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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-005075-40
    Sponsor's Protocol Code Number:2013-005075-40
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-02-03
    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 ConcernedFinland - Fimea
    A.2EudraCT number2013-005075-40
    A.3Full title of the trial
    The effect of Liraglutide treatment on postprandial chylomicron and VLDL
    kinetics, liver fat and de novo lipogenesis. A single-center randomized
    controlled study.
    Liraglutidin vaikutus aterian jälkeiseen kylomikronien ja VLDL:n
    kinetiikkaan, maksan rasvaan ja maksan rasvojen uudismuodostukseen -
    Yhden keskuksen satunnaistettu ja lumelääkekontrolloitu tutkimus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Liraglutide on lipid synthesis and metabolism after mixed meal. A
    single-center randomized controlled study.
    Liraglutidin vaikutus aterian jälkeiseen rasvojen uudismuodostukseen ja
    aineenvaihduntaan. -Yhden keskuksen satunnaistettu ja
    lumelääkekontrolloitu tutkimus.
    A.3.2Name or abbreviated title of the trial where available
    LIRA
    LIRA
    A.4.1Sponsor's protocol code number2013-005075-40
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1149-8774
    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 SponsorResearch Programs' Unit, Diabetes & Obesity, University of Helsinki
    B.1.3.4CountryFinland
    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 Nodisk AG
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationResearch Programs' Unit, Diabetes & Obesity, University of Helsinki
    B.5.2Functional name of contact pointClinical trials information
    B.5.3 Address:
    B.5.3.1Street AddressPB 700
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00029 HUS
    B.5.3.4CountryFinland
    B.5.6E-mailtiimi.taskinen@hus.fi
    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 Liraglutide
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk AG
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 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
    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
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    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
    The aim of this study is to elucidate the mechanisms underlying the positive effect of incretin therapy on lipoprotein metabolism, liver fat and cardiovascular risk markers.
    1) To examine the effect of liraglutide on triglycerides (TG) and apoB48 production rates (PR) and/or fractional catabolic rates (FRC) in the lipoprotein fraction chylomicrons (Sf>400) in patients with T2DM. This will be fulfilled by kinetic modeling during a standardized fat-rich mixed-meal test.
    2) To evaluate the in humans the effect of treatment with liraglutide compared to baseline on hepatic de novo lipogenesis and liver fat content in patients with T2DM, assessed during a standardized fat-rich mixed meal test.
    Tutkia liraglutidin vaikutusmekanismeja lipoproteiiniaineenvaihduntaan, maksan rasvoittumiseen ja kardiovaskulaariskin merkkiaineisiin.
    1) Liraglutidin vaikutus triglyseridien ja apoB-48:n tuotantonopeuteen ja katabolian nopeuteen kylomikronifraktiossa käyttäen aterianjälkeistä kinetiikkamallinnusta tyypin 2 diabetesta sairastavilla
    2) Liraglutidin vaikutus maksan rasvojen uudismuodostukseen ja maksan rasvoittumiseen tyypin 2 diabetesta sairastavilla
    E.2.2Secondary objectives of the trial
    To evaluate the effect of treatment with liraglutide compared to baseline in patients with T2DM, assessed during a standardized fat-rich mixed-meal test combined with stable isotope administration on:
    -production rates (PR) of TG, apo-B48 and apo-B100 in the lipoprotein fractions VLDL1 (Sf 60–400) and VLDL2 (Sf 20–60)
    -fractional catabolic rates (FCRs) of TG, ap-B48 and apo-B100 in the lipoprotein fraction VLDL1 (Sf 60–400) and VLDL2 (sf 20–60)
    -fasting and postprandial serum total TG, total cholesterol, and total apo-B, apo-B48, RLP-chol and RLP-TG, apo-CIII and apo-A5 as well as fasting LDL and HDL size. RLP-chol and RLP-TG are surrogate markers of remnants. Apo-CIII and apo-A5 are key regulators of the lipolytic cascade.
    -TRL clearance assessed as effect on post-heparin lipoprotein lipase (LPL) and hepatic lipase (HL) activities. LPL and HL are the key enzymes regulating lipolysis of TRLs and remnant removal by the liver.
    - fasting and postprandial glucose, insulin and C-pept
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Obese subjects with T2D and a large waist (waist > 88 cm in women and > 92 cm in men, BMI 27–40 kg/m2, triglycerides between 1.0 – 4.0 mmol/L and LDL < 4.5 mmol/l) treated with a lifestyle or metformin (any dose) (HbA1c 6.5-9% ) and aged 30 – 75 years will be included. Subjects may or may not use statins
    E.4Principal exclusion criteria
    ● Type 1 diabetes
    ● Apo E2/2 phenotype
    ● ALT/AST > 3x ULN
    ● GFR < 60 ml/min, clinically significant TSH outside normal range
    ● Lipid-lowering drugs other than statins within 6 months
    ● Treatment with pioglitazone, insulin, sulphonylureas, gliptines, glinides, SGLT-2 inhibitors or thiazide diuretics (at a dose of > 25 mg / day) within 6 months
    ● Blood pressure > 160 mmHg systolic and/or > 105 diastolic
    ● History of pancreatitis or stomach / other major bleeding, thyroid neoplasia, persistent hypothyroidism or persistent hyperthyroidism
    ● Any medical condition that puts the patient in the risk of dehydration
    ● Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
    ● Females of childbearing potential who are not using adequate contraceptive methods
    ● Subjects who have experienced side-effects previously from GLP-1 agonists
    ● Non-compliance or withdrawal of consent
    E.5 End points
    E.5.1Primary end point(s)
    1) effect of liraglutide on triglycerides (TG) and apoB48 production rates (PR) and/or fractional catabolic rates (FRC) in the lipoprotein fraction chylomicrons (Sf>400) in patients with T2DM. This will be fulfilled by kinetic modeling during a standardized fat-rich mixed-meal test.
    2) effect of treatment with liraglutide compared to baseline on hepatic de novo lipogenesis and liver fat content in patients with T2DM, assessed during a standardized fat-rich mixed meal test.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline vs 3.5 months after treatment
    E.5.2Secondary end point(s)
    The effect of treatment with liraglutide compared to baseline in patients with T2DM, assessed during a standardized fat-rich mixed-meal test combined with stable isotope administration on:
    -production rates (PR) of TG, apo-B48 and apo-B100 in the lipoprotein fractions VLDL1 (Sf 60–400) and VLDL2 (Sf 20–60)
    -fractional catabolic rates (FCRs) of TG, ap-B48 and apo-B100 in the lipoprotein fraction VLDL1 (Sf 60–400) and VLDL2 (sf 20–60)
    -fasting and postprandial serum total TG, total cholesterol, and total apo-B, apo-B48, RLP-chol and RLP-TG, apo-CIII and apo-A5 as well as fasting LDL and HDL size. RLP-chol and RLP-TG are surrogate markers of remnants. Apo-CIII and apo-A5 are key regulators of the lipolytic cascade.
    -TRL clearance assessed as effect on post-heparin lipoprotein lipase (LPL) and hepatic lipase (HL) activities. LPL and HL are the key enzymes regulating lipolysis of TRLs and remnant removal by the liver.
    -fasting and postprandial glucose, insulin and C-peptide, assessed also during an OGTT.
    -fasting visceral andsubcutaneous fat depots assessed by MRS in both fasting and in postprandial period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline vs 3.5 months after 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 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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
    Trial end is the last day of the use of the investigational drug
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state26
    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 Decision2014-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-19
    P. End of Trial
    P.End of Trial StatusOngoing
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