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Clinical Trial Details

Trial ID: L5923
Source ID: NCT02580591
Associated Drug: Empagliflozin
Title: Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02580591/results
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Empagliflozin|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]), Change from baseline in Glycated hemoglobin (HbA1c) for full analysis set (FAS) (observed cases \[OC\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline., Baseline to week 26|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD)), Change from baseline in Glycated hemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data \[OC-AD\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline., Baseline to week 26 | Secondary: Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG), Rate per patient-year of investigator-reported symptomatic hypoglycemic adverse events (AEs) with confirmed plasma glucose (PG) \<54 milligram per deciliter (mg/dL) (\<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycemic AEs (i.e. all investigator-reported AEs that had confirmed PG \<54 mg/dL \[\<3.0 mmol/L\] with symptoms reported and all severe hypoglycemic events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate. This is key secondary endpoints., Week 5 to Week 26, Week 1 to Week 26|Change From Baseline in Body Weight at Week 26, Change from baseline in body weight is presented With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline., Baseline to week 26|Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26, Change from baseline in Total daily insulin dose (TDID) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline., Baseline to week 26|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26, Change from baseline in Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline., Baseline to week 26
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 977
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2015-12-22
Completion Date: 2017-09-20
Results First Posted: 2018-11-02
Last Update Posted: 2018-11-02
Locations: Healthscan Clinical Trials LLC, Montgomery, Alabama, 36106, United States|John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States|Valley Research, Fresno, California, 93720, United States|Marin Endocrine Care and Research, Greenbrae, California, 94904, United States|Pacific Research Partners, LLC, Oakland, California, 94607, United States|NorCal Endocrinology and Internal Medicine, San Ramon, California, 94583, United States|William Sansum Diabetes Center, Santa Barbara, California, 93105, United States|University of Colorado Denver, Aurora, Colorado, 80045, United States|International Research Associates, LLC, Hialeah, Florida, 33012, United States|Solutions Through Advanced Research, Inc., Jacksonville, Florida, 32225, United States|University of Miami, Miami, Florida, 33136, United States|Suncoast Clinical Research, Inc., New Port Richey, Florida, 34652, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|Physicians Research Associates, LLC, Lawrenceville, Georgia, 30046, United States|Sestron Clinical Research, Marietta, Georgia, 30060, United States|Eagle's Landing Diabetes and Endocrinology, Stockbridge, Georgia, 30281, United States|Northwest Endo Diabetes Research, LLC, Arlington Heights, Illinois, 60005, United States|Kentucky Diabetes Endocrinology Center, Lexington, Kentucky, 40503, United States|University of Maryland School of Medicine, Baltimore, Maryland, 21201, United States|MODEL Clinical Research, Baltimore, Maryland, 21204, United States|Clinical Research Consultants, LLC, Kansas City, Missouri, 64111, United