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Clinical Trial Details

Trial ID: L5646
Source ID: NCT01159600
Associated Drug: Placebo Identical To Bi 10773 High Dose
Title: Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01159600/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo identical to BI 10773 high dose|DRUG: Placebo identical to BI 10773 low dose|DRUG: BI 10773|DRUG: BI 10773|DRUG: Placebo identical to BI 10773 low dose|DRUG: BI 10773|DRUG: Placebo identical to BI 10773 high dose
Outcome Measures: Primary: HbA1c Change From Baseline, Change from baseline in HbA1c after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication., Baseline and 24 weeks | Secondary: Body Weight Change From Baseline, Body weight change from baseline after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication., Baseline and 24 weeks|Mean Daily Plasma Glucose (MDG) Change From Baseline, Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication., Baseline and 24 weeks | Other: Confirmed Hypoglycaemic Adverse Events, Number of patients with confirmed hypoglycaemic events, as reported as adverse events., From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1504
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2010-07
Completion Date:
Results First Posted: 2014-06-17
Last Update Posted: 2014-06-17
Locations: 1245.23.10145 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States|1245.23.10046 Boehringer Ingelheim Investigational Site, Tempe, Arizona, United States|1245.23.10095 Boehringer Ingelheim Investigational Site, Huntington Park, California, United States|1245.23.10109 Boehringer Ingelheim Investigational Site, Huntington Park, California, United States|1245.23.10074 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States|1245.23.10149 Boehringer Ingelheim Investigational Site, Rancho Cucamonga, California, United States|1245.23.10127 Boehringer Ingelheim Investigational Site, Waterbury, Connecticut, United States|1245.23.10042 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States|1245.23.10133 Boehringer Ingelheim Investigational Site, Jupiter, Florida, United States|1245.23.10080 Boehringer Ingelheim Investigational Site, Decatur, Georgia, United States|1245.23.10001 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1245.23.10159 Boehringer Ingelheim Investigational Site, Des Moines, Iowa, United States|1245.23.10117 Boehringer Ingelheim Investigational Site, Arkansas City, Kansas, United States|1245.23.10157 Boehringer Ingelheim Investigational Site, Newton, Kansas, United States|1245.23.10148 Boehringer Ingelheim Investigational Site, Lexington, Kentucky, United States|1245.23.10034 Boehringer Ingelheim Investigational Site, Rochester, New York, United States|1245.23.10123 Boehringer Ingelheim Investigational Site, Smithtown, New York, United States|1245.23.10120 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States|1245.23.10031 Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States|1245.23.10158 Boehringer Ingelheim Investigational Site, Mount Pleasant, South Carolina, United States|1245.23.10015 Boehringer Ingelheim Investigational Site, Simpsonville, South Carolina, United States|1245.23.10156 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1245.23.10153 Boehringer Ingelheim Investigational Site, Hurst, Texas, United States|1245.23.10143 Boehringer Ingelheim Investigational Site, Killeen, Texas, United States|1245.23.10106 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1245.23.20032 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1245.23.20023 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada|1245.23.20028 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada|1245.23.20033 Boehringer Ingelheim Investigational Site, Victoria, British Columbia, Canada|1245.23.20024 Boehringer Ingelheim Investigational Site, Paradise, Newfoundland and Labrador, Canada|1245.23.20031 Boehringer Ingelheim Investigational Site, St. John's, Newfoundland and Labrador, Canada|1245.23.20026 Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, Canada|1245.23.20001 Boehringer Ingelheim Investigational Site, Barrie, Ontario, Canada|1245.23.20022 Boehringer Ingelheim Investigational Site, Brampton, Ontario, Canada|1245.23.20035 Boehringer Ingelheim Investigational Site, Corunna, Ontario, Canada|1245.23.20030 Boehringer Ingelheim Investigational Site, Etobicoke, Ontario, Canada|1245.23.20037 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada|1245.23.20029 Boehringer Ingelheim Investigational Site, London, Ontario, Canada|1245.23.20003 Boehringer Ingelheim Investigational Site, Markham, Ontario, Canada|1245.23.20040 Boehringer Ingelheim Investigational Site, Oakville, Ontario, Canada|1245.23.20034 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada|1245.23.20039 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1245.23.20027 Boehringer Ingelheim Investigational Site, Laval, Quebec, Canada|1245.23.20025 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada|1245.23.20036 Boehringer Ingelheim Investigational Site, Sherbrooke, Quebec, Canada|1245.23.20038 Boehringer Ingelheim Investigational Site, Ville Saint-Laurent, Quebec, Canada|1245.23.86031 Boehringer Ingelheim Investigational Site, Beijing, China|1245.23.86032 Boehringer Ingelheim Investigational Site, Beijing, China|1245.23.86033 Boehringer Ingelheim Investigational Site, Beijing, China|1245.23.86034 Boehringer Ingelheim Investigational Site, Beijing, China|1245.23.86035 Boehringer Ingelheim Investigational Site, Beijing, China|1245.23.86048 Boehringer Ingelheim Investigational Site, Chengdu, China|1245.23.86058 Boehringer Ingelheim Investigational Site, Chongqing, China|1245.23.86038 Boehringer Ingelheim Investigational Site, Dalian, China|1245.23.86002 Boehringer Ingelheim Investigational Site, Guangzhou, China|1245.23.86052 Boehringer Ingelheim Investigational Site, Guangzhou, China|1245.23.86037 Boehringer Ingelheim Investigational Site, Haerbin, China|1245.23.86049 Boehringer Ingelheim Investigational Site, Jinan, China|1245.23.86053 Boehringer Ingelheim Investigational Site, Jinan, China|1245.23.86055 Boehringer Ingelheim Investigational Site, Nan Ning, China|1245.23.86056 Boehringer Ingelheim Investigational Site, Nan Ning, China|1245.23.86042 Boehringer Ingelheim Investigational Site, Nanjing, China|1245.23.86043 Boehringer Ingelheim Investigational Site, Nanjing, China|1245.23.86039 Boehringer Ingelheim Investigational Site, Shanghai, China|1245.23.86040 Boehringer Ingelheim Investigational Site, Shanghai, China|1245.23.86054 Boehringer Ingelheim Investigational Site, Shantou, China|1245.23.86057 Boehringer Ingelheim Investigational Site, Shenyang, China|1245.23.86045 Boehringer Ingelheim Investigational Site, Shijiazhuang, China|1245.23.86013 Boehringer Ingelheim Investigational Site, Suzhou, China|1245.23.86036 Boehringer Ingelheim Investigational Site, Tianjin, China|1245.23.86041 Boehringer Ingelheim Investigational Site, Xi'An, China|1245.23.86051 Boehringer Ingelheim Investigational Site, Zhenjiang, China|1245.23.33015 Boehringer Ingelheim Investigational Site, Arras, France|1245.23.33008 Boehringer Ingelheim Investigational Site, Bersée, France|1245.23.33020 Boehringer Ingelheim Investigational Site, Bischheim, France|1245.23.33002 Boehringer Ingelheim Investigational Site, Bondy Cedex, France|1245.23.33016 Boehringer Ingelheim Investigational Site, Bruay La Buissiere, France|1245.23.33001 Boehringer Ingelheim Investigational Site, Corbeil Essonnes, France|1245.23.33010 Boehringer Ingelheim Investigational Site, Croix, France|1245.23.33009 Boehringer Ingelheim Investigational Site, Hautmont, France|1245.23.33003 Boehringer Ingelheim Investigational Site, La Rochelle Cedex 1, France|1245.23.33045 Boehringer Ingelheim Investigational Site, Marseille, France|1245.23.33014 Boehringer Ingelheim Investigational Site, Mundolsheim, France|1245.23.33004 Boehringer Ingelheim Investigational Site, Narbonne Cedex, France|1245.23.33012 Boehringer Ingelheim Investigational Site, Schiltigheim, France|1245.23.33013 Boehringer Ingelheim Investigational Site, Strasbourg, France|1245.23.33019 Boehringer Ingelheim Investigational Site, Strasbourg, France|1245.23.33007 Boehringer Ingelheim Investigational Site, Vieux Condé, France|1245.23.33018 Boehringer Ingelheim Investigational Site, Wattrelos, France|1245.23.49001 Boehringer Ingelheim Investigational Site, Dormagen, Germany|1245.23.49009 Boehringer Ingelheim Investigational Site, Flörsheim, Germany|1245.23.49004 Boehringer Ingelheim Investigational Site, Hatten, Germany|1245.23.49007 