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Clinical Trial Details

Trial ID: L4763
Source ID: NCT01719003
Associated Drug: Metformin 500 Mg Bid
Title: Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01719003/results
Conditions: Diabetes Mellitus, Type 2|Hyperglycemia
Interventions: DRUG: Metformin 500 mg bid|DRUG: Metformin 1000 mg bid|DRUG: Empagliflozin low dose qd|DRUG: Empagliflozin high dose qd|DRUG: Empagliflozin low dose bid|DRUG: Metformin 500 mg bid|DRUG: Empagliflozin high dose bid|DRUG: Empagliflozin low dose bid|DRUG: Metformin 1000 mg bid|DRUG: Metformin 500 mg bid|DRUG: Metformin 1000 mg bid|DRUG: Empagliflozin high dose bid|DRUG: Metformin 1000 mg bid|DRUG: Empagliflozin high dose bid
Outcome Measures: Primary: HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24, Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means, baseline and 24 weeks | Secondary: FPG (Fasting Plasma Glucose) Change From Baseline at Week 24, Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means., baseline and 24 weeks|Body Weight Change From Baseline at Week 24, Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means., baseline and 24 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1413
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2012-10
Completion Date: 2014-12
Results First Posted: 2016-02-19
Last Update Posted: 2016-02-19
Locations: 1276.1.10014 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States|1276.1.10019 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States|1276.1.10044 Boehringer Ingelheim Investigational Site, Hot Springs, Alaska, United States|1276.1.10010 Boehringer Ingelheim Investigational Site, Glendale, Arizona, United States|1276.1.10035 Boehringer Ingelheim Investigational Site, Searcy, Arkansas, United States|1276.1.10046 Boehringer Ingelheim Investigational Site, Chula Vista, California, United States|1276.1.10006 Boehringer Ingelheim Investigational Site, Huntington Beach, California, United States|1276.1.10043 Boehringer Ingelheim Investigational Site, La Mesa, California, United States|1276.1.10009 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States|1276.1.10040 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States|1276.1.10045 Boehringer Ingelheim Investigational Site, Oceanside, California, United States|1276.1.10042 Boehringer Ingelheim Investigational Site, Colorado Springs, Colorado, United States|1276.1.10001 Boehringer Ingelheim Investigational Site, Denver, Colorado, United States|1276.1.10003 Boehringer Ingelheim Investigational Site, Northglenn, Colorado, United States|1276.1.10026 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States|1276.1.10024 Boehringer Ingelheim Investigational Site, Oldsmar, Florida, United States|1276.1.10027 Boehringer Ingelheim Investigational Site, Port Orange, Florida, United States|1276.1.10023 Boehringer Ingelheim Investigational Site, Marietta, Georgia, United States|1276.1.10034 Boehringer Ingelheim Investigational Site, Evansville, Indiana, United States|1276.1.10032 Boehringer Ingelheim Investigational Site, Fall River, Massachusetts, United States|1276.1.10036 Boehringer Ingelheim Investigational Site, Bridgman, Michigan, United States|1276.1.10037 Boehringer Ingelheim Investigational Site, Hazelwood, Missouri, United States|1276.1.10007 Boehringer Ingelheim Investigational Site, Las Vegas, Nevada, United States|1276.1.10015 Boehringer Ingelheim Investigational Site, Union, New Jersey, United States|1276.1.10033 Boehringer Ingelheim Investigational Site, Asheboro, North Carolina, United States|1276.1.10022 Boehringer Ingelheim Investigational Site, Burlington, North Carolina, United States|1276.1.10002 Boehringer Ingelheim Investigational Site, Lenoir, North Carolina, United States|1276.1.10005 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States|1276.1.10011 Boehringer Ingelheim Investigational Site, Gallipolis, Ohio, United States|1276.1.10030 Boehringer Ingelheim Investigational Site, Columbia, South Carolina, United States|1276.1.10008 Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States|1276.1.10013 Boehringer Ingelheim Investigational Site, Hodges, South Carolina, United States|1276.1.10017 Boehringer Ingelheim Investigational Site, Humboldt, Tennessee, United States|1276.1.10018 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1276.1.10025 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1276.1.10028 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1276.1.10016 Boehringer Ingelheim Investigational Site, Kingwood, Texas, United States|1276.1.10021 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1276.1.10041 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1276.1.10004 Boehringer Ingelheim Investigational Site, Manassas, Virginia, United States|1276.1.10012 Boehringer Ingelheim Investigational Site, Wenatchee, Washington, United States|1276.1.55008 Boehringer Ingelheim Investigational Site, Belém, Brazil|1276.1.55003 Boehringer Ingelheim Investigational Site, Brasilia, Brazil|1276.1.55006 Boehringer Ingelheim Investigational Site, Fortaleza, Brazil|1276.1.55007 Boehringer Ingelheim Investigational Site, Fortaleza, Brazil|1276.1.55009 Boehringer Ingelheim Investigational Site, Fortaleza, Brazil|1276.1.55004 Boehringer Ingelheim Investigational Site, Goiania, Brazil|1276.1.55002 Boehringer Ingelheim Investigational Site, Porto Alegre, Brazil|1276.1.55001 Boehringer Ingelheim Investigational Site, Sao Paulo, Brazil|1276.1.20003 Boehringer Ingelheim Investigational Site, Coquitlam, British Columbia, Canada|1276.1.20012 Boehringer Ingelheim Investigational Site, Coquitlam, British Columbia, Canada|1276.1.20008 Boehringer Ingelheim Investigational Site, Victoria, British Columbia, Canada|1276.1.20004 Boehringer Ingelheim Investigational Site, Antigonish, Nova Scotia, Canada|1276.1.20005 Boehringer Ingelheim Investigational Site, Hawkesbury, Ontario, Canada|1276.1.20013 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada|1276.1.20010 Boehringer Ingelheim Investigational Site, Strathroy, Ontario, Canada|1276.1.20006 Boehringer Ingelheim Investigational Site, Thornhill, Ontario, Canada|1276.1.20007 Boehringer Ingelheim Investigational Site, Mirabel, Quebec, Canada|1276.1.20001 Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada|1276.1.20002 Boehringer Ingelheim Investigational Site, Quebec, Canada|1276.1.42002 Boehringer Ingelheim Investigational Site, Benatky nad Jizerou, Czech Republic|1276.1.42008 Boehringer Ingelheim Investigational Site, Olomouc, Czech Republic|1276.1.42007 Boehringer Ingelheim Investigational Site, Ostrava, Czech Republic|1276.1.42009 Boehringer Ingelheim Investigational Site, Plzen, Czech Republic|1276.1.42004 Boehringer Ingelheim Investigational Site, Praha 10, Czech Republic|1276.1.42010 Boehringer Ingelheim Investigational Site, Praha 1, Czech Republic|1276.1.42003 Boehringer Ingelheim Investigational Site, Praha 3, Czech Republic|1276.1.95001 Boehringer Ingelheim Investigational Site, Abbasia Cairo, Egypt, Egypt|1276.1.95003 Boehringer Ingelheim Investigational Site, Al Manial, Cairo, Egypt, Egypt|1276.1.95004 Boehringer Ingelheim Investigational Site, Alexandria, Egypt|1276.1.95002 Boehringer Ingelheim Investigational Site, El Darasa Cairo Egypt, Egypt|1276.1.33004 Boehringer Ingelheim Investigational Site, Behren Les Forbach, France|1276.1.33012 Boehringer Ingelheim Investigational Site, Bersée, France|1276.1.33005 Boehringer Ingelheim Investigational Site, Cournonterral, France|1276.1.33007 Boehringer Ingelheim Investigational Site, Hautmont, France|1276.1.33013 Boehringer Ingelheim Investigational Site, Paris, France|1276.1.33001 Boehringer Ingelheim Investigational Site, Poitiers, France|1276.1.33003 Boehringer Ingelheim Investigational Site, Savonnières, France|1276.1.33006 Boehringer Ingelheim Investigational Site, St Genis des Fontaines, France|1276.1.33002 Boehringer Ingelheim Investigational Site, Thouars, France|1276.1.33011 Boehringer Ingelheim Investigational Site, Thun St amand, France|1276.1.33010 Boehringer Ingelheim Investigational Site, Tours, France|1276.1.33009 Boehringer Ingelheim Investigational Site, Vandome, France|1276.1.33008 Boehringer Ingelheim