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    Summary
    EudraCT Number:2017-000043-40
    Sponsor's Protocol Code Number:GLOBE2017
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-01-30
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-000043-40
    A.3Full title of the trial
    GLP-1 for bridging of hyperglycaemia during cardiac surgery: a randomized controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of alternative drug to insulin for the treatment of high blood glucose concentration in cardiac surgery patients
    A.3.2Name or abbreviated title of the trial where available
    The GLOBE trial
    A.4.1Sponsor's protocol code numberGLOBE2017
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1183-2689
    A.5.4Other Identifiers
    Name:UTN registerNumber:U1111-1183-2689
    Name:CCMO numberNumber:NL60461.018.17
    Name:Nederlands Trial RegisterNumber:NTR6323
    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 SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    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
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointDr. J. Hermanides
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205669111
    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 AuthorisationEuropean Union
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    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
    Hyperglyceamia during Cardiac Surgery
    E.1.1.1Medical condition in easily understood language
    High blood glucose concentration in patients undergoing cardiac surgery
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10060439
    E.1.2Term Stress induced hyperglycaemia
    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 study is to investigate the potential of liraglutide to lower the proportion of patients needing insulin therapy during cardiac surgery when aiming for a perioperative plasma glucose of <8 mmol l-1.
    E.2.2Secondary objectives of the trial
    the secondary objectives of this study are to assess the effect of perioperative liraglutide treatment on total perioperative insulin need, glycaemic control and postoperative complications during and after cardiac surgery.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Before the first study drug treatment the sensor of a subcutaneous continuous glucose monitor is inserted into the subcutaneous tissue. This will be done in a subset of 26 patients included in the AMC or OLVG (for logistical reasons).
    To show a difference in % time in target range (%TIR) of 10% with a SD of 9%, a significance of 0.05, and 80% power, we need a sample size of 13 in both groups. Hence, we aim to include 26 patients in a per protocol sub-analysis.
    E.3Principal inclusion criteria
    • Adult patients, aged 18-80 years (inclusive),
    • No known diabetes mellitus, or
    • Known diabetes mellitus type 2 on oral glucose lowering medication, diet or total daily insulin dose ≤0.5 IU/kg
    • Scheduled for an elective cardiac surgical procedure.
    • Informed consent obtained before any trial-related activities are carried out.
    E.4Principal exclusion criteria
    • Diabetes mellitus type 1
    • Emergency surgery
    • Receiving oral corticosteroid therapy
    • History of pancreatic surgery or acute or chronic pancreatitis
    • Personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia23 syndrome type 2 (MEN2)
    • Heart failure NYHA class IV
    • Serum-creatinine ≥ 133 μmol l-1 for males and ≥ 115 μmol l-1 for females, measured within 6 months before date of surgery.
    • Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
    • Current treatment with GLP-1 analogues
    • Known or suspected allergy to trial products or other drugs in the same class
    E.5 End points
    E.5.1Primary end point(s)
    The main outcome measure is the proportion of patients needing insulin therapy in the perioperative period (morning of surgery until transfer to the Intensive Care Unit)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Morning of surgery until transfer to the Intensive Care Unit
    E.5.2Secondary end point(s)
    We will assess the following secondary outcome parameters:
    • Total perioperative insulin use (IU/day)
    • Number of insulin administrations
    • Composite postoperative complications*
    • Glucose control in the perioperative period, as assessed by the mean perioperative glucose
    • Number of perioperative hyperglycaemic events (>11 mmol l-1)
    • Number of moderate perioperative hypoglycaemic events (<4 mmol l-1)
    • Number of severe perioperative hypoglycaemic events (<2.3 mmol l-1)
    • Percent of time spent in target range (4 – 8 mmol l-1)
    • Proportion of patients with postoperative nausea and vomiting
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day of surgery until 30 days after surgery
    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 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) 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 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 concerned5
    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
    End of trial: 30 days after surgery of the last patient included in the trial
    Premature study termination will be considered when the benefit to risk ratio changes during the study. This can be due to events reported in this study, but also due to events reported in other studies or regular patient care.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 174
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state274
    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 Decision2017-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-30
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