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Diabetes Mellitus, Type 1Phase 3NCT02580591

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

A Phase 3 study testing Empagliflozin in people with Diabetes Mellitus, Type 1, run by Boehringer Ingelheim at 189 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Empagliflozin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
977 participants
Where
189 sitesin 24 countries
Study dates
22 Dec 2015to 20 Sep 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

189 sites in 24 countries.

189 sites in 24 countries

United States39 sites

  • Northwest Endo Diabetes Research, LLC

    Arlington Heights, Illinois, 60005

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Texas Diabetes & Endocrinology PA

    Austin, Texas, 78749

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • MODEL Clinical Research

    Baltimore, Maryland, 21204

  • AM Diabetes and Endocrinology Center

    Bartlett, Tennessee, 38133

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • University Diabetes and Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • Virginia Endocrinology Research

    Chesapeake, Virginia, 23321

  • John Muir Physician Network Clinical Research Center

    Concord, California, 94520

  • Texas Health Physicians Group

    Dallas, Texas, 75218

  • Dallas Diabetes and Endocrine Center

    Dallas, Texas, 75230

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Valley Research

    Fresno, California, 93720

  • Holzer Clinic LLC

    Gallipolis, Ohio, 45631

  • Marin Endocrine Care and Research

    Greenbrae, California, 94904

  • Desert Endocrinology Clinical Research Center

    Henderson, Nevada, 89052

  • International Research Associates, LLC

    Hialeah, Florida, 33012

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida, 32225

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111

  • Palm Research Center

    Las Vegas, Nevada, 89128

  • Physicians Research Associates, LLC

    Lawrenceville, Georgia, 30046

  • Kentucky Diabetes Endocrinology Center

    Lexington, Kentucky, 40503

  • Sestron Clinical Research

    Marietta, Georgia, 30060

  • University of Miami

    Miami, Florida, 33136

  • Healthscan Clinical Trials LLC

    Montgomery, Alabama, 36106

  • Diabetes and Endocrinology Consultants, PC

    Morehead City, North Carolina, 28557

  • Strand Physician Specialists dba Carolina Health Specialists

    Myrtle Beach, South Carolina, 29572

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Pacific Research Partners, LLC

    Oakland, California, 94607

  • COR Clinical Research, LLC

    Oklahoma City, Oklahoma, 73103

  • Endocrine-Diabetes Care and Resource Center

    Rochester, New York, 14607

  • Endeavor Clinical Trials, PA

    San Antonio, Texas, 78229

  • NorCal Endocrinology and Internal Medicine

    San Ramon, California, 94583

  • William Sansum Diabetes Center

    Santa Barbara, California, 93105

  • Endocrine Associates of Long Island, PC

    Smithtown, New York, 11787

  • Eagle's Landing Diabetes and Endocrinology

    Stockbridge, Georgia, 30281

  • Diabetes Endocrinology Research Center of Western New York

    Williamsville, New York, 14221

Other trials in United States

Poland12 sites

  • DiabSerwis S.C., Chorzow

    Chorzów, 41-500

  • Medical Centre Pratia Gdynia

    Gdynia, 81-338

  • Medical Centre Pratia Katowice I

    Katowice, 40-954

  • Medical Centre Pratia Krakow

    Krakow, 30-002

  • University Hospital in Krakow

    Krakow, 31-501

  • Independent Public Clin.Hosp.no1Lublin,Dep.Internal Diseases

    Lublin, 20-081

  • Witold Chodzko Institute Rural Medic,Dep.Diabetology,Lublin

    Lublin, 20-090

  • Reg.Spec.Hosp.Olsztyn,Clin,Endocrinology,Diabetics.&Int.Med.

    Olsztyn, 10-561

  • Clinical Research Center Medicome, Oswiecim

    Oświęcim, 32-600

  • Omedica Medical Centre, Poznan

    Poznan, 60-111

  • Medical Centre Pratia Warszawa

    Warsaw, 01-868

  • NZOZ Med-Art.Specialist Clinics, Zory

    Żory, 44-240

Other trials in Poland

United Kingdom12 sites

  • Royal Bournemouth and Christchurch Hospital

    Bournemouth, BH7 7DW

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • Hull Royal Infirmary

    Hull, HU3 2RW

  • Ipswich Hospital

    Ipswich, IP4 5PD

  • Leicester General Hospital

    Leicester, LE5 4PW

  • Guy's Hospital

    London, SE1 9RT

  • King's College Hospital

    London, SE5 9RJ

  • St Mary's Hospital

    London, W2 1NY

  • James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Queen's Medical Centre

    Nottingham, NG7 2UH

  • George Eliot Hospital

    Nuneaton, CV10 7DJ

Other trials in United Kingdom

Germany11 sites

  • Diabetes-Klinik Bad Mergentheim GmbH & Co. KG

    Bad Mergentheim, 97980

  • Diabetologische Schwerpunktpraxis, Bosenheim

    Bosenheim, 55545

  • Praxis Dr. Busch, Dortmund

    Dortmund, 44137

  • GWT-TUD GmbH

    Dresden, 01307

  • ZKS Südbrandenburg GmbH

    Elsterwerda, 04910

  • InnoDiab Forschung GmbH

    Essen, 45136

  • Praxis Dr. Kaiser, Frankfurt

    Frankfurt, 60388

  • Institut für Diabetesforschung Münster GmbH

    Münster, 48145

  • Diabetologische Schwerpunktpraxis

    Münster, 48153

  • Praxis Dr. Behnke, Neuwied

    Neuwied, 56564

  • Praxis Dr. Hilgenberg

    Rehburg-Loccum, 31547

Other trials in Germany

Italy9 sites

  • Inrca-Irccs

    Ancona, 60124

  • A.O. Spedali Civili di Brescia

    Brescia, 25123

  • Osp. Campo di Marte

    Lucca, 55100

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, 80131

  • Policlinico Gemelli

    Roma, 00168

  • Osp. S. Giovanni Calibita Fatebenefratelli

    Roma, 00186

  • IRCCS Gruppo Multimedica

    Sesto San Giovanni (MI), 20099

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

  • Ospedale Molinette, AO Città della Salute e della

    Torino, 10126

Other trials in Italy

Canada8 sites

  • Richmond Road and Diagnostic Treatment Centre

    Calgary, Alberta, T2T 5C7

  • Centre for Studies in Family Medicine

    London, Ontario, N6G 2M1

  • Omnispec Recherche Clinique Inc.

    Mirabel, Quebec, J7J 2K8

  • Clinique des maladies Lipidiques de Quebec

    Québec, G1V 4M6

  • The Bailey Clinic

    Red Deer, Alberta, T4N 6V7

  • Eastern Health (MUN)

    St. John's, Newfoundland and Labrador, A1B 3V6

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Applied Medical Informatics Research INC.

    Westmount, Quebec, H3Z 1E5

Other trials in Canada

Spain8 sites

  • Hospital A Coruña

    A Coruña, 15006

  • CM Avances Médicos

    Granada, 18003

  • Hospital de la Inmaculada Concepción

    Granada, 18004

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Endo-Diabesidad-Clínica Durán & Asociados

    Seville, 41018

  • Hospital Virgen Macarena

    Seville, 41071

  • Hospital Clínico de Valencia

    Valencia, 46010

Other trials in Spain

Czechia7 sites

  • University Hospital Brno

    Brno, 625 00

  • Diahaza s.r.o.Intern.Med.Outpat.Clin.Dep.Diabetology,Holesov

    Holešov, 769 01

  • AIDIN VK s.r.o.,Department Diabetology, Hranice

    Hranice, 753 01

  • Univ. Hospital Kralovske Vinohrady

    Prague, 100 42

  • DiaGolfova s.r.o., Department Diabetology, Prague

    Prague, 102 00

  • Milan Kvapil s.r.o.,Diabetology ambulance,Prague

    Prague, 149 00

  • ResTrial s.r.o.Diabetology Ambulance,Prague

    Prague, 18100

Other trials in Czechia

France7 sites

  • HOP Jean Minjoz

    Besançon, 25030

  • HOP Le Creusot

    Le Creusot, 71200

  • HOP Paris Saint-Joseph

    Paris, 75014

  • HOP Bichat

    Paris, 75018

  • HOP de Poitiers

    Poitiers, 86021

  • HOP Civil

    Strasbourg, 67091

  • HOP Rangueil

    Toulouse Cédex 04, 31059

Other trials in France

Hungary7 sites

  • Clinexpert Kft.

    Budapest, 1033

  • Synexus Magyarorszag Kft.

    Budapest, 1036

  • University Debrecen Hospital

    Debrecen, 4032

  • CRU Hungary Ltd, Private Practice, Miskolc

    Miskolc, 3529

  • Clinfan SMO Ltd.

    Szekszárd, 7100

  • Csongrad Country Dr Bugyi Istvan Hosp.

    Szentes, 6600

  • Zala Country Hospital, Diabetic Outpatient Clinic

    Zalaegerszeg, 8900

Other trials in Hungary

Latvia7 sites

  • Zemgales Center of diabetes, Jelgava

    Jelgava, 3001

  • A. Lucenko's Internist & Endocrinologist Doctor's Practice

    Liepāja, 3401

  • Dace Teterovska Doctor's Practice in Endocrinology,Ogre

    Ogre, 5001

  • P. Stradins Clinical University Hospital, Riga

    Riga, 1002

  • Riga Health Center, Private Practice

    Riga, 1002

  • Sigulda Hospital, Outpatient department

    Sigulda, 2150

  • VSV Centrs, Stalte Private Practice, Talsi

    Talsi, 3201

Other trials in Latvia

Portugal7 sites

  • Hospital de Braga-Escala Braga

    Braga, 4710-243

  • Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

    Covilha, 6200-251

  • APDP - Associação Protectora dos Diabéticos de Portugal

    Lisbon, 1250-189

  • H. Santo António - Centro Hospitalar do Porto

    Porto, 4099-001

  • Centro Hospitalar São João,EPE

    Porto, 4200-319

  • ULSAM, EPE - Hospital de Santa Luzia

    Viana do Castelo, 4901-858

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4400-129

Other trials in Portugal

Greece6 sites

  • "Korgialeneio-Benakeio" Hellenic Red Cross Hospital

    Athens, 115 26

  • General Hospital of Athens "Laiko"

    Athens, 11527

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45500

  • General Hospital of Nikaia

    Nikaia, 18484

  • General Hopsital of Thessaloniki "Ippokrateio"

    Thessaloniki, 54642

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57010

Other trials in Greece

Netherlands6 sites

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD

  • Ziekenhuisgroep Twente locatie Almelo

    Almelo, 7609 PP

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • Gelre Ziekenhuizen Apeldoorn

    Apeldoorn, 7334 DZ

  • EB Utrecht Research

    Utrecht, 3511 NH

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Russia6 sites

  • City Clinical Hospital no. 67, Moscow

    Moscow, 123423

  • CJSC"Polyclinic complex",Dep.Endocrinology,St.Petersburg

    Saint Petersburg, 190013

  • City Outpatient dep.no.107;clinc.pharmacology,st.petersburg

    Saint Petersburg, 195030

  • Medical Academy named after I. Mechnikov, St. Petersburg

    Saint Petersburg, 195067

  • City Hospital Saint Elizaveta, Dept. Endocrinology

    Saint Petersburg, 195257

  • Policlinic No. 1 of Russian Academy of Sciences, St. Petersburg

    Saint Petersburg, 199034

Other trials in Russia

South Africa6 sites

  • LCS Clinical Research Unit

    Bryanston, 2021

  • TREAD Research

    Cape Town, 7530

  • Dr Hilton Kaplan

    Cape Town, 7708

  • Dr. L. A.Distiller

    Johannesburg, 2198

  • VX Pharma (Pty) Ltd Pretoria

    Pretoria, 0087

  • Diabetes Care Centre

    Pretoria, 0181

Other trials in South Africa

Finland5 sites

  • HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki

    Helsinki, 00290

  • Mehiläinen Jyväskylä

    Jyväskylä, 40100

  • Satakunnan Diabetesasema, Pori

    Pori, 28100

  • FinnMedi Oy, Tampere

    Tampere, 33520

  • TYKS

    Turku, FI-20520

Other trials in Finland

Mexico5 sites

  • Clínica EndocrInol en Diabetes Obesidad y Tiroides (DOT)

    Aguascalientes, 20129

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20230

  • Unidad de Investigacion Clinica Cardiometabolica de Occident

    Guadalajara, 44150

  • Instituto Jaliscience de Inv. en Diabetes y Obesidad, S.C.

    Guadalajara, 44600

  • Unidad de Patologia Clinica

    Guadalajara, CP 44650

Other trials in Mexico

Romania5 sites

  • Nicodiab SRL, Bucharest

    Bucharest, 010507

  • Milit. Cent. Emerg. Univ. Hosp. Dr. Davila, Met. Dis. Dept.

    Bucharest, 010825

  • SC Medical Centre "Sanatatea Ta" SRL, Bucharest

    Bucharest, 020603

  • SC Pelican Impex SRL, Cabinet Nr. 201, Diabetes Dept.

    Oradea, Bihor County, 410469

  • Centrul Medical Dr Negrisanu SRL

    Timișoara, 300456

Other trials in Romania

Sweden5 sites

  • Ängelholms Sjukhus

    Ängelholm, 262 81

  • CTC Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Karlskoga lasarett

    Karlskoga, 691 81

  • Skånes universitetssjukhus, Lund

    Lund, 221 85

  • S3 Clinical Research Centers

    Vällingby, 162 68

Other trials in Sweden

Australia4 sites

  • Coffs Endocrine & Diabetes Services

    Coffs Harbour, New South Wales, 2450

  • Eastern Clinical Research Unit

    East Ringwood, Victoria, 3135

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • SA Endocrine Research P/L

    Keswick, South Australia, 5035

Other trials in Australia

Norway4 sites

  • M3 Helse AS

    Hamar, N-2317

  • Oslo Universitetssykehus HF, Lipidklinikken

    Oslo, N-0027

  • Stavanger Helseforskning

    Stavanger, N-4068

  • Universitetssykehuset Nord-Norge, Tromsø

    Tromsø, N-9038

Other trials in Norway

New Zealand2 sites

  • South Pacific Clinical Trials

    Auckland, New Zealand, 0610

  • Lipid and Diabetes Research Group

    Christchurch, 8011

Other trials in New Zealand

Ireland1 site

  • Mater Misericordiae University Hospital

    Dublin, 7

Other trials in Ireland

About this study

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)

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

Being tested
Empagliflozin, Placebo
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02580591
Study groupRoleWhat they receive
Empagliflozin low doseExperimentalNot described
Receives: Drug: Empagliflozin; Drug: Placebo
Empagliflozin high doseExperimentalNot described
Receives: Drug: Empagliflozin; Drug: Placebo
Empagliflozin medium doseExperimentalNot described
Receives: Drug: Empagliflozin; Drug: Placebo
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to week 26

  2. 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.

    Measured: Baseline to week 26

Secondary outcomes (4)

  1. 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.

    Measured: Week 5 to Week 26, Week 1 to Week 26

  2. 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.

    Measured: Baseline to week 26

  3. 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.

    Measured: Baseline to week 26

  4. 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.

    Measured: Baseline to week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2015 (estimated)
  2. Study start22 Dec 2015
  3. Primary completion12 Sep 2017
  4. Study completion20 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
977 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02580591
Sponsor's protocol ID
1245.72
Other IDs
2014-005256-26, 2014
Status last verified
Oct 2018
First submitted
19 Oct 2015
Last updated
2 Nov 2018

Publications

  • Song C, Dhaliwal S, Bapat P, Scarr D, Bakhsh A, Budhram D, Verhoeff NJ, Weisman A, Fralick M, Ivers NM, Cherney DZI, Tomlinson G, Lovblom LE, Mumford D, Perkins BA. Point-of-Care Capillary Blood Ketone Measurements and the Prediction of Future Ketoacidosis Risk in Type 1 Diabetes. Diabetes Care. 2023 Nov 1;46(11):1973-1977. doi: 10.2337/dc23-0840.

    PubMed 37616393

  • 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.

    PubMed 30287422

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin in people with Diabetes Mellitus, Type 1, run by Boehringer Ingelheim at 189 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, Poland, United Kingdom, Germany, Italy and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) (time frame: Baseline to week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02580591, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.

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