States|Desert Endocrinology Clinical Research Center, Henderson, Nevada, 89052, United States|Palm Research Center, Las Vegas, Nevada, 89128, United States|Endocrine-Diabetes Care and Resource Center, Rochester, New York, 14607, United States|Endocrine Associates of Long Island, PC, Smithtown, New York, 11787, United States|Diabetes Endocrinology Research Center of Western New York, Williamsville, New York, 14221, United States|Diabetes and Endocrinology Consultants, PC, Morehead City, North Carolina, 28557, United States|Holzer Clinic LLC, Gallipolis, Ohio, 45631, United States|COR Clinical Research, LLC, Oklahoma City, Oklahoma, 73103, United States|Strand Physician Specialists dba Carolina Health Specialists, Myrtle Beach, South Carolina, 29572, United States|AM Diabetes and Endocrinology Center, Bartlett, Tennessee, 38133, United States|Holston Medical Group, Bristol, Tennessee, 37620, United States|University Diabetes and Endocrine Consultants, Chattanooga, Tennessee, 37411, United States|Texas Diabetes & Endocrinology PA, Austin, Texas, 78749, United States|Texas Health Physicians Group, Dallas, Texas, 75218, United States|Dallas Diabetes and Endocrine Center, Dallas, Texas, 75230, United States|Research Institute of Dallas, Dallas, Texas, 75231, United States|Endeavor Clinical Trials, PA, San Antonio, Texas, 78229, United States|Virginia Endocrinology Research, Chesapeake, Virginia, 23321, United States|Coffs Endocrine & Diabetes Services, Coffs Harbour, New South Wales, 2450, Australia|Lyell McEwin Hospital, Elizabeth Vale, South Australia, 5112, Australia|SA Endocrine Research P/L, Keswick, South Australia, 5035, Australia|Eastern Clinical Research Unit, East Ringwood, Victoria, 3135, Australia|Richmond Road and Diagnostic Treatment Centre, Calgary, Alberta, T2T 5C7, Canada|The Bailey Clinic, Red Deer, Alberta, T4N 6V7, Canada|Eastern Health (MUN), St. John's, Newfoundland and Labrador, A1B 3V6, Canada|Centre for Studies in Family Medicine, London, Ontario, N6G 2M1, Canada|St. Michael's Hospital, Toronto, Ontario, M5B 1W8, Canada|Omnispec Recherche Clinique Inc., Mirabel, Quebec, J7J 2K8, Canada|Applied Medical Informatics Research INC., Westmount, Quebec, H3Z 1E5, Canada|Clinique des maladies Lipidiques de Quebec, Quebec, G1V 4M6, Canada|University Hospital Brno, Brno, 625 00, Czechia|Diahaza s.r.o.Intern.Med.Outpat.Clin.Dep.Diabetology,Holesov, Holesov, 769 01, Czechia|AIDIN VK s.r.o.,Department Diabetology, Hranice, Hranice, 753 01, Czechia|Univ. Hospital Kralovske Vinohrady, Prague, 100 42, Czechia|DiaGolfova s.r.o., Department Diabetology, Prague, Prague, 102 00, Czechia|Milan Kvapil s.r.o.,Diabetology ambulance,Prague, Prague, 149 00, Czechia|ResTrial s.r.o.Diabetology Ambulance,Prague, Prague, 18100, Czechia|HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki, Helsinki, 00290, Finland|Mehiläinen Jyväskylä, Jyväskylä, 40100, Finland|Satakunnan Diabetesasema, Pori, Pori, 28100, Finland|FinnMedi Oy, Tampere, Tampere, 33520, Finland|TYKS, Turku, FI-20520, Finland|HOP Jean Minjoz, Besancon, 25030, France|HOP Le Creusot, Le Creusot, 71200, France|HOP Paris Saint-Joseph, Paris, 75014, France|HOP Bichat, Paris, 75018, France|HOP de Poitiers, Poitiers, 86021, France|HOP Civil, Strasbourg, 67091, France|HOP Rangueil, Toulouse Cédex 04, 31059, France|Diabetes-Klinik Bad Mergentheim GmbH & Co. KG, Bad Mergentheim, 97980, Germany|Diabetologische Schwerpunktpraxis, Bosenheim, Bosenheim, 55545, Germany|Praxis Dr. Busch, Dortmund, Dortmund, 44137, Germany|GWT-TUD GmbH, Dresden, 01307, Germany|ZKS Südbrandenburg GmbH, Elsterwerda, 04910, Germany|InnoDiab Forschung GmbH, Essen, 