Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
NCT ID: NCT02414958
Last Updated: 2019-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
730 participants
INTERVENTIONAL
2015-06-30
2017-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Empagliflozin low dose
Empagliflozin tablets once daily
Empagliflozin
Empagliflozin high dose
Empagliflozin tablets once daily
Empagliflozin
Placebo
Placebo tablets matching empagliflozin once daily
Placebo
Interventions
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Empagliflozin
Empagliflozin
Placebo
Eligibility Criteria
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Inclusion Criteria
* Fasting C-peptide value of \< 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the central laboratory
* Use of, and be willing, based on the Investigator's judgement, to continue throughout the duration of the trial, either:
* Multiple Daily Injections (MDI) of insulin consisting of at least one basal insulin injection and at least three daily bolus injections OR
* Continuous Subcutaneous Insulin Infusion (CSII) of any insulin type, with at least 5 months experience of using CSII prior to Visit 1
* HbA1c \>/= 7.5% and \</= 10.0% at Visit 5 measured by the central laboratory
* Age \>/= 18 years at Visit 1
Exclusion Criteria
* Pancreas, pancreatic islet cells or renal transplant recipient
* T1DM treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, Glucagon-like-peptide 1 (GLP-1) analogues, Sodium-Glucose Co-Transporter (SGLT-2) inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to Visit 1
* Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to Visit 1 and until randomisation
* Occurence of Diabetic Ketoacidosis (DKA) within 3 months prior to Visit 1 and until randomisation
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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AMCR Institute, Inc.
Escondido, California, United States
Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States
National Research Institute
Los Angeles, California, United States
Mills-Peninsula Health Services
San Mateo, California, United States
Metabolic Institute of America
Tarzana, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Creekside Endocrine Associates, PC
Denver, Colorado, United States
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
Baptist Diabetes Associates, PA
Miami, Florida, United States
Physicians Research Associates, LLC
Lawrenceville, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Northwest Endo Diabetes Research, LLC
Arlington Heights, Illinois, United States
Midwest Endocrinology
Crystal Lake, Illinois, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Diabetes anddocrine Associates, PC
Omaha, Nebraska, United States
Desert Endocrinology Clinical Research Center
Henderson, Nevada, United States
Palm Research Center
Las Vegas, Nevada, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States
Albany Medical Center / Albany Medical College
Albany, New York, United States
University Physicians Group Research Division
Staten Island, New York, United States
Diabetes and Endocrinology Consultants, PC
Morehead City, North Carolina, United States
The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
Diabetes and Obesity Clinical Trials Center
Nashville, Tennessee, United States
North Texas Endocrine Center
Dallas, Texas, United States
Office of Dr. Michelle Zaniewski-Singh
Houston, Texas, United States
Texas Diabetes and Endocrinology
Round Rock, Texas, United States
Bateman Horne Center
Salt Lake City, Utah, United States
Advanced Research Institute
South Ogden, Utah, United States
Larry D Stonesifer, MD Inc., PS
Federal Way, Washington, United States
Rainier Clinical Research Center, Inc
Renton, Washington, United States
The Polyclinic
Seattle, Washington, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States
Coffs Endocrine & Diabetes Services
Coffs Harbour, New South Wales, Australia
AIM Centre
Merewether, New South Wales, Australia
Royal Brisbane & Women's Hospital-Endocrinology
Herston, Queensland, Australia
VIVIT Instit.am LKH Feldkirch,Abt.f.Innere Med.u.Kardiologie
Feldkirch, , Austria
LKH Steyr, Kardiologie
Steyr, , Austria
KH Rudolfstiftung, 1. Med. Abt., Wien
Vienna, , Austria
Hospital Hietzing
Vienna, , Austria
Arlon - HOSP Sud Luxembourg - Vivalia
Arlon, , Belgium
Bonheiden - HOSP Imelda
Bonheiden, , Belgium
ULB Hopital Erasme
Brussels, , Belgium
Brussels - UNIV UZ Brussel
Brussels, , Belgium
Edegem - UNIV UZ Antwerpen
Edegem, , Belgium
UNIV UZ Gent
Ghent, , Belgium
La Louvière - UNIV CHU Tivoli
La Louvière, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Liège - HOSP CHR de la Citadelle
Liège, , Belgium
Merksem - HOSP ZNA Jan Palfijn
Merksem, , Belgium
LMC Endocrinology Centres (Calgary) Ltd.
Calgary, Alberta, Canada
The Bailey Clinic
Red Deer, Alberta, Canada
Royal Jubilee Hospital
Victoria, British Columbia, Canada
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada
CHUM - Pavillon R
Montreal, Migration Data, Canada
Capital District Health Auth.
Halifax, Nova Scotia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
LMC Thornhill/Vaughan
Thornhill, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
General Univ.hosp.in Prague (VFN), Diabetes ambulance
Prague, , Czechia
Diabetology and Internal Practice Dr. Vladimir Lelek
Slaný, , Czechia
Masaryk Hospital, Internal Department
Ústí nad Labem, , Czechia
Aalborg Sygehus Syd
Aalborg, , Denmark
Aarhus Universitets Hospital
Aarhus C, , Denmark
Steno Diabetes Center Copenhagen
Gentofte Municipality, , Denmark
Nordsjællands Hospital - Hillerød
Hillerød, , Denmark
Køge Sygehus
Køge, , Denmark
IteLasaretti
Kuopio, , Finland
Terveystalo Oulu, Diapolis
Oulu, , Finland
TYKS
Turku, , Finland
HOP Côte de Nacre
Caen, , France
HOP Saint-Louis
La Rochelle, , France
HOP de Narbonne, diabéto endo, Narbonne
Narbonne, , France
HOP Robert Debré
Reims, , France
HOP de Brabois
Vandœuvre-lès-Nancy, , France
HOP les Portes du Sud, Diabéto, Vénissieux
Vénissieux, , France
Studienzentrum Aschaffenburg
Aschaffenburg, , Germany
Gemeinschaftspraxis, Asslar
Aßlar, , Germany
ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH
Berlin, , Germany
InnoDiab Forschung GmbH
Essen, , Germany
Praxis Dr. Kosch, Pirna
Pirna, , Germany
Allgemeinmedizinische und Diabetologische Schwerpunktpraxis
Rehlingen-Siersburg, , Germany
Praxis Dr. Hirschhäuser
Saarbrücken, , Germany
Praxis Dr. Segner, St. Ingbert
Saint Ingbert/Oberwürzbach, , Germany
Ambulanzzentrum Schweinfurt
Schweinfurt, , Germany
Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
Academisch Medisch Centrum (AMC)
Amsterdam, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
Bethesda Ziekenhuis Hoogeveen
Hoogeveen, , Netherlands
Sint Franciscus Gasthuis
Rotterdam, , Netherlands
Albert Schweitzer Ziekenhuis, Zwijndrecht
Zwijndrecht, , Netherlands
Helse Møre og Romsdal HF, Ålesund sjukehus
Ålesund, , Norway
Sykehuset Innlandet HF, Avd. Hamar
Hamar, , Norway
Akershus Universitetssykehus HF
Lørenskog, , Norway
Oslo Universitetssykehus HF, Aker Sykehus
Oslo, , Norway
Med Univ Bialystok Clin Dep Endocrinol, Diabetol & Int Dis
Bialystok, , Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny
Bialystok, , Poland
Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow
Krakow, , Poland
NZOZ Specialized Ambulance "MEDICA"
Lublin, , Poland
Marcinkowski Poznan Univ of Med Sci, Clin Dept Diab, Poznan
Poznan, , Poland
NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom
Radom, , Poland
Centrum Medyczne Medyk
Rzeszów, , Poland
NBR Polska
Warsaw, , Poland
C.A.P. Sardenya
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital de la Inmaculada Concepción
Granada, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital General de Segovia
Segovia, , Spain
Hospital Nuestra Señora de Valme
Seville, , Spain
Hospital Virgen Macarena
Seville, , Spain
Ladulaas Kliniska Studier
Borås, , Sweden
Centralsjukhuset, Karlstad
Karlstad, , Sweden
Läkarhuset, Vällingby
Vällingby, , Sweden
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Milton Keynes Hospital
Buckinghamshire, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Wellcome Trust Clinical Research Facility
Edinburgh, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
Royal London Hospital
London, , United Kingdom
Queen's Medical Centre
Nottingham, , United Kingdom
George Eliot Hospital
Nuneaton, , United Kingdom
East Surrey Hospital
Surrey, , United Kingdom
Queen Elizabeth II Hospital
Welwyn Garden City, , United Kingdom
Countries
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References
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Song C, Dhaliwal S, Bapat P, Scarr D, Bakhsh A, Budhram D, Verhoeff NJ, Weisman A, Fralick M, Ivers NM, Cherney DZI, Tomlinson G, Lovblom LE, Mumford D, Perkins BA. Point-of-Care Capillary Blood Ketone Measurements and the Prediction of Future Ketoacidosis Risk in Type 1 Diabetes. Diabetes Care. 2023 Nov 1;46(11):1973-1977. doi: 10.2337/dc23-0840.
Rosenstock J, Marquard J, Laffel LM, Neubacher D, Kaspers S, Cherney DZ, Zinman B, Skyler JS, George J, Soleymanlou N, Perkins BA. Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials. Diabetes Care. 2018 Dec;41(12):2560-2569. doi: 10.2337/dc18-1749. Epub 2018 Oct 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-001922-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1245.69
Identifier Type: -
Identifier Source: org_study_id
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