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    Summary
    EudraCT Number:2012-001623-12
    Sponsor's Protocol Code Number:MagnaVictoria
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-01-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-001623-12
    A.3Full title of the trial
    Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging based evaluation of new anti-diabetic oral medication, effects on heart function and body fat distribution
    A.3.2Name or abbreviated title of the trial where available
    MAGNA VICTORIA
    A.4.1Sponsor's protocol code numberMagnaVictoria
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportNovo Nordisk
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31715262993
    B.5.5Fax number31715248256
    B.5.6E-mailh.j.lamb@lumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Victoza
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIRAGLUTIDE
    D.3.9.1CAS number 204656-20-2
    D.3.9.4EV Substance CodeSUB25238
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.6 to 1.8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adults with type 2 diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    Adults with type 2 diabetes mellitus
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    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
    To assess the effects of 26 weeks Liraglutide treatment on cardiac function in type 2 diabetes mellitus (DM2) of Western European and South Asian origin.
    E.2.2Secondary objectives of the trial
    To assess the effects of 26 weeks Liraglutide treatment on vascular function, glycemic control, fat distribution and brown adipose tissue in DM2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient group:
    • Informed consent
    Western European origin:
    • Age > 18 years and < 70 years
    • BMI > 25 kg/m2
    • DM2 treated with metformin, metformin + SU derivative, metformin + SU derivative + insulin, or metformin + insulin for at least 3 months in the maximum tolerable dosage
    • HbA1c ≥ 7% and ≤ 10.0 %
    • EGFR > 60 ml/min
    • Normal sitting blood pressure: systolic blood pressure < 140 mm Hg and stable for at least one month
    South Asian origin:
    • Age > 18 years and < 75 years
    • BMI > 23 kg/m2
    • DM2 treated with metformin and/or SU derivative and/or insulin for at least 3 months in stable dosage
    • HbA1c ≥ 6.5% and ≤ 11.0 %
    • EGFR > 30 ml/min
    E.4Principal exclusion criteria
    Patient group:
    • Use of thiazolidinediones (TZD), GLP-1 analogues, DPP-IV inhibitors, fibrates, prednisone, cytostatic or antiretroviral therapy within 6 months prior to the study
    • Hereditary lipoprotein disease
    • Psychiatric disorders and / or use of antipsychotic or antidepressant drugs at present or in the past
    • Hepatic disease (AST/ALT > 2 times reference values)
    • Endocrine disease other than diabetes mellitus type 2
    • Any significant chronic disease (e.g. inflammatory bowel disease)
    • Any significant abnormal laboratory results found during the medical screening procedure
    • Gastrointestinal surgery (e.g. gastric bypass)
    • Pregnant woman or a woman who is breast-feeding
    • Female of child-bearing potential intending to become pregnant or is not using adequate contraceptive methods while sexually active
    • Allergy to intravenous contrast
    • Known or suspected hypersensitivity to trial products or related products
    • Chronic pancreatitis or previous acute pancreatitis
    • Personal history or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia type 2
    • Claustrophobia
    • Metal implants or other contraindications for MRI
    • Recent participation in other research projects within the last 3 months or participation in 2 or more projects in one year

    Western European origin:
    • History or presence of cardiovascular disease

    South Asian origin:
    • Uncontrolled treated or untreated hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg)
    • Acute coronary or cerebrovascular event within 30 days prior to study
    • Congestive heart failure NYHA III-IV

    Healthy control group:
    • Known acute or chronic disease based on history (which is of influence on primary/secondary outcome measures, at the discretion of the investigator) and physical examination and standard laboratory tests (blood counts, fasting blood glucose, lipids, eGFR, liver enzymes, and electrocardiogram)
    • Chronic use of any drug (which is of influence on primary/secondary outcome measures, at the discretion of the investigator) and impaired glucose tolerance (as excluded by a 75-g oral glucose tolerance test)
    • Pregnant woman or a woman who is breast-feeding
    • Female of child-bearing potential intending to become pregnant or is not using adequate contraceptive methods while sexually active
    • Allergy to intravenous contrast
    • Claustrophobia
    • Metal implants or other contraindications for MRI
    E.5 End points
    E.5.1Primary end point(s)
    • Systolic function: stroke volume, ejection fraction, cardiac output, cardiac index, peak ejection rate
    • Diastolic function: early peak filling rate (E), early deceleration peak (E dec peak), atrial peak filling rate (A), E/A ratio, peak mitral annulus longitudinal motion (Ea), MR estimate of LV filling pressure (E/Ea)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient group: Baseline and after 26 weeks
    Healthy control group: Baseline
    E.5.2Secondary end point(s)
    Heart dimensions including:
    • End-diastolic volume, end-systolic volume, LV mass, LV mass index, LVMI/EDVI, percentage scar tissue

    Aorta and carotid vessel wall imaging including:
    • Total vessel wall area, average vessel wall thickness, minimum vessel wall thickness, maximum vessel wall thickness, distensibility
    • Carotid artery intima media thickness (IMT), measured by echography

    Body fat distribution:
    • Adipose tissue distribution, including visceral and subcutaneous fat volume at level of L4-L5, total body fat distribution, brown adipose tissue
    • Epicardial fat volume
    • ¹H-MR spectroscopy of the heart, liver, and kidney triglyceride content

    Glycemic control:
    - HBA1C and fasting blood glucose levels

    Energy expenditure:
    - Indirect calorimetry
    E.5.2.1Timepoint(s) of evaluation of this end point
    MRI Baseline and after 26 weeks, glycemic control every four 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) 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 Yes
    E.8.1.7.1Other trial design description
    Healthy control group, observational
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Healthy control group, no intervention
    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
    Not applicable
    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
    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: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state160
    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)
    Outpatient clinic of local institution
    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 Decision2013-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-03-09
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