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    Summary
    EudraCT Number:2019-001487-30
    Sponsor's Protocol Code Number:MIMET-2019
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-12-04
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-001487-30
    A.3Full title of the trial
    The Myocardial Infarction and new treatment with Metformin study (MIMET) – a registry-based randomised controlled multicenter trial to study metformin and the prevention of cardiovascular events in patients with acute myocardial infarction and newly detected prediabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Myocardial Infarction, prediabetes and addition of metformin (MIMET) - a registry-based randomised controlled trial.
    A.3.2Name or abbreviated title of the trial where available
    MIMET
    A.4.1Sponsor's protocol code numberMIMET-2019
    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 SponsorKarolinska Institutet
    B.1.3.4CountrySweden
    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 supportVetenskapsrådet
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Institute
    B.5.2Functional name of contact pointDepartment of medicine
    B.5.3 Address:
    B.5.3.1Street AddressK2 Cardiology
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code17176
    B.5.3.4CountrySweden
    B.5.4Telephone number00000000
    B.5.5Fax number00000000
    B.5.6E-mailjohn.pernow@ki.se
    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 Metformin
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 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.3.9.4EV Substance CodeSUB08831MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study will investigate metformin and the prevention of cardiovascular events in patients with acute myocardial infarction and newly detected prediabetes.
    E.1.1.1Medical condition in easily understood language
    The study will investigate metformin and the prevention of cardiovascular events in patients with acute myocardial infarction and newly detected prediabetes.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    To investigate if metformin compared to standard care has beneficial effects on the occurrence of a composite CV endpoint (all-cause mortality, MI, heart failure or stroke) in patients with AMI and newly detected prediabetes or isolated post-load glucose diabetes levels (identified by oral glucose tolerance test [OGTT], HbA1c or fasting glucose levels).
    E.2.2Secondary objectives of the trial
    To determine if metformin compared to standard care has beneficial effects on the occurrence of specific CV and non-CV events in patients with AMI and newly detected prediabetes.

    Safety objectives
    To assess the safety in using metformin by registering number of SAEs with at least a possible relationship to the study medication, and to collect all registered cases of hospitalisation for lactic acidosis and hospitalisation for severe hypoglycaemia.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The following subgroup analyses is planned: outcome by sex; previous MI (prior to the index AMI); previous heart failure; previous coronary revascularisation; index AMI treated with revascularisation or medication or no therapy; STEMI; NSTEMI; age group ≤65 or >65 years; current smoking; prediabetes inclusion criteria (dichotomised by OGTT 2-hour levels or HbA1c), participating in physical exercise program (according to SEPHIA definition).
    In a substudy, the prognostic impact (major CV events) of prediabetes identified by OGTT (2-hour post glucose load) compared to fasting states (fasting glucose or HbA1c) will be compared to understand if OGTT has additional screening value to discover dysglycaemia patients with CV risk.
    Further explorative analyses (see below 6.4 for explorative objectives) will be addressing time to hospitalisation with renal failure, hospitalisation with fracture, hospitalisation with amputation and vitamin B12 deficiency.
    E.3Principal inclusion criteria
    I. AMI
    II. Swedish citizens with a personal ID number ≥18 years and ≤80 years
    III. Newly diagnosed prediabetes:
    a. HbA1c 42-47 mmol/mol or
    b. Capillary or venous fasting plasma glucose concentration 6.1-6.9 mmol/L or
    c. 2-hour post-load capillary glucose concentration 8.9-12.1 mmol/L or
    d. 2-hour post-load venous plasma glucose concentration 7.8-11.0 mmol/L
    e. HbA1c <48 mmol/mol and 2-hour post-load capillary glucose concentration >12.1 mmol/L or 2-h post-load venous plasma glucose concentration >11.0 mmol/L (thus elevated 2-hour glucose levels in the diabetes range but without HbA1c levels diagnostic for diabetes, only revealed by OGTT)
    IV. Naïve to metformin and other glucose lowering therapy
    V. Signed informed consent

