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

October 31, 2018 updated by: Boehringer Ingelheim

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
977

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC])
Time Frame: Baseline to week 26
Change from baseline in Glycated hemoglobin (HbA1c) for full analysis set (FAS) (observed cases [OC]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.
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))
Time Frame: Baseline to week 26
Change from baseline in Glycated hemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data [OC-AD]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.
Baseline to week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG)
Time Frame: Week 5 to Week 26, Week 1 to Week 26
Rate per patient-year of investigator-reported symptomatic hypoglycemic adverse events (AEs) with confirmed plasma glucose (PG) <54 milligram per deciliter (mg/dL) (<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycemic AEs (i.e. all investigator-reported AEs that had confirmed PG <54 mg/dL [<3.0 mmol/L] with symptoms reported and all severe hypoglycemic events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate. This is key secondary endpoints.
Week 5 to Week 26, Week 1 to Week 26
Change From Baseline in Body Weight at Week 26
Time Frame: Baseline to week 26
Change from baseline in body weight is presented With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.
Baseline to week 26
Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26
Time Frame: Baseline to week 26
Change from baseline in Total daily insulin dose (TDID) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.
Baseline to week 26
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26
Time Frame: Baseline to week 26
Change from baseline in Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.
Baseline to week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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