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   43843   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

    Download PDF

    Clinical Trial Results:
    Perioperative intravenous insulin, GIK or GLP-1 treatment in DM

    Summary
    EudraCT number
    		 2012-005291-34
    Trial protocol
    		 NL  
    Global end of trial date
    20 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 May 2021
    First version publication date
    06 May 2021
    Other versions
    Summary report(s)
    		 publication

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NL41467
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amsterdam UMC
    Sponsor organisation address
    Meibergdreef 9, Amsterdam, Netherlands,
    Public contact
    J.A.W. Polderman, AMC, Amsterdam, J.A.Polderman@amc.uva.nl
    Scientific contact
    J.A.W. Polderman, AMC, Amsterdam, J.A.Polderman@amc.uva.nl
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the optimal treatment strategy for diabetes mellitus during non-cardiac surgery
    Protection of trial subjects
    All trial subjects were followed until 30 days after surgery.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 167
    Worldwide total number of subjects
    167
    EEA total number of subjects
    167
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    93
    From 65 to 84 years
    74
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were recuited on the pre-assessment visit

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 167
    Number of subjects completed
    		 167

    Period 1
    Period 1 title
    Recruitment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GIK infusion
    Arm description
    		 patients receiving a GIK infusion perioperatively
    Arm type
    		 Active comparator

    Investigational medicinal product name
    novorapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    novorapid was added to glucose 5% solution for intravenous drip

    Investigational medicinal product name
    potassium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 ampule of potassium was added to glucose 5% solution for infusion

    Arm title
    		 Bolus
    Arm description
    		 received insulin boluses
    Arm type
    		 Active comparator

    Investigational medicinal product name
    novorapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    novorapid was added to glucose 5% solution for intravenous drip

    Arm title
    		 liraglutide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    liraglutide
    Investigational medicinal product code
    Other name
    victoza
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide 0,6 en 1,2 mg

    Number of subjects in period 1
    		GIK infusion Bolus liraglutide
    Started
    59
    55
    53
    Completed
    53
    53
    44
    Not completed
    6
    2
    9
         Protocol deviation
    6
    2
    9

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    GIK infusion
    Reporting group description
    		 patients receiving a GIK infusion perioperatively

    Reporting group title
    Bolus
    Reporting group description
    		 received insulin boluses

    Reporting group title
    liraglutide
    Reporting group description
    		 -

    Reporting group values
    		 GIK infusion Bolus liraglutide Total
    Number of subjects
    		 59 55 53 167
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 28 32 25 85
        From 65-84 years
    		 31 23 28 82
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62 ( 8.1 ) 61 ( 8.6 ) 62 ( 8.8 ) -
    Gender categorical
    gender
    Units: Subjects
        Female
    		 29 27 28 84
        Male
    		 30 28 25 83

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    GIK infusion
    Reporting group description
    		 patients receiving a GIK infusion perioperatively

    Reporting group title
    Bolus
    Reporting group description
    		 received insulin boluses

    Reporting group title
    liraglutide
    Reporting group description
    		 -

    Primary: glucose 1 hour postoperative

    		 Close Top of page
    End point title
    		 glucose 1 hour postoperative
    End point description
    glucose 1 hour postoperative
    End point type
    Primary
    End point timeframe
    glucose 1 hour postoperative
    End point values
    		 GIK infusion Bolus liraglutide
    Number of subjects analysed
    53
    53
    44
    Units: mmol/l
    median (inter-quartile range (Q1-Q3))
        primary endpoint
    7.5 (6.4 to 8.3)
    7.6 (6.4 to 8.9)
    6.6 (5.6 to 7.7)
    Statistical analysis title
    		 Mann Withney U
    Comparison groups
    GIK infusion v Bolus v liraglutide
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 0.05
    Variability estimate
    Standard deviation

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    until 30 days postoperatively
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    GIK infusion
    Reporting group description
    		 patients receiving a GIK infusion perioperatively

    Reporting group title
    Bolus
    Reporting group description
    		 received insulin boluses

    Reporting group title
    liraglutide
    Reporting group description
    		 -

    Serious adverse events
    		 GIK infusion Bolus liraglutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 53 (11.32%)
    5 / 53 (9.43%)
    2 / 49 (4.08%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Blood and lymphatic system disorders
    Embolism
    Additional description: lung embolism or bleeding
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 53 (5.66%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Infection
    Additional description: wound infection or sepsis
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 53 (3.77%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 GIK infusion Bolus liraglutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 53 (7.55%)
    1 / 53 (1.89%)
    1 / 49 (2.04%)
    Endocrine disorders
    hypoglycemia
    Additional description: mild hypoglycemia under 4.0 mmol per liter
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    4 / 53 (7.55%)
    1 / 53 (1.89%)
    1 / 49 (2.04%)
         occurrences all number
    4
    1
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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 06:55:23 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA