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    Summary
    EudraCT Number:2015-002519-14
    Sponsor's Protocol Code Number:2015-775
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-30
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-002519-14
    A.3Full title of the trial
    The MIRAD study - Mineralocorticoid Receptor Antagonists in Type 2 Diabetes.
    A randomised, double-blind, placebo-controlled study of the effect of Mineralocorticoid Receptor Antagonists in Type 2 Diabetes on glucose and fat metabolism, myocardial function and vascular function.
    MIRAD - Mineralokortikoid Receptor Antagonister hos type 2 sukkersyge patienter: Et randomiseret, dobbelt-blindet, placebo-kontrolleret studie af effekten af Eplerenon på hjertets funktion og struktur samt sukker og fedtstofskiftet hos patienter med type 2 sukkersyge
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MIneralocorticoid Receptor Antagonists in Type 2 Diabetes
    Mineralokortikoid Receptor Antagonister hos type 2 sukkersyge patienter
    A.3.2Name or abbreviated title of the trial where available
    The MIRAD study
    MIRAD-studiet
    A.4.1Sponsor's protocol code number2015-775
    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 SponsorHerlev Hospital
    B.1.3.4CountryDenmark
    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 supportThe Danish Heart Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Research Council of Herlev Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHerlev Hospital
    B.5.2Functional name of contact pointForskingsenheden
    B.5.3 Address:
    B.5.3.1Street Addressherlev ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.6E-mailcaroline.michaela.nervil.kistorp@regionh.dk
    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 Eplerenone
    D.2.1.1.2Name of the Marketing Authorisation holderTeva
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOropharyngeal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNeplerenone
    D.3.9.3Other descriptive nameEPLERENONE
    D.3.9.4EV Substance CodeSUB06574MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboCoated tablet
    D.8.4Route of administration of the placeboOropharyngeal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    diabetes (type 2)
    sukkersyge ( type 2)
    E.1.1.1Medical condition in easily understood language
    diabetes
    sukkersyge
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10012594
    E.1.2Term Diabetes
    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
    Primary objective to investigate the effect of Eplerenone 200 mg once daily compared to placebo on:
    • Liver fat content by proton MR spectroscopy
    undersøge effekten af eplerenon sammenlignet med placebo på leverens fedtindhold målt ved MR scanning
    E.2.2Secondary objectives of the trial
    Secondary objectives to investigate the effect of Eplerenone on:
    • Fat mass distribution: total abdominal fat, VAT/subcutaneous and lower body fat
    • Insulin resistance by HOMA and Matsuda index, glucose homeostasis by HbA1c
    • Global longitudinal strain (GLS)
    • Systolic and diastolic function of the left ventricule: LVEF, EDV, ESV, S’, E’
    • Regional and global fibrosis, and LV mass by MRI
    • Biomarkers of myocardial stress and fibrosis: NT-proBNP, MR-proANP, Galectin-3, GDF-15, MR-proADM
    • Biomarkers of adipocyte function: adiponectin, leptin, TNF-α, FFA, IL-6, MCP-1, MAC-1, FGF-21
    • Biomarkers of molecular biology: microRNA profiles, gene, RNA, SNPs-profiles, telomere length in white blood cells
    • Urinary albumin/creatinine ratio
    • Pulse-wave velocity and pulse-wave analysis
    • 24 hour blood pressure
    • Quality of life (WHO-5, W-BQ12)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Able to understand the written patient information and to give informed consent
    • Type 2 diabetes mellitus (WHO criteria), diagnosed at least 3 months prior to baseline
    • NT-proBNP ≥ 70 pg/ml5 (taken within the last 6 months prior to baseline)
    • Stable dose of anti-diabetics within 30 days prior to baseline
    • Blood pressure treatment according to standard guidelines
    • Negative pregnancy test (fertile women)
    • Be willing to change/pause potassium sparing medication
    E.4Principal exclusion criteria
    • Allergic to the study medication
    • Systolic HF (LVEF ≤ 40%)
    • Impaired kidney function, eGFR ≤ 40 ml/min
    • Severe liver insufficiency (Child-Pugh class C)
    • Treatment with MR antagonist within 3 months prior to baseline
    • Serum-potassium ≥ 5.0 mmol/l
    • Serum-sodium < 135 mmol/l
    • Blood pressure ≥ 160/90 mmHg
    • Myocardial infarction, unstable angina pectoris or bypass graft surgery within 3 months prior to baseline
    • Atrial fibrillation
    • ECG showing malign ventricular arrhythmia or prolonged QT-interval (>500ms)
    • Untreated heart valve disease
    • ICD-unit/pacemaker
    • Pregnancy or desire hereof or breastfeeding
    • Women in the fertile age not using safe contraceptives (spiral, hormonal contraceptives)
    • Cancer unless complete remission ≥ 5 year
    • Alcohol-/drug-abuse
    • Inflammatory bowel disease
    • Other concomitant disease or treatment that according to the investigator’s assessment makes the patient unsuitable to participate in the study
    • Simultaneous participation in another clinical study
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints
    • Changes in liver fat content by proton MR spectroscopy from baseline to week 26
    E.5.1.1Timepoint(s) of evaluation of this end point
    at baseline and efter 26 weeks
    E.5.2Secondary end point(s)
    Secondary endpoints change from baseline to 26 week in:
    • Fat mass distribution: total abdominal fat, VAT/subcutaneous and lower body fat
    • Insulin resistance by HOMA and Matsuda index, glucose homeostasis by HbA1c
    • Global longitudinal strain (GLS)
    • Systolic and diastolic function of the left ventricule: LVEF, EDV, ESV, S’, E’
    • Regional and global fibrosis, and LV mass by MRI
    • Biomarkers of myocardial stress and fibrosis: NT-proBNP, MR-proANP, Galectin-3, GDF-15, MR-proADM
    • Biomarkers of adipocyte function: adiponectin, leptin, TNF-α, FFA, IL-6, MCP-1, MAC-1, FGF-21
    • Biomarkers of molecular biology: microRNA profiles, gene, RNA, SNPs-profiles, telomere length in white blood cells
    • Urinary albumin/creatinine ratio
    • Pulse-wave velocity and pulse-wave analysis
    • 24 hour blood pressure
    • Quality of life (WHO-5, W-BQ12)
    E.5.2.1Timepoint(s) of evaluation of this end point
    at baseline and after 26 weeks
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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
    LVLS
    Sidste patients sidste besøg
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state130
    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
    nej
    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 Decision2015-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-10
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