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    Clinical Trial Results:
    Acyl and desacyl ghrelin: The Yin and Yang of glucose homeostasis and insulin sensitivity? -Acute metabolic effects of desacyl ghrelin in insulin resistant patients

    Summary
    EudraCT number
    		 2013-000022-63
    Trial protocol
    		 DK  
    Global end of trial date
    08 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2020
    First version publication date
    01 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1-10-72-393-12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University
    Sponsor organisation address
    Palle Juel Jensens Boulevard, Aarhus N, Denmark, 8200
    Public contact
    Esben T Vestergaard, Aarhus University, 45 78461631,
    Scientific contact
    Esben T Vestergaard, Aarhus University, 45 78461631,
    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
    01 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial is to investigate the effects of desacyl ghrelin on insulin resistance
    Protection of trial subjects
    Measurement of haematological, inflammation, kidney function, liver function, HbA1c, plasma glucose, and thyroid parameters. Clinical examination incl. blood pressure and pulse measurements.
    Background therapy
    		 None.
    Evidence for comparator
    		 N/A.
    Actual start date of recruitment
    01 Apr 2013
    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
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period April 2014 to February 2015. Region: Denmark. Criteria: • men with type 2 diabetes according to ADA, Standards of Medical Care in Diabetes‚ 2011. Diabetes Care. 2011 January 1, 2011;34(Supplement 1):S11-S61. • age 18-65 years • HbA1c < 11 %

    Pre-assignment
    Screening details
    		 Criteria: • men with type 2 diabetes according to ADA, Standards of Medical Care in Diabetes‚ 2011. Diabetes Care. 2011 January 1, 2011;34(Supplement 1):S11-S61. • age 18-65 years • HbA1c < 11 % 12 subjects were screened, 1 fulfiled exclusion criteria (IHD) and 1 decided not to participate. None significant events were observed.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Unacylated ghrein
    Arm description
    		 UAG infusion (DAG 1.0 µg/kg/h i.v.)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Unacylated ghrelin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    1.0 µg/kg/h i.v.,

    Arm title
    		 Placebo
    Arm description
    		 Isotonic saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Isotonic saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    0.9% saline.

    Number of subjects in period 1
    		Unacylated ghrein Placebo
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    39-60 years
    Units: years
        arithmetic mean (full range (min-max))
    		 52.4 (39 to 60) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 10 10
    Ethnic group
    Caucasians
    Units: Subjects
        Ethnic group
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    Unacylated ghrein
    Reporting group description
    		 UAG infusion (DAG 1.0 µg/kg/h i.v.)

    Reporting group title
    Placebo
    Reporting group description
    		 Isotonic saline

    Primary: Insulin sensitivity

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    End point title
    		 Insulin sensitivity
    End point description
    End point type
    Primary
    End point timeframe
    April 2014-February 2015
    End point values
    		 Unacylated ghrein Placebo
    Number of subjects analysed
    10
    10
    Units: mg glucose/kg body weight pr minute
        arithmetic mean (standard error)
    4.69 ( 0.56 )
    4.98 ( 0.43 )
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Unacylated ghrein v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.66
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    April 2014-February 2015
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Own database
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All included subjects.

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (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
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (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: Wi did not experience any adverse events at all.

    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.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30722063
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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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