Investigational Site, Vieux Condé, France|1276.1.49005 Boehringer Ingelheim Investigational Site, Berlin, Germany|1276.1.49008 Boehringer Ingelheim Investigational Site, Celle, Germany|1276.1.49006 Boehringer Ingelheim Investigational Site, Dortmund, Germany|1276.1.49011 Boehringer Ingelheim Investigational Site, Dresden, Germany|1276.1.49003 Boehringer Ingelheim Investigational Site, Essen, Germany|1276.1.49007 Boehringer Ingelheim Investigational Site, Ingelheim, Germany|1276.1.49014 Boehringer Ingelheim Investigational Site, Neuwied, Germany|1276.1.49004 Boehringer Ingelheim Investigational Site, Offenbach, Germany|1276.1.49002 Boehringer Ingelheim Investigational Site, Stuhr-Brinkum, Germany|1276.1.49012 Boehringer Ingelheim Investigational Site, Teuchern, Germany|1276.1.50002 Boehringer Ingelheim Investigational Site, Barbena Santa Rosa, Guatemala|1276.1.50003 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala|1276.1.50005 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala|1276.1.50006 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala|1276.1.50001 Boehringer Ingelheim Investigational Site, Quetzaltenango, Guatemala|1276.1.82006 Boehringer Ingelheim Investigational Site, Deagu, Korea, Republic of|1276.1.82010 Boehringer Ingelheim Investigational Site, Goyang, Korea, Republic of|1276.1.82001 Boehringer Ingelheim Investigational Site, Incheon, Korea, Republic of|1276.1.82009 Boehringer Ingelheim Investigational Site, Pusan, Korea, Republic of|1276.1.82002 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1276.1.82004 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1276.1.82005 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1276.1.82007 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1276.1.82008 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1276.1.82003 Boehringer Ingelheim Investigational Site, Wonju, Korea, Republic of|1276.1.96001 Boehringer Ingelheim Investigational Site, Beirut, Lebanon|1276.1.96002 Boehringer Ingelheim Investigational Site, El Chouf, Lebanon|1276.1.96003 Boehringer Ingelheim Investigational Site, Saida, Lebanon|1276.1.96004 Boehringer Ingelheim Investigational Site, Saida, Lebanon|1276.1.60002 Boehringer Ingelheim Investigational Site, Ipoh, Perak, Malaysia|1276.1.60001 Boehringer Ingelheim Investigational Site, Johor Bahru, Malaysia|1276.1.60003 Boehringer Ingelheim Investigational Site, Kubang Kerian, Malaysia|1276.1.52004 Boehringer Ingelheim Investigational Site, Aguascalientes, Mexico|1276.1.52007 Boehringer Ingelheim Investigational Site, Aguascalientes, Mexico|1276.1.52002 Boehringer Ingelheim Investigational Site, Ciudad de Mexico, Mexico|1276.1.52003 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1276.1.52001 Boehringer Ingelheim Investigational Site, Monterrey, Mexico|1276.1.52006 Boehringer Ingelheim Investigational Site, San Lucas tepetlcalco, Mexico|1276.1.52005 Boehringer Ingelheim Investigational Site, Zapopan, Mexico|1276.1.51001 Boehringer Ingelheim Investigational Site, Lima, Peru|1276.1.51002 Boehringer Ingelheim Investigational Site, Lima, Peru|1276.1.51003 Boehringer Ingelheim Investigational Site, Lima, Peru|1276.1.51004 Boehringer Ingelheim Investigational Site, Lima, Peru|1276.1.51005 Boehringer Ingelheim Investigational Site, Lima, Peru|1276.1.63009 Boehringer Ingelheim Investigational Site, Cebu City, Cebu, Philippines|1276.1.63002 Boehringer Ingelheim Investigational Site, Cebu City, Philippines, Philippines|1276.1.63004 Boehringer Ingelheim Investigational Site, Davao City, Philippines|1276.1.63003 Boehringer Ingelheim Investigational Site, Iloilo City, Philippines|1276.1.63006 Boehringer Ingelheim Investigational Site, Manila, Philippines|1276.1.63001 Boehringer Ingelheim Investigational Site, Marikina City, Philippines|1276.1.63005 Boehringer Ingelheim Investigational Site, Maybunga, Pasig City, Philippines|1276.1.63007 Boehringer Ingelheim Investigational Site, San Juan City, Philippines|1276.1.63008 Boehringer Ingelheim Investigational Site, Tarlac, Philippines|1276.1.70012 Boehringer Ingelheim Investigational Site, Barnaul, Russian