    E.4Principal exclusion criteria
    I. Type 1 diabetes
    II. Known type 2 diabetes
    III. Indication for glucose lowering treatment
    IV. Acute condition with high risk for volume depletion, circulatory shock,
    hypoxia
    V. Serious illness, other than cardiovascular, with short life expectancy
    VI. Renal failure (eGFR <60ml/min)
    VII. Hepatic failure
    VIII. Malignancy within the last year
    IX. Contraindication or hypersensitivity to the study drug
    X. Alcohol or drug abuse
    XI. Pregnancy or breastfeeding
    XII. Women of childbearing potential without adequate anticonception during any part of the study period
    XIII. Previous hospitalisation for lactic acidosis
    XIV. Predicted inability to comply with the study protocol

    E.5 End points
    E.5.1Primary end point(s)
    Time to major CV event defined as a composite endpoint of first of all-cause mortality or main diagnosis of MI, heart failure or stroke (reported in SWEDEHEART, the National Patient Register and the Cause of Death Register).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each patient will be followed until the 24 month visit, data on events will continuously be collected during this time and at the patient´s end of study, no data on events after the patient’s end of study will be collected. The primary and secondary endpoints will be collected from SWEDEHEART (RIKSHIA and SEPHIA) and national registries (the National Patient Register, the Cause of Death Register and the Prescribed Drug Register).
    E.5.2Secondary end point(s)
    1. Time to first event included in the composite endpoint of CV mortality, main diagnosis of MI, heart failure or stroke. CV mortality is defined as underlying CV cause of death in the cause of death register (I00-I99). MI, heart failure and stroke as defined in the primary endpoint detailed in 6.1.
    2. Time to first event included in the composite endpoint of all-cause mortality, main diagnosis of MI, stroke and revascularisation (CABG or PCI >4 months after the index AMI). Coronary revascularisation is defined as CABG or PCI in the national patient register (Z95, FNA-FNE, FNG).

    3. Time to all-cause mortality

    4. Time to CV mortality

    5. Time to hospitalisation with MI

    6. Time to hospitalisation with stroke

    7. Time to hospitalisation with heart failure.
    8. Time to new cancer diagnosis. Cancer is defined as the first occurrence of any cancer in the National Patient Register (C00-97).

    9. Time to initiation of any glucose lowering therapy, ATC code A10 in the Prescribed Drug Register, excluding randomisation to metformin (ATC code A10BA02) in the active treatment arm.

    10. Time to diabetes diagnosis. Defined as ICD code E10-E11 in National Patient Register and/or ATC code A10 in the Prescribed Drug Register excluding randomisation to metformin (ATC code A10BA02) in the active treatment arm.

    11. Analyses of primary and secondary endpoints including all available registry follow-up for all patients at end of trial. These analyses will include about 2-4 years of follow-up for each patient, where the first two years are under protocol-guided treatment within the trial.

    Safety endpoints
    1. Serious Adverse Events with at least a possible relationship to the study medication
    2. Lactic acidosis (E11.1D).
    3. Hypoglycaemia (E11.0C, E11.6A, E15.9, E16.0-E16.2).
    Lactic acidosis and hypoglycaemia are collected from the National Patient Register and eCRF

    Long term follow up
    Analyses of primary and secondary endpoints including all available registry follow-up for all patients at end of trial. No data on events after the patient’s end of study will be collected
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each patient will be followed until the 24 month visit, data on events will continuously be collected during this time and at the patient´s end of study, no data on events after the patient’s end of study will be collected. Also, at the patient´s end of the study, causes of hospitalisation, new onset morbidity and medication use, will be imported from the National Patient Register and the Prescribed Drug Register into the study database. Safety endpoints, all registered cases of hospitalisation for lactic acidosis and hospitalisation for severe hypoglycaemia, will be collected at patient´s end of study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) Yes
    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 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
    Standard care alone
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    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 years4
    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: 2000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3160
    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 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 state5160
    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)
    Continued treatment after study conclusion will be at the discretion of the patient and his/her health care provider.
    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 Decision2020-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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