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Clinical Trial Details

Trial ID: L5819
Source ID: NCT01734785
Associated Drug: Linagliptin
Title: Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01734785/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Linagliptin|DRUG: Empagliflozin + Linagliptin|DRUG: Empagliflozin + Linagliptin|DRUG: Empagliflozin + Linagliptin|DRUG: Empagliflozin placebo + Linagliptin placebo|DRUG: Empagliflozin + Linagliptin
Outcome Measures: Primary: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment, Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication., Baseline and 24 weeks | Secondary: Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment., Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication., Baseline and 24 weeks|Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment, Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication., Baseline and 24 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 607
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2013-02-08
Completion Date: 2015-03-23
Results First Posted: 2016-04-18
Last Update Posted: 2024-09-19
Locations: 1275.9.01013 Boehringer Ingelheim Investigational Site, Gulf Shores, Alabama, United States|1275.9.01009 Boehringer Ingelheim Investigational Site, Norwalk, California, United States|1275.9.01015 Boehringer Ingelheim Investigational Site, San Diego, California, United States|1275.9.01017 Boehringer Ingelheim Investigational Site, San Diego, California, United States|1275.9.01011 Boehringer Ingelheim Investigational Site, Northglenn, Colorado, United States|1275.9.01010 Boehringer Ingelheim Investigational Site, Coral Gables, Florida, United States|1275.9.01004 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1275.9.01006 Boehringer Ingelheim Investigational Site, Oldsmar, Florida, United States|1275.9.01001 Boehringer Ingelheim Investigational Site, Palm Coast, Florida, United States|1275.9.01027 Boehringer Ingelheim Investigational Site, Port Orange, Florida, United States|1275.9.01029 Boehringer Ingelheim Investigational Site, Blue Ridge, Georgia, United States|1275.9.01003 Boehringer Ingelheim Investigational Site, Marietta, Georgia, United States|1275.9.01022 Boehringer Ingelheim Investigational Site, Savannah, Georgia, United States|1275.9.01031 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1275.9.01019 Boehringer Ingelheim Investigational Site, Methuen, Massachusetts, United States|1275.9.01024 Boehringer Ingelheim Investigational Site, Troy, Michigan, United States|1275.9.01023 Boehringer Ingelheim Investigational Site, Saint Louis, Missouri, United States|1275.9.01002 Boehringer Ingelheim Investigational Site, Omaha, Nebraska, United States|1275.9.01007 Boehringer Ingelheim Investigational Site, Newington, New Hampshire, United States|1275.9.01016 Boehringer Ingelheim Investigational Site, Asheboro, North Carolina, United States|1275.9.01025 Boehringer Ingelheim Investigational Site, Burlington, North Carolina, United States|1275.9.01014 Boehringer Ingelheim Investigational Site, Shelby, North Carolina, United States|1275.9.01028 Boehringer Ingelheim Investigational Site, Winston-Salem, North Carolina, United States|1275.9.01018 Boehringer Ingelheim Investigational Site, Dayton, Ohio, United States|1275.9.01005 Boehringer Ingelheim Investigational Site, Corvallis, Oregon, United States|1275.9.01032 Boehringer Ingelheim Investigational Site, Corpus Christi, Texas, United States|1275.9.01030 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1275.9.01021 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1275.9.61009 Boehringer Ingelheim Investigational Site, Liverpool, New South Wales, Australia|1275.9.61001 Boehringer Ingelheim Investigational Site, St Leonards, New South Wales, Australia|1275.9.61003 Boehringer Ingelheim Investigational Site, Carina Heights, Queensland, Australia|1275.9.61002 Boehringer Ingelheim Investigational Site, Herston, Queensland, Australia|1275.9.61006 Boehringer Ingelheim Investigational Site, Malvern, Victoria, Australia|1275.9.61007 Boehringer Ingelheim Investigational Site, Nedlands, Western Australia, Australia|1275.9.55002 Boehringer Ingelheim Investigational Site, Brasilia, Brazil|1275.9.55005 Boehringer Ingelheim Investigational Site, Goiania, Brazil|1275.9.55001 Boehringer Ingelheim Investigational Site, Sao Paulo, Brazil|1275.9.55003 Boehringer Ingelheim Investigational Site, Sao Paulo, Brazil|1275.9.55004 Boehringer Ingelheim Investigational Site, Sao Paulo, Brazil|1275.9.01101 Boehringer Ingelheim Investigational Site, Burnaby, British Columbia, Canada|1275.9.01103 Boehringer Ingelheim Investigational Site, Victoria, British Columbia, Canada|1275.9.01105 Boehringer Ingelheim Investigational Site, Cornwall, Ontario, Canada|1275.9.01106 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada|1275.9.01104 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1275.9.01102 Boehringer Ingelheim Investigational Site, Waterloo, Ontario, Canada|1275.9.34008 Boehringer Ingelheim Investigational Site, Barcelona, El Salvador|1275.9.33006 Boehringer Ingelheim Investigational Site, Bourg des Comptes, France|1275.9.33008 Boehringer Ingelheim Investigational Site, Dessenheim, France|1275.9.33003 Boehringer Ingelheim Investigational Site, La Riche, France|1275.9.33012 Boehringer Ingelheim Investigational Site, Paris, France|1275.9.33002 Boehringer Ingelheim Investigational Site, Saint Avertin, France|1275.9.33005 Boehringer Ingelheim Investigational Site, Savonnieres, France|1275.9.33004 Boehringer Ingelheim Investigational Site, Tours, France|1275.9.82006 Boehringer Ingelheim Investigational Site, Daejeon, Korea, Republic of|1275.9.82009 Boehringer Ingelheim Investigational Site, Deagu, Korea, Republic of|1275.9.82002 Boehringer Ingelheim Investigational Site, Goyang, Korea, Republic of|1275.9.82004 Boehringer Ingelheim Investigational Site, Seongnam, Korea, Republic of|1275.9.82001 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1275.9.82005 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1275.9.82007 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1275.9.82008 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1275.9.82010 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1275.9.64005 Boehringer Ingelheim Investigational Site, Auckland, New Zealand, New Zealand|1275.9.64006 Boehringer Ingelheim Investigational Site, Auckland, New Zealand, New Zealand|1275.9.64008 Boehringer Ingelheim Investigational Site, Birkenhead Auckland, New Zealand|1275.9.64007 Boehringer Ingelheim Investigational Site, Christchurch Central, New Zealand|1275.9.64004 Boehringer Ingelheim Investigational Site, Christchurch, New Zealand, New Zealand|1275.9.64002 Boehringer Ingelheim Investigational Site, Otahuhu Auckland, New Zealand|1275.9.64001 Boehringer Ingelheim Investigational Site, Takapuna Auckland, New Zealand|1275.9.64003 Boehringer Ingelheim Investigational Site, Tauranga, New Zealand, New Zealand|1275.9.47001 Boehringer Ingelheim Investigational Site, Bergen, Norway|1275.9.47002 Boehringer Ingelheim Investigational Site, Oslo, Norway|1275.9.47003 Boehringer Ingelheim Investigational Site, Oslo, Norway|1275.9.47007 Boehringer Ingelheim Investigational Site, Oslo, Norway|1275.9.47006 Boehringer Ingelheim Investigational Site, Svelvik, Norway|1275.9.34011 Boehringer Ingelheim Investigational Site, A Coruña, Spain|1275.9.34009 Boehringer Ingelheim Investigational Site, Alicante, Spain|1275.9.34005 Boehringer Ingelheim Investigational Site, Badía Del Vallès - Barcelona, Spain|1275.9.34001 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1275.9.34003 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1275.9.34004 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1275.9.34002 Boehringer Ingelheim Investigational Site, Sevilla, Spain|1275.9.34010 Boehringer Ingelheim Investigational Site, Valencia, Spain|1275.9.34006 Boehringer Ingelheim Investigational Site, Vic, Spain|1275.9.88606 Boehringer Ingelheim Investigational Site, Kaohsiung, Taiwan|1275.9.88607 Boehringer Ingelheim Investigational Site, Kaohsiung, Taiwan|1275.9.88602 Boehringer Ingelheim Investigational Site, New Taipei, Taiwan|1275.9.88603 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1275.9.88604 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1275.9.88605 Boehringer Ingelheim Investigational Site, Tainan, Taiwan
URL: https://clinicaltrials.gov/show/NCT01734785

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress