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    Clinical Trial Results:
    A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis.

    Summary
    EudraCT number
    		 2005-002997-31
    Trial protocol
    		 GB  
    Global end of trial date
    11 Jan 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Dec 2019
    First version publication date
    21 Dec 2019
    Other versions
    Summary report(s)
    		 end of trial letter to MHRA
    end of declaration form

    Trial information

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    Trial identification
    Sponsor protocol code
    SCH/05/015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sheffield Children's Hospital NHS Foundation Trust
    Sponsor organisation address
    Western Bank, Sheffield, United Kingdom, S10 2TH
    Public contact
    Dominic Nash, Sheffield Children's Hospital NHS Foundation Trust, 44 01143053478, dominic.nash@nhs.net
    Scientific contact
    Dominic Nash, Sheffield Children's Hospital NHS Foundation Trust, 44 01143053478, dominic.nash@nhs.net
    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
    11 Jan 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jan 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To examine whether treatment with a long acting insulin analogue in the prediabetic phase improves growth & lung function and whether it delays progression to the development of overt diabetes in cystic fibrosis
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Oct 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: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    40
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study duration will be 3 years – 2 years for recruitment and 1 year for run-out. The expected total duration of participation in the study for each participant is 12 months. The end of trial is 12 months after the recruitment of the last patient.

    Pre-assignment
    Screening details
    		 Not applicable

    Period 1
    Period 1 title
    overall trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 intervention
    Arm description
    		 insulin detemir 0.2u/kg given as a single daily dose before breakfast
    Arm type
    		 Experimental

    Investigational medicinal product name
    insulin determir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    insulin detemir 0.2u/kg given as a single daily dose before breakfast

    Number of subjects in period 1
    		intervention
    Started
    40
    Completed
    40
    Period 2
    Period 2 title
    control
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 control
    Arm description
    		 No injection given
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		control
    Started
    40
    Completed
    40

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 insulin detemir 0.2u/kg given as a single daily dose before breakfast
    Reporting group title
    control
    Reporting group description
    		 No injection given

    Primary: end of study

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    End point title
    		 end of study [1]
    End point description
    1. Measurements of beta-cell function. Multiple regression models will be constructed to examine which measures of beta cell function and glucose tolerance at baseline best predict future glucose tolerance, pulmonary function and clinical status at 12 months. 2. height, weight, BMI, triceps and biceps skin fold thickness 3. respiratory function testing including measurement of FEV1, FVC, Shwachman score and record of respiratory exacerbations 4. 3 monthly glycosylated haemoglobin, examination of home testing blood sugar profiles 5. Adverse event monitoring (complications of CF, hypoglycaemia, other side effects).
    End point type
    Primary
    End point timeframe
    end of study
    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: Previous studies of insulin in CFRD shoed a difference in FVC of 12.6% (SD+/- 5.0%) and in FEV1 of 6.5% (SD +/- 4.0) following treatment. Assuming a much smaller 5% difference in FVC & FEV1 only 15 children are needed in each arm of the treatment aspect of the study to demonstrate a significant beneficial effect of insulin (95% confidence – 80% power) No other statistical analysis was performed
    End point values
    		 intervention control
    Number of subjects analysed
    40
    40
    Units: NA
    40
    40
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Duration of trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 0%
    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: No serious adverse events were reported

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Oct 2007
    Dr Fiona Campbell is to replace Dr Steven Conway as principal investigator at the Leeds site

    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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