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    Clinical Trial Results:
    The effect of glucagon-like-peptide 1 (GLP-1) analogues on inflammation in humans with diabetic kidney disease.

    Summary
    EudraCT number
    2012-005482-12
    Trial protocol
    IE  
    Global end of trial date
    01 Nov 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Dec 2018
    First version publication date
    07 Dec 2018
    Other versions
    Summary report(s)
    Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    GLP-1-2012-01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01847313
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University College Dublin
    Sponsor organisation address
    Belfield, Dublin, Ireland,
    Public contact
    Karl Neff, UCD Clinical Research Centre, St Vincent's University Hospital, karljneff@gmail.com
    Scientific contact
    Karl Neff, UCD Clinical Research Centre, St Vincent's University Hospital, karljneff@gmail.com
    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
    09 Nov 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: The primary objective of this study is to compare the change in pro-inflammatory cytokine monocyte-chemotactic protein 1 (MCP-1) in urine in subjects treated with liraglutide over a 26 week treatment period versus a matched control group who received no liraglutide.
    Protection of trial subjects
    NA
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Apr 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ireland: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    8
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    All subjects recruited within the Diabetes Clinics of St Vincent's Healthcare Group in line with inclusion and exclusion criteria as listed below.

    Pre-assignment
    Screening details
    Criteria: Inclusion Criteria: • Type 2 diabetes with a HbA1c of 42-75mmol/mol (6-9%DCCT) • Male or female aged above 30 years • Have a negative pregnancy test at screening (women of child bearing potential only) • Body mass index (BMI) of 25kg/m2 or greater • On a renin-angiotensin system antagonist, at a stable dose, for at least 8 weeks befo

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Standard Care and Liraglutide
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Glucagon like peptide 1 receptor agonist, NN2211
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.6 mg daily

    Arm title
    Standard Care alone
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    Standard Care and Liraglutide Standard Care alone
    Started
    10
    10
    Completed
    10
    10
    Period 2
    Period 2 title
    End of Study
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Standard Care and Liraglutide
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Glucagon like peptide 1 receptor agonist, NN2211
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.6 mg daily

    Arm title
    Standard Care alone
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    Standard Care and Liraglutide Standard Care alone
    Started
    10
    10
    Completed
    10
    8
    Not completed
    0
    2
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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

    Reporting group values
    Baseline Total
    Number of subjects
    20 20
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    8 8
        From 65-84 years
    12 12
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65 ± 9 -
    Gender categorical
    Units: Subjects
        Female
    6 6
        Male
    14 14
    Urinary Albumin Excretion Rate
    Units: ug/ml
        arithmetic mean (standard deviation)
    106.9 ± 109 -
    MCP-1:Creatinine Ratio in Urine
    Units: ng/mmol
        arithmetic mean (standard deviation)
    27.2 ± 19.6 -
    sCD163:creatinine ratio in urine
    Units: pg/mmol
        arithmetic mean (standard deviation)
    44 ± 51 -
    sCD163 in serum
    Units: ng/ml
        arithmetic mean (standard deviation)
    100 ± 45 -

    End points

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    End points reporting groups
    Reporting group title
    Standard Care and Liraglutide
    Reporting group description
    -

    Reporting group title
    Standard Care alone
    Reporting group description
    -
    Reporting group title
    Standard Care and Liraglutide
    Reporting group description
    -

    Reporting group title
    Standard Care alone
    Reporting group description
    -

    Primary: Urinary MCP1:Creatinine ratio

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    End point title
    Urinary MCP1:Creatinine ratio [1]
    End point description
    End point type
    Primary
    End point timeframe
    Six months
    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: As per our statistical plan, we tested for significance between baseline and end of study in both groups. There was no significant difference and therefore further statistical analysis was not completed. Urinary MCP-1 creatinine ratios did not change from baseline to 26 weeks in either Standard Therapy (p=0.33) or liraglutide groups (p=0.46). There was no difference in urinary MCP-1 between groups at baseline (p=0.21) or at 26 weeks (p=0.55).
    End point values
    Standard Care and Liraglutide Standard Care alone Standard Care and Liraglutide Standard Care alone
    Number of subjects analysed
    9
    8
    9
    8
    Units: ng/mmol
        arithmetic mean (standard deviation)
    32.8 ± 25.7
    20.8 ± 6.0
    27.9 ± 14.3
    24.3 ± 15.4
    No statistical analyses for this end point

    Secondary: Urine Albumin Excretion Rate

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    End point title
    Urine Albumin Excretion Rate
    End point description
    End point type
    Secondary
    End point timeframe
    Six months
    End point values
    Standard Care and Liraglutide Standard Care alone Standard Care and Liraglutide Standard Care alone
    Number of subjects analysed
    10
    10
    9
    7
    Units: ug/min
        arithmetic mean (standard deviation)
    106.9 ± 109.5
    122.8 ± 142.1
    144.1 ± 232.6
    132.4 ± 101.3
    No statistical analyses for this end point

    Secondary: sCD163 in Serum

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    End point title
    sCD163 in Serum
    End point description
    End point type
    Secondary
    End point timeframe
    Six months
    End point values
    Standard Care and Liraglutide Standard Care alone Standard Care and Liraglutide Standard Care alone
    Number of subjects analysed
    10
    8
    10
    8
    Units: ng/ml
        arithmetic mean (standard deviation)
    98 ± 45
    106 ± 47
    82 ± 34
    84 ± 23
    No statistical analyses for this end point

    Secondary: sCD163:creatinine ratio in urine

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    End point title
    sCD163:creatinine ratio in urine
    End point description
    End point type
    Secondary
    End point timeframe
    Six months
    End point values
    Standard Care and Liraglutide Standard Care alone Standard Care and Liraglutide Standard Care alone
    Number of subjects analysed
    10
    8
    10
    8
    Units: pg/mmol
        arithmetic mean (standard deviation)
    51 ± 60
    37 ± 38
    27.9 ± 14.0
    24.3 ± 14.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Starting from the first administration of the IMP through to the End of Study Visit (30 weeks) all Adverse Event and Serious Adverse event information was collected at each visit.
    Adverse event reporting additional description
    AEs were collected by the PI and Sub-investigators and recorded in the CRF/site file/medical record. AEs/ SAEs were recorded in the CRF module for AE in verbatim terms. In case of several signs/symptoms, a single syndrome or diagnosis was recorded. In the event of an AE, investigators adjudicated whether the AE was serious, the start date, the stop
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    NA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Standard Care alone
    Reporting group description
    -

    Reporting group title
    Standard Care with Liraglutide
    Reporting group description
    -

    Serious adverse events
    Standard Care alone Standard Care with Liraglutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Cardiac disorders
    Heart failure
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Paroxysmal atrial fibrillation
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Standard Care alone Standard Care with Liraglutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 10 (70.00%)
    8 / 10 (80.00%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Hypokalaemia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Dyspepsia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Loose stool
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Ingrown toenail
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Viral illness
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0

    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.
    Nil
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