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    Summary
    EudraCT Number:2018-004289-33
    Sponsor's Protocol Code Number:MAAAGI
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-07-08
    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 number2018-004289-33
    A.3Full title of the trial
    Metformin for Abdominal Aortic Aneurysm Inhibition
    A randomized controlled trial

    MAAAGI trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does metformin reduce growth rate of small abdominal aortic aneurysms?
    A.4.1Sponsor's protocol code numberMAAAGI
    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 SponsorDepartment of Surgical, Sciences Uppsala University
    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 supportDepartment of Surgical Sciences
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Surgical Sciences
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressAkademiska sjukhuset ing 70 1 tr
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code751 85
    B.5.3.4CountrySweden
    B.5.6E-mailanders.wanhainen@surgsci.uu.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 holderMerck Santé
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Small abdominal aortic aneurysm (AAA) under active surveillance; 30-49 mm in diameter for men and 30-44 mm in diameter for women
    E.1.1.1Medical condition in easily understood language
    Small abdominal aortic aneurysm under surveillance where the aneurysm diameter is below threshold for surgical repair and not expected to reach this threshold within 24 months of study start
    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 2 g metformin daily over 60 months reduce yearly growth rate of small abdominal aortic aneurysms in patients with no history of diabetes
    At 24 months a Stop/Go interim analysis will be performed for safety and efficacy
    E.2.2Secondary objectives of the trial
    To investigate if metformin 2 g per day is tolerable and safe, affects quality of life, affects biomarkers associated with aortic aneurysms and may represent a cost effective medical treatment in patients with a small abdominal aortic aneurysm and no history diabetes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent
    2. Male and female patients
    3. Age 50-80 years
    4. Documented AAA Ø 30-49 mm for men and 30-44 mm for women
    5. No history of diabetes mellitus and fasting p-glucose <7.0 mmol/L
    E.4Principal exclusion criteria
    1. Short expected survival.
    2. History of current or previous diabetes mellitus.
    3. Current or previous use of metformin.
    4. Not expected to tolerate metformin.
    5. Contraindication to metformin according to summary of product characteristics (SmPc in FASS 2019) including: Renal failure with glomerular filtration rate (GFR) <45ml/min, progressing or unstable heart failure, recent myocardial infarction, liver impairment or alcoholism evidenced by patient history or clinical examination.
    6. Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm post aortic dissection or previous surgery of the infrarenal aorta.
    7. Enrolled in either another investigational drug or medical device study or another investigational study of an approved drug or medical device within 30 days prior to enrolment of the current study.
    8. Any condition or laboratory finding which in the opinion of the Investigator makes the patient unsuitable for inclusion.
    9. Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    To examine if 2 g metformin administered daily over a five-year period slows AAA growth rate in patients with small AAAs who do not have diabetes mellitus measured as computed tomography (CT) imaging assessed AAA diameter.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline versus 24 and 60 months of treatment
    E.5.2Secondary end point(s)
    Secondary outcomes
    To examine if metformin; a) limits increase in CT-assessed AAA volume; b) ultrasound assessed AAA diameter; c) improve health-related quality of life; and d) represent a cost-effective treatment to reduce the need for AAA surgery.

    Safety objective
    To determine adverse events; primarily related to known side effects of metformin and possible unexpected effects on AAA, related to metformin treatment after two and five years treatment.

    Exploratory objectives
    To examine; a) if there is a dose or time related response of metformin regarding the primary or secondary endpoints; and b) if metformin favorably modify circulating inflammation and matrix remodeling biomarkers; or c) affect perivascular adipose tissue.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline versus 24 and 60 months of treatment
    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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    Primary outcome measures are performed by an operator blinded to treatment allocation
    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 treatment - best medical care
    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 concerned7
    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 years6
    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) No
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state500
    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)
    The subjects will be followed as per routine for AAA, but possible long term effect of metformin will be followed by noting outcome of growth rate and rate of surgery over 5 years following trial completion.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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