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    Clinical Trial Results:
    Effect of Strict Control of Blood Sugar with Insulin Regimen on Prevention of Atrial Fibrillation after Coronary Artery Bypass Grafting.

    Summary
    EudraCT number
    		 2004-004348-39
    Trial protocol
    		 GB  
    Global end of trial date
    04 Jul 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2021
    First version publication date
    19 Feb 2021
    Other versions
    Summary report(s)
    		 End of study report

    Trial information

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    Trial identification
    Sponsor protocol code
    2004HS0191H
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Royal Brompton and Harefield NHS Foundation Trust
    Sponsor organisation address
    Research Office, Sydney Street, London, United Kingdom, SW3 6NP
    Public contact
    Ira Jakupovic, Royal Brompton and Harefield NHS Foundation Trust, 3518109 3518109, i.jakupovic@rbht.nhs.uk
    Scientific contact
    Ira Jakupovic, Royal Brompton and Harefield NHS Foundation Trust, 3518109 3518109, i.jakupovic@rbht.nhs.uk
    Sponsor organisation name
    Royal Brompton and Harefield NHS Foundation Trust
    Sponsor organisation address
    Research Office, Sydney Street, London, United Kingdom, SW3 6NP
    Public contact
    Ira Jakupovic, Royal Brompton and Harefield NHS Foundation Trust, 0207 3518109, i.jakupovic@rbht.nhs.uk
    Scientific contact
    Ira Jakupovic, Royal Brompton and Harefield NHS Foundation Trust, 0207 3518109, i.jakupovic@rbht.nhs.uk
    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
    04 Jul 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 May 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2008
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Prevention of Atrial Fibrillation following Coronary Artery Bypass Grafting.
    Protection of trial subjects
    n/a
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Sep 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 77
    Worldwide total number of subjects
    77
    EEA total number of subjects
    0
    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)
    77
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients admitted for primary, isolated CABG, were recruited to participate in the study. A total 88 patients were enrolled for the study between September 2005 and May 2008.

    Pre-assignment
    Screening details
    		 n/a

    Period 1
    Period 1 title
    Overal Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    n/a

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Soluble Insuling Actrapid
    Arm description
    		 Control Group – The patients were treated routinely with intravenous insulin when blood glucose level exceeds 10 mmol/L.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Soluble Insulin Actrapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Control Group – The patients were treated routinely with intravenous insulin when blood glucose level exceeds 10 mmol/L.

    Arm title
    		 Soluble Insulin Actrapid with Algorithm
    Arm description
    		 Treatment Group - Patients were treated with intravenous insulin using the Algorithm for Intensive Insulin Therapy to maintain blood glucose between 4.0 to 6.0 mmol/L starting from the time of induction for surgery and continued for 96 hours post-operatively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Actrapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Treatment Group - Patients were treated with intravenous insulin using the Algorithm for Intensive Insulin Therapy to maintain blood glucose between 4.0 to 6.0 mmol/L starting from the time of induction for surgery and continued for 96 hours post-operatively.

    Number of subjects in period 1
    		Soluble Insuling Actrapid Soluble Insulin Actrapid with Algorithm
    Started
    41
    36
    Completed
    41
    36

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Soluble Insuling Actrapid
    Reporting group description
    		 Control Group – The patients were treated routinely with intravenous insulin when blood glucose level exceeds 10 mmol/L.

    Reporting group title
    Soluble Insulin Actrapid with Algorithm
    Reporting group description
    		 Treatment Group - Patients were treated with intravenous insulin using the Algorithm for Intensive Insulin Therapy to maintain blood glucose between 4.0 to 6.0 mmol/L starting from the time of induction for surgery and continued for 96 hours post-operatively.

    Primary: Incidence of AF

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    End point title
    		 Incidence of AF [1]
    End point description
    The present study was undertaken to find out the incidence of atrial fibrillation on strict control of blood glucose with Insulin infusion up to four days following CABG. In addition, this study aimed to look after other beneficial effects of tight glycaemic control on the outcome after CABG. In this randomised trial, patients treated with insulin infusion to maintain blood glucose level between 4.0 to 6.0 mmol/L for four days were compared with control group receiving standard treatment after CABG.
    End point type
    Primary
    End point timeframe
    The incidence of atrial fibrillation on strict control of blood glucose with Insulin infusion up to four days following CABG.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Details of statistical analyis sumbitted with the end of study report.
    End point values
    		 Soluble Insuling Actrapid Soluble Insulin Actrapid with Algorithm
    Number of subjects analysed
    41
    36
    Units: mmol/L
    41
    36
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events occurring during the course of the clinical trial were to be collected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Attached is the final report study report, sent to the MHRA in 2008.

    More information

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    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
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    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.

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