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Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Empagliflozin
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:

  • Male or female patient receiving insulin for the treatment of documented diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 1 year at the time of Visit 1
  • 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

Additional inclusion criteria may apply

Exclusion criteria:

  • History of Type 2 Diabetes Mellitus (T2DM), 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 (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

Additional exclusion criteria may apply

Sites / Locations

  • AMCR Institute, Inc.
  • Diabetes/Lipid Management and Research Center
  • National Research Institute
  • Mills-Peninsula Health Services
  • Metabolic Institute of America
  • University Clinical Investigators, Inc.
  • Creekside Endocrine Associates, PC
  • The Center for Diabetes and Endocrine Care
  • East Coast Institute for Research, LLC
  • Baptist Diabetes Associates, PA
  • Physicians Research Associates, LLC
  • Endocrine Research Solutions, Inc.
  • Rocky Mountain Diabetes and Osteoporosis Center
  • Northwest Endo Diabetes Research, LLC
  • Midwest Endocrinology
  • Iowa Diabetes and Endocrinology Research Center
  • Diabetes anddocrine Associates, PC
  • Desert Endocrinology Clinical Research Center
  • Palm Research Center
  • Southern New Hampshire Diabetes and Endocrinology
  • Albany Medical Center / Albany Medical College
  • University Physicians Group Research Division
  • Diabetes and Endocrinology Consultants, PC
  • The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital
  • Diabetes and Obesity Clinical Trials Center
  • North Texas Endocrine Center
  • Office of Dr. Michelle Zaniewski-Singh
  • Texas Diabetes and Endocrinology
  • Bateman Horne Center
  • Advanced Research Institute
  • Larry D Stonesifer, MD Inc., PS
  • Rainier Clinical Research Center, Inc
  • The Polyclinic
  • MultiCare Institute for Research and Innovation
  • Coffs Endocrine & Diabetes Services
  • AIM Centre
  • Royal Brisbane & Women's Hospital-Endocrinology
  • VIVIT Instit.am LKH Feldkirch,Abt.f.Innere Med.u.Kardiologie
  • LKH Steyr, Kardiologie
  • KH Rudolfstiftung, 1. Med. Abt., Wien
  • Hospital Hietzing
  • Arlon - HOSP Sud Luxembourg - Vivalia
  • Bonheiden - HOSP Imelda
  • Brussels - UNIV UZ Brussel
  • ULB Hopital Erasme
  • Edegem - UNIV UZ Antwerpen
  • UNIV UZ Gent
  • La Louvière - UNIV CHU Tivoli
  • UZ Leuven
  • Centre Hospitalier Universitaire de Liège
  • Liège - HOSP CHR de la Citadelle
  • Merksem - HOSP ZNA Jan Palfijn
  • LMC Endocrinology Centres (Calgary) Ltd.
  • The Bailey Clinic
  • Royal Jubilee Hospital
  • Health Sciences Centre Winnipeg
  • CHUM - Pavillon R
  • Capital District Health Auth.
  • Kingston General Hospital
  • LMC Thornhill/Vaughan
  • Mount Sinai Hospital
  • Royal Victoria Hospital
  • General Univ.hosp.in Prague (VFN), Diabetes ambulance
  • Diabetology and Internal Practice Dr. Vladimir Lelek
  • Masaryk Hospital, Internal Department
  • Aalborg Sygehus Syd
  • Aarhus Universitets Hospital
  • Steno Diabetes Center Copenhagen
  • Nordsjællands Hospital - Hillerød
  • Køge Sygehus
  • IteLasaretti
  • Terveystalo Oulu, Diapolis
  • TYKS
  • HOP Côte de Nacre
  • HOP Saint-Louis
  • HOP de Narbonne, diabéto endo, Narbonne
  • HOP Robert Debré
  • HOP de Brabois
  • HOP les Portes du Sud, Diabéto, Vénissieux
  • Studienzentrum Aschaffenburg
  • Gemeinschaftspraxis, Asslar
  • ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH
  • InnoDiab Forschung GmbH
  • Praxis Dr. Kosch, Pirna
  • Allgemeinmedizinische und Diabetologische Schwerpunktpraxis
  • Praxis Dr. Hirschhäuser
  • Praxis Dr. Segner, St. Ingbert
  • Ambulanzzentrum Schweinfurt
  • Noordwest Ziekenhuisgroep
  • Academisch Medisch Centrum (AMC)
  • Rijnstate Hospital
  • Martini Ziekenhuis
  • Bethesda Ziekenhuis Hoogeveen
  • Sint Franciscus Gasthuis
  • Albert Schweitzer Ziekenhuis, Zwijndrecht
  • Sykehuset Innlandet HF, Avd. Hamar
  • Akershus Universitetssykehus HF
  • Oslo Universitetssykehus HF, Aker Sykehus
  • Helse Møre og Romsdal HF, Ålesund sjukehus
  • Med Univ Bialystok Clin Dep Endocrinol, Diabetol & Int Dis
  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny
  • Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow
  • NZOZ Specialized Ambulance "MEDICA"
  • Marcinkowski Poznan Univ of Med Sci, Clin Dept Diab, Poznan
  • NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom
  • Centrum Medyczne Medyk
  • NBR Polska
  • C.A.P. Sardenya
  • Hospital Vall d'Hebron
  • Hospital de la Inmaculada Concepción
  • Hospital Virgen de la Victoria
  • Hospital General de Segovia
  • Hospital Nuestra Señora de Valme
  • Hospital Virgen Macarena
  • Ladulaas Kliniska Studier
  • Centralsjukhuset, Karlstad
  • Läkarhuset, Vällingby
  • Chung Shan Medical University Hospital
  • China Medical University Hospital
  • Chi Mei Medical Center
  • National Taiwan University Hospital
  • Tri-Service General Hospital
  • Milton Keynes Hospital
  • Addenbrooke's Hospital
  • Wellcome Trust Clinical Research Facility
  • Leicester General Hospital
  • Royal London Hospital
  • Queen's Medical Centre
  • George Eliot Hospital
  • East Surrey Hospital
  • Queen Elizabeth II Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Empagliflozin low dose

Empagliflozin high dose

Placebo

Arm Description

Empagliflozin tablets once daily

Empagliflozin tablets once daily

Placebo tablets matching empagliflozin once daily

Outcomes

Primary Outcome Measures

Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26
Change from baseline in glycated haemoglobin (HbA1c) for full analysis set (FAS) (observed cases [OC]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.
Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD) )
Change from baseline in glycated haemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data [OC-AD]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.

Secondary Outcome Measures

Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG)
This is a key secondary endpoint. Rate per patient-year of investigator-reported symptomatic hypoglycaemia adverse events (AEs) with confirmed plasma glucose (PG) <54 milligram per deciliter (mg/dL) (<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycaemia AEs (i.e. all investigator-reported AEs that had confirmed PG <54 mg/dL [<3.0 mmol/L] with symptoms reported and all severe hypoglycaemia events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate.
Change From Baseline in Body Weight at Week 26
Change from baseline in body weight is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.
Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26
Change from baseline in the percentage of time spent in target glucose range of >70 to ≤180 mg/dL (>3.9 to ≤10.0 mmol/L) as determined by continuous glucose monitoring (CGM) is presented in week 23 to 26. Least squares mean is actually an adjusted event rate.
Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26
Change from baseline in interstitial glucose variability based on the IQR as determined by CGM is presented for week 23 to 26. Least squares mean is actually an adjusted event rate.
Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26
Change from baseline in TDID is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26
Change from baseline in SBP and DBP is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.

Full Information

First Posted
April 8, 2015
Last Updated
December 12, 2018
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02414958
Brief Title
Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
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 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 30, 2015 (Actual)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
October 23, 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
Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.

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
730 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin low dose
Arm Type
Experimental
Arm Description
Empagliflozin tablets once daily
Arm Title
Empagliflozin high dose
Arm Type
Experimental
Arm Description
Empagliflozin tablets once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matching empagliflozin once daily
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26
Description
Change from baseline in glycated haemoglobin (HbA1c) for full analysis set (FAS) (observed cases [OC]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.
Time Frame
Baseline to week 26
Title
Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD) )
Description
Change from baseline in glycated haemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data [OC-AD]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.
Time Frame
Baseline to week 26
Secondary Outcome Measure Information:
Title
Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG)
Description
This is a key secondary endpoint. Rate per patient-year of investigator-reported symptomatic hypoglycaemia adverse events (AEs) with confirmed plasma glucose (PG) <54 milligram per deciliter (mg/dL) (<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycaemia AEs (i.e. all investigator-reported AEs that had confirmed PG <54 mg/dL [<3.0 mmol/L] with symptoms reported and all severe hypoglycaemia events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate.
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 randomised trial medication. Least squares mean is adjusted mean change from baseline.
Time Frame
Baseline to week 26
Title
Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26
Description
Change from baseline in the percentage of time spent in target glucose range of >70 to ≤180 mg/dL (>3.9 to ≤10.0 mmol/L) as determined by continuous glucose monitoring (CGM) is presented in week 23 to 26. Least squares mean is actually an adjusted event rate.
Time Frame
Week 23 to 26
Title
Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26
Description
Change from baseline in interstitial glucose variability based on the IQR as determined by CGM is presented for week 23 to 26. Least squares mean is actually an adjusted event rate.
Time Frame
Week 23 to 26
Title
Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26
Description
Change from baseline in TDID is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.
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 SBP and DBP is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.
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: Male or female patient receiving insulin for the treatment of documented diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 1 year at the time of Visit 1 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 Additional inclusion criteria may apply Exclusion criteria: History of Type 2 Diabetes Mellitus (T2DM), 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 (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 Additional exclusion criteria may 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
AMCR Institute, Inc.
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Diabetes/Lipid Management and Research Center
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Mills-Peninsula Health Services
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Metabolic Institute of America
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Creekside Endocrine Associates, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
The Center for Diabetes and Endocrine Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Baptist Diabetes Associates, PA
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Physicians Research Associates, LLC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Endocrine Research Solutions, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
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
Midwest Endocrinology
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60012
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Diabetes anddocrine Associates, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
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
89148
Country
United States
Facility Name
Southern New Hampshire Diabetes and Endocrinology
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Albany Medical Center / Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
University Physicians Group Research Division
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301
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
The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Diabetes and Obesity Clinical Trials Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
North Texas Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Office of Dr. Michelle Zaniewski-Singh
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Texas Diabetes and Endocrinology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Bateman Horne Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Advanced Research Institute
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Larry D Stonesifer, MD Inc., PS
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Rainier Clinical Research Center, Inc
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
The Polyclinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
MultiCare Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
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
AIM Centre
City
Merewether
State/Province
New South Wales
ZIP/Postal Code
2291
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital-Endocrinology
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
VIVIT Instit.am LKH Feldkirch,Abt.f.Innere Med.u.Kardiologie
City
Feldkirch
ZIP/Postal Code
6807
Country
Austria
Facility Name
LKH Steyr, Kardiologie
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
KH Rudolfstiftung, 1. Med. Abt., Wien
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Hospital Hietzing
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Arlon - HOSP Sud Luxembourg - Vivalia
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Facility Name
Bonheiden - HOSP Imelda
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Brussels - UNIV UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
ULB Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Edegem - UNIV UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UNIV UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
La Louvière - UNIV CHU Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Liège - HOSP CHR de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Merksem - HOSP ZNA Jan Palfijn
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
LMC Endocrinology Centres (Calgary) Ltd.
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 2G4
Country
Canada
Facility Name
The Bailey Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Health Sciences Centre Winnipeg
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
CHUM - Pavillon R
City
Montreal
State/Province
Migration Data
ZIP/Postal Code
Quebec
Country
Canada
Facility Name
Capital District Health Auth.
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
LMC Thornhill/Vaughan
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L4J 8L7
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
General Univ.hosp.in Prague (VFN), Diabetes ambulance
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Diabetology and Internal Practice Dr. Vladimir Lelek
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Masaryk Hospital, Internal Department
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Aalborg Sygehus Syd
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Aarhus Universitets Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Steno Diabetes Center Copenhagen
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Nordsjællands Hospital - Hillerød
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Køge Sygehus
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
IteLasaretti
City
Kuopio
ZIP/Postal Code
FI-70100
Country
Finland
Facility Name
Terveystalo Oulu, Diapolis
City
Oulu
ZIP/Postal Code
FI-90100
Country
Finland
Facility Name
TYKS
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland
Facility Name
HOP Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
HOP Saint-Louis
City
La Rochelle Cedex 1
ZIP/Postal Code
17000
Country
France
Facility Name
HOP de Narbonne, diabéto endo, Narbonne
City
Narbonne
ZIP/Postal Code
11100
Country
France
Facility Name
HOP Robert Debré
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
HOP de Brabois
City
Vandoeuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
HOP les Portes du Sud, Diabéto, Vénissieux
City
Vénissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Studienzentrum Aschaffenburg
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Gemeinschaftspraxis, Asslar
City
Asslar
ZIP/Postal Code
35614
Country
Germany
Facility Name
ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
InnoDiab Forschung GmbH
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Praxis Dr. Kosch, Pirna
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Allgemeinmedizinische und Diabetologische Schwerpunktpraxis
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Praxis Dr. Hirschhäuser
City
Saarbrücken
ZIP/Postal Code
66121
Country
Germany
Facility Name
Praxis Dr. Segner, St. Ingbert
City
Saint Ingbert/Oberwürzbach
ZIP/Postal Code
66386
Country
Germany
Facility Name
Ambulanzzentrum Schweinfurt
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
Noordwest Ziekenhuisgroep
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Academisch Medisch Centrum (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Bethesda Ziekenhuis Hoogeveen
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Facility Name
Sint Franciscus Gasthuis
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis, Zwijndrecht
City
Zwijndrecht
ZIP/Postal Code
3331 LZ
Country
Netherlands
Facility Name
Sykehuset Innlandet HF, Avd. Hamar
City
Hamar
ZIP/Postal Code
N-2318
Country
Norway
Facility Name
Akershus Universitetssykehus HF
City
Lørenskog
ZIP/Postal Code
N-1478
Country
Norway
Facility Name
Oslo Universitetssykehus HF, Aker Sykehus
City
Oslo
ZIP/Postal Code
N-0424
Country
Norway
Facility Name
Helse Møre og Romsdal HF, Ålesund sjukehus
City
Ålesund
ZIP/Postal Code
N-6026
Country
Norway
Facility Name
Med Univ Bialystok Clin Dep Endocrinol, Diabetol & Int Dis
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny
City
Bialystok
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow
City
Krakow
ZIP/Postal Code
31011
Country
Poland
Facility Name
NZOZ Specialized Ambulance "MEDICA"
City
Lublin
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Marcinkowski Poznan Univ of Med Sci, Clin Dept Diab, Poznan
City
Poznan
ZIP/Postal Code
60-834
Country
Poland
Facility Name
NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom
City
Radom
ZIP/Postal Code
26610
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
NBR Polska
City
Warsaw
ZIP/Postal Code
00-465
Country
Poland
Facility Name
C.A.P. Sardenya
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de la Inmaculada Concepción
City
Granada
ZIP/Postal Code
18004
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital General de Segovia
City
Segovia
ZIP/Postal Code
40002
Country
Spain
Facility Name
Hospital Nuestra Señora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Ladulaas Kliniska Studier
City
Borås
ZIP/Postal Code
506 30
Country
Sweden
Facility Name
Centralsjukhuset, Karlstad
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Läkarhuset, Vällingby
City
Vällingby
ZIP/Postal Code
162 68
Country
Sweden
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Chi Mei Medical Center
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Milton Keynes Hospital
City
Buckinghamshire
ZIP/Postal Code
MK65LD
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Wellcome Trust Clinical Research Facility
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Leicester General Hospital
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
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
Facility Name
East Surrey Hospital
City
Surrey
ZIP/Postal Code
RH1 5RH
Country
United Kingdom
Facility Name
Queen Elizabeth II Hospital
City
Welwyn Garden City
ZIP/Postal Code
AL7 4HQ
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
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

Learn more about this trial

Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

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