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    Clinical Trial Results:
    The effect of prednisolone versus hydrocortisone as glucocorticoid replacement therapy on hypoglycaemia frequency in people with Type 1 diabetes and adrenal insufficiency: a pilot study.

    Summary
    EudraCT number
    		 2008-002336-15
    Trial protocol
    		 GB  
    Global end of trial date
    20 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 May 2019
    First version publication date
    03 May 2019
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    578
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Prof Stephanie Amiel, King's College London, +44 0207848 5639, stephanie.amiel@kcl.ac.uk
    Scientific contact
    Prof Stephanie Amiel, King's College London, +44 0207848 5639, stephanie.amiel@kcl.ac.uk
    Sponsor organisation name
    King's College Hospital
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE59RS
    Public contact
    Prof Stephanie Amiel, King's College London, +44 0207848 5639, stephanie.amiel@kcl.a.uk
    Scientific contact
    Prof Stephanie Amiel, King's College London, +44 0207848 5639, stephanie.amiel@kcl.ac.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
    20 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Sep 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    In people with type 1 diabetes and adrenal insufficiency, who are established on hydrocortisone as glucocorticoid replacement, frequency of nocturnal hypoglycaemia will be reduced by changing the glucocorticoid replacement from hydrocortisone to prednisolone
    Protection of trial subjects
    The trial included a familiarisation phase: 1 week The purpose of this phase is to familiarise study participants with the monitoring and recording processes required for the study and provide some baseline data. Participants to take their normal hydrocortisone regimen, as prescribed by their doctor. Insulin self adjustment and recording: o Participants to continue their normal insulin regimen. Dose adjustment according to their usual principles of flexible insulin therapy encouraged. o Participants to record their insulin doses taken in the DAFNE (Dose Adjustment For Normal Eating) Diary provided Self blood glucose monitoring: o Participants to continue usual monitoring of capillary blood glucose levels with a minimum of four readings per day. To record all capillary blood glucose readings taken in the DAFNE Diary provided o Participants to check capillary blood glucose readings at 3 am on one occasion during the week. Hypoglycaemia reporting: Participants to record details of all hypoglycaemic events on the Hypoglycaemia Record Sheet provided. To report all levels < 3mmol/l and provide details of the episode including time, glucose level, symptoms, recognition, treatment and possible precipitant. Adverse event / missed medication recording: participants to record unusual events (eg exercise/illness) and missed medication in the DAFNE Diary
    Background therapy
    		 The study lasts eleven weeks for each participant and consists of a one week familiarisation phase followed by the five week prednisolone phase and the five week hydrocortisone phase in random order. The study includes eight hospital visits. Extra visits may be required if the CGMS sensor stops working and needs to be replaced
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Dec 2012
    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: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the diabetes department of King's College Hospital NHS Foundation Trust. The first patient was recruited in December 2012. Only 2 further patients were recruited and the trial was terminated early in September 2017 due to lack of recruitment.

    Pre-assignment
    Screening details
    		 1. Age 2. Sex 3. Weight and height 4. Ethnic group 5. Date of diagnosis of diabetes 6. Current insulin regimen and start date 7. Date of participation in a DAFNE (Dose Adjustment For Normal Eating) course or similar 8. Presence of diabetes microvascular complications .

    Period 1
    Period 1 title
    Whole trial period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open label study. Participants will be randomised to either: hydrocortisone phase followed by prednisolone phase, or prednisolone phase followed by hydrocortisone phase.

    Arms
    Arm title
    		 Whole trial
    Arm description
    		 Participants will be randomised to either: hydrocortisone phase followed by prednisolone phase, prednisolone phase followed by hydrocortisone phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15mg - prednisolone will be calculated equivalent to normal hydrocortisone regimen. Normal daily dose of hydrocortisone will be converted into the equivalent total dose of prednisolone using hydrocortisone 20mg = prednisolone 5mg. Up to 15 mg per day in total

    Investigational medicinal product name
    Hydrocortisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Maximum dose allowed 30 mg

    Number of subjects in period 1
    		Whole trial
    Started
    3
    Completed
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Whole trial period
    Reporting group description
    		 -

    Reporting group values
    		 Whole trial period Total
    Number of subjects
    		 3 3
    Age categorical
    Only adult patients recruited
    Units: Subjects
        Adults (18-64 years)
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Whole trial
    Reporting group description
    		 Participants will be randomised to either: hydrocortisone phase followed by prednisolone phase, prednisolone phase followed by hydrocortisone phase.

    Primary: Frequency of moderate nocturnal biochemical hypoglycaemia

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    End point title
    		 Frequency of moderate nocturnal biochemical hypoglycaemia [1]
    End point description
    End point type
    Primary
    End point timeframe
    From randomisation to last dose of IMP.
    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: No statistical analysis was possible for this trial as the trial terminated early due to lack of recruitment
    End point values
    		 Whole trial
    Number of subjects analysed
    3
    Units: episodes of low interstitial glucose
    0
    Attachments
    		 Lack of data for analysis
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From consent to final study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Whole trial
    Reporting group description
    		 -

    Serious adverse events
    		 Whole trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Whole trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    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: Hperglycaemia and hypoglycaemia were non-reportable AEs for this trial. No other AEs were reported for the 3 patients who completed treatment.

    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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