Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)

A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-3)

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Empagliflozin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 977
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • Coffs Endocrine & Diabetes Services
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Lyell McEwin Hospital
    • Keswick, South Australia, Australia, 5035
      • SA Endocrine Research P/L
  • Victoria
    • East Ringwood, Victoria, Australia, 3135
      • Eastern Clinical Research Unit
• Canada
  • Quebec, Canada, G1V 4M6
    • Clinique des Maladies Lipidiques de Québec
  • Alberta
    • Calgary, Alberta, Canada, T2T 5C7
      • Richmond Road and Diagnostic Treatment Centre
    • Red Deer, Alberta, Canada, T4N 6V7
      • The Bailey Clinic
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Eastern Health (MUN)
  • Ontario
    • London, Ontario, Canada, N6G 2M1
      • Centre for Studies in Family Medicine
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Omnispec Recherche Clinique Inc.
    • Westmount, Quebec, Canada, H3Z 1E5
      • Applied Medical Informatics Research Inc.
• Czechia
  • Brno, Czechia, 625 00
    • University Hospital Brno
  • Holesov, Czechia, 769 01
    • Diahaza s.r.o.Intern.Med.Outpat.Clin.Dep.Diabetology,Holesov
  • Hranice, Czechia, 753 01
    • AIDIN VK s.r.o.,Department Diabetology, Hranice
  • Prague, Czechia, 100 42
    • Univ. Hospital Kralovske Vinohrady
  • Prague, Czechia, 102 00
    • DiaGolfova s.r.o., Department Diabetology, Prague
  • Prague, Czechia, 149 00
    • Milan Kvapil s.r.o.,Diabetology ambulance,Prague
  • Prague, Czechia, 18100
    • ResTrial s.r.o.Diabetology Ambulance,Prague
• Finland
  • Helsinki, Finland, 00290
    • HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki
  • Jyväskylä, Finland, 40100
    • Mehiläinen Jyväskylä
  • Pori, Finland, 28100
    • Satakunnan Diabetesasema, Pori
  • Tampere, Finland, 33520
    • FinnMedi Oy, Tampere
  • Turku, Finland, FI-20520
    • TYKS
• France
  • Besancon, France, 25030
    • HOP Jean Minjoz
  • Le Creusot, France, 71200
    • HOP Le Creusot
  • Paris, France, 75014
    • HOP Paris Saint-Joseph
  • Paris, France, 75018
    • HOP Bichat
  • Poitiers, France, 86021
    • HOP de Poitiers
  • Strasbourg, France, 67091
    • HOP Civil
  • Toulouse Cédex 04, France, 31059
    • HOP Rangueil
• Germany
  • Bad Mergentheim, Germany, 97980
    • Diabetes-Klinik Bad Mergentheim GmbH & Co. KG
  • Bosenheim, Germany, 55545
    • Diabetologische Schwerpunktpraxis, Bosenheim
  • Dortmund, Germany, 44137
    • Praxis Dr. Busch, Dortmund
  • Dresden, Germany, 01307
    • GWT-TUD GmbH
  • Elsterwerda, Germany, 04910
    • ZKS Südbrandenburg GMBH
  • Essen, Germany, 45136
    • InnoDiab Forschung Gmbh
  • Frankfurt, Germany, 60388
    • Praxis Dr. Kaiser, Frankfurt
  • Münster, Germany, 48145
    • Institut für Diabetesforschung Münster GmbH
  • Münster, Germany, 48153
    • Diabetologische Schwerpunktpraxis
  • Neuwied, Germany, 56564
    • Praxis Dr. Behnke, Neuwied
  • Rehburg-Loccum, Germany, 31547
    • Praxis Dr. Hilgenberg
• Greece
  • Athens, Greece, 115 26
    • "Korgialeneio-Benakeio" Hellenic Red Cross Hospital
  • Athens, Greece, 11527
    • General Hospital of Athens "LAIKO"
  • Ioannina, Greece, 45500
    • Univ. Gen. Hosp. of Ioannina
  • Nikaia, Greece, 18484
    • General Hospital of Nikaia
  • Thessaloniki, Greece, 54642
    • General Hopsital of Thessaloniki "Ippokrateio"
  • Thessaloniki, Greece, 57010
    • General Hospital of Thessaloniki "G. Papanikolaou"
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft.
  • Budapest, Hungary, 1036
    • Synexus Magyarorszag Kft.
  • Debrecen, Hungary, 4032
    • University Debrecen Hospital
  • Miskolc, Hungary, 3529
    • CRU Hungary Ltd, Private Practice, Miskolc
  • Szekszard, Hungary, 7100
    • Clinfan SMO Ltd.
  • Szentes, Hungary, 6600
    • Csongrad Country Dr Bugyi Istvan Hosp.
  • Zalaegerszeg, Hungary, 8900
    • Zala Country Hospital, Diabetic Outpatient Clinic
• Ireland
  • Dublin, Ireland, 7
    • Mater Misericordiae University Hospital
• Italy
  • Ancona, Italy, 60124
    • Inrca-Irccs
  • Brescia, Italy, 25123
    • A.O. Spedali Civili di Brescia
  • Lucca, Italy, 55100
    • Osp. Campo di Marte
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria "Federico II"
  • Roma, Italy, 00168
    • Policlinico Gemelli
  • Roma, Italy, 00186
    • Osp. S. Giovanni Calibita Fatebenefratelli
  • Sesto San Giovanni (MI), Italy, 20099
    • IRCCS Gruppo Multimedica
  • Siena, Italy, 53100
    • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Torino, Italy, 10126
    • Ospedale Molinette, AO Città della Salute e della
• Latvia
  • Jelgava, Latvia, 3001
    • Zemgales Center of diabetes, Jelgava
  • Liepaja, Latvia, 3401
    • A. Lucenko's Internist & Endocrinologist Doctor's Practice
  • Ogre, Latvia, 5001
    • Dace Teterovska Doctor's Practice in Endocrinology,Ogre
  • Riga, Latvia, 1002
    • P. Stradins Clinical University Hospital, Riga
  • Riga, Latvia, 1002
    • Riga Health Center, Private Practice
  • Sigulda, Latvia, 2150
    • Sigulda Hospital, Outpatient department
  • Talsi, Latvia, 3201
    • VSV Centrs, Stalte Private Practice, Talsi
• Mexico
  • Aguascalientes, Mexico, 20129
    • Clínica EndocrInol en Diabetes Obesidad y Tiroides (DOT)
  • Aguascalientes, Mexico, 20230
    • Hospital Cardiologica Aguascalientes
  • Guadalajara, Mexico, 44150
    • Unidad de Investigacion Clinica Cardiometabolica de Occident
  • Guadalajara, Mexico, 44600
    • Instituto Jaliscience de Inv. en Diabetes y Obesidad, S.C.
  • Guadalajara, Mexico, CP 44650
    • Unidad de patologia Clinica
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Noordwest Ziekenhuisgroep
  • Almelo, Netherlands, 7609 PP
    • Ziekenhuisgroep Twente locatie Almelo
  • Amersfoort, Netherlands, 3813 TZ
    • Meander Medisch Centrum
  • Apeldoorn, Netherlands, 7334 DZ
    • Gelre Ziekenhuizen Apeldoorn
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
  • Utrecht, Netherlands, 3511 NH
    • EB Utrecht Research
• New Zealand
  • Auckland, New Zealand, New Zealand, 0610
    • South Pacific Clinical Trials
  • Christchurch, New Zealand, 8011
    • Lipid and Diabetes Research Group
• Norway
  • Hamar, Norway, N-2317
    • M3 Helse AS
  • Oslo, Norway, N-0027
    • Oslo Universitetssykehus HF, Lipidklinikken
  • Stavanger, Norway, N-4068
    • Stavanger Helseforskning
  • Tromsø, Norway, N-9038
    • Universitetssykehuset Nord-Norge, Tromsø
• Poland
  • Chorzow, Poland, 41-500
    • DiabSerwis S.C., Chorzow
  • Gdynia, Poland, 81-338
    • Medical Centre Pratia Gdynia
  • Katowice, Poland, 40-954
    • Medical Centre Pratia Katowice I
  • Krakow, Poland, 30-002
    • Medical Centre Pratia Krakow
  • Krakow, Poland, 31-501
    • University Hospital in Krakow
  • Lublin, Poland, 20-081
    • Independent Public Clin.Hosp.no1Lublin,Dep.Internal Diseases
  • Lublin, Poland, 20-090
    • Witold Chodzko Institute Rural Medic,Dep.Diabetology,Lublin
  • Olsztyn, Poland, 10-561
    • Reg.Spec.Hosp.Olsztyn,Clin,Endocrinology,Diabetics.&Int.Med.
  • Oswiecim, Poland, 32-600
    • Clinical Research Center Medicome, Oswiecim
  • Poznan, Poland, 60-111
    • Omedica Medical Centre, Poznan
  • Warsaw, Poland, 01-868
    • Medical Centre Pratia Warszawa
  • Zory, Poland, 44-240
    • NZOZ Med-Art.Specialist Clinics, Zory
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga-Escala Braga
  • Covilhã, Portugal, 6200-251
    • Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã
  • Lisboa, Portugal, 1250-189
    • APDP - Associação Protectora dos Diabéticos de Portugal
  • Porto, Portugal, 4099-001
    • H. Santo António - Centro Hospitalar do Porto
  • Porto, Portugal, 4200-319
    • Centro Hospitalar São João,EPE
  • Viana do Castelo, Portugal, 4901-858
    • ULSAM, EPE - Hospital de Santa Luzia
  • Vila Nova de Gaia, Portugal, 4400-129
    • Centro Hospitalar de Vila Nova de Gaia
• Romania
  • Bucharest, Romania, 010507
    • Nicodiab SRL, Bucharest
  • Bucharest, Romania, 010825
    • Milit. Cent. Emerg. Univ. Hosp. Dr. Davila, Met. Dis. Dept.
  • Bucharest, Romania, 020603
    • SC Medical Centre "Sanatatea Ta" SRL, Bucharest
  • Oradea, Bihor County, Romania, 410469
    • SC Pelican Impex SRL, Cabinet Nr. 201, Diabetes Dept.
  • Timisoara, Romania, 300456
    • Centrul Medical Dr Negrisanu SRL
• Russian Federation
  • Moscow, Russian Federation, 123423
    • City Clinical Hospital no. 67, Moscow
  • St. Petersburg, Russian Federation, 190013
    • CJSC"Polyclinic complex",Dep.Endocrinology,St.Petersburg
  • St. Petersburg, Russian Federation, 195030
    • City Outpatient dep.no.107;clinc.pharmacology,st.petersburg
  • St. Petersburg, Russian Federation, 195067
    • Medical Academy named after I. Mechnikov, St. Petersburg
  • St. Petersburg, Russian Federation, 195257
    • City Hospital Saint Elizaveta, Dept. Endocrinology
  • St. Petersburg, Russian Federation, 199034
    • Policlinic No. 1 of Russian Academy of Sciences, St. Petersburg
• South Africa
  • Bryanston, South Africa, 2021
    • LCS Clinical Research Unit
  • Cape Town, South Africa, 7530
    • Tread Research
  • Cape Town, South Africa, 7708
    • Dr Hilton Kaplan
  • Johannesburg, South Africa, 2198
    • Dr. L. A.Distiller
  • Pretoria, South Africa, 0087
    • VX Pharma (Pty) Ltd Pretoria
  • Pretoria, South Africa, 0181
    • Diabetes Care Centre
• Spain
  • A Coruña, Spain, 15006
    • Hospital A Coruña
  • Granada, Spain, 18003
    • CM Avances Médicos
  • Granada, Spain, 18004
    • Hospital de la Inmaculada Concepción
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Sevilla, Spain, 41018
    • Endo-Diabesidad-Clínica Durán & Asociados
  • Sevilla, Spain, 41071
    • Hospital Virgen Macarena
  • Valencia, Spain, 46010
    • Hospital Clinico de Valencia
• Sweden
  • Göteborg, Sweden, 413 45
    • CTC Sahlgrenska Universitetssjukhuset
  • Karlskoga, Sweden, 691 81
    • Karlskoga Lasarett
  • Lund, Sweden, 221 85
    • Skånes universitetssjukhus, Lund
  • Vällingby, Sweden, 162 68
    • S3 Clinical Research Centers
  • Ängelholm, Sweden, 262 81
    • Ängelholms sjukhus
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • Royal Bournemouth and Christchurch Hospital
  • Bradford, United Kingdom, BD9 6RJ
    • Bradford Royal Infirmary
  • Hull, United Kingdom, HU3 2RW
    • Hull Royal Infirmary
  • Ipswich, United Kingdom, IP4 5PD
    • Ipswich Hospital
  • Leicester, United Kingdom, LE5 4PW
    • Leicester General Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • London, United Kingdom, W2 1NY
    • St Mary's Hospital
  • London, United Kingdom, SE5 9RJ
    • King's College Hospital
  • Middlesbrough, United Kingdom, TS4 3BW
    • James Cook University Hospital
  • Newcastle Upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Nottingham, United Kingdom, NG7 2UH
    • Queen's Medical Centre
  • Nuneaton, United Kingdom, CV10 7DJ
    • George Eliot Hospital
• United States
  • Alabama
    • Montgomery, Alabama, United States, 36106
      • Healthscan Clinical Trials LLC
  • California
    • Concord, California, United States, 94520
      • John Muir Physician Network Clinical Research Center
    • Fresno, California, United States, 93720
      • Valley Research
    • Greenbrae, California, United States, 94904
      • Marin Endocrine Care and Research
    • Oakland, California, United States, 94607
      • Pacific Research Partners, LLC
    • San Ramon, California, United States, 94583
      • NorCal Endocrinology and Internal Medicine
    • Santa Barbara, California, United States, 93105
      • William Sansum Diabetes Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Florida
    • Hialeah, Florida, United States, 33012
      • International Research Associates, LLC
    • Jacksonville, Florida, United States, 32225
      • Solutions Through Advanced Research, Inc.
    • Miami, Florida, United States, 33136
      • University of Miami
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Lawrenceville, Georgia, United States, 30046
      • Physicians Research Associates, LLC
    • Marietta, Georgia, United States, 30060
      • Sestron Clinical Research
    • Stockbridge, Georgia, United States, 30281
      • Eagle's Landing Diabetes and Endocrinology
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Endo Diabetes Research, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Kentucky Diabetes Endocrinology Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
    • Baltimore, Maryland, United States, 21204
      • Model Clinical Research
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Clinical Research Consultants, LLC
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Desert Endocrinology Clinical Research Center
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center
  • New York
    • Rochester, New York, United States, 14607
      • Endocrine-Diabetes Care and Resource Center
    • Smithtown, New York, United States, 11787
      • Endocrine Associates of Long Island, PC
    • Williamsville, New York, United States, 14221
      • Diabetes Endocrinology Research Center of Western New York
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Diabetes and Endocrinology Consultants, PC
  • Ohio
    • Gallipolis, Ohio, United States, 45631
      • Holzer Clinic LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • COR Clinical Research, LLC
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Strand Physician Specialists dba Carolina Health Specialists
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • AM Diabetes And Endocrinology Center
    • Bristol, Tennessee, United States, 37620
      • Holston Medical Group
    • Chattanooga, Tennessee, United States, 37411
      • University Diabetes and Endocrine Consultants
  • Texas
    • Austin, Texas, United States, 78749
      • Texas Diabetes & Endocrinology PA
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes and Endocrine Center
    • Dallas, Texas, United States, 75231
      • Research Institute of Dallas
    • Dallas, Texas, United States, 75218
      • Texas Health Physicians Group
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials, PA
  • Virginia
    • Chesapeake, Virginia, United States, 23321
      • Virginia Endocrinology Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Signed and dated written informed consent
• Male or female patient receiving insulin for the treatment of documented diagnosis of type 1 diabetes mellitus (T1DM) > 1 year
• C-peptide value of < 0.7 ng/mL
• Use of Multiple Daily Injections (MDI) of insulin or insulin pump user with total daily insulin >= 0.3 and <= 1.5 U/kg
• Glycated haemoglobin (HbA1c) >= 7.5% and <= 10.0%
• Good understanding of T1DM
• Age >= 18 years
• Body Mass Index (BMI) >= 18.5 kg/m2
• Estimated glomerular filtration rate >= 30 mL/min/1.73 m2
• Women of child-bearing potential must use highly effective methods of birth control
• Compliance with trial medication administration between 80% and 120% during placebo run-in period Further inclusion criteria apply

Exclusion criteria:

• History of type 2 diabetes mellitus, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
• Pancreas, pancreatic islet cells or renal transplant recipient
• T1DM treatment with any other antihyperglycaemic drug except subcutaneous basal and bolus insulin within last 3 months
• Occurrence of severe hypoglycaemia within last 3 months and until randomisation
• Occurence of diabetic ketoacidosis within 3 months prior to Visit 1 and until Visit 6
• Irregular sleep/wake cycle
• Acute coronary syndrome, stroke or Transient Ischaemic Attack (TIA) within last 3 months
• Severe gastroparesis
• Brittle diabetes
• Liver disease
• Eating disorders
• Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen
• Treatment with systemic corticosteroids
• Change in dose of thyroid hormones within last 6 weeks and until randomisation
• Cancer or treatment for cancer in the last five years
• Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells
• Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial
• Alcohol or drug abuse
• Intake of an investigational drug in another trial within last 30 days Further exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; For blinding purposes
Experimental: Empagliflozin low dose	Drug: Empagliflozin; Drug: Placebo; For blinding purposes
Experimental: Empagliflozin high dose	Drug: Empagliflozin; Drug: Placebo; For blinding purposes
Experimental: Empagliflozin medium dose	Drug: Empagliflozin; Drug: Placebo; For blinding purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Eli Lilly and Company

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2015
• Primary Completion (Actual): September 12, 2017
• Study Completion (Actual): September 20, 2017

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: 1245.72; 2014-005256-26 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No