Federation|1276.1.70011 Boehringer Ingelheim Investigational Site, Kemerovo, Russian Federation|1276.1.70015 Boehringer Ingelheim Investigational Site, Novosibirsk, Russian Federation|1276.1.70016 Boehringer Ingelheim Investigational Site, Novosibirsk, Russian Federation|1276.1.70018 Boehringer Ingelheim Investigational Site, Novosibirsk, Russian Federation|1276.1.70007 Boehringer Ingelheim Investigational Site, Petrozavodsk, Russian Federation|1276.1.70009 Boehringer Ingelheim Investigational Site, Saratov, Russian Federation|1276.1.70010 Boehringer Ingelheim Investigational Site, Smolensk, Russian Federation|1276.1.70005 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1276.1.70006 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1276.1.70017 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1276.1.70013 Boehringer Ingelheim Investigational Site, Yaroslavl, Russian Federation|1276.1.38104 Boehringer Ingelheim Investigational Site, Belgrade, Serbia|1276.1.38105 Boehringer Ingelheim Investigational Site, Belgrade, Serbia|1276.1.38106 Boehringer Ingelheim Investigational Site, Belgrade, Serbia|1276.1.38107 Boehringer Ingelheim Investigational Site, Belgrade, Serbia|1276.1.38103 Boehringer Ingelheim Investigational Site, Kragujevac, Serbia|1276.1.38101 Boehringer Ingelheim Investigational Site, Nis, Serbia|1276.1.38108 Boehringer Ingelheim Investigational Site, Novi Sad, Serbia|1276.1.38102 Boehringer Ingelheim Investigational Site, Zajecar, Serbia|1276.1.34048 Boehringer Ingelheim Investigational Site, Alicante, Spain|1276.1.34050 Boehringer Ingelheim Investigational Site, Alzira, Spain|1276.1.34028 Boehringer Ingelheim Investigational Site, Madrid, Spain|1276.1.34045 Boehringer Ingelheim Investigational Site, pozuelo de Alarcon, Spain|1276.1.34034 Boehringer Ingelheim Investigational Site, Sabadell (Barcelona), Spain|1276.1.34027 Boehringer Ingelheim Investigational Site, Salamanca, Spain|1276.1.34052 Boehringer Ingelheim Investigational Site, Tarragona, Spain|1276.1.34051 Boehringer Ingelheim Investigational Site, Zaragoza, Spain|1276.1.88005 Boehringer Ingelheim Investigational Site, Kaohsiung City,, Taiwan|1276.1.88002 Boehringer Ingelheim Investigational Site, New Taipei City, Taiwan|1276.1.88001 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1276.1.88003 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1276.1.88004 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1276.1.88006 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1276.1.66001 Boehringer Ingelheim Investigational Site, Bangkok, Thailand, Thailand|1276.1.66003 Boehringer Ingelheim Investigational Site, Bangkok, Thailand, Thailand|1276.1.66002 Boehringer Ingelheim Investigational Site, Nakhon Ratchasima, Thailand|1276.1.90003 Boehringer Ingelheim Investigational Site, Ankara, Turkey|1276.1.90004 Boehringer Ingelheim Investigational Site, Antalya, Turkey|1276.1.90006 Boehringer Ingelheim Investigational Site, Denizli, Turkey|1276.1.90002 Boehringer Ingelheim Investigational Site, Erzurum, Turkey|1276.1.90005 Boehringer Ingelheim Investigational Site, Istanbul, Turkey|1276.1.90001 Boehringer Ingelheim Investigational Site, Izmir, Turkey|1276.1.44002 Boehringer Ingelheim Investigational Site, Bolton, United Kingdom|1276.1.44001 Boehringer Ingelheim Investigational Site, Bradford on Avon, United Kingdom|1276.1.44005 Boehringer Ingelheim Investigational Site, Chippenham, United Kingdom|1276.1.44006 Boehringer Ingelheim Investigational Site, Dagenham, United Kingdom|1276.1.44004 Boehringer Ingelheim Investigational Site, Doncaster, United Kingdom|1276.1.44008 Boehringer Ingelheim Investigational Site, Glasgow, United Kingdom|1276.1.44003 Boehringer Ingelheim Investigational Site, Leeds, United Kingdom|1276.1.44007 Boehringer Ingelheim Investigational Site, Manchester, United Kingdom|1276.1.44011 Boehringer Ingelheim Investigational Site, Mortimer, United Kingdom|1276.1.44009 Boehringer Ingelheim Investigational Site, Sandbach, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01719003

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details