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    Summary
    EudraCT Number:2015-000410-22
    Sponsor's Protocol Code Number:U1111-1140-6242
    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 number2015-000410-22
    A.3Full title of the trial
    Influence of liraglutide on diastolic cardiac function and myocardial perfusion as determined by magnetic resonance imaging in patients with type 2 diabetes: a double-blind randomized parallel-group trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An MR-scan study of Liraglutide on cardiac function and cardiac blood flow in patients with type 2 diabetes and impaired filling of the heart.
    Et MR-studie over Liraglutids effekt på hjertets pumpefunktion og gennemblødning hos patienter med type 2 sukkersyge og nedsat fyldningsevne af hjertet.
    A.4.1Sponsor's protocol code numberU1111-1140-6242
    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 SponsorThe Cardiovascular MR Group, Dept. 2011, Rigshospitalet
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Cardiovascular MR Group, Dept. 2011, Rigshospitalet
    B.5.2Functional name of contact pointAtt: Annemie Bojer/Niels Vejlstrup
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4522857526
    B.5.6E-mailasbojer@gmail.com
    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 Victoza
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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 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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    Type 2 diabetes mellitus and diastolic heart faliure
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes patients with impaired filling ability of the heart.
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10069211
    E.1.2Term Diastolic heart failure
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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
    The primary objective of this trial is to test if 18 weeks of treatment with liraglutide (up to 1.8 mg s.c. once daily) improves (or worsens) diastolic performance in T2DM patients with diastolic dysfunction, compared to placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to evaluate whether 18 weeks of treatment with liraglutide (up to 1.8 mg s.c. once daily) improves (or worsen) myocardial perfusion and echocardiographic indices of diastolic dysfunction in T2DM patients with diastolic dysfunction, compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patient fully capable of informed consent
    • Informed consent
    • Age 18-80 years (both years inclusive)
    • T2DM diagnosed at least 3 months
    • NYHA class I-III
    • E/e* ≥ 9 or e* (lateral) ≤10 cm/sec, or both
    • LVEF > 50%
    • LVEDV/BSA < 97 ml/m2
    • Stable on heart medication for 6 weeks prior to randomization
    • Stable on antidiabetic treatment for 30 days prior to randomization
    • T2DM must be either treated with one or more oral anti-diabetic drugs or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs
    E.4Principal exclusion criteria
    • Lack of consent.
    • NYHA class IV
    • Type 1 diabetes mellitus
    • Incretin-based therapy (GLP-1 receptor agonists; exenatide, liraglutide or other and DPP-IV inhibitors) within 30 days prior to randomization
    • Glitazon therapy within 30 days prior to randomization
    • Hypertension with inadequate blood pressure control: Systolic blood pressure > 140 mmHg and/or diastolic blood pressure >85 mmHg
    • Supine systolic blood pressure <85 mmHg
    • Significant valvular heart disease
    • Hypertrophic cardiomyopathy, ARVC/D, non-compaction or amyloidosis
    • Myocardial infarction, unstable angina, angina on exertion (≥CCS class 2) or coronary revascularization within 3 months prior to randomization
    • Hospitalisation due to incompensated heart disease within 30 days to randomization
    • HbA1c >10%
    • eGFR< 60 ml/min/1,73 m2
    • Liver disease with aspartate aminotransferase/alanine aminotransferase >3 times upper limit of normal
    • Hypokalaemia (P-potassium <3.5 mmol/L) or hyperkalaemia (P-potassium >5.5 mmol/L)
    • Anaemia (haemoglobin <6.5 mmol/L)
    • Conditions that may be associated with changes in markers of fibroses or collagen turnover (eg. on-going or active rheumatological disease requiring anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)
    • Prolonged use (> 2 weeks) of glucocorticoids or NSAIDs within 2 weeks prior to the beginning of the trail
    • Women of childbearing potential who are not on acceptable contraception
    • Pregnant or breastfeeding women
    • Cancer (except basal cell skin cancer or squamous cell skin cancer) unless complete remission for ≥ 5 years
    • Alcohol/drug abuse
    • Chronic or previous acute pancreatitis
    • History of thyroid adenoma or carcinoma
    • Inflammatory bowel disease
    • Clinical signs of diabetic gastroparesis
    • ICD/pacemaker or other contraindications to MRI scan
    • Severe claustrophobia
    • Atrial fibrillation
    • Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia at rest, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis
    • Known or suspected hypersensitivity to trial product or related products
    • Current participation in any other clinical intervention trial
    • Receipt of an investigational drug with 30 days prior to the beginning of the trail
    • Other concominant disease or treatment that according to investigator’s assessment makes the patient unsuitable for participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints will be change in diastolic properties as assessed by cardiac MRI:
    • LA passive emptying fraction (%)
    • LV peak filling rate (LVPFR) (ml/s)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured during week 18 (on medication, placebo/liraglutide) and compared to baseline (before placebo/liraglutide treatment is started)
    E.5.2Secondary end point(s)
    The secondary endpoints consist of changes in:
    • MRI indices of myocardial perfusion
    • echocardiographic indices of diastolic dysfunction
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measured during week 18 (on medication, placebo/liraglutide) and compared to baseline (before placebo/liraglutide treatment is started)
    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 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 Yes
    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 years2
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 Yes
    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 state40
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-01
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