45136, Germany|Praxis Dr. Kaiser, Frankfurt, Frankfurt, 60388, Germany|Institut für Diabetesforschung Münster GmbH, Münster, 48145, Germany|Diabetologische Schwerpunktpraxis, Münster, 48153, Germany|Praxis Dr. Behnke, Neuwied, Neuwied, 56564, Germany|Praxis Dr. Hilgenberg, Rehburg-Loccum, 31547, Germany|"Korgialeneio-Benakeio" Hellenic Red Cross Hospital, Athens, 115 26, Greece|General Hospital of Athens "Laiko", Athens, 11527, Greece|Univ. Gen. Hosp. of Ioannina, Ioannina, 45500, Greece|General Hospital of Nikaia, Nikaia, 18484, Greece|General Hopsital of Thessaloniki "Ippokrateio", Thessaloniki, 54642, Greece|General Hospital of Thessaloniki "G. Papanikolaou", Thessaloniki, 57010, Greece|Clinexpert Kft., Budapest, 1033, Hungary|Synexus Magyarorszag Kft., Budapest, 1036, Hungary|University Debrecen Hospital, Debrecen, 4032, Hungary|CRU Hungary Ltd, Private Practice, Miskolc, Miskolc, 3529, Hungary|Clinfan SMO Ltd., Szekszard, 7100, Hungary|Csongrad Country Dr Bugyi Istvan Hosp., Szentes, 6600, Hungary|Zala Country Hospital, Diabetic Outpatient Clinic, Zalaegerszeg, 8900, Hungary|Mater Misericordiae University Hospital, Dublin, 7, Ireland|Inrca-Irccs, Ancona, 60124, Italy|A.O. Spedali Civili di Brescia, Brescia, 25123, Italy|Osp. Campo di Marte, Lucca, 55100, Italy|Azienda Ospedaliera Universitaria "Federico II", Napoli, 80131, Italy|Policlinico Gemelli, Roma, 00168, Italy|Osp. S. Giovanni Calibita Fatebenefratelli, Roma, 00186, Italy|IRCCS Gruppo Multimedica, Sesto San Giovanni (MI), 20099, Italy|A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena, 53100, Italy|Ospedale Molinette, AO Città della Salute e della, Torino, 10126, Italy|Zemgales Center of diabetes, Jelgava, Jelgava, 3001, Latvia|A. Lucenko's Internist & Endocrinologist Doctor's Practice, Liepaja, 3401, Latvia|Dace Teterovska Doctor's Practice in Endocrinology,Ogre, Ogre, 5001, Latvia|P. Stradins Clinical University Hospital, Riga, Riga, 1002, Latvia|Riga Health Center, Private Practice, Riga, 1002, Latvia|Sigulda Hospital, Outpatient department, Sigulda, 2150, Latvia|VSV Centrs, Stalte Private Practice, Talsi, Talsi, 3201, Latvia|Clínica EndocrInol en Diabetes Obesidad y Tiroides (DOT), Aguascalientes, 20129, Mexico|Hospital Cardiologica Aguascalientes, Aguascalientes, 20230, Mexico|Unidad de Investigacion Clinica Cardiometabolica de Occident, Guadalajara, 44150, Mexico|Instituto Jaliscience de Inv. en Diabetes y Obesidad, S.C., Guadalajara, 44600, Mexico|Unidad de Patologia Clinica, Guadalajara, CP 44650, Mexico|Noordwest Ziekenhuisgroep, Alkmaar, 1815 JD, Netherlands|Ziekenhuisgroep Twente locatie Almelo, Almelo, 7609 PP, Netherlands|Meander Medisch Centrum, Amersfoort, 3813 TZ, Netherlands|Gelre Ziekenhuizen Apeldoorn, Apeldoorn, 7334 DZ, Netherlands|EB Utrecht Research, Utrecht, 3511 NH, Netherlands|Universitair Medisch Centrum Utrecht, Utrecht, 3584 CX, Netherlands|South Pacific Clinical Trials, Auckland, New Zealand, 0610, New Zealand|Lipid and Diabetes Research Group, Christchurch, 8011, New Zealand|M3 Helse AS, Hamar, N-2317, Norway|Oslo Universitetssykehus HF, Lipidklinikken, Oslo, N-0027, Norway|Stavanger Helseforskning, Stavanger, N-4068, Norway|Universitetssykehuset Nord-Norge, Tromsø, Tromsø, N-9038, Norway|DiabSerwis S.C., Chorzow, Chorzow, 41-500, Poland|Medical Centre Pratia Gdynia, Gdynia, 81-338, Poland|Medical Centre Pratia Katowice I, Katowice, 40-954, Poland|Medical Centre Pratia Krakow, Krakow, 30-002, Poland|University Hospital in Krakow, Krakow, 31-501, Poland|Independent Public Clin.Hosp.no1Lublin,Dep.Internal Diseases, Lublin, 20-081, Poland|Witold Chodzko Institute Rural Medic,Dep.Diabetology,Lublin, Lublin, 20-090, Poland|Reg.Spec.Hosp.Olsztyn,Clin,Endocrinology,Diabetics.