Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
- Registration Number
- NCT02580591
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 977
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin low dose Placebo - Empagliflozin high dose Empagliflozin - Empagliflozin high dose Placebo - Empagliflozin medium dose Empagliflozin - Empagliflozin medium dose Placebo - Placebo Placebo - Empagliflozin low dose Empagliflozin -
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) Baseline to week 26 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.
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)) Baseline to week 26 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.
- Secondary Outcome Measures
Name Time Method Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG) Week 5 to Week 26, Week 1 to Week 26 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.
Change From Baseline in Body Weight at Week 26 Baseline to 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.
Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26 Baseline to 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.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26 Baseline to 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.
Trial Locations
- Locations (189)
International Research Associates, LLC
đŸ‡ºđŸ‡¸Hialeah, Florida, United States
University of Maryland School of Medicine
đŸ‡ºđŸ‡¸Baltimore, Maryland, United States
Sestron Clinical Research
đŸ‡ºđŸ‡¸Marietta, Georgia, United States
MODEL Clinical Research
đŸ‡ºđŸ‡¸Baltimore, Maryland, United States
University Diabetes and Endocrine Consultants
đŸ‡ºđŸ‡¸Chattanooga, Tennessee, United States
Dallas Diabetes and Endocrine Center
đŸ‡ºđŸ‡¸Dallas, Texas, United States
Coffs Endocrine & Diabetes Services
đŸ‡¦đŸ‡ºCoffs Harbour, New South Wales, Australia
FinnMedi Oy, Tampere
đŸ‡«đŸ‡®Tampere, Finland
Nicodiab SRL, Bucharest
đŸ‡·đŸ‡´Bucharest, Romania
Inrca-Irccs
đŸ‡®đŸ‡¹Ancona, Italy
General Hospital of Nikaia
đŸ‡¬đŸ‡·Nikaia, Greece
TREAD Research
đŸ‡¿đŸ‡¦Cape Town, South Africa
Hospital A Coruña
đŸ‡ªđŸ‡¸A Coruña, Spain
Research Institute of Dallas
đŸ‡ºđŸ‡¸Dallas, Texas, United States
Eagle's Landing Diabetes and Endocrinology
đŸ‡ºđŸ‡¸Stockbridge, Georgia, United States
Holston Medical Group
đŸ‡ºđŸ‡¸Bristol, Tennessee, United States
Richmond Road and Diagnostic Treatment Centre
đŸ‡¨đŸ‡¦Calgary, Alberta, Canada
AM Diabetes and Endocrinology Center
đŸ‡ºđŸ‡¸Bartlett, Tennessee, United States
Texas Health Physicians Group
đŸ‡ºđŸ‡¸Dallas, Texas, United States
University Hospital Brno
đŸ‡¨đŸ‡¿Brno, Czechia
John Muir Physician Network Clinical Research Center
đŸ‡ºđŸ‡¸Concord, California, United States
TYKS
đŸ‡«đŸ‡®Turku, Finland
HOP Jean Minjoz
đŸ‡«đŸ‡·Besancon, France
Valley Research
đŸ‡ºđŸ‡¸Fresno, California, United States
Solutions Through Advanced Research, Inc.
đŸ‡ºđŸ‡¸Jacksonville, Florida, United States
Suncoast Clinical Research, Inc.
đŸ‡ºđŸ‡¸New Port Richey, Florida, United States
Physicians Research Associates, LLC
đŸ‡ºđŸ‡¸Lawrenceville, Georgia, United States
Diabetes Endocrinology Research Center of Western New York
đŸ‡ºđŸ‡¸Williamsville, New York, United States
Mehiläinen Jyväskylä
đŸ‡«đŸ‡®Jyväskylä, Finland
Clinique des maladies Lipidiques de Quebec
đŸ‡¨đŸ‡¦Quebec, Canada
Eastern Health (MUN)
đŸ‡¨đŸ‡¦St. John's, Newfoundland and Labrador, Canada
Eastern Clinical Research Unit
đŸ‡¦đŸ‡ºEast Ringwood, Victoria, Australia
HOP Paris Saint-Joseph
đŸ‡«đŸ‡·Paris, France
Satakunnan Diabetesasema, Pori
đŸ‡«đŸ‡®Pori, Finland
St. Michael's Hospital
đŸ‡¨đŸ‡¦Toronto, Ontario, Canada
Holzer Clinic LLC
đŸ‡ºđŸ‡¸Gallipolis, Ohio, United States
HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki
đŸ‡«đŸ‡®Helsinki, Finland
ResTrial s.r.o.Diabetology Ambulance,Prague
đŸ‡¨đŸ‡¿Prague, Czechia
Lyell McEwin Hospital
đŸ‡¦đŸ‡ºElizabeth Vale, South Australia, Australia
HOP de Poitiers
đŸ‡«đŸ‡·Poitiers, France
Univ. Hospital Kralovske Vinohrady
đŸ‡¨đŸ‡¿Prague, Czechia
Diahaza s.r.o.Intern.Med.Outpat.Clin.Dep.Diabetology,Holesov
đŸ‡¨đŸ‡¿Holesov, Czechia
HOP Le Creusot
đŸ‡«đŸ‡·Le Creusot, France
InnoDiab Forschung GmbH
đŸ‡©đŸ‡ªEssen, Germany
AIDIN VK s.r.o.,Department Diabetology, Hranice
đŸ‡¨đŸ‡¿Hranice, Czechia
Universitetssykehuset Nord-Norge, Tromsø
đŸ‡³đŸ‡´Tromsø, Norway
DiabSerwis S.C., Chorzow
đŸ‡µđŸ‡±Chorzow, Poland
Oslo Universitetssykehus HF, Lipidklinikken
đŸ‡³đŸ‡´Oslo, Norway
Medical Centre Pratia Gdynia
đŸ‡µđŸ‡±Gdynia, Poland
Medical Centre Pratia Katowice I
đŸ‡µđŸ‡±Katowice, Poland
Medical Centre Pratia Krakow
đŸ‡µđŸ‡±Krakow, Poland
Reg.Spec.Hosp.Olsztyn,Clin,Endocrinology,Diabetics.&Int.Med.
đŸ‡µđŸ‡±Olsztyn, Poland
SC Pelican Impex SRL, Cabinet Nr. 201, Diabetes Dept.
đŸ‡·đŸ‡´Oradea, Bihor County, Romania
CRU Hungary Ltd, Private Practice, Miskolc
đŸ‡đŸ‡ºMiskolc, Hungary
CJSC"Polyclinic complex",Dep.Endocrinology,St.Petersburg
đŸ‡·đŸ‡ºSt. Petersburg, Russian Federation
M3 Helse AS
đŸ‡³đŸ‡´Hamar, Norway
University Hospital in Krakow
đŸ‡µđŸ‡±Krakow, Poland
Omedica Medical Centre, Poznan
đŸ‡µđŸ‡±Poznan, Poland
Csongrad Country Dr Bugyi Istvan Hosp.
đŸ‡đŸ‡ºSzentes, Hungary
Sigulda Hospital, Outpatient department
đŸ‡±đŸ‡»Sigulda, Latvia
Stavanger Helseforskning
đŸ‡³đŸ‡´Stavanger, Norway
SC Medical Centre "Sanatatea Ta" SRL, Bucharest
đŸ‡·đŸ‡´Bucharest, Romania
Centrul Medical Dr Negrisanu SRL
đŸ‡·đŸ‡´Timisoara, Romania
Policlinic No. 1 of Russian Academy of Sciences, St. Petersburg
đŸ‡·đŸ‡ºSt. Petersburg, Russian Federation
Diabetes Care Centre
đŸ‡¿đŸ‡¦Pretoria, South Africa
Independent Public Clin.Hosp.no1Lublin,Dep.Internal Diseases
đŸ‡µđŸ‡±Lublin, Poland
CTC Sahlgrenska Universitetssjukhuset
đŸ‡¸đŸ‡ªGöteborg, Sweden
LCS Clinical Research Unit
đŸ‡¿đŸ‡¦Bryanston, South Africa
VX Pharma (Pty) Ltd Pretoria
đŸ‡¿đŸ‡¦Pretoria, South Africa
Queen's Medical Centre
đŸ‡¬đŸ‡§Nottingham, United Kingdom
Witold Chodzko Institute Rural Medic,Dep.Diabetology,Lublin
đŸ‡µđŸ‡±Lublin, Poland
Clinical Research Center Medicome, Oswiecim
đŸ‡µđŸ‡±Oswiecim, Poland
Hospital de Braga-Escala Braga
đŸ‡µđŸ‡¹Braga, Portugal
Dr Hilton Kaplan
đŸ‡¿đŸ‡¦Cape Town, South Africa
Medical Academy named after I. Mechnikov, St. Petersburg
đŸ‡·đŸ‡ºSt. Petersburg, Russian Federation
City Clinical Hospital no. 67, Moscow
đŸ‡·đŸ‡ºMoscow, Russian Federation
Hospital ClĂnico de Valencia
đŸ‡ªđŸ‡¸Valencia, Spain
Hospital General Universitario Gregorio MaraĂ±Ă³n
đŸ‡ªđŸ‡¸Madrid, Spain
Dr. L. A.Distiller
đŸ‡¿đŸ‡¦Johannesburg, South Africa
S3 Clinical Research Centers
đŸ‡¸đŸ‡ªVällingby, Sweden
Ă„ngelholms Sjukhus
đŸ‡¸đŸ‡ªĂ„ngelholm, Sweden
Endo-Diabesidad-ClĂnica DurĂ¡n & Asociados
đŸ‡ªđŸ‡¸Sevilla, Spain
City Hospital Saint Elizaveta, Dept. Endocrinology
đŸ‡·đŸ‡ºSt. Petersburg, Russian Federation
Leicester General Hospital
đŸ‡¬đŸ‡§Leicester, United Kingdom
CM Avances MĂ©dicos
đŸ‡ªđŸ‡¸Granada, Spain
George Eliot Hospital
đŸ‡¬đŸ‡§Nuneaton, United Kingdom
Hull Royal Infirmary
đŸ‡¬đŸ‡§Hull, United Kingdom
Hospital Virgen Macarena
đŸ‡ªđŸ‡¸Sevilla, Spain
Ipswich Hospital
đŸ‡¬đŸ‡§Ipswich, United Kingdom
Hospital Universitario Infanta Leonor
đŸ‡ªđŸ‡¸Madrid, Spain
Karlskoga lasarett
đŸ‡¸đŸ‡ªKarlskoga, Sweden
SkĂ¥nes universitetssjukhus, Lund
đŸ‡¸đŸ‡ªLund, Sweden
University of Miami
đŸ‡ºđŸ‡¸Miami, Florida, United States
Palm Research Center
đŸ‡ºđŸ‡¸Las Vegas, Nevada, United States
COR Clinical Research, LLC
đŸ‡ºđŸ‡¸Oklahoma City, Oklahoma, United States
Endeavor Clinical Trials, PA
đŸ‡ºđŸ‡¸San Antonio, Texas, United States
King's College Hospital
đŸ‡¬đŸ‡§London, United Kingdom
St Mary's Hospital
đŸ‡¬đŸ‡§London, United Kingdom
Royal Victoria Infirmary
đŸ‡¬đŸ‡§Newcastle Upon Tyne, United Kingdom
The Bailey Clinic
đŸ‡¨đŸ‡¦Red Deer, Alberta, Canada
Omnispec Recherche Clinique Inc.
đŸ‡¨đŸ‡¦Mirabel, Quebec, Canada
Applied Medical Informatics Research INC.
đŸ‡¨đŸ‡¦Westmount, Quebec, Canada
Diabetes-Klinik Bad Mergentheim GmbH & Co. KG
đŸ‡©đŸ‡ªBad Mergentheim, Germany
Praxis Dr. Busch, Dortmund
đŸ‡©đŸ‡ªDortmund, Germany
ZKS SĂ¼dbrandenburg GmbH
đŸ‡©đŸ‡ªElsterwerda, Germany
Clinexpert Kft.
đŸ‡đŸ‡ºBudapest, Hungary
Zala Country Hospital, Diabetic Outpatient Clinic
đŸ‡đŸ‡ºZalaegerszeg, Hungary
Endocrine Associates of Long Island, PC
đŸ‡ºđŸ‡¸Smithtown, New York, United States
Osp. S. Giovanni Calibita Fatebenefratelli
đŸ‡®đŸ‡¹Roma, Italy
VSV Centrs, Stalte Private Practice, Talsi
đŸ‡±đŸ‡»Talsi, Latvia
Synexus Magyarorszag Kft.
đŸ‡đŸ‡ºBudapest, Hungary
William Sansum Diabetes Center
đŸ‡ºđŸ‡¸Santa Barbara, California, United States
Pacific Research Partners, LLC
đŸ‡ºđŸ‡¸Oakland, California, United States
Healthscan Clinical Trials LLC
đŸ‡ºđŸ‡¸Montgomery, Alabama, United States
NorCal Endocrinology and Internal Medicine
đŸ‡ºđŸ‡¸San Ramon, California, United States
Marin Endocrine Care and Research
đŸ‡ºđŸ‡¸Greenbrae, California, United States
Atlanta Diabetes Associates
đŸ‡ºđŸ‡¸Atlanta, Georgia, United States
Northwest Endo Diabetes Research, LLC
đŸ‡ºđŸ‡¸Arlington Heights, Illinois, United States
Desert Endocrinology Clinical Research Center
đŸ‡ºđŸ‡¸Henderson, Nevada, United States
Diabetes and Endocrinology Consultants, PC
đŸ‡ºđŸ‡¸Morehead City, North Carolina, United States
Virginia Endocrinology Research
đŸ‡ºđŸ‡¸Chesapeake, Virginia, United States
Strand Physician Specialists dba Carolina Health Specialists
đŸ‡ºđŸ‡¸Myrtle Beach, South Carolina, United States
Centre for Studies in Family Medicine
đŸ‡¨đŸ‡¦London, Ontario, Canada
SA Endocrine Research P/L
đŸ‡¦đŸ‡ºKeswick, South Australia, Australia
Milan Kvapil s.r.o.,Diabetology ambulance,Prague
đŸ‡¨đŸ‡¿Prague, Czechia
DiaGolfova s.r.o., Department Diabetology, Prague
đŸ‡¨đŸ‡¿Prague, Czechia
HOP Bichat
đŸ‡«đŸ‡·Paris, France
HOP Rangueil
đŸ‡«đŸ‡·Toulouse CĂ©dex 04, France
HOP Civil
đŸ‡«đŸ‡·Strasbourg, France
Praxis Dr. Kaiser, Frankfurt
đŸ‡©đŸ‡ªFrankfurt, Germany
Diabetologische Schwerpunktpraxis, Bosenheim
đŸ‡©đŸ‡ªBosenheim, Germany
GWT-TUD GmbH
đŸ‡©đŸ‡ªDresden, Germany
Diabetologische Schwerpunktpraxis
đŸ‡©đŸ‡ªMĂ¼nster, Germany
"Korgialeneio-Benakeio" Hellenic Red Cross Hospital
đŸ‡¬đŸ‡·Athens, Greece
Institut fĂ¼r Diabetesforschung MĂ¼nster GmbH
đŸ‡©đŸ‡ªMĂ¼nster, Germany
Praxis Dr. Behnke, Neuwied
đŸ‡©đŸ‡ªNeuwied, Germany
Praxis Dr. Hilgenberg
đŸ‡©đŸ‡ªRehburg-Loccum, Germany
Univ. Gen. Hosp. of Ioannina
đŸ‡¬đŸ‡·Ioannina, Greece
General Hospital of Athens "Laiko"
đŸ‡¬đŸ‡·Athens, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
đŸ‡¬đŸ‡·Thessaloniki, Greece
General Hopsital of Thessaloniki "Ippokrateio"
đŸ‡¬đŸ‡·Thessaloniki, Greece
University Debrecen Hospital
đŸ‡đŸ‡ºDebrecen, Hungary
Clinfan SMO Ltd.
đŸ‡đŸ‡ºSzekszard, Hungary
Mater Misericordiae University Hospital
đŸ‡®đŸ‡ªDublin, Ireland
A.O. Spedali Civili di Brescia
đŸ‡®đŸ‡¹Brescia, Italy
Policlinico Gemelli
đŸ‡®đŸ‡¹Roma, Italy
Osp. Campo di Marte
đŸ‡®đŸ‡¹Lucca, Italy
Azienda Ospedaliera Universitaria "Federico II"
đŸ‡®đŸ‡¹Napoli, Italy
IRCCS Gruppo Multimedica
đŸ‡®đŸ‡¹Sesto San Giovanni (MI), Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
đŸ‡®đŸ‡¹Siena, Italy
Hospital Cardiologica Aguascalientes
đŸ‡²đŸ‡½Aguascalientes, Mexico
Dace Teterovska Doctor's Practice in Endocrinology,Ogre
đŸ‡±đŸ‡»Ogre, Latvia
Ospedale Molinette, AO CittĂ della Salute e della
đŸ‡®đŸ‡¹Torino, Italy
Zemgales Center of diabetes, Jelgava
đŸ‡±đŸ‡»Jelgava, Latvia
A. Lucenko's Internist & Endocrinologist Doctor's Practice
đŸ‡±đŸ‡»Liepaja, Latvia
P. Stradins Clinical University Hospital, Riga
đŸ‡±đŸ‡»Riga, Latvia
ClĂnica EndocrInol en Diabetes Obesidad y Tiroides (DOT)
đŸ‡²đŸ‡½Aguascalientes, Mexico
Noordwest Ziekenhuisgroep
đŸ‡³đŸ‡±Alkmaar, Netherlands
Gelre Ziekenhuizen Apeldoorn
đŸ‡³đŸ‡±Apeldoorn, Netherlands
Ziekenhuisgroep Twente locatie Almelo
đŸ‡³đŸ‡±Almelo, Netherlands
EB Utrecht Research
đŸ‡³đŸ‡±Utrecht, Netherlands
Meander Medisch Centrum
đŸ‡³đŸ‡±Amersfoort, Netherlands
Universitair Medisch Centrum Utrecht
đŸ‡³đŸ‡±Utrecht, Netherlands
South Pacific Clinical Trials
đŸ‡³đŸ‡¿Auckland, New Zealand, New Zealand
Lipid and Diabetes Research Group
đŸ‡³đŸ‡¿Christchurch, New Zealand
Milit. Cent. Emerg. Univ. Hosp. Dr. Davila, Met. Dis. Dept.
đŸ‡·đŸ‡´Bucharest, Romania
City Outpatient dep.no.107;clinc.pharmacology,st.petersburg
đŸ‡·đŸ‡ºSt. Petersburg, Russian Federation
Hospital de la Inmaculada ConcepciĂ³n
đŸ‡ªđŸ‡¸Granada, Spain
Bradford Royal Infirmary
đŸ‡¬đŸ‡§Bradford, United Kingdom
Royal Bournemouth and Christchurch Hospital
đŸ‡¬đŸ‡§Bournemouth, United Kingdom
James Cook University Hospital
đŸ‡¬đŸ‡§Middlesbrough, United Kingdom
Medical Centre Pratia Warszawa
đŸ‡µđŸ‡±Warsaw, Poland
NZOZ Med-Art.Specialist Clinics, Zory
đŸ‡µđŸ‡±Zory, Poland
APDP - AssociaĂ§Ă£o Protectora dos DiabĂ©ticos de Portugal
đŸ‡µđŸ‡¹Lisboa, Portugal
H. Santo AntĂ³nio - Centro Hospitalar do Porto
đŸ‡µđŸ‡¹Porto, Portugal
ULSAM, EPE - Hospital de Santa Luzia
đŸ‡µđŸ‡¹Viana do Castelo, Portugal
Unidad de Investigacion Clinica Cardiometabolica de Occident
đŸ‡²đŸ‡½Guadalajara, Mexico
Riga Health Center, Private Practice
đŸ‡±đŸ‡»Riga, Latvia
Instituto Jaliscience de Inv. en Diabetes y Obesidad, S.C.
đŸ‡²đŸ‡½Guadalajara, Mexico
Centro Hospitalar da Cova da Beira Hospital PĂªro da CovilhĂ£
đŸ‡µđŸ‡¹CovilhĂ£, Portugal
Centro Hospitalar SĂ£o JoĂ£o,EPE
đŸ‡µđŸ‡¹Porto, Portugal
Centro Hospitalar de Vila Nova de Gaia
đŸ‡µđŸ‡¹Vila Nova de Gaia, Portugal
Unidad de Patologia Clinica
đŸ‡²đŸ‡½Guadalajara, Mexico
University of Colorado Denver
đŸ‡ºđŸ‡¸Aurora, Colorado, United States
Kentucky Diabetes Endocrinology Center
đŸ‡ºđŸ‡¸Lexington, Kentucky, United States
Clinical Research Consultants, LLC
đŸ‡ºđŸ‡¸Kansas City, Missouri, United States
Endocrine-Diabetes Care and Resource Center
đŸ‡ºđŸ‡¸Rochester, New York, United States
Texas Diabetes & Endocrinology PA
đŸ‡ºđŸ‡¸Austin, Texas, United States
Guy's Hospital
đŸ‡¬đŸ‡§London, United Kingdom