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Clinical Trial Details

Trial ID: L3409
Source ID: NCT02414958
Associated Drug: Empagliflozin
Title: Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02414958/results
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Empagliflozin|DRUG: Empagliflozin|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26, Change from baseline in glycated haemoglobin (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 randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects., Baseline to week 26|Change From Baseline in Glycated Haemoglobin (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 haemoglobin (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 randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects., Baseline to week 26 | Secondary: Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG), This is a key secondary endpoint. Rate per patient-year of investigator-reported symptomatic hypoglycaemia adverse events (AEs) with confirmed plasma glucose (PG) \<54 milligram per deciliter (mg/dL) (\<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycaemia AEs (i.e. all investigator-reported AEs that had confirmed PG \<54 mg/dL \[\<3.0 mmol/L\] with symptoms reported and all severe hypoglycaemia 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., 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 randomised trial medication. Least squares mean is adjusted mean change from baseline., Baseline to week 26|Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26, Change from baseline in the percentage of time spent in target glucose range of \>70 to ≤180 mg/dL (\>3.9 to ≤10.0 mmol/L) as determined by continuous glucose monitoring (CGM) is presented in week 23 to 26. Least squares mean is actually an adjusted event rate., Week 23 to 26|Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26, Change from baseline in interstitial glucose variability based on the IQR as determined by CGM is presented for week 23 to 26. Least squares mean is actually an adjusted event rate., Week 23 to 26|Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26, Change from baseline in TDID is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised 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 SBP and DBP is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised 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: 730
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2015-06-30
Completion Date: 2017-10-23
Results First Posted: 2018-11-20
Last Update Posted: 2019-01-03
Locations: AMCR Institute, Inc., Escondido, California, 92025, United States|Diabetes/Lipid Management and Research Center, Huntington Beach, California, 92648, United States|National Research Institute, Los Angeles, California, 90057, United States|Mills-Peninsula Health Services, San Mateo, California, 94401, United States|Metabolic Institute of America, Tarzana, California, 91356, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Creekside Endocrine Associates, PC, Denver, Colorado, 80246, United States|The Center for Diabetes and Endocrine Care, Fort Lauderdale, Florida, 33312, United States|East Coast Institute for Research, LLC, Jacksonville, Florida, 32204, United States|Baptist Diabetes Associates, PA, Miami, Florida, 33156, United States|Physicians Research Associates, LLC, Lawrenceville, Georgia, 30046, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States|Northwest Endo Diabetes Research, LLC, Arlington Heights, Illinois, 60005, United States|Midwest Endocrinology, Crystal Lake, Illinois, 60012, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Diabetes anddocrine Associates, PC, Omaha, Nebraska, 68114, United States|Desert Endocrinology Clinical Research Center, Henderson, Nevada, 89052, United States|Palm Research Center, Las Vegas, Nevada, 89148, United States|Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, 03063, United States|Albany Medical Center / Albany Medical College, Albany, New York, 12206, United States|University Physicians Group Research Division, Staten Island, New York, 10301, United States|Diabetes and Endocrinology Consultants, PC, Morehead City, North Carolina, 28557, United States|The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital, Cincinnati, Ohio, 45219, United States|Diabetes and Obesity Clinical Trials Center, Nashville, Tennessee, 37212, United States|North Texas Endocrine Center, Dallas, Texas, 75231, United States|Office of Dr. Michelle Zaniewski-Singh, Houston, Texas, 77090, United States|Texas Diabetes and Endocrinology, Round Rock, Texas, 78681, United States|Bateman Horne Center, Salt Lake City, Utah, 84102, United States|Advanced Research Institute, South Ogden, Utah, 84405, United States|Larry D Stonesifer, MD Inc., PS, Federal Way, Washington, 98003, United States|Rainier Clinical Research Center, Inc, Renton, Washington, 98057, United States|The Polyclinic, Seattle, Washington, 98104, United States|MultiCare Institute for Research and Innovation, Tacoma, Washington, 98405, United States|Coffs Endocrine & Diabetes Services, Coffs Harbour, New South Wales, 2450, Australia|AIM Centre, Merewether, New South Wales, 2291, Australia|Royal Brisbane & Women's Hospital-Endocrinology, Herston, Queensland, 4006, Australia|VIVIT Instit.am LKH Feldkirch,Abt.f.Innere Med.u.Kardiologie, Feldkirch, 6807, Austria|LKH Steyr, Kardiologie, Steyr, 4400, Austria|KH Rudolfstiftung, 1. Med. Abt., Wien, Wien, 1030, Austria|Hospital Hietzing, Wien, 1130, Austria|Arlon - HOSP Sud Luxembourg - Vivalia, Arlon, 6700, Belgium|Bonheiden - HOSP Imelda, Bonheiden, 2820, Belgium|Brussels - UNIV UZ Brussel, Brussel, 1090, Belgium|ULB Hopital Erasme, Bruxelles, 1070, Belgium|Edegem - UNIV UZ Antwerpen, Edegem, 2650, Belgium|UNIV UZ Gent, Gent, 9000, Belgium|La Louvière - UNIV CHU Tivoli, La Louvière, 7100, Belgium|UZ Leuven, Leuven, 3000, Belgium|Centre Hospitalier Universitaire de Liège, Liège, 4000, Belgium|Liège - HOSP CHR de la Citadelle, Liège, 4000, Belgium|Merksem - HOSP ZNA Jan Palfijn, Merksem, 2170, Belgium|LMC Endocrinology Centres (Calgary) Ltd., Calgary, Alberta, T2H 2G4, Canada|The Bailey Clinic, Red Deer, Alberta, T4N 6V7, Canada|Royal Jubilee Hospital, Victoria, British Columbia, V8R 1J8, Canada|Health Sciences Centre Winnipeg, Winnipeg, Manitoba, R3E 3P4, Canada|CHUM - Pavillon R, Montreal, Migration Data, Quebec, Canada|Capital District Health Auth., Halifax, Nova Scotia, B3H 1V7, Canada|Kingston General Hospital, Kingston, Ontario, K7L 2V7, Canada|LMC Thornhill/Vaughan, Thornhill, Ontario, L4J 8L7, Canada|Mount Sinai Hospital, Toronto, Ontario, M5T 3L9, Canada|Royal Victoria Hospital, Montreal, Quebec, H3A 1A1, Canada|General Univ.hosp.in Prague (VFN), Diabetes ambulance, Praha 2, 128 08, Czechia|Diabetology and Internal Practice Dr. Vladimir Lelek, Slany, 274 01, Czechia|Masaryk Hospital, Internal Department, Usti nad Labem, 401 13, Czechia|Aalborg Sygehus Syd, Aalborg, 9100, Denmark|Aarhus Universitets Hospital, Aarhus C, 8000, Denmark|Steno Diabetes Center Copenhagen, Gentofte, 2820, Denmark|Nordsjællands Hospital - Hillerød, Hillerød, 3400, Denmark|Køge Sygehus, Køge, 4600, Denmark|IteLasaretti, Kuopio, FI-70100, Finland|Terveystalo Oulu, Diapolis, Oulu, FI-90100, Finland|TYKS, Turku, FI-20520, Finland|HOP Côte de Nacre, Caen, 14033, France|HOP Saint-Louis, La Rochelle Cedex 1, 17000, France|HOP de Narbonne, diabéto endo, Narbonne, Narbonne, 11100, France|HOP Robert Debré, Reims, 51092, France|HOP de Brabois, Vandoeuvre-lès-Nancy, 54511, France|HOP les Portes du Sud, Diabéto, Vénissieux, Vénissieux, 69200, France|Studienzentrum Aschaffenburg, Aschaffenburg, 63739, Germany|Gemeinschaftspraxis, Asslar, Asslar, 35614, Germany|ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH, Berlin, 10115, Germany|InnoDiab Forschung GmbH, Essen, 45136, Germany|Praxis Dr. Kosch, Pirna, Pirna, 01796, Germany|Allgemeinmedizinische und Diabetologische Schwerpunktpraxis, Rehlingen-Siersburg, 66780, Germany|Praxis Dr. Hirschhäuser, Saarbrücken, 66121, Germany|Praxis Dr. Segner, St. Ingbert, Saint Ingbert/Oberwürzbach, 66386, Germany|Ambulanzzentrum Schweinfurt, Schweinfurt, 97421, Germany|Noordwest Ziekenhuisgroep, Alkmaar, 1815 JD, Netherlands|Academisch Medisch Centrum (AMC), Amsterdam, 1105 AZ, Netherlands|Rijnstate Hospital, Arnhem, 6815 AD, Netherlands|Martini Ziekenhuis, Groningen, 9728 NT, Netherlands|Bethesda Ziekenhuis Hoogeveen, Hoogeveen, 7909 AA, Netherlands|Sint Franciscus Gasthuis, Rotterdam, 3045 PM, Netherlands|Albert Schweitzer Ziekenhuis, Zwijndrecht, Zwijndrecht, 3331 LZ, Netherlands|Sykehuset Innlandet HF, Avd. Hamar, Hamar, N-2318, Norway|Akershus Universitetssykehus HF, Lørenskog, N-1478, Norway|Oslo Universitetssykehus HF, Aker Sykehus, Oslo, N-0424, Norway|Helse Møre og Romsdal HF, Ålesund sjukehus, Ålesund, N-6026, Norway|Med Univ Bialystok Clin Dep Endocrinol, Diabetol & Int Dis, Bialystok, 15-276, Poland|NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny, Bialystok, 15-435, Poland|Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow, Krakow, 31011, Poland|NZOZ Specialized Ambulance "MEDICA", Lublin, 20-538, Poland|Marcinkowski Poznan Univ of Med Sci, Clin Dept Diab, Poznan, Poznan, 60-834, Poland|NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom, Radom, 26610, Poland|Centrum Medyczne Medyk, Rzeszow, 35-055, Poland|NBR Polska, Warsaw, 00-465, Poland|C.A.P. Sardenya, Barcelona, 08025, Spain|Hospital Vall d'Hebron, Barcelona, 08035, Spain|Hospital de la Inmaculada Concepción, Granada, 18004, Spain|Hospital Virgen de la Victoria, Malaga, 29010, Spain|Hospital General de Segovia, Segovia, 40002, Spain|Hospital Nuestra Señora de Valme, Sevilla, 41014, Spain|Hospital Virgen Macarena, Sevilla, 41071, Spain|Ladulaas Kliniska Studier, Borås, 506 30, Sweden|Centralsjukhuset, Karlstad, Karlstad, 651 85, Sweden|Läkarhuset, Vällingby, Vällingby, 162 68, Sweden|Chung Shan Medical University Hospital, Taichung, 402, Taiwan|China Medical University Hospital, Taichung, 40447, Taiwan|Chi Mei Medical Center, Tainan, 710, Taiwan|National Taiwan University Hospital, Taipei, 100, Taiwan|Tri-Service General Hospital, Taipei, 11490, Taiwan|Milton Keynes Hospital, Buckinghamshire, MK65LD, United Kingdom|Addenbrooke's Hospital, Cambridge, CB2 0QQ, United Kingdom|Wellcome Trust Clinical Research Facility, Edinburgh, EH4 2XU, United Kingdom|Leicester General Hospital, Leicester, LE5 4PW, United Kingdom|Royal London Hospital, London, E1 1BB, United Kingdom|Queen's Medical Centre, Nottingham, NG7 2UH, United Kingdom|George Eliot Hospital, Nuneaton, CV10 7DJ, United Kingdom|East Surrey Hospital, Surrey, RH1 5RH, United Kingdom|Queen Elizabeth II Hospital, Welwyn Garden City, AL7 4HQ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02414958

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress