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Clinical Trial Details

Trial ID: L6919
Source ID: NCT01649297
Associated Drug: Placebo
Title: A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01649297/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: empagliflozin (low dose qd)|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Empagliflozin (high dose qd)|DRUG: empagliflozin (high dose bid)|DRUG: Placebo|DRUG: empagliflozin (low dose bid)
Outcome Measures: Primary: HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16, Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means., Baseline and 16 weeks | Secondary: Fasting Plasma Glucose (FPG) Change From Baseline at Week 16, Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means., Baseline and 16 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 983
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2012-10
Completion Date: 2013-12
Results First Posted: 2015-07-23
Last Update Posted: 2015-07-23
Locations: 1276.10.11036 Boehringer Ingelheim Investigational Site, Florence, Alabama, United States|1276.10.11049 Boehringer Ingelheim Investigational Site, Jonesboro, Arkansas, United States|1276.10.11040 Boehringer Ingelheim Investigational Site, Lomita, California, United States|1276.10.11033 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States|1276.10.11002 Boehringer Ingelheim Investigational Site, Rancho Cucamonga, California, United States|1276.10.11050 Boehringer Ingelheim Investigational Site, Sacramento, California, United States|1276.10.11015 Boehringer Ingelheim Investigational Site, West Hills, California, United States|1276.10.11012 Boehringer Ingelheim Investigational Site, Norwalk, Connecticut, United States|1276.10.11047 Boehringer Ingelheim Investigational Site, Waterbury, Connecticut, United States|1276.10.11010 Boehringer Ingelheim Investigational Site, Bradenton, Florida, United States|1276.10.11005 Boehringer Ingelheim Investigational Site, Davie, Florida, United States|1276.10.11004 Boehringer Ingelheim Investigational Site, Jacksonville, Florida, United States|1276.10.11051 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1276.10.11009 Boehringer Ingelheim Investigational Site, Oakland Park, Florida, United States|1276.10.11044 Boehringer Ingelheim Investigational Site, Palm Harbor, Florida, United States|1276.10.11030 Boehringer Ingelheim Investigational Site, Dunwoody, Georgia, United States|1276.10.11027 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1276.10.11020 Boehringer Ingelheim Investigational Site, Elwood, Indiana, United States|1276.10.11001 Boehringer Ingelheim Investigational Site, Bangor, Maine, United States|1276.10.11048 Boehringer Ingelheim Investigational Site, Sterling Heights, Michigan, United States|1276.10.11058 Boehringer Ingelheim Investigational Site, Jackson, Mississippi, United States|1276.10.11055 Boehringer Ingelheim Investigational Site, Edison, New Jersey, United States|1276.10.11011 Boehringer Ingelheim Investigational Site, Brooklyn, New York, United States|1276.10.11035 Boehringer Ingelheim Investigational Site, North Myrtle Beach, North Carolina, United States|1276.10.11041 Boehringer Ingelheim Investigational Site, Winston-Salem, North Carolina, United States|1276.10.11018 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States|1276.10.11043 Boehringer Ingelheim Investigational Site, Dayton, Ohio, United States|1276.10.11017 Boehringer Ingelheim Investigational Site, Kettering, Ohio, United States|1276.10.11022 Boehringer Ingelheim Investigational Site, Fleetwood, Pennsylvania, United States|1276.10.11003 Boehringer Ingelheim Investigational Site, Johnson City, Tennessee, United States|1276.10.11042 Boehringer Ingelheim Investigational Site, Corpus Christi, Texas, United States|1276.10.11013 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1276.10.11026 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1276.10.11031 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1276.10.11034 