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    Clinical Trial Results:
    The effect of liraglutide on bone turnover, bone mass and bone cell function

    Summary
    EudraCT number
    		 2015-001284-40
    Trial protocol
    		 DK  
    Global end of trial date
    02 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2020
    First version publication date
    04 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    160315
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital, Dept. of Endocrinology and Internal Medicine
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 95, Aarhus N, Denmark, 8200
    Public contact
    Department of Endocrinology, Aarhus University Hospital, katrhygu@rm.dk
    Scientific contact
    Department of Endocrinology, Aarhus University Hospital, katrhygu@rm.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
    18 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aims of the study are to investigate the effect of the GLP-1 analogue liraglutide ("Victoza") in participants with type 2 diabetes on bone turnover, bone mass, and bone structure.
    Protection of trial subjects
    Participants were given oral and written information concerning the study and any possible harmfull side-effects prior to giving informed consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2015
    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: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    31
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Biochemistry and DXA-scan

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment
    Arm description
    		 Liraglutide 1.8 mg/day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide up to 1.8 mg s.c. per day for 180 days

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline, placebo for PR1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Up to 1.8 mg s.c. per day for 180 days

    Number of subjects in period 1
    		Treatment Placebo
    Started
    30
    30
    Completed
    27
    29
    Not completed
    3
    1
         Personal reasons
    -
    1
         Adverse event, non-fatal
    3
    -

    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
    		 60 60
    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 (full range (min-max))
    		 63 (42 to 78) -
    Gender categorical
    Units: Subjects
        Female
    		 30 30
        Male
    		 30 30

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Liraglutide 1.8 mg/day

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Change in plasma CTX from baseline to end of study

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    End point title
    		 Change in plasma CTX from baseline to end of study
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, week 1, week 4, week 13, week 26
    End point values
    		 Treatment Placebo
    Number of subjects analysed
    30
    30
    Units: micrograms per liter
        number (confidence interval 95%)
    0.07 (0.03 to 0.10)
    0.03 (0.00 to 0.06)
    Statistical analysis title
    		 Linear mixed effects model
    Comparison groups
    Placebo v Treatment
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Procollagen type I N-terminal propeptide

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    End point title
    		 Procollagen type I N-terminal propeptide
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, weeks 1, 4, 13, and 26
    End point values
    		 Treatment Placebo
    Number of subjects analysed
    30
    30
    Units: Micrograms per liter
        number (confidence interval 95%)
    0.8 (-2.3 to 3.9)
    2.0 (-1.0 to 5.0)
    No statistical analyses for this end point

    Secondary: Osteocalcin

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    End point title
    		 Osteocalcin
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, weeks 1, 4, 13, and 26
    End point values
    		 Treatment Placebo
    Number of subjects analysed
    30
    30
    Units: Micrograms per liter
        number (confidence interval 95%)
    0.9 (-0.2 to 1.9)
    0.5 (-0.5 to 1.5)
    No statistical analyses for this end point

    Secondary: Total hip areal bone mineral density

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    End point title
    		 Total hip areal bone mineral density
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, week 1, 4, 13, and 26
    End point values
    		 Treatment Placebo
    Number of subjects analysed
    30
    30
    Units: grams per cm2
        number (confidence interval 95%)
    0.00 (0.00 to 0.01)
    0.00 (-0.02 to 0.00)
    No statistical analyses for this end point

    Secondary: Glycated hemoglobin A1c

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    End point title
    		 Glycated hemoglobin A1c
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, week 1, 4, 13, and 26
    End point values
    		 Treatment Placebo
    Number of subjects analysed
    30
    30
    Units: mmol per mol
        number (confidence interval 95%)
    -6 (-8 to -4)
    -2 (-4 to 0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline - two weeks after last visit (week 26)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Liraglutide 1.8 mg/day

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 30 (66.67%)
    13 / 30 (43.33%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Tiredness
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 30 (6.67%)
         occurrences all number
    4
    2
    Gastrointestinal disorders
    Gastrointestinal complaints
    Additional description: Diarrhoea, constipation, loss of appetite, nausea, abdominal pains, reflux
         subjects affected / exposed
    20 / 30 (66.67%)
    13 / 30 (43.33%)
         occurrences all number
    20
    13
    Endocrine disorders
    Hypoglycemia
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    3
    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.
    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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