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Clinical Trial Details

Trial ID: L4414
Source ID: NCT01778049
Associated Drug: Bi 10773
Title: Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01778049/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BI 10773|DRUG: BI 10773 Placebo|DRUG: BI 10773 / BI 1356|DRUG: BI 10773|DRUG: BI 10773 / BI 1356|DRUG: BI 10773 / BI 1356 Placebo|DRUG: BI 10773|DRUG: BI 10773|DRUG: BI 10773|DRUG: BI 10773 / BI 1356 Placebo|DRUG: BI 10773 Placebo|DRUG: BI 10773 / BI 1356 Placebo|DRUG: BI 10773|DRUG: BI 10773 / BI 1356 Placebo
Outcome Measures: Primary: Change From Baseline of HbA1c After 24 Weeks of Treatment., Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference. Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial., Baseline and 24 weeks | Secondary: Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks., Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24., Baseline and 24 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 708
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2013-01
Completion Date: 2015-03
Results First Posted: 2016-04-04
Last Update Posted: 2016-04-04
Locations: 1275.10.01019 Boehringer Ingelheim Investigational Site, Chino, California, United States|1275.10.01008 Boehringer Ingelheim Investigational Site, Huntington Beach, California, United States|1275.10.01003 Boehringer Ingelheim Investigational Site, San Diego, California, United States|1275.10.01024 Boehringer Ingelheim Investigational Site, San Diego, California, United States|1275.10.01002 Boehringer Ingelheim Investigational Site, Sylmar, California, United States|1275.10.01011 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1275.10.01009 Boehringer Ingelheim Investigational Site, Orlando, Florida, United States|1275.10.01023 Boehringer Ingelheim Investigational Site, Oviedo, Florida, United States|1275.10.01006 Boehringer Ingelheim Investigational Site, Tamarac, Florida, United States|1275.10.01017 Boehringer Ingelheim Investigational Site, Conyers, Georgia, United States|1275.10.01016 Boehringer Ingelheim Investigational Site, Snellville, Georgia, United States|1275.10.01012 Boehringer Ingelheim Investigational Site, Avon, Indiana, United States|1275.10.01013 Boehringer Ingelheim Investigational Site, Muncie, Indiana, United States|1275.10.01010 Boehringer Ingelheim Investigational Site, Elkton, Maryland, United States|1275.10.01001 Boehringer Ingelheim Investigational Site, Stevensville, Michigan, United States|1275.10.01007 Boehringer Ingelheim Investigational Site, Salisbury, North Carolina, United States|1275.10.01005 Boehringer Ingelheim Investigational Site, Bismarck, North Dakota, United States|1275.10.01020 Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States|1275.10.01022 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States|1275.10.01021 Boehringer Ingelheim Investigational Site, Union, South Carolina, United States|1275.10.01014 Boehringer Ingelheim Investigational Site, North Richland Hills, Texas, United States|1275.10.01018 Boehringer Ingelheim Investigational Site, Draper, Utah, United States|1275.10.01015 Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States|1275.10.01025 Boehringer Ingelheim Investigational Site, Virginia Beach, Virginia, United States|1275.10.54005 Boehringer Ingelheim Investigational Site, Caba, Argentina|1275.10.54012 Boehringer Ingelheim Investigational Site, Caba, Argentina|1275.10.54002 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1275.10.54007 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1275.10.54013 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1275.10.54006 Boehringer Ingelheim Investigational Site, Cordoba, Argentina|1275.10.54008 Boehringer Ingelheim Investigational Site, Cordoba, Argentina|1275.10.54011 Boehringer Ingelheim Investigational Site, Córdoba, Argentina|1275.10.54003 Boehringer Ingelheim Investigational Site, Godoy Cruz, Mendoza, Argentina|1275.10.54009 Boehringer Ingelheim Investigational Site, Mar del Plata, Argentina|1275.10.54004 Boehringer Ingelheim Investigational Site, Salta, Argentina|1275.10.54001 Boehringer Ingelheim Investigational Site, San Isidro, Argentina|1275.10.54010 Boehringer Ingelheim Investigational Site, Zarate, Argentina|1275.10.61008 Boehringer Ingelheim Investigational Site, Cardiff, New South Wales, Australia|1275.10.61002 Boehringer Ingelheim Investigational Site, East Ringwood, Victoria, Australia|1275.10.61001 Boehringer Ingelheim Investigational Site, Heidelberg Heights, Victoria, Australia|1275.10.61009 Boehringer Ingelheim Investigational Site, Mirrabooka, Western Australia, Australia|1275.10.02004 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada|1275.10.02001 Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada|1275.10.02003 Boehringer Ingelheim Investigational Site, Chilliwack, British Columbia, Canada|1275.10.02009 Boehringer Ingelheim Investigational Site, Coquitlam, British Columbia, Canada|1275.10.02012 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada|1275.10.02006 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada|1275.10.02008 