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1276.10.11028 Boehringer Ingelheim Investigational Site, Pearland, Texas, United States|1276.10.11029 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1276.10.11016 Boehringer Ingelheim Investigational Site, Port Orchard, Washington, United States|1276.10.11024 Boehringer Ingelheim Investigational Site, Spokane, Washington, United States|1276.10.61002 Boehringer Ingelheim Investigational Site, Wollongong, New South Wales, Australia|1276.10.61001 Boehringer Ingelheim Investigational Site, Box Hill, Victoria, Australia|1276.10.20008 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1276.10.20005 Boehringer Ingelheim Investigational Site, Surrey, British Columbia, Canada|1276.10.20010 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada|1276.10.20002 Boehringer Ingelheim Investigational Site, Bathurst, New Brunswick, Canada|1276.10.20001 Boehringer Ingelheim Investigational Site, Brampton, Ontario, Canada|1276.10.20007 Boehringer Ingelheim Investigational Site, Corunna, Ontario, Canada|1276.10.20006 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada|1276.10.20004 Boehringer Ingelheim Investigational Site, Drummondville, Quebec, Canada|1276.10.20003 Boehringer Ingelheim Investigational Site, Point Claire, Quebec, Canada|1276.10.20009 Boehringer Ingelheim Investigational Site, Victoriaville, Quebec, Canada|1276.10.37203 Boehringer Ingelheim Investigational Site, Pärnu, Estonia|1276.10.37201 Boehringer Ingelheim Investigational Site, Tallinn, Estonia|1276.10.37202 Boehringer Ingelheim Investigational Site, Tallinn, Estonia|1276.10.37204 Boehringer Ingelheim Investigational Site, Viljandi County, Estonia|1276.10.33002 Boehringer Ingelheim Investigational Site, Aire sur l'Adour, France|1276.10.33003 Boehringer Ingelheim Investigational Site, Bischheim, France|1276.10.33009 Boehringer Ingelheim Investigational Site, Bourg des Comptes, France|1276.10.33014 Boehringer Ingelheim Investigational Site, Bourges, France|1276.10.33007 Boehringer Ingelheim Investigational Site, Broglie, France|1276.10.33001 Boehringer Ingelheim Investigational Site, Mont de Marsan, France|1276.10.33008 Boehringer Ingelheim Investigational Site, Paris, France|1276.10.33006 Boehringer Ingelheim Investigational Site, Saint Vinecnt de Tyrosse, France|1276.10.33011 Boehringer Ingelheim Investigational Site, Segre, France|1276.10.33004 Boehringer Ingelheim Investigational Site, Strasbourg, France|1276.10.99501 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia|1276.10.99502 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia|1276.10.99503 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia|1276.10.99504 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia|1276.10.99505 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia|1276.10.99506 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia|1276.10.49001 Boehringer Ingelheim Investigational Site, Aschaffenburg, Germany|1276.10.49006 Boehringer Ingelheim Investigational Site, Berlin, Germany|1276.10.49007 Boehringer Ingelheim Investigational Site, Berlin, Germany|1276.10.49005 Boehringer Ingelheim Investigational Site, Essen, Germany|1276.10.49004 Boehringer Ingelheim Investigational Site, Frankfurt, Germany|1276.10.49002 Boehringer Ingelheim Investigational Site, Nürnberg, Germany|1276.10.49003 Boehringer Ingelheim Investigational Site, Rehlingen-Siersburg, Germany|1276.10.50201 Boehringer Ingelheim Investigational Site, Guatemala Ciudad, Guatemala|1276.10.50203 Boehringer Ingelheim Investigational Site, Guatemala Ciudad, Guatemala|1276.10.50204 Boehringer Ingelheim Investigational Site, Guatemala Ciudad, Guatemala|1276.10.50205 Boehringer Ingelheim Investigational Site, Guatemala Ciudad, Guatemala|1276.10.50202 Boehringer Ingelheim Investigational Site, Quetzaltenango Ciudad, Guatemala|1276.10.39004 Boehringer Ingelheim Investigational Site, Arenzano (GE), Italy|1276.10.39003 Boehringer Ingelheim Investigational Site, Bologna, Italy|1276.10.39007 Boehringer Ingelheim Investigational Site, Catanzaro, Italy|1276.10.39009 Boehringer Ingelheim Investigational Site, Catanzaro, Italy|1276.10.39002 Boehringer Ingelheim Investigational Site, Napoli, Italy|1276.10.39006 Boehringer Ingelheim Investigational Site, Palermo, Italy|1276.10.39001 Boehringer Ingelheim Investigational Site, Roma, Italy|1276.10.39008 Boehringer Ingelheim Investigational Site, Roma, Italy|1276.10.39005 Boehringer Ingelheim Investigational Site, Torino, Italy|1276.10.37102 Boehringer Ingelheim Investigational Site, Daugavpils, Latvia|1276.10.37104 Boehringer Ingelheim Investigational Site, Ogre, Latvia|1276.10.37101 Boehringer Ingelheim Investigational Site, Riga, Latvia|1276.10.37103 Boehringer Ingelheim Investigational Site, Tukums, Latvia|1276.10.37003 Boehringer Ingelheim Investigational Site, Kaunas, Lithuania|1276.10.37004 Boehringer Ingelheim Investigational Site, Kaunas, Lithuania|1276.10.37002 Boehringer Ingelheim Investigational Site, Klaipeda, Lithuania|1276.10.37001 Boehringer Ingelheim Investigational Site, Vilnius, Lithuania|1276.10.52001 Boehringer Ingelheim Investigational Site, Ciudad de Mexico, Mexico|1276.10.52002 Boehringer Ingelheim Investigational Site, Ciudad de Mexico, Mexico|1276.10.52003 Boehringer Ingelheim Investigational Site, Durango, Mexico|1276.10.52005 Boehringer Ingelheim Investigational Site, Pachuca, Mexico|1276.10.52004 Boehringer Ingelheim Investigational Site, Tijuana, Mexico|1276.10.64001 Boehringer Ingelheim Investigational Site, Christchurch, New Zealand|1276.10.64002 Boehringer Ingelheim Investigational Site, Greenlane East Auckland NZ, New Zealand|1276.10.48001 Boehringer Ingelheim Investigational Site, Bialystok, Poland|1276.10.48002 Boehringer Ingelheim Investigational Site, Bialystok, Poland|1276.10.48008 Boehringer Ingelheim Investigational Site, Gizycko, Poland|1276.10.48005 Boehringer Ingelheim Investigational Site, Katowice, Poland|1276.10.48006 Boehringer Ingelheim Investigational Site, Katowice, Poland|1276.10.48004 Boehringer Ingelheim Investigational Site, Krakow, Poland|1276.10.48003 Boehringer Ingelheim Investigational Site, Warszawa, Poland|1276.10.70001 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1276.10.70002 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1276.10.70003 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1276.10.70004 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1276.10.70005 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1276.10.70007 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1276.10.70008 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1276.10.70009 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1276.10.27004 Boehringer Ingelheim Investigational Site, Paarl, South Africa|1276.10.27003 Boehringer Ingelheim Investigational Site, Parow, South Africa|1276.10.27006 Boehringer Ingelheim Investigational Site, Plumstead, Cape Town, South Africa|1276.10.27001 Boehringer Ingelheim Investigational Site, Pretoria, South Africa|1276.10.27005 Boehringer Ingelheim Investigational Site, Pretoria, South Africa|1276.10.27002 Boehringer Ingelheim Investigational Site, Somerset West, South Africa|1276.10.34005 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1276.10.34001 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat, Spain|1276.10.34003 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat, Spain|1276.10.34002 Boehringer Ingelheim Investigational Site, Les Borges del Camp, Spain|1276.10.34004 Boehringer Ingelheim Investigational Site, Sant Adria del Besos, Spain|1276.10.34006 Boehringer Ingelheim Investigational Site, Vic, Spain|1276.10.38002 Boehringer Ingelheim Investigational Site, Kharkiv, Ukraine|1276.10.38007 Boehringer Ingelheim Investigational Site, Kharkiv, Ukraine|1276.10.38001 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1276.10.38004 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1276.10.38005 Boehringer Ingelheim Investigational Site, Kyiv, Ukraine
URL: https://clinicaltrials.gov/show/NCT01649297

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress