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    Summary
    EudraCT Number:2017-003779-75
    Sponsor's Protocol Code Number:ENDURANCE
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-13
    Trial 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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-003779-75
    A.3Full title of the trial
    Randomized clinical trial to assess the impact of treatment with empagliflozine on systemic inflammatory and renal parameters in patients with Diabetes Mellitus type 2 and ischemic heart disease.
    ENsayo clínico aleatorizaDo para evalUar el impacto del tratamiento con empagliflozina sobre paRámetros inflAmatorios sistémicos y reNales en paCientEs con DMT2 y cardiopatía isquêmica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess the inflammatory and renal parameters in patients with diabetes mellitus type 2 in treatment with empagliflozine
    Ensayo clínico para evaluar los parámetros inflamatorios y renales en pacientes con Diabetes Mellitus tipo 2 en tratamiento con empagliflozina
    A.4.1Sponsor's protocol code numberENDURANCE
    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 SponsorHospital Universitario La Paz
    B.1.3.4CountrySpain
    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 supportServicio de Endocrinología y Nutrición del Hospital Universitario La Paz
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario La Paz
    B.5.2Functional name of contact pointHoi Tong
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number912071466
    B.5.5Fax number912071466
    B.5.6E-mailhoi.tong@idipaz.es
    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 AuthorisationSpain
    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 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 INNEmpagliflozine
    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 number10
    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 placeboTablet
    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
    Type 2 Diabetes Mellitus
    Diabetes Mellitus tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes Mellitus
    Diabetes Mellitus tipo 2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to evaluate the effect of treatment with empagliflozin 10 mg daily, on renal and systemic inflammation parameters, in patients with type 2 diabetes mellitus and ischemic heart disease at 6 months of treatment.
    El objetivo del estudio es evaluar el efecto del tratamiento con empagliflozina 10 mg al día, sobre parámetros de inflamación a nivel renal y sistémicos,en pacientes con diabetes mellitus tipo 2 y cardiopatía isquémica a los 6 meses de tratamiento.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of empagliflozin treatment on renal and systemic inflammation parameters (IL- &, TNF alpha) in patients with type 2 diabetes mellitus with ischemic heart disease at 3 months of treatment.

    2. Study the general situation of the patient including concomitant medication and morbidity.
    3. Evaluate the continuity of treatment according to the appearance of adverse effects.
    4. To evaluate specifically the appearance of hypoglycemia and its degree of severity.
    1.Evaluar el efecto del tratamiento con empagliflozina sobre parámetros de inflamación a nivel renal y sistémicos (IL-&, TNF alfa) en pacientes con diabetes mellitus tipo 2 con cardiopatía isquémica a los 3 meses de tratamiento.

    2.Estudiar la situación general del paciente incluyendo la medicación concomitante y la morbilidad.
    3.Evaluar la continuidad del tratamiento en función de la aparición de efectos adversos.
    4.Evaluar específicamente la aparición de hipoglucemias y su grado de severidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients diagnosed with type 2 DM with poor metabolic control (glycosylated hemoglobin> 6.5%)
    2. Patients who have suffered an acute myocardial infarction or who have undergone a coronary revascularization procedure within 30 days prior to the start of the study.
    3. Over 18 and under 85
    4. Treatment with any hypoglycaemia including insulin.
    5. Left ventricular ejection fraction preserved (LVEF> 40%)
    6. Patients who have signed their consent to participate in the study
    1. Pacientes diagnosticados de DM tipo 2 con mal control metabólico (Hemoglobina glicosilada > 6,5 %)
    2. Pacientes que hayan sufrido un infarto agudo de miocardio o que hayan sido sometidos a un procedimiento de revascularizaciíon coronaria en los 30 días previos al inicio del estudio.
    3. Mayores de 18 y menores de 85 años
    4. Tratamiento con cualquier hipoglucemiante incluida insulina.
    5. Fracción de eyección del ventrículo izquierdo conservada (FEVI > 40 %)
    6. Pacientes que hayan firmado su consentimiento para participar en el estudio
    E.4Principal exclusion criteria
    1. Patients with type 1 DM.
    2. Previous or current treatment with an SGLT2 inhibitor.
    3. Creatinine clearance <60 ml / min / 1.73m2.
    1. Pacientes con DM tipo 1.
    2. Tratamiento previo o actual con un inhibidor de SGLT2.
    3. Aclaramiento de creatinina < 60 ml/min/1.73m2.
    E.5 End points
    E.5.1Primary end point(s)
    Main variable: Inflammatory activity determined by PCR, VSG, homocysteine, high sensitivity PCR, IL-6, IL-10, TNF alpha, MCP-1, TGF beta, CTGF, Endothelin 1, angiotensin 2.
    Variable Principal: Actividad inflamatoria determinada mediante PCR, VSG, homocisteina, PCR alta sensibilidad, IL-6, IL -10, TNF alfa, MCP-1, TGF beta, CTGF, Endotelina 1, angiotensina 2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    1. General: Age, sex, height, weight, BMI, time of evolution of DM2, previous macrovascular complications, microvascular complications, blood pressure, heart rate.
    2. Pharmacological: hypoglycaemic (including insulin), lipid-lowering, antihypertensive, antiplatelet, anticoagulants.
    3. Hematological: hemoglobin, hematocrit
    4. Lipid profile: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
    5. Cardio-renal: Nt-ProBNP, Cr, urea, proteinuria (albumin / creatinine index), sodium and potassium in urine. Plastic and urinary osmolarity.
    6. Endocrinological: fasting glucose, HbA1c, peptide c, ketone bodies in urine, ketonemia. Venous gasometry, severe hypoglycemia insulin?
    7. Markers of oxidative stress: oxidant capacity in urine.
    1.Generales: Edad, sexo, talla, peso, IMC, tiempo de evolución de la DM2, complicaciones macrovasculares previas, complicaciones microvasculares, tensión arterial, frecuencia cardiaca.
    2.Farmacológicos: hipoglucemiantes (incluido insulina), hipolipemiantes, antihipertensivos, antiagregantes, anticoagulantes.
    3.Hematológicos: hemoglobina, hematocrito
    4.Perfil lipídico: colesterol total, LDL colesterol, HDL colesterol, triglicéridos
    5.Cardio-renales: Nt-ProBNP, Cr, urea, proteinuria (índice albúmina/creatinina), sodio y potasio en orina. Osmolaridad plamática y urinaria.
    6.Endocrinológicos: glucosa en ayunas, HbA1c, péptido c, cuerpos cetónicos en orina, cetonemia. Gasometría venosa, hipoglucemias graves ¿insulina?
    7.Marcadores de estrés oxidativo: capacidad oxidante en orina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    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 No
    E.6.4Safety No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Otro tratamiento para la diabetes mellitus tipo 2 de acuerdo a la práctica clínica habitual
    Other Type 2 diabetes mellitus treatment according to usual clinical practice
    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
    LVLS
    Última visita programada del último sujeto incluido
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state80
    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
    Ninguno
    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 Decision2018-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-31
    P. End of Trial
    P.End of Trial StatusOngoing
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