014 Boehringer Ingelheim Investigational Site, Rotterdam, Netherlands|1245.28.47002 Boehringer Ingelheim Investigational Site, Hønefoss, Norway|1245.28.47001 Boehringer Ingelheim Investigational Site, Oslo, Norway|1245.28.47003 Boehringer Ingelheim Investigational Site, Sandefjord, Norway|1245.28.63016 Boehringer Ingelheim Investigational Site, Cavite City, Philippines|1245.28.63013 Boehringer Ingelheim Investigational Site, Cebu City, Philippines|1245.28.63020 Boehringer Ingelheim Investigational Site, Jaro Iloilo City, Philippines|1245.28.63004 Boehringer Ingelheim Investigational Site, Manila, Philippines|1245.28.63015 Boehringer Ingelheim Investigational Site, Manila, Philippines|1245.28.63012 Boehringer Ingelheim Investigational Site, Pasig City, Philippines|1245.28.63011 Boehringer Ingelheim Investigational Site, Quezon City, Philippines|1245.28.63010 Boehringer Ingelheim Investigational Site, Tacloban, Philippines|1245.28.63014 Boehringer Ingelheim Investigational Site, Tagbilaran City, Bohol, Philippines|1245.28.35006 Boehringer Ingelheim Investigational Site, Amadora, Portugal|1245.28.35002 Boehringer Ingelheim Investigational Site, Lisboa, Portugal|1245.28.35012 Boehringer Ingelheim Investigational Site, Porto, Portugal|1245.28.35016 Boehringer Ingelheim Investigational Site, Vila Nova de Gaia, Portugal|1245.28.76019 Boehringer Ingelheim Investigational Site, Boksburg North, South Africa|1245.28.76018 Boehringer Ingelheim Investigational Site, Bryanston, South Africa|1245.28.76016 Boehringer Ingelheim Investigational Site, Cape Town, South Africa|1245.28.76017 Boehringer Ingelheim Investigational Site, Cape Town, South Africa|1245.28.76012 Boehringer Ingelheim Investigational Site, Durban, South Africa|1245.28.76015 Boehringer Ingelheim Investigational Site, Durban, South Africa|1245.28.76013 Boehringer Ingelheim Investigational Site, Krugersdorp, South Africa|1245.28.76023 Boehringer Ingelheim Investigational Site, Lenasia South, South Africa|1245.28.76024 Boehringer Ingelheim Investigational Site, Lenasia, South Africa|1245.28.76014 Boehringer Ingelheim Investigational Site, Pretoria, South Africa|1245.28.34004 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1245.28.34011 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1245.28.34002 Boehringer Ingelheim Investigational Site, Burjasot, Spain|1245.28.34003 Boehringer Ingelheim Investigational Site, Centelles, Spain|1245.28.34009 Boehringer Ingelheim Investigational Site, Granada, Spain|1245.28.34012 Boehringer Ingelheim Investigational Site, Madrid, Spain|1245.28.34013 Boehringer Ingelheim Investigational Site, Madrid, Spain|1245.28.34005 Boehringer Ingelheim Investigational Site, Mataró, Spain|1245.28.34001 Boehringer Ingelheim Investigational Site, Pineda de Mar, Spain|1245.28.34010 Boehringer Ingelheim Investigational Site, San Sebastian de los Reyes, Spain|1245.28.34006 Boehringer Ingelheim Investigational Site, Tarrega - Lleida, Spain|1245.28.46009 Boehringer Ingelheim Investigational Site, Borås, Sweden|1245.28.46008 Boehringer Ingelheim Investigational Site, Lund, Sweden|1245.28.46001 Boehringer Ingelheim Investigational Site, Malmö, Sweden|1245.28.46002 Boehringer Ingelheim Investigational Site, Stockholm, Sweden|1245.28.46006 Boehringer Ingelheim Investigational Site, Stockholm, Sweden|1245.28.46007 Boehringer Ingelheim Investigational Site, Stockholm, Sweden|1245.28.46004 Boehringer Ingelheim Investigational Site, Uppsala, Sweden|1245.28.46005 Boehringer Ingelheim Investigational Site, Örebro, Sweden|1245.28.41015 Boehringer Ingelheim Investigational Site, Ascona, Switzerland|1245.28.41017 Inselspital Bern, Bern, Switzerland|1245.28.88004 Boehringer Ingelheim Investigational Site, Changhua, Taiwan|1245.28.88003 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1245.28.88005 Boehringer Ingelheim Investigational Site, Tainan Hsien, Taiwan|1245.28.88002 Boehringer Ingelheim Investigational Site, Taipei Hsien, Taiwan|1245.28.88001 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1245.28.66006 Boehringer Ingelheim Investigational Site, Bangkok, Thailand|1245.28.66007 Boehringer Ingelheim Investigational Site, Bangkok, Thailand|1245.28.66004 Boehringer Ingelheim Investigational Site, Muang District, Thailand|1245.28.66008 Boehringer Ingelheim Investigational Site, Nakhonratchasima, Thailand|1245.28.44006 Boehringer Ingelheim Investigational Site, Addlestone, United Kingdom|1245.28.44020 Boehringer Ingelheim Investigational Site, Ashford, United Kingdom|1245.28.44008 Boehringer Ingelheim Investigational Site, Balham, United Kingdom|1245.28.44035 Boehringer Ingelheim Investigational Site, Barnstable, United Kingdom|1245.28.44016 Boehringer Ingelheim Investigational Site, Blackpool, United Kingdom|1245.28.44021 Boehringer Ingelheim Investigational Site, Bradford on Avon, United Kingdom|1245.28.44019 Boehringer Ingelheim Investigational Site, Burbage, United Kingdom|1245.28.44027 Boehringer Ingelheim Investigational Site, Chestfield, Whitstable, United Kingdom|1245.28.44011 Boehringer Ingelheim Investigational Site, Chippenham, United Kingdom|1245.28.44022 Boehringer Ingelheim Investigational Site, Chippenham, United Kingdom|1245.28.44043 Boehringer Ingelheim Investigational Site, Coventry, United Kingdom|1245.28.44025 Boehringer Ingelheim Investigational Site, Doncaster, United Kingdom|1245.28.44030 Boehringer Ingelheim Investigational Site, Ely, United Kingdom|1245.28.44007 Boehringer Ingelheim Investigational Site, Midsomer Norton, United Kingdom|1245.28.44023 Boehringer Ingelheim Investigational Site, Nantwich, United Kingdom|1245.28.44017 Boehringer Ingelheim Investigational Site, Whitstable, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01167881

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress