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    Summary
    EudraCT Number:2014-003189-26
    Sponsor's Protocol Code Number:Version1.2
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-003189-26
    A.3Full title of the trial
    Metformin and its Effects on Myocardial Dimension and Left ventricular hypertrophy in normotensive patients with Coronary Artery Disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The MET REMODEL Study
    A.3.2Name or abbreviated title of the trial where available
    The MET REMODEL Study
    A.4.1Sponsor's protocol code numberVersion1.2
    A.5.4Other Identifiers
    Name:Sponsor ReferenceNumber:2013CV08
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Dundee/NHS Tayside
    B.1.3.4Country
    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 supportBritish Heart Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Dundee, Tayside Clinical Trials Unit
    B.5.2Functional name of contact pointDr Stephen McSwiggan
    B.5.3 Address:
    B.5.3.1Street AddressTASC, Level 3 Residencies, Ninewells Hospital
    B.5.3.2Town/ cityDundee
    B.5.3.3Post codeDD1 9SY
    B.5.4Telephone number01382383233
    B.5.6E-mails.j.mcswiggan@dundee.ac.uk
    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 Diagemet
    D.2.1.1.2Name of the Marketing Authorisation holderGenus Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameMetformin hydrochloride Extended Release
    D.3.4Pharmaceutical form Capsule, hard
    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 INNmetformin
    D.3.9.1CAS number 657-24-9
    D.3.9.3Other descriptive namemetformin hydrochloride
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1000 to 2000
    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 placeboCapsule, hard
    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
    Cardiovascular disease
    E.1.1.1Medical condition in easily understood language
    Heart disease
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10022489
    E.1.2Term Insulin resistance
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10051615
    E.1.2Term Atherosclerotic cardiovascular disease
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10025164
    E.1.2Term LVH
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal research question is to find out if metformin (a drug commonly used for the treatment of type 2 diabetes)changes the thickness of the left side of the heart in patients who have heart disease and who may be at risk of developing diabetes
    E.2.2Secondary objectives of the trial
    This study will also check if metformin improves the pumping ability of the heart, or makes it more efficient in patients with prior heart disease who may be at risk of developing diabetes in future. This will be measured by scanning the heart with an ultrasound and then an MRI scanner.
    We will also try to establish if metformin promotes weight loss in these patients who may benefit from a reduction in abdominal fat.
    The participants recruited will also be at increased risk of developing diabetes as they will have been screened for Insulin resistance. Insulin resistance is a medical term where the ability of cells in the body to use insulin is reduced resulting in a build up of sugar in the body which can lead to type 2 diabetes. We will examine if metformin improves insulin resistance in this group.

    As these patients have established heart diseases and are possibly predisposed to developing diabetes we will examine if metformin improves the health of peripheral blood vessels u
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Participant is willing and able to give informed consent for participation in the study
    2) Aged 18 years or over
    3) Documented Ischaemic Heart Disease: either angio-graphically documented coronary artery disease or a previous history of myocardial infarction/angina.
    4) Have screening echocardiography based diagnosis of LVH based on ASE criteria (males >115g/m2, females >95g/m2)
    5) Fasting insulin resistance index ≥ 2.7 at screening
    6) Clinic Blood pressure < 140/85 mm Hg or 24hr BP <135/85 daytime average in screening
    7)Able (in the Investigators opinion) and willing to comply with all study requirements.
    E.4Principal exclusion criteria
    1) Severe cognitive impairment precluding written informed consent
    2) Type 1 or 2 Diabetes mellitus
    3) Chronic Heart Failure as evidenced by an echocardiogram or a diagnosis of CHF
    4) Left Ventricular Ejection Fraction <45% on echocardiography screening
    5) Contraindications to cardiac MRI (pacemakers, claustrophobia, metal implants, history of penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
    6) Malignancy (receiving active treatment) or other life threatening diseases
    7) renal disease; CKD class 3B or worse (to exclude risk of lactic acidosis)
    8) Pregnancy and lactating women
    9) Any other considered by a study physician to be inappropriate for inclusion
    10) Participants who have participated in any other clinical trial within the previous 30 days will be excluded.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is to determine if metformin induces a change in Left Ventricular Mass Index in patients with IHD and IR when compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline- 0 weeks
    Endpoint- 12 months
    E.5.2Secondary end point(s)
    • To determine if there is a change in LV Mass, LV end systolic volume, LV end diastolic volume or LV ejection fraction with metformin in patients with IHD and IR compared with placebo.
    • To determine if there is a change in central and abdominal obesity with metformin in patients with IHD and IR compared with placebo.
    • To determine if there is a difference in endothelial function with metformin compared with placebo, measured by FMD and PWA and skin reactive hyperaemia.
    • To determine if there is an improvement in IR when treated with metformin compared to placebo in patients with IHD and IR.
    • To determine if there are changes in inflammatory and other cardiovascular blood markers, when treated with metformin compared to placebo in patients with IHD and IR.
    • Safety and efficacy of Metformin XR will be determined by monitoring changes from randomisation till the end of the study or so long the patient remains in the study, whichever is earlier.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline- 0 weeks
    Endpoint- 12 months
    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 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 trial1
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 64
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-30
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