Boehringer Ingelheim Investigational Site, Künzing, Germany|1245.23.49002 Boehringer Ingelheim Investigational Site, Neuwied, Germany|1245.23.49008 Boehringer Ingelheim Investigational Site, Nürnberg, Germany|1245.23.49010 Boehringer Ingelheim Investigational Site, Rednitzhembach, Germany|1245.23.49006 Boehringer Ingelheim Investigational Site, Rehburg-Loccum, Germany|1245.23.49011 Boehringer Ingelheim Investigational Site, Rehlingen-Siersburg, Germany|1245.23.49005 Boehringer Ingelheim Investigational Site, Saarbrücken, Germany|1245.23.49003 Boehringer Ingelheim Investigational Site, Unterschneidheim, Germany|1245.23.91101 Boehringer Ingelheim Investigational Site, Coimbatore, India|1245.23.91104 Boehringer Ingelheim Investigational Site, Indore, India|1245.23.91103 Boehringer Ingelheim Investigational Site, Maharashtra, India|1245.23.91102 Boehringer Ingelheim Investigational Site, Nagpur, India|1245.23.91105 Boehringer Ingelheim Investigational Site, Pune, India|1245.23.82012 Boehringer Ingelheim Investigational Site, Anyang, Korea, Republic of|1245.23.82004 Boehringer Ingelheim Investigational Site, Busan, Korea, Republic of|1245.23.82011 Boehringer Ingelheim Investigational Site, Goyang, Korea, Republic of|1245.23.82009 Boehringer Ingelheim Investigational Site, Ilsan, Korea, Republic of|1245.23.82001 Boehringer Ingelheim Investigational Site, Incheon, Korea, Republic of|1245.23.82006 Boehringer Ingelheim Investigational Site, Jeonju, Korea, Republic of|1245.23.82005 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1245.23.82007 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1245.23.82008 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1245.23.82010 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1245.23.82014 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1245.23.82002 Boehringer Ingelheim Investigational Site, Suwon, Korea, Republic of|1245.23.82003 Boehringer Ingelheim Investigational Site, Wonju, Korea, Republic of|1245.23.52003 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1245.23.52004 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1245.23.52001 Boehringer Ingelheim Investigational Site, Monterrey, Mexico|1245.23.52002 Boehringer Ingelheim Investigational Site, Monterrey, Mexico|1245.23.74005 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia|1245.23.74002 Boehringer Ingelheim Investigational Site, Lucenec, Slovakia|1245.23.74006 Boehringer Ingelheim Investigational Site, Nitra, Slovakia|1245.23.74014 Boehringer Ingelheim Investigational Site, Nove Zamky, Slovakia|1245.23.74001 Boehringer Ingelheim Investigational Site, Povazska Bystrica, Slovakia|1245.23.74004 Boehringer Ingelheim Investigational Site, Presov, Slovakia|1245.23.74003 Boehringer Ingelheim Investigational Site, Trebisov, Slovakia|1245.23.38003 Boehringer Ingelheim Investigational Site, Celje, Slovenia|1245.23.38002 Boehringer Ingelheim Investigational Site, Koper, Slovenia|1245.23.38001 Boehringer Ingelheim Investigational Site, Maribor, Slovenia|1245.23.88010 Boehringer Ingelheim Investigational Site, Kaohsiung, Taiwan|1245.23.88011 Boehringer Ingelheim Investigational Site, Kaohsiung, Taiwan|1245.23.88012 Boehringer Ingelheim Investigational Site, Kaohsiung, Taiwan|1245.23.88013 Boehringer Ingelheim Investigational Site, Kaohsiung, Taiwan|1245.23.88009 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1245.23.88014 Boehringer Ingelheim Investigational Site, Tainan, Taiwan|1245.23.88006 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1245.23.88007 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1245.23.88021 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1245.23.88008 Boehringer Ingelheim Investigational Site, Taoyuan County, Taiwan|1245.23.90003 Boehringer Ingelheim Investigational Site, Erzurum, Turkey|1245.23.90001 Boehringer Ingelheim Investigational Site, Gaziantep, Turkey|1245.23.90002 Boehringer Ingelheim Investigational Site, Istanbul, Turkey|1245.23.90006 Boehringer Ingelheim Investigational Site, Istanbul, Turkey|1245.23.90007 Boehringer Ingelheim Investigational Site, Istanbul, Turkey|1245.23.90004 Boehringer Ingelheim Investigational Site, Izmir, Turkey
URL: https://clinicaltrials.gov/show/NCT01159600

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress