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    Summary
    EudraCT Number:2016-000214-30
    Sponsor's Protocol Code Number:P000805
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2016-000214-30
    A.3Full title of the trial
    Empagliflozin and its effect on heart failure in type 2 diabetes
    Wirkung von Empagliflozin auf Herzinsuffizienz in Patienten mit Diabetes mellitus Typ 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Empagliflozin and its effect on heart failure in type 2 diabetes
    Wirkung von Empagliflozin auf Herzinsuffizienz in Patienten mit Diabetes mellitus Typ 2
    A.3.2Name or abbreviated title of the trial where available
    EFFORT
    A.4.1Sponsor's protocol code numberP000805
    A.5.4Other Identifiers
    Name:DRKSNumber:00009894
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversitätsklinikum Freiburg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer Ingelheim (BI) Pharma GmbH & Co
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Freiburg
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressHugstetter Straße 55
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79106
    B.5.3.4CountryGermany
    B.5.6E-mailjochen.seufert@uniklinik-freiburg.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Jardiance
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNempagliflozin
    D.3.9.1CAS number 864070-44-0
    D.3.9.3Other descriptive nameEMPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB35915
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Heart failure and type 2 diabetes
    Herzinsuffizienz and Diabetes mellitus Typ 2
    E.1.1.1Medical condition in easily understood language
    Heart failure and type 2 diabetes
    Herzinsuffizienz and Diabetes mellitus Typ 2
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10019280
    E.1.2Term Heart failures
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the EFFORT study is to investigate effects of empagliflozin on quality of life in diabetic patients with HFrEF or HFpEF.
    Das primäre Ziel der EFFORT-Studie ist die Untersuchung der Wirkung von Empagliflozin auf die Lebensqualität von Patienten mit Diabetes mellitus und mit HFrEF oder HFpEF.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate cognitive function, cardiac performance, structural changes of the heart, HF symptoms, changes in biomarkers after treatment with empagliflozin as compared to placebo.
    Die sekundären Ziele sind die Analyse der kognitiven Funktion, der Herzleistung, von strukturellen Veränderungen des Herzens, HF Symptomen und Veränderungen bezüglich Biomarkern unter Behandlung mit Empagliflozin im Vergleich zu Placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged > 18 years and ≤ 85 years old
    2. A diagnosis of type 2 diabetes mellitus with duration ≥ 3 months
    3. HbA1c ≥ 6.5 and ≤ 10.0% at screening
    4. NYHA class I-IV
    5. Treatment with one or two oral anti-diabetic medications (metformin, DPP-IV inhibitors, GLP-1 receptor agonists, acarbose, sulfonylureas) or treatment with any insulin alone or in combination with one or two oral anti-diabetic medications
    6. Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73cm²
    7. Written informed consent obtained according to international guidelines and local laws
    8. Ability to understand the nature of the trial and the trial related procedures and to comply with them
    1. Männliche oder weibliche Patienten im Alter von > 18 und ≤ 85 Jahren
    2. Diagnose eines Typ-2-Diabetes mellitus seit ≥ 3 Monaten
    3. HbA1c > 6.5 % und <= 10 bei Screening
    4. NYHA-Klasse I-IV
    5. Behandlung mit ein oder zwei oralen Antidiabetika (Metformin, DDP-4-Inhibitoren, GLP-1-Rezeptor-Agonisten, Arcabose, Sulfonylharnstoffe) oder Behandlung mit einem Insulin als Monotherapie oder in Kombination mit ein oder zwei oralen Antidiabetika
    6. Geschätzte glomeruläre Filtrationsrate (eGFR) ≥ 45 ml/min/1,73 cm²
    7. Vorliegen einer schriftlichen Einwilligungserklärung entsprechend den internationalen Richtlinien und den lokalen gesetzlichen Vorschriften.
    8. Fähigkeit, die Inhalte der Studie sowie die studienspezifischen Abläufe zu verstehen und einzuhalten
    E.4Principal exclusion criteria
    1. Type 1 diabetes mellitus
    2. Treatment with empagliflozin or other SGLT-2 inhibitors for more than 7 consecutive days within 2 months prior to registration
    3. Treatment with pioglitazone or other glitazones at registration
    4. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes within 30 days prior to registration
    5. Current acute decompensated HF requiring augmented therapy with diuretics, vasodilators and/or inotropic drugs within 30 days prior to registration
    6. History of stroke or cardiac surgery, or percutaneous coronary intervention within 60 days prior to registration
    7. Transcatheter/transapical aortic valve Implantation (TAVI) or MitraClip procedure within six months preceding registration
    8. Implantation of cardiac resynchronisation therapy (CRT) device or cardiac contractility modulation (CCM) device within six months preceding registration (for implantable cardioverter-defibrillator (ICD) and pacemaker a necessary lapse of time prior registration will be defined by the investigator)
    9. Uncontrolled hypertension (systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg measured in resting seated position for 10 minutes)
    10. Symptomatic hypotension, or an SBP < 85 mmHg
    11. Blood haemoglobin < 10 g/dl
    12. Known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
    13. Severe hepatic impairment
    14. Known latent autoimmune diabetes in adults (LADA) or chronic pancreatitis
    1. Type-1-Diabetes mellitus
    2. Behandlung mit Empagliflozin oder anderen SGLT-2-Inhibitoren an mehr als 7 aufeinander folgenden Tagen innerhalb von 2 Monaten vor Registrierung
    3. Behandlung mit Pioglitazon oder anderen Glitazonen bei Registrierung
    4. Akute Dekompensation der glykämischen Kontrolle mit der Notwendigkeit für eine umgehende Intensivierung der Therapie zur Verhinderung akuter diabetischer Komplikationen innerhalb von 30 Tagen vor Registrierung
    5. Aktuell akut dekompensierte Herzinsuffizienz mit der Notwendigkeit für eine verstärkte Behandlung mit Diuretika, Vasodilatoren und/oder inotropen Substanzen innerhalb von 30 Tagen vor Registrierung
    6. Schlaganfall, Herzchirurgie oder perkutane Koronarintervention innerhalb von 60 Tagen vor Registrierung
    7. Transkatheter/transapikale-Aortenklappen-Implantation (TAVI) oder MitraClip-Prozedur innerhalb von sechs Monaten vor Registrierung
    8. Implantation eines Geräts zur kardialen Resynchronisationstherapie (CRT) oder eines Geräts zur kardialen Kontraktilitätsmodulation (CCM) innerhalb von sechs Monaten vor Registrierung
    9. Unkontrollierter Bluthochdruck (systolischer Blutdruck (SBP)) > 180 mmHg und/oder diastolischer Blutdruck (DBP) > 110 mmHg, gemessen nach 10 Minuten ruhigen Sitzens)
    10. Symptomatische Hypotension, oder ein SBP < 85 mmHg
    11. Blut-Haemoglobin-Wert < 10 g/dl
    12. Patienten mit der bekannten seltenen hereditären Galactose-Intoleranz, Lapp-Laktase-Mangel oder Glucose-Galactose-Malabsorption
    13. Schwere Leberinsuffizienz
    14. Bekannter verzögert auftretender, autoimmun bedingter Diabetes beim Erwachsenen (LADA) oder chronische Pankreatitis
    E.5 End points
    E.5.1Primary end point(s)
    Change in quality of life assessed by the Minnesota Living with Heart Failure questionnaire (MLHFQ) total score 6 months after randomization as compared to baseline.
    Veränderung der Lebensqualität 6 Monate nach Randomisierung im Vergleich zu Baseline, beurteilt anhand des Summenscores des Minnesota Living with Heart Failure questionnaire (MLHFQ) Fragebogens
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 6
    Monat 6
    E.5.2Secondary end point(s)
    • Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
    • Cognitive function assessed by the Mini-Mental State Examination (MMSE).
    • Exercise capacity
    • Structural changes of the heart assessed by echocardiography and cardiac MRI (only for EFFORT-2 patients)
    • Biomarkers
    • Blood osmolarity and copeptin
    • Changes in HF symptoms
    • Changes in whole-body composition

    Assessment of safety:
    AEs, AEs of special interest and SAEs, laboratory parameters, heart rate and blood pressure.
    • Lebensqualität beurteilt anhand des Kansas City Cardiomyopathy Questionnaire (KCCQ) Fragebogens
    • Kognitive Funktion beurteilt anhand des Mini-Mental State Examination (MMSE) Tests
    • Körperliche Leistungsfähigkeit
    • Strukturelle Veränderungen des Herzens, beurteilt durch Echokardiographie und Kardio-MRT (nur für EFFORT-2 Patienten)
    • Biomarker
    • Blutosmolarität und Copeptin
    • Veränderung von HF-Symptomen
    • Veränderung der Körperzusammensetzung
    Beurteilung der Sicherheit:
    Unerwünschte Ereignisse (UEs), UEs von besonderem Interesse und schwerwiegende UEs, Laborparameter, Puls und Blutdruck
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 6 and over the time
    Monat 6 und im Verlauf
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient last visit
    Letzte Studienvisite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state270
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nach Versorgungsleitlinien
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-19
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