&Int.Med., Olsztyn, 10-561, Poland|Clinical Research Center Medicome, Oswiecim, Oswiecim, 32-600, Poland|Omedica Medical Centre, Poznan, Poznan, 60-111, Poland|Medical Centre Pratia Warszawa, Warsaw, 01-868, Poland|NZOZ Med-Art.Specialist Clinics, Zory, Zory, 44-240, Poland|Hospital de Braga-Escala Braga, Braga, 4710-243, Portugal|Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã, Covilhã, 6200-251, Portugal|APDP - Associação Protectora dos Diabéticos de Portugal, Lisboa, 1250-189, Portugal|H. Santo António - Centro Hospitalar do Porto, Porto, 4099-001, Portugal|Centro Hospitalar São João,EPE, Porto, 4200-319, Portugal|ULSAM, EPE - Hospital de Santa Luzia, Viana do Castelo, 4901-858, Portugal|Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, 4400-129, Portugal|Nicodiab SRL, Bucharest, Bucharest, 010507, Romania|Milit. Cent. Emerg. Univ. Hosp. Dr. Davila, Met. Dis. Dept., Bucharest, 010825, Romania|SC Medical Centre "Sanatatea Ta" SRL, Bucharest, Bucharest, 020603, Romania|SC Pelican Impex SRL, Cabinet Nr. 201, Diabetes Dept., Oradea, Bihor County, 410469, Romania|Centrul Medical Dr Negrisanu SRL, Timisoara, 300456, Romania|City Clinical Hospital no. 67, Moscow, Moscow, 123423, Russian Federation|CJSC"Polyclinic complex",Dep.Endocrinology,St.Petersburg, St. Petersburg, 190013, Russian Federation|City Outpatient dep.no.107;clinc.pharmacology,st.petersburg, St. Petersburg, 195030, Russian Federation|Medical Academy named after I. Mechnikov, St. Petersburg, St. Petersburg, 195067, Russian Federation|City Hospital Saint Elizaveta, Dept. Endocrinology, St. Petersburg, 195257, Russian Federation|Policlinic No. 1 of Russian Academy of Sciences, St. Petersburg, St. Petersburg, 199034, Russian Federation|LCS Clinical Research Unit, Bryanston, 2021, South Africa|TREAD Research, Cape Town, 7530, South Africa|Dr Hilton Kaplan, Cape Town, 7708, South Africa|Dr. L. A.Distiller, Johannesburg, 2198, South Africa|VX Pharma (Pty) Ltd Pretoria, Pretoria, 0087, South Africa|Diabetes Care Centre, Pretoria, 0181, South Africa|Hospital A Coruña, A Coruña, 15006, Spain|CM Avances Médicos, Granada, 18003, Spain|Hospital de la Inmaculada Concepción, Granada, 18004, Spain|Hospital General Universitario Gregorio Marañón, Madrid, 28007, Spain|Hospital Universitario Infanta Leonor, Madrid, 28031, Spain|Endo-Diabesidad-Clínica Durán & Asociados, Sevilla, 41018, Spain|Hospital Virgen Macarena, Sevilla, 41071, Spain|Hospital Clínico de Valencia, Valencia, 46010, Spain|CTC Sahlgrenska Universitetssjukhuset, Göteborg, 413 45, Sweden|Karlskoga lasarett, Karlskoga, 691 81, Sweden|Skånes universitetssjukhus, Lund, Lund, 221 85, Sweden|S3 Clinical Research Centers, Vällingby, 162 68, Sweden|Ängelholms Sjukhus, Ängelholm, 262 81, Sweden|Royal Bournemouth and Christchurch Hospital, Bournemouth, BH7 7DW, United Kingdom|Bradford Royal Infirmary, Bradford, BD9 6RJ, United Kingdom|Hull Royal Infirmary, Hull, HU3 2RW, United Kingdom|Ipswich Hospital, Ipswich, IP4 5PD, United Kingdom|Leicester General Hospital, Leicester, LE5 4PW, United Kingdom|Guy's Hospital, London, SE1 9RT, United Kingdom|King's College Hospital, London, SE5 9RJ, United Kingdom|St Mary's Hospital, London, W2 1NY, United Kingdom|James Cook University Hospital, Middlesbrough, TS4 3BW, United Kingdom|Royal Victoria Infirmary, Newcastle Upon Tyne, NE1 4LP, United Kingdom|Queen's Medical Centre, Nottingham, NG7 2UH, United Kingdom|George Eliot Hospital, Nuneaton, CV10 7DJ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02580591

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress