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Clinical Trial Details

Trial ID: L4844
Source ID: NCT01306214
Associated Drug: Placebo
Title: Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01306214/results
Conditions: Diabetes Mellitus, Type 2|Obesity
Interventions: DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: BI 10773|DRUG: BI 10773
Outcome Measures: Primary: Change From Baseline in HbA1c After 18 Weeks of Treatment, The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment., Baseline and 18 weeks | Secondary: Change From Baseline in Insulin Dose After 52 Weeks of Treatment, The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment, Baseline and 52 weeks|Change From Baseline in Body Weight After 52 Weeks of Treatment, The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment, Baseline and 52 weeks|Change From Baseline in HbA1c After 52 Weeks of Treatment, The secondary endpoint was the change from baseline in HbA1c 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: 566
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2011-02
Completion Date: 2013-04
Results First Posted: 2014-06-17
Last Update Posted: 2014-06-17
Locations: 1245.49.10005 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States|1245.49.10011 Boehringer Ingelheim Investigational Site, Chandler, Arizona, United States|1245.49.10004 Boehringer Ingelheim Investigational Site, Tucson, Arizona, United States|1245.49.10002 Boehringer Ingelheim Investigational Site, Corona, California, United States|1245.49.10013 Boehringer Ingelheim Investigational Site, El Cajon, California, United States|1245.49.10030 Boehringer Ingelheim Investigational Site, Lomita, California, United States|1245.49.10014 Boehringer Ingelheim Investigational Site, Spring Valley, California, United States|1245.49.10019 Boehringer Ingelheim Investigational Site, Westlake Village, California, United States|1245.49.10024 Boehringer Ingelheim Investigational Site, Denver, Colorado, United States|1245.49.10018 Boehringer Ingelheim Investigational Site, Hialeah, Florida, United States|1245.49.10016 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1245.49.10021 Boehringer Ingelheim Investigational Site, Blue Ridge, Georgia, United States|1245.49.10009 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1245.49.10015 Boehringer Ingelheim Investigational Site, Evansville, Indiana, United States|1245.49.10023 Boehringer Ingelheim Investigational Site, Greenville, North Carolina, United States|1245.49.10007 Boehringer Ingelheim Investigational Site, Fargo, North Dakota, United States|1245.49.10006 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States|1245.49.10025 Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States|1245.49.10022 Boehringer Ingelheim Investigational Site, Memphis, Tennessee, United States|1245.49.10003 Boehringer Ingelheim Investigational Site, Austin, Texas, United States|1245.49.10001 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1245.49.10031 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1245.49.10033 Boehringer Ingelheim Investigational Site, Bountiful, Utah, United States|1245.49.10032 Boehringer Ingelheim Investigational Site, Salt Lake City, Utah, United States|1245.49.10026 Boehringer Ingelheim Investigational Site, Norfolk, Virginia, United States|1245.49.10020 Boehringer Ingelheim Investigational Site, Renton, Washington, United States|1245.49.32010 Boehringer Ingelheim Investigational Site, Bonheiden, Belgium|1245.49.32002 Boehringer Ingelheim Investigational Site, Edegem, Belgium|1245.49.32007 Boehringer Ingelheim Investigational Site, Huy, Belgium|1245.49.32014 Boehringer Ingelheim Investigational Site, Jette, Belgium|1245.49.32013 Boehringer Ingelheim Investigational Site, La Louvière, Belgium|1245.49.32012 Boehringer Ingelheim Investigational Site, Leuven, Belgium|1245.49.59003 Boehringer Ingelheim Investigational Site, Pleven, Bulgaria|1245.49.59004 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria|1245.49.59001 Boehringer Ingelheim Investigational Site, Stara Zagora, Bulgaria|1245.49.57003 Boehringer Ingelheim Investigational Site, Barranquilla, Colombia|1245.49.57005 Boehringer Ingelheim Investigational Site, Bogota, Colombia|1245.49.57006 Boehringer Ingelheim Investigational Site, Bogota, Colombia|1245.49.57004 Boehringer Ingelheim Investigational Site, Bogotá, Colombia|1245.49.57002 Boehringer Ingelheim Investigational Site, Medellín, Colombia|1245.49.42013 Boehringer Ingelheim Investigational Site, Breclav, Czech Republic|1245.49.42003 Boehringer Ingelheim Investigational Site, Brno, Czech Republic|1245.49.42010 Boehringer Ingelheim Investigational Site, Brno, Czech Republic|1245.49.42011 Boehringer Ingelheim Investigational Site, Chrudim, Czech Republic|1245.49.42009 Boehringer Ingelheim Investigational Site, Hodonin, Czech Republic|1245.49.42012 Boehringer Ingelheim Investigational Site, Svitavy56802, Czech Republic|1245.49.72001 Boehringer Ingelheim Investigational Site, Kuopio, Finland|1245.49.72002 Boehringer Ingelheim Investigational Site, Oulu, Finland|1245.49.72003 Boehringer Ingelheim Investigational Site, Turku, Finland|1245.49.33001 Boehringer Ingelheim Investigational Site, Grenoble Cedex, France|1245.49.33011 Boehringer Ingelheim Investigational Site, Le Creusot, France|1245.49.33012 Boehringer Ingelheim Investigational Site, Marseille, France|1245.49.33003 Boehringer Ingelheim Investigational Site, Nantes cedex 1, France|1245.49.33010 Boehringer Ingelheim Investigational Site, Narbonne Cedex, France|1245.49.33004 Boehringer Ingelheim Investigational Site, Pierre Benite, France|1245.49.33007 Boehringer Ingelheim Investigational Site, Point-à-Pitre Cedex, France|1245.49.33008 Boehringer Ingelheim Investigational Site, Saint Priest en Jarez, France|1245.49.33009 Boehringer Ingelheim Investigational Site, Vénissieux Cedex, France|1245.49.49104 Boehringer Ingelheim Investigational Site, Bosenheim, Germany|1245.49.49013 Boehringer Ingelheim Investigational Site, Dresden, Germany|1245.49.49101 Boehringer Ingelheim Investigational Site, Mainz, Germany|1245.49.49002 Boehringer Ingelheim Investigational Site, Neuwied, Germany|1245.49.49005 Boehringer Ingelheim Investigational Site, Saarbrücken, Germany|1245.49.49102 Boehringer Ingelheim Investigational Site, Wangen, Germany|1245.49.50201 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala|1245.49.50202 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala|1245.49.50203 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala|1245.49.50204 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala|1245.49.50205 Boehringer Ingelheim Investigational Site, Quetzaltenango, Guatemala|1245.49.52011 Boehringer Ingelheim Investigational Site, Aguascalientes, Mexico|1245.49.52012 Boehringer Ingelheim Investigational Site, Cuautla, Mexico|1245.49.52003 Boehringer Ingelheim Investigational Site, Durango, Mexico|1245.49.52005 Boehringer Ingelheim Investigational Site, Durango, Mexico|1245.49.52004 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1245.49.52006 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1245.49.52008 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1245.49.52002 Boehringer Ingelheim Investigational Site, Monterrey, Mexico|1245.49.52009 Boehringer Ingelheim Investigational Site, Monterrey, Mexico|1245.49.52010 Boehringer Ingelheim Investigational Site, Monterrey, Mexico|1245.49.52001 Boehringer Ingelheim Investigational Site, México, D.F., Mexico|1245.49.51002 Boehringer Ingelheim Investigational Site, Arequipa, Peru|1245.49.51006 Boehringer Ingelheim Investigational Site, Arequipa, Peru|1245.49.51010 Boehringer Ingelheim Investigational Site, Jesus Maria, Peru|1245.49.51001 Boehringer Ingelheim Investigational Site, Lima, Peru|1245.49.51008 Boehringer Ingelheim Investigational Site, Lima, Peru|1245.49.51009 Boehringer Ingelheim Investigational Site, Lima, Peru|1245.49.70008 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1245.49.70009 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1245.49.70006 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1245.49.70010 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1245.49.34039 Boehringer Ingelheim Investigational Site, Avila, Spain|1245.49.34038 Boehringer Ingelheim Investigational Site, Madrid, Spain|1245.49.34044 Boehringer Ingelheim Investigational Site, Madrid, Spain|1245.49.34043 Boehringer Ingelheim Investigational Site, MBoadilla del Monte (Madrid), Spain|1245.49.34047 Boehringer Ingelheim Investigational Site, Palma de Mallorca, Spain|1245.49.34045 Boehringer Ingelheim Investigational Site, pozuelo de Alarcon, Spain|1245.49.34016 Boehringer Ingelheim Investigational Site, Santiago de Compostela (La Coruña), Spain|1245.49.34041 Boehringer Ingelheim Investigational Site, Valencia, Spain|1245.49.75016 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine|1245.49.75007 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1245.49.75014 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1245.49.75015 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1245.49.75013 Boehringer Ingelheim Investigational Site, Kyiv, Ukraine
URL: https://clinicaltrials.gov/show/NCT01306214

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress