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    Clinical Trial Results:
    Liraglutide Kidney: A randomised, double-blinded, cross-over study investigating the short-term impact of liraglutide on kidney function in diabetic patients

    Summary
    EudraCT number
    		 2012-003577-26
    Trial protocol
    		 DK  
    Global end of trial date
    27 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2016
    First version publication date
    06 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    U1111-1131-5236
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01664676
    WHO universal trial number (UTN)
    		 U1111-1131-5236
    Sponsors
    Sponsor organisation name
    Aarhus University Hosptital, MEA
    Sponsor organisation address
    Noerrebrogade 44, Aarhus, Denmark, 8000
    Public contact
    Clinical Trial Information, Aarhus University Hosptital, MEA, 45 20894030, jsk@dadlnet.dk
    Scientific contact
    Clinical Trial Information, Aarhus University Hosptital, MEA, 45 20894030, jsk@dadlnet.dk
    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
    27 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the impact of a single dose liraglutide 1.2 mg on Glomerular Filtration Rate (GFR).
    Protection of trial subjects
    Patients were moved internally in the hospital by wheeled transportation.
    Background therapy
    		 Lithium tablets (16.2 mmol) Isotonic NaCl infusion (100 ml/h)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 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: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Key inclusion criteria: Male gender; T2D; metformin treatment; age 20–60 years; BMI 20–32 kg/m2. Key exclusion criteria: Antidiabetic treatment other than metformin; HbA1c >8%; impaired liver or renal function; uncontrolled hypertension (>180/110mmHg); ≥3 types of antihypertensive drugs

    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
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    No

    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 in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single dose of 1.2 mg liraglutide subcutaneous in the abdomen

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Isotonic saline
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single dose of 1.2 mg placebo liraglutide (0.4 ml isotonic saline) subcutaneous in the abdomen

    Number of subjects in period 1
    		Liraglutide Placebo
    Started
    11
    11
    Completed
    11
    11

    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
    		 11 11
    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
    Units: years
        arithmetic mean (standard deviation)
    		 54 ± 5 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change in GFR between liraglutide and placebo arm

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    End point title
    		 Change in GFR between liraglutide and placebo arm
    End point description
    End point type
    Primary
    End point timeframe
    10 to 15h after liraglutide or place-liraglutide sc. injection
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    11
    11
    Units: ml/min
        arithmetic mean (standard deviation)
    104.6 ± 9.9
    106.2 ± 11.5
    Statistical analysis title
    		 Change in GFR, t-test
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.55
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    First patient first visit to last patient last visit
    Adverse event reporting additional description
    We did not experience any AE either non-serious or serious.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Frequency threshold for reporting non-serious adverse events: 1%
    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: We did not experience any AE either serious og non-serious

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26910107
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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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