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    Summary
    EudraCT Number:2014-001778-32
    Sponsor's Protocol Code Number:U1111-1149-7801
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-06-17
    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 number2014-001778-32
    A.3Full title of the trial
    Glycaemic and cardiovascular efficacy of liraglutide in prediabetic patients with end-stage renal disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of liraglutide in patients with prediabetes and kidney failure
    Effekten af liraglutid hos patienter med prædiabetes og nyresvigt
    A.3.2Name or abbreviated title of the trial where available
    The LiRA2 study
    A.4.1Sponsor's protocol code numberU1111-1149-7801
    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 SponsorBo Feldt-Rasmussen
    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 organisationDepartment of Nephrology, Rigshospitalet
    B.5.2Functional name of contact pointAfd. 2132 att Bo Feldt-Rasmussen
    B.5.3 Address:
    B.5.3.1Street AddressRigshospitalet, afd. 2132, Blegdamsvej 9
    B.5.3.2Town/ cityCopenhagen Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535452135
    B.5.5Fax number4535452240
    B.5.6E-mailbo.feldt-rasmussen@regionh.dk
    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
    Prediabetes and dialysis dependent end-stage renal disease
    E.1.1.1Medical condition in easily understood language
    Early signs of diabetes and chronic kidney failure treated with dialysis
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10014646
    E.1.2Term End stage renal disease (ESRD)
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10065542
    E.1.2Term Prediabetes
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10012347
    E.1.2Term Dependence on renal dialysis
    E.1.2System Organ Class 100000004869
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The trial will examine the effects of liraglutide treatment on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease. The primary objective is to determine the efficacy of the treatment on glucose tolerance evaluated during a 3h 75g-oral glucose tolerance test (OGTT).
    E.2.2Secondary objectives of the trial
    Secondary objectives include various clinical and biochemical cardiovascular and safety parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female; age: 18 - 85 years
    • End-stage renal diasease treated with chronic maintenance dialysis (haemodialysis or peritoneal dialysis)
    • Impaired glucose tolerance (2h plasma glucose ≥ 7,8 and < 11.1 mmol/l following a 75g-OGTT) and/or impaired fasting glucose (fasting plasma glucose ≥ 6.1 and < 7.0 mmol/l) evaluated at the screening visit
    E.4Principal exclusion criteria
    • Diabetes mellitus type 1 or type 2 (diagnose according to WHO criteria)
    • Chronic pancreatitis / previous acute pancreatitis
    • Known or suspected hypersensitivity to trial product(s) or related products
    • Treatment with oral glucocorticoids, calcineurin inhibitors or incretin-based therapy which in the Investigator’s opinion could interfere with glucose or lipid metabolism 90 days prior to screening
    • Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, which in the investigator’s opinion could interfere with the results of the trial
    • Clinical suspicion of cardiac disease currently investigated
    • Cardiac disease defined as: decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
    • Body mass index (BMI) <20 kg/m2 and/or >50 kg/m2
    • Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods*
    • Impaired liver function (transaminases > two times upper reference levels)
    • The receipt of any investigational product 90 days prior to this trial
    • Known or suspected abuse of alcohol or narcotics
    • Screening calcitonin ≥ 50 ng/l
    • Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2

    Lawfully detained, institutionalised and patients who are unable to give informed consent due to physical or mental conditions will not be included.

    * Intrauterine devices and hormonal contraceptives (oral pills, patches, implants, vaginal rings, and injections) are considered as adequate contraceptives. Females of childbearing potential must use one of these contraceptives throughout the entire study plus 1 week after last injection with study medication. Surgical sterile (by bilateral vasectomy, tubectomy, hysterectomy or oophorectomy) or postmenopausal (defined as amenorrheic for at least one year) female participants are not considered as having a childbearing potential and are not required to use contraception.
    E.5 End points
    E.5.1Primary end point(s)
    Difference between the two treatment arms in area under the curve for the plasma glucose concentrations during a 3h 75g-OGTT on the trial visit of week 26.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The trial visit of week 26
    E.5.2Secondary end point(s)
    • hypoglycaemia (safety parameter)
    • fasting plasma glucose, proinsulin, insulin and glucagon
    • insulin resistance (evaluated by HOMA-IR)
    • beta-cell function (evaluated by HOMA-β)
    • change in glycaemic state following oral glucose tolerance test (normal glucose tolerance (NGT, fasting plasma glucose < 6.1 mmol/l and 2h plasma glucose < 7.8 mmol/l), IFG (fasting plasma glucose ≥ 6.1 and < 7.0 mmol/l), IGT (2h plasma glucose ≥ 7,8 and < 11.1 mmol/l) and DM (fasting plasma glucose ≥ 7 mmol/l or 2h plasma glucose ≥ 11.1 mmol/l))
    • blood pressure
    • pulse
    • weight
    • body composition by DXA scan
    • cardiac function and perfusion(r-PET/CT)
    • cardiac autonomic function (heart rate variability by ECG)
    • Arterial stiffness: Augmentation index from Pulse wave analysis (PWA)
    • cardiovascular and endothelial risk markers (TnT, TnI, CK-MB, hsCRP, PAI-1, tPA, urat, vWF, VCAM, ICAM, TNFalpha, proBNP, E-selectin and asymmetric dimethylarginin)
    • Prothrombotic state (fibrinogen, activated partial thromboplastin time (APTT) and thromboelastography (TEG))
    • lipid profile
    • plasma liraglutide
    E.5.2.1Timepoint(s) of evaluation of this end point
    The trial visit of week 26
    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) 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 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 months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    End-stage renal disease patients (incurable)
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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 Decision2014-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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