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada|1275.10.02005 Boehringer Ingelheim Investigational Site, Moncton, New Brunswick, Canada|1275.10.02013 Boehringer Ingelheim Investigational Site, Burlington, Ontario, Canada|1275.10.02002 Boehringer Ingelheim Investigational Site, Strathroy, Ontario, Canada|1275.10.02007 Boehringer Ingelheim Investigational Site, Sudbury, Ontario, Canada|1275.10.02011 Boehringer Ingelheim Investigational Site, Drummondville, Quebec, Canada|1275.10.02010 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada|1275.10.34014 Boehringer Ingelheim Investigational Site, Ávila, El Salvador|1275.10.49007 Boehringer Ingelheim Investigational Site, Asslar, Germany|1275.10.49014 Boehringer Ingelheim Investigational Site, Berlin, Germany|1275.10.49016 Boehringer Ingelheim Investigational Site, Elsterwerda, Germany|1275.10.49012 Boehringer Ingelheim Investigational Site, Hamburg, Germany|1275.10.49005 Boehringer Ingelheim Investigational Site, Hatten, Germany|1275.10.49008 Boehringer Ingelheim Investigational Site, Kiel Kronshagen, Germany|1275.10.49004 Boehringer Ingelheim Investigational Site, Köln, Germany|1275.10.49010 Boehringer Ingelheim Investigational Site, Lübeck, Germany|1275.10.49003 Boehringer Ingelheim Investigational Site, Münster, Germany|1275.10.49006 Boehringer Ingelheim Investigational Site, Pirna, Germany|1275.10.49013 Boehringer Ingelheim Investigational Site, St. Ingbert/Oberwürzbach, Germany|1275.10.49001 Boehringer Ingelheim Investigational Site, Unterschneidheim, Germany|1275.10.49015 Boehringer Ingelheim Investigational Site, Wangen, Germany|1275.10.39005 Boehringer Ingelheim Investigational Site, Ancona, Italy|1275.10.39006 Boehringer Ingelheim Investigational Site, Catania, Italy|1275.10.39009 Boehringer Ingelheim Investigational Site, Catania, Italy|1275.10.39014 Boehringer Ingelheim Investigational Site, Catania, Italy|1275.10.39007 Boehringer Ingelheim Investigational Site, Latina, Italy|1275.10.39012 Boehringer Ingelheim Investigational Site, Milano, Italy|1275.10.39013 Boehringer Ingelheim Investigational Site, Milano, Italy|1275.10.39015 Boehringer Ingelheim Investigational Site, Olbia (OT), Italy|1275.10.39016 Boehringer Ingelheim Investigational Site, Orbassano (TO), Italy|1275.10.39004 Boehringer Ingelheim Investigational Site, Palermo, Italy|1275.10.39003 Boehringer Ingelheim Investigational Site, Pistoia, Italy|1275.10.39008 Boehringer Ingelheim Investigational Site, Roma, Italy|1275.10.39001 Boehringer Ingelheim Investigational Site, Sesto San Giovanni (MI), Italy|1275.10.39010 Boehringer Ingelheim Investigational Site, Siena, Italy|1275.10.39011 Boehringer Ingelheim Investigational Site, Terni, Italy|1275.10.35104 Boehringer Ingelheim Investigational Site, Cantanhede, Portugal|1275.10.35112 Boehringer Ingelheim Investigational Site, Porto, Portugal|1275.10.35103 Boehringer Ingelheim Investigational Site, Sandim, Portugal|1275.10.35105 Boehringer Ingelheim Investigational Site, Tornada, Portugal|1275.10.35108 Boehringer Ingelheim Investigational Site, Valadares, Portugal|1275.10.35101 Boehringer Ingelheim Investigational Site, Vila Nova de Gaia, Portugal|1275.10.07004 Boehringer Ingelheim Investigational Site, Chelyabinsk, Russian Federation|1275.10.07006 Boehringer Ingelheim Investigational Site, Saint-Petersburg, Russian Federation|1275.10.07001 Boehringer Ingelheim Investigational Site, Saratov, Russian Federation|1275.10.07005 Boehringer Ingelheim Investigational Site, Saratov, Russian Federation|1275.10.07003 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1275.10.07002 Boehringer Ingelheim Investigational Site, Yaroslavl, Russian Federation|1275.10.34003 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1275.10.34004 Boehringer Ingelheim Investigational Site, Canet de Mar, Spain|1275.10.34008 Boehringer Ingelheim Investigational Site, Centelles, Spain|1275.10.34009 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat (Barcelona), Spain|1275.10.34012 Boehringer Ingelheim Investigational Site, La Roca del Vallès, Spain|1275.10.34006 Boehringer Ingelheim Investigational Site, Madrid, Spain|1275.10.34010 Boehringer Ingelheim Investigational Site, Malaga, Spain|1275.10.34011 Boehringer Ingelheim Investigational Site, Mataró, Spain|1275.10.34001 Boehringer Ingelheim Investigational Site, Málaga, Spain|1275.10.34013 Boehringer Ingelheim Investigational Site, Pineda de Mar, Spain|1275.10.34002 Boehringer Ingelheim Investigational Site, Sabadell, Spain|1275.10.34005 Boehringer Ingelheim Investigational Site, Tarragona, Spain|1275.10.38006 Boehringer Ingelheim Investigational Site, Chernivtsi, Ukraine|1275.10.38007 Boehringer Ingelheim Investigational Site, Dnipropetrovs'k, Ukraine|1275.10.38002 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1275.10.38003 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1275.10.38004 Boehringer Ingelheim Investigational Site, Lviv, Ukraine|1275.10.38001 Boehringer Ingelheim Investigational Site, Vinnitsa, Ukraine|1275.10.38005 Boehringer Ingelheim Investigational Site, Zhytomyr, Ukraine
URL: https://clinicaltrials.gov/show/NCT01778049

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