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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Empagliflozin
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Healthscan Clinical Trials LLC
  • John Muir Physician Network Clinical Research Center
  • Valley Research
  • Marin Endocrine Care and Research
  • Pacific Research Partners, LLC
  • NorCal Endocrinology and Internal Medicine
  • William Sansum Diabetes Center
  • University of Colorado Denver
  • International Research Associates, LLC
  • Solutions Through Advanced Research, Inc.
  • University of Miami
  • Suncoast Clinical Research, Inc.
  • Atlanta Diabetes Associates
  • Physicians Research Associates, LLC
  • Sestron Clinical Research
  • Eagle's Landing Diabetes and Endocrinology
  • Northwest Endo Diabetes Research, LLC
  • Kentucky Diabetes Endocrinology Center
  • University of Maryland School of Medicine
  • MODEL Clinical Research
  • Clinical Research Consultants, LLC
  • Desert Endocrinology Clinical Research Center
  • Palm Research Center
  • Endocrine-Diabetes Care and Resource Center
  • Endocrine Associates of Long Island, PC
  • Diabetes Endocrinology Research Center of Western New York
  • Diabetes and Endocrinology Consultants, PC
  • Holzer Clinic LLC
  • COR Clinical Research, LLC
  • Strand Physician Specialists dba Carolina Health Specialists
  • AM Diabetes and Endocrinology Center
  • Holston Medical Group
  • University Diabetes and Endocrine Consultants
  • Texas Diabetes & Endocrinology PA
  • Texas Health Physicians Group
  • Dallas Diabetes and Endocrine Center
  • Research Institute of Dallas
  • Endeavor Clinical Trials, PA
  • Virginia Endocrinology Research
  • Coffs Endocrine & Diabetes Services
  • Lyell McEwin Hospital
  • SA Endocrine Research P/L
  • Eastern Clinical Research Unit
  • Richmond Road and Diagnostic Treatment Centre
  • The Bailey Clinic
  • Eastern Health (MUN)
  • Centre for Studies in Family Medicine
  • St. Michael's Hospital
  • Omnispec Recherche Clinique Inc.
  • Applied Medical Informatics Research INC.
  • Clinique des maladies Lipidiques de Quebec
  • University Hospital Brno
  • Diahaza s.r.o.Intern.Med.Outpat.Clin.Dep.Diabetology,Holesov
  • AIDIN VK s.r.o.,Department Diabetology, Hranice
  • Univ. Hospital Kralovske Vinohrady
  • DiaGolfova s.r.o., Department Diabetology, Prague
  • Milan Kvapil s.r.o.,Diabetology ambulance,Prague
  • ResTrial s.r.o.Diabetology Ambulance,Prague
  • HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki
  • Mehiläinen Jyväskylä
  • Satakunnan Diabetesasema, Pori
  • FinnMedi Oy, Tampere
  • TYKS
  • HOP Jean Minjoz
  • HOP Le Creusot
  • HOP Paris Saint-Joseph
  • HOP Bichat
  • HOP de Poitiers
  • HOP Civil
  • HOP Rangueil
  • Diabetes-Klinik Bad Mergentheim GmbH & Co. KG
  • Diabetologische Schwerpunktpraxis, Bosenheim
  • Praxis Dr. Busch, Dortmund
  • GWT-TUD GmbH
  • ZKS Südbrandenburg GmbH
  • InnoDiab Forschung GmbH
  • Praxis Dr. Kaiser, Frankfurt
  • Institut für Diabetesforschung Münster GmbH
  • Diabetologische Schwerpunktpraxis
  • Praxis Dr. Behnke, Neuwied
  • Praxis Dr. Hilgenberg
  • "Korgialeneio-Benakeio" Hellenic Red Cross Hospital
  • General Hospital of Athens "Laiko"
  • Univ. Gen. Hosp. of Ioannina
  • General Hospital of Nikaia
  • General Hopsital of Thessaloniki "Ippokrateio"
  • General Hospital of Thessaloniki "G. Papanikolaou"
  • Clinexpert Kft.
  • Synexus Magyarorszag Kft.
  • University Debrecen Hospital
  • CRU Hungary Ltd, Private Practice, Miskolc
  • Clinfan SMO Ltd.
  • Csongrad Country Dr Bugyi Istvan Hosp.
  • Zala Country Hospital, Diabetic Outpatient Clinic
  • Mater Misericordiae University Hospital
  • Inrca-Irccs
  • A.O. Spedali Civili di Brescia
  • Osp. Campo di Marte
  • Azienda Ospedaliera Universitaria "Federico II"
  • Policlinico Gemelli
  • Osp. S. Giovanni Calibita Fatebenefratelli
  • IRCCS Gruppo Multimedica
  • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Ospedale Molinette, AO Città della Salute e della
  • Zemgales Center of diabetes, Jelgava
  • A. Lucenko's Internist & Endocrinologist Doctor's Practice
  • Dace Teterovska Doctor's Practice in Endocrinology,Ogre
  • P. Stradins Clinical University Hospital, Riga
  • Riga Health Center, Private Practice
  • Sigulda Hospital, Outpatient department
  • VSV Centrs, Stalte Private Practice, Talsi
  • Clínica EndocrInol en Diabetes Obesidad y Tiroides (DOT)
  • Hospital Cardiologica Aguascalientes
  • Unidad de Investigacion Clinica Cardiometabolica de Occident
  • Instituto Jaliscience de Inv. en Diabetes y Obesidad, S.C.
  • Unidad de Patologia Clinica
  • Noordwest Ziekenhuisgroep
  • Ziekenhuisgroep Twente locatie Almelo
  • Meander Medisch Centrum
  • Gelre Ziekenhuizen Apeldoorn
  • EB Utrecht Research
  • Universitair Medisch Centrum Utrecht
  • South Pacific Clinical Trials
  • Lipid and Diabetes Research Group
  • M3 Helse AS
  • Oslo Universitetssykehus HF, Lipidklinikken
  • Stavanger Helseforskning
  • Universitetssykehuset Nord-Norge, Tromsø
  • DiabSerwis S.C., Chorzow
  • Medical Centre Pratia Gdynia
  • Medical Centre Pratia Katowice I
  • Medical Centre Pratia Krakow
  • University Hospital in Krakow
  • Independent Public Clin.Hosp.no1Lublin,Dep.Internal Diseases
  • Witold Chodzko Institute Rural Medic,Dep.Diabetology,Lublin
  • Reg.Spec.Hosp.Olsztyn,Clin,Endocrinology,Diabetics.&Int.Med.
  • Clinical Research Center Medicome, Oswiecim
  • Omedica Medical Centre, Poznan
  • Medical Centre Pratia Warszawa
  • NZOZ Med-Art.Specialist Clinics, Zory
  • Hospital de Braga-Escala Braga
  • Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã
  • APDP - Associação Protectora dos Diabéticos de Portugal
  • H. Santo António - Centro Hospitalar do Porto
  • Centro Hospitalar São João,EPE
  • ULSAM, EPE - Hospital de Santa Luzia
  • Centro Hospitalar de Vila Nova de Gaia
  • Nicodiab SRL, Bucharest
  • Milit. Cent. Emerg. Univ. Hosp. Dr. Davila, Met. Dis. Dept.
  • SC Medical Centre "Sanatatea Ta" SRL, Bucharest
  • SC Pelican Impex SRL, Cabinet Nr. 201, Diabetes Dept.
  • Centrul Medical Dr Negrisanu SRL
  • City Clinical Hospital no. 67, Moscow
  • CJSC"Polyclinic complex",Dep.Endocrinology,St.Petersburg
  • City Outpatient dep.no.107;clinc.pharmacology,st.petersburg
  • Medical Academy named after I. Mechnikov, St. Petersburg
  • City Hospital Saint Elizaveta, Dept. Endocrinology
  • Policlinic No. 1 of Russian Academy of Sciences, St. Petersburg
  • LCS Clinical Research Unit
  • TREAD Research
  • Dr Hilton Kaplan
  • Dr. L. A.Distiller
  • VX Pharma (Pty) Ltd Pretoria
  • Diabetes Care Centre
  • Hospital A Coruña
  • CM Avances Médicos
  • Hospital de la Inmaculada Concepción
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario Infanta Leonor
  • Endo-Diabesidad-Clínica Durán & Asociados
  • Hospital Virgen Macarena
  • Hospital Clínico de Valencia
  • CTC Sahlgrenska Universitetssjukhuset
  • Karlskoga lasarett
  • Skånes universitetssjukhus, Lund
  • S3 Clinical Research Centers
  • Ängelholms Sjukhus
  • Royal Bournemouth and Christchurch Hospital
  • Bradford Royal Infirmary
  • Hull Royal Infirmary
  • Ipswich Hospital
  • Leicester General Hospital
  • Guy's Hospital
  • King's College Hospital
  • St Mary's Hospital
  • James Cook University Hospital
  • Royal Victoria Infirmary
  • Queen's Medical Centre
  • George Eliot Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Empagliflozin low dose

Empagliflozin high dose

Empagliflozin medium dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 19, 2015
Last Updated
October 31, 2018
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02580591
Brief Title
Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 22, 2015 (Actual)
Primary Completion Date
September 12, 2017 (Actual)
Study Completion Date
September 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
977 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin low dose
Arm Type
Experimental
Arm Title
Empagliflozin high dose
Arm Type
Experimental
Arm Title
Empagliflozin medium dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
For blinding purposes
Primary Outcome Measure Information:
Title
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC])
Description
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.
Time Frame
Baseline to week 26
Title
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))
Description
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.
Time Frame
Baseline to week 26
Secondary Outcome Measure Information:
Title
Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG)
Description
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.
Time Frame
Week 5 to Week 26, Week 1 to Week 26
Title
Change From Baseline in Body Weight at Week 26
Description
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.
Time Frame
Baseline to week 26
Title
Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26
Description
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.
Time Frame
Baseline to week 26
Title
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26
Description
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.
Time Frame
Baseline to week 26

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
30287422
Citation
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.
Results Reference
derived

Learn more about this trial

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

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