Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-003577-26
    Sponsor's Protocol Code Number:U1111-1131-5236
    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:2012-09-26
    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 number2012-003577-26
    A.3Full title of the trial
    Liraglutide Kidney:
    A randomised, double-blinded, cross-over study investigating the short-term impact of liraglutide on kidney function in diabetic patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Liraglutide Kidney:
    A study investigating the short-term impact of liraglutide on kidney function in diabetic patients
    A.4.1Sponsor's protocol code numberU1111-1131-5236
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1131-5236
    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 SponsorAarhus University Hospital
    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.4.1Name of organisation providing supportDanish Agency for Science Technology and Innovation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAarhus University Hospital, dep. MEA
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hosptital, MEA
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressNørrebrogade 44, building 2
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.6E-mailjsk@dadlnet.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 Yes
    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
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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 the impact of a single dose liraglutide on Glomerular Filtration Rate (GFR).
    E.2.2Secondary objectives of the trial
    To investigate the impact of a single dose liraglutide on:
    Renal blood flow, diuresis, albuminuria, kidney perfusion and oxygenation, tubular proximal sodium reabsorption, sodium clearance, potassium clearance, calcium clearance, osmolar- and free water clearance, P-angiotensin-II, P-aldosterone, P-renin, P-Atrial Natriuretic Peptide (ANP), U-angiotensinogen, adrenaline level, noradrenaline level, P-GLP-1 and P-glucagon, oxidative stress, inflammation, kidney injury markers, blood pressure and pulse.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.
    Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
    2.
    Male gender
    3.
    T2DM, diagnosed according to international guidelines
    4.
    Age 20-60 years, both included
    5.
    Body Mass Index (BMI): 20-32 kg/m2, both included
    6.
    Metformin treatment
    7.
    Albumin/creatinine ratio < 25 mg/mmol
    E.4Principal exclusion criteria
    1.
    Known or suspected allergy to trial product or related products
    2.
    Previous participation in this trial
    3.
    Previous treatment with GLP-1 analogues or DPP-4 inhibitors
    4.
    Current treatment with any antidiabetic drug other than metformin
    5.
    Poorly regulated glycemic control (HbA1c > 8%)
    6.
    Impaired kidney function: estimated GFR < 70ml/min (estimated from creatinine concentration)
    7.
    Impaired liver function: liver parameters exceed 2 times or more the upper normal limit, according to the hospital lab
    8.
    Subjects with active malignancy
    9.
    Severe cardiac insufficiency classified according to NYHA III-IV
    10.
    Unstable angina pectoris, acute myocardial infarction (AMI) within the last 12 months
    11.
    Severe, uncontrolled hypertension: sitting blood pressure (BP) > 180/110 mmHg
    12.
    Antihypertensive treatment consisting of more than two different pharmaceutical products
    13.
    Symptoms related to benign prostate hyperplasia
    14.
    Claustrophobia
    15.
    Any metal body implants
    16.
    History of pancreatitis, type 1 diabetes, gastroparesis or multiple endocrine neoplasia syndrome type 2
    17.
    Personal or family history of medullary thyroid carcinoma
    18.
    Any diseases judged by the investigator that could affect the trial
    19.
    Any medication judged by the investigator that could affect the trial
    E.5 End points
    E.5.1Primary end point(s)
    Single dose 51Cr-EDTA plasma clearance.
    E.5.1.1Timepoint(s) of evaluation of this end point
    By measuring plasma activity every 30 min for the last 1.5 hours of the 5 hours clearance period we can estimate area under the curve (AUC) by extrapolation. Clearance can be estimated as total bolus activity divided by AUC.
    E.5.2Secondary end point(s)
    fMRI (Functional Magnetic Resonance Imaging ). Renal blood flow will be estimated bilaterally in the renal arteries. Using BOLD (Blood Oxygen Level Dependent) technique renal oxygenation in both cortex and medulla will be estimated. If possible (MR protocols are under development) renal perfusion in both cortex and medulla will be estimated using arterial spin labelling technique. The scans will be performed by the coordinating investigator and the data will be analyzed in collaboration with a MR physicist from Department of Nuclear Medicine, Aarhus University Hospital. The MR techniques involved are all non invasive with no exposure of radiation and no contrast injection.
    Urine production (flow) in the night (21.30 – 7.30) and during the clamp period (7.30-12.30).
    Measurements of urine albumin excretion during the night (21.30 – 7.30) and during the clamp period (7.30-12.30).
    Electrolyte excretion (sodium, potassium, calcium and osmolal) during the night (21.30-7.30). Evaluated from the electrolyte urine concentrations from the collection at 7.30.
    Lithium Clearance, Clith=Uflow*Ulith/Plith with Plith=P1-P2/(2.3*log(P1/P2)). P1 and P2 is the plasma lithium concentration at time 7.30 and 12.30. Uflow is the urine flow from 7.30 to 12.30 and Ulith is the urine lithium concentration in the urine collection at 12.30. Lithium clearance is a marker of proximal tubular sodium reabsorption.
    Electrolyte clearances during clamp period: Measurements of sodium, potassium, calcium and osmolal clearance. CX= Uflow*UX/(½PX1+½PX2) where PX1 and PX2 are the plasma concentration of electrolyte X at time 7.30 and 12.30. Uflow is the urine flow from 7.30 to 12.30 and UX is the urine concentration of electrolyte X at collection time 12.30.
    Hormone concentrations. Average values of P-angiotensin-II, P-aldosterone, P-renin, P-ANP and P-methanephrine, P-GLP-1 and P-glucagon measured at time 7.30 and 12.30.
    Urinary excretion of adrenaline, noradrenaline and methanephrine, angiotensinogen, during clamp period (7.30-12.30).
    Oxidative stress level. Urinary excretion of 8-OHdG (8-hydroxy-2’-deoxyguanosine) during the night (21.30 – 7.30) and during the clamp period (7.30-12.30). 8-OHdG is a marker of oxidative DNA damage.
    Inflammatory level. Plasma values of high-sensitive C-reactive protein (P-HS-CRP) measured 7.30 and 12.30.
    Markers of kidney injury. Urinary excretion of neutrophil gelatinase associated protein (NGAL) and kidney injury molecule 1 (KIM1) during the night (21.30 – 7.30) and during the clamp period (7.30-12.30).
    The measurements of P-glucose and the amount of glucose and Actrapid infused in the clamp period will be recorded.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See secondary endpoints (E.5.2)
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.6Cross over Yes
    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 years1
    E.8.9.1In the Member State concerned months4
    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: 12
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 state12
    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 Decision2012-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-27
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 18 15:04:13 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA