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    Summary
    EudraCT Number:2013-002348-99
    Sponsor's Protocol Code Number:AUTH88622
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-14
    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 ConcernedGreece - EOF
    A.2EudraCT number2013-002348-99
    A.3Full title of the trial
    A randomised, double blind, placebo-controlled study of the effect of liraglutide on arterial blood pressure in hypertensive patients with type 2 diabetes mellitus
    Μία τυχαιοποιημένη, διπλά τυφλή, ελεγχόμενη με εικονικό φάρμακο μελέτη της επίδρασης της λιραγλουτίδης στην αρτηριακή πίεση υπερτασικών ασθενών με σακχαρώδη διαβήτη τύπου 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of liraglutide on arterial blood pressure in hypertensive patients with type 2 diabetes mellitus
    Mελέτη της επίδρασης της λιραγλουτίδης στην αρτηριακή πίεση υπερτασικών ασθενών με σακχαρώδη διαβήτη τύπου 2
    A.3.2Name or abbreviated title of the trial where available
    LIRA
    A.4.1Sponsor's protocol code numberAUTH88622
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1125-9028
    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 SponsorAristotle University Thessaloniki
    B.1.3.4CountryGreece
    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 HELLAS
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCRAxis
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street Address352 Kifisias Avenue
    B.5.3.2Town/ cityHalandri,
    B.5.3.3Post code11532
    B.5.3.4CountryGreece
    B.5.4Telephone number+302106818303
    B.5.5Fax number+302106818680
    B.5.6E-mailinfo@craxis.gr
    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 AuthorisationGreece
    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.3.1Product nameVIctoza
    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 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
    Hypertention, Type 2 Diabetes
    Υπέρταση, Διαβήτης τύπου 2
    E.1.1.1Medical condition in easily understood language
    Hypertention, Diabetes
    Υπέρταση, Διαβήτης
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    A randomised, double blind, placebo-controlled study in patients with type 2 diabetes mellitus (T2DM), investigating the effect of liraglutide on blood pressure (BP), assessed by 24 h ambulatory blood pressure monitoring (ABPM).
    Μία τυχαιοποιημένη, διπλά τυφλή, ελεγχόμενη με εικονικό φάρμακο μελέτη, σε ασθενείς με σακχαρώδη διαβήτη τύπου 2 (ΣΔΤ2), που ερευνά την επίδραση της λιραγλουτίδης στην αρτηριακή πίεση (ΑΠ), μετά από 24ωρη καταγραφή
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Type 2 diabetes mellitus
    2. Age >18 years
    3. Patients on stable antihyperglycaemic treatment for at least 12 weeks prior to recruitment. Stable treatment is considered stable medication and dose.
    4. HbA1c: 7.5%-10%
    5. Patients with prehypertension or stage 1 hypertension (JNC7) [1], on stable antihypertensive agent treatment for at least 6 weeks prior to the start of the study.
    6. Prior to randomisation, on visit 1 and visit 2a, patients must have:
    a. mean sitting systolic BP (SBP) >95 and <160 mmHg,
    b. mean sitting diastolic BP (DBP) >50 and <100 mmHg,
    c. a decrease in SBP of <20 mmHg or increase in heart rate (HR) of <30 beats per min (bpm) when standing from the sitting position, and
    d. a pulse rate >40 bpm in the sitting position
    7. Creatinine clearance ≥60 mL/min
    8. Good clinical condition as determined by medical history, vital signs, ECG, physical examination, laboratory tests (haematology, chemistry, urine analysis)
    9. Ability to provide written informed consent
    1. Σακχαρώδης διαβήτης τύπου 2
    2. Ηλικία >18 ετών
    3. Ασθενείς σε σταθερή αντιυπεργλυκαιμική αγωγή για τουλάχιστον 12 εβδομάδες πριν την εισαγωγή στη μελέτη. Σταθερή αγωγή θεωρείται η χορήγηση συγκεκριμένου φαρμακευτικού σκευάσματος και συγκεκριμένης δόσης.
    4. HbA1c: 7.5%-10%
    5. Ασθενείς με προ-υπέρταση ή υπέρταση σταδίου 1 (JNC7) [1], σε θεραπεία με σταθερή αντιυπερτασική αγωγή για τουλάχιστον 6 εβδομάδες πριν την έναρξη της μελέτης.
    6. Πριν την τυχαιοποίηση, στην επίσκεψη 1 και 2α, οι ασθενείς πρέπει να έχουν:
    i. μέση συστολική ΑΠ (ΣΑΠ) σε καθιστή θέση >95 και <160 mmHg,
    ii. μέση διαστολική ΑΠ (ΔΑΠ) σε καθιστή θέση >50 και <100 mmHg,
    iii. ελάττωση της ΣΑΠ κατά <20 mmHg ή αύξηση της καρδιακής συχνότητας (ΚΣ) κατά <30 ανά λεπτό κατά την μετάβαση από την καθιστή στην όρθια θέση, και
    iv. σφύξεις >40/λεπτό σε καθιστή θέση.
    7. Κάθαρση κρεατινίνης ≥60 mL/min
    8. Καλή φυσική κατάσταση όπως καθορίζεται από το ιατρικό ιστορικό, τα ζωτικά σημεία, το ΗΚΓ, τη φυσική εξέταση και τις εργαστηριακές εξετάσεις (αιματολογικές, βιοχημικές, ανάλυση ούρων).
    9. Ικανότητα του ασθενούς να παρέχει γραπτή συγκατάθεση.
    E.4Principal exclusion criteria
    1. Patients who used insulin, a GLP-1 agonist or a DPP-4 inhibitor during the previous 3 months
    2. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice). A pregnancy test will be performed in women with childbearing potential during the V1.
    3. Night shift workers who sleep during the daytime
    4. History of drug or alcohol dependency
    5. Hepatic or renal dysfunction
    a. SGOT (ALT) or SGPT (AST) >2 times the upper limit of normal
    b. Creatinine clearance <60 mL/ min
    6. Lipase >= 3 x UNL
    7. Hypersensitivity to trial drug or similar
    8. Previous history of pancreatitis
    9. Type 1 diabetes, familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma, personal history of non-familial medullary thyroid carcinoma
    10. History or presence of immunological or haematological disorders
    11. Known or suspected secondary hypertension
    12. Medication that may affect BP (steroids/NSAIDs)
    13. Upper arm circumference >42 cm
    14. Any clinical condition that would not allow safe completion of the protocol according to investigators opinion
    1. Ασθενείς σε θεραπεία με ινσουλίνη, GLP-1 αγωνιστές ή DPP-4 αναστολείς κατά τους προηγούμενους 3 μήνες.
    2. Γυναίκες σε αναπαραγωγική ηλικία που κυοφορούν, θηλάζουν ή είναι πιθανό να εγκυμονήσουν ή δεν χρησιμοποιούν επαρκή μέθοδο αντισύλληψης (επαρκή μέτρα αντισύλληψης όπως αυτά καθορίζονται από την τοπική νομοθεσία και πρακτική). Τεστ κύησης θα πραγματοποιηθεί στις γυναίκες αναπαραγωγικής ηλικίας κατά την επίσκεψη 1.
    3. Ασθενείς που εργάζονται σε βραδινή βάρδια και κοιμούνται κατά τη διάρκεια της ημέρας
    4. Ιστορικό εξάρτησης από αλκοόλ ή ναρκωτικές ουσίες
    5. Ηπατική ή νεφρική δυσλειτουργία:
    a. SGOT (ALT) ή SGPT (AST) >2 φορές πάνω από το ανώτερο φυσιολογικό όριο
    b. Κάθαρση κρεατινίνης <60 mL/min
    6. Λιπάση ≥3 φορές πάνω από το ανώτερο φυσιολογικό όριο
    7. Υπερευαισθησία στο φάρμακο της μελέτης ή άλλο παρόμοιο
    8. Προηγούμενο ιστορικό παγκρεατίτιδας
    9. Διαβήτης τύπου 1, οικογενειακό ή ατομικό ιστορικό πολλαπλής ενδοκρινικής νεοπλασίας τύπου 2 (MEN2) ή οικογενούς μυελοειδούς καρκινώματος του θυρεοειδή, ατομικό ιστορικό μη οικογενούς μυελοειδούς καρκινώματος του θυρεοειδή
    10. Ιστορικό ή παρουσία ανοσολογικής ή αιματολογικής διαταραχής
    11. Γνωστή δευτεροπαθής ή υποψία ύπαρξης δευτεροπαθούς αρτηριακής υπέρτασης
    12. Φάρμακα που μπορεί να επηρεάσουν την ΑΠ (στεροειδή/ΜΣΑΦ)
    13. Περιφέρεια βραχίονα >42 cm
    14. Οποιαδήποτε κλινική κατάσταση που δεν θα επέτρεπε την ασφαλή ολοκλήρωση του πρωτοκόλλου σύμφωνα με τη γνώμη των ερευνητών.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the difference in the change of mean 24 h SBP between the two groups (liraglutide and placebo).
    Το πρωτεύον καταληκτικό σημείο είναι η διαφορά στη μεταβολή της μέσης 24ωρης ΣΑΠ ανάμεσα στις δύο ομάδες (λιραγλουτίδης και εικονικού φαρμάκου).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of trial
    Ολοκλήρωση της μελέτης
    E.5.2Secondary end point(s)
    1. Difference in the change in mean daytime and mean night time SBP and DBP and heart rate between the two groups
    2. Difference in the change in weight between the two groups
    3. Difference in the change in renal sodium handling (sodium fractional excretion [FENa], proximal and distal sodium reabsorption) between the two groups
    4. Difference in the changes in glycaemic control (assessed by HbA1c and fasting blood glucose) and insulin sensitivity (HOMA%S) between the two groups
    5. Difference in the change of antihypertensive medication necessary to treat in accordance to the current medical practice and the related guidelines
    1. Η διαφορά στη μεταβολή της μέσης ημερήσιας και μέσης νυχτερινής ΣΑΠ και ΔΑΠ καθώς και στην καρδιακή συχνότητα μεταξύ των δύο ομάδων
    2. Η διαφορά στη μεταβολή του βάρους μεταξύ των δύο ομάδων
    3. Η διαφορά στη μεταβολή της ρύθμισης του νατρίου από το νεφρό (κλασματική απέκκριση νατρίου [FENa], εγγύς και άπω επαναρρόφηση του νατρίου) μεταξύ των δύο ομάδων
    4. Η διαφορά στη μεταβολή του γλυκαιμικού ελέγχου (εκτιμώμενη από την HbA1c και τις τιμές γλυκόζης νηστείας) και της ευαισθησίας στην ινσουλίνη (HOMA%S) μεταξύ των δύο ομάδων
    5. Η διαφορά στη μεταβολή της αντιυπερτασικής αγωγής που είναι απαραίτητη για τη θεραπεία σύμφωνα με την παρούσα ιατρική πρακτική και τις σχετικές κατευθυντήριες οδηγίες
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of trial
    Ολοκλήρωση της μελέτης
    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 No
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 112
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state112
    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 Decision2014-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-19
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