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    Clinical Trial Results:
    A randomised, double blind, placebo-controlled study of the effect of liraglutide on arterial blood pressure in hypertensive patients with type 2 diabetes mellitus

    Summary
    EudraCT number
    		 2013-002348-99
    Trial protocol
    		 GR  
    Global end of trial date
    19 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Nov 2018
    First version publication date
    02 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AUTH88622
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1125-9028
    Sponsors
    Sponsor organisation name
    Aristotle University Thessaloniki
    Sponsor organisation address
    49 Konstantinoupoleos Street, Thessaloniki, Greece,
    Public contact
    Apostolos Tsapas, Second Medical Department, +30 2310992850, atsapas@auth.gr
    Scientific contact
    Apostolos Tsapas, Second Medical Department, +30 2310992850, atsapas@auth.gr
    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
    31 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    A randomised, double blind, placebo-controlled study in patients with type 2 diabetes mellitus (T2DM), investigating the effect of liraglutide on blood pressure (BP), assessed by 24 h ambulatory blood pressure monitoring (ABPM).
    Protection of trial subjects
    Written informed consent was obtained from all trial participants before study entry. The protocol was developed in line with the Declaration of Helsinki and was approved by all institutional review boards as well as the Greek national ethics committee. Subjects enrolled into the study were asked about potential adverse events at every contact with the study site.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Nov 2014
    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
    Greece: 62
    Worldwide total number of subjects
    62
    EEA total number of subjects
    62
    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)
    40
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 We included adults with inadequatelly controlled type 2 diabetes (HbA1c 7.0-10%) and pre-hypertension or stage 1 hypertension (based on JNC-7 criteria) on stable background atnihyperglycaemic and antihypertensive therapy for at least 12 and 6 weeks respectively prior to recruitement.

    Period 1
    Period 1 title
    Active treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Liraglutide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Once daily 0.6 mg titrated to 1.2 mg after the first week

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Once daily

    Number of subjects in period 1
    		Liraglutide Placebo
    Started
    31
    31
    Completed
    29
    29
    Not completed
    2
    2
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    2

    Baseline characteristics

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Liraglutide Placebo Total
    Number of subjects
    		 31 31 62
    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)
    		 60.5 ( 12.0 ) 59.9 ( 9.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 9 21
        Male
    		 19 22 41
    Duration of diabetes
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 8.0 (5.0 to 11.0) 10.0 (6.0 to 14.0) -
    Body weight
    Units: kg
        arithmetic mean (standard deviation)
    		 94.4 ( 14.8 ) 101.7 ( 21.9 ) -

    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: 24-h systolic blood pressure

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    End point title
    		 24-h systolic blood pressure
    End point description
    End point type
    Primary
    End point timeframe
    Five weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    31
    Units: mmHg
        arithmetic mean (standard error)
    -4.72 ( 1.43 )
    1.02 ( 1.43 )
    Statistical analysis title
    		 Analysis of covariance
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: 24-h diastolic blood pressure

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    End point title
    		 24-h diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Five weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    31
    Units: mmHg
        arithmetic mean (standard error)
    -0.58 ( 0.99 )
    0.84 ( 0.99 )
    No statistical analyses for this end point

    Secondary: 24-h heart rate

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    End point title
    		 24-h heart rate
    End point description
    End point type
    Secondary
    End point timeframe
    Five weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    31
    Units: beats/min
        arithmetic mean (standard error)
    8.55 ( 1.03 )
    2.39 ( 1.03 )
    No statistical analyses for this end point

    Secondary: Daytime systolic blood pressure

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    End point title
    		 Daytime systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Five weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    31
    Units: mmHg
        arithmetic mean (standard error)
    -5.61 ( 1.47 )
    0.83 ( 1.47 )
    No statistical analyses for this end point

    Secondary: Daytime diastolic blood pressure

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    End point title
    		 Daytime diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Five weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    31
    Units: mmHg
        arithmetic mean (standard error)
    -1.10 ( 1.02 )
    0.60 ( 1.02 )
    No statistical analyses for this end point

    Secondary: Daytime heart rate

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    End point title
    		 Daytime heart rate
    End point description
    End point type
    Secondary
    End point timeframe
    Five weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    31
    Units: beats/min
        arithmetic mean (standard error)
    8.35 ( 1.06 )
    2.16 ( 1.06 )
    No statistical analyses for this end point

    Secondary: Nighttime systolic blood pressure

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    End point title
    		 Nighttime systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Five weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    31
    Units: mmHg
        arithmetic mean (standard error)
    -1.67 ( 1.65 )
    1.77 ( 1.65 )
    No statistical analyses for this end point

    Secondary: Nighttime diastolic blood pressure

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    End point title
    		 Nighttime diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Five weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    31
    Units: mmHg
        arithmetic mean (standard error)
    -0.30 ( 1.07 )
    0.67 ( 1.07 )
    No statistical analyses for this end point

    Secondary: Nighttime heart rate

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    End point title
    		 Nighttime heart rate
    End point description
    End point type
    Secondary
    End point timeframe
    Five weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    31
    Units: beats/min
        arithmetic mean (standard error)
    9.25 ( 1.11 )
    3.09 ( 1.11 )
    No statistical analyses for this end point

    Secondary: Sodium excretion

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    End point title
    		 Sodium excretion
    End point description
    End point type
    Secondary
    End point timeframe
    Five weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    31
    Units: mmol/24-h
        arithmetic mean (standard error)
    -16.86 ( 14.93 )
    -13.93 ( 14.93 )
    No statistical analyses for this end point

    Secondary: Lithium excretion at endpoint

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    End point title
    		 Lithium excretion at endpoint
    End point description
    End point type
    Secondary
    End point timeframe
    Five weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    31
    Units: mg/24-h
        arithmetic mean (standard error)
    3.71 ( 20.20 )
    -7.21 ( 40.53 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Active treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Liraglutide Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Liraglutide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 31 (12.90%)
    4 / 31 (12.90%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Dizziness
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 31 (0.00%)
         occurrences all number
    1
    1
    Generalised rash
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Injection-site rash
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Constipation
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Sep 2016
    Lower haemoglobin A1c threshold for inclusion changed to 7.0%, lower estimated glomerular filtration rate threshold for inclusion changed to 30 ml/min, 24-h arterial blood pressure monitoring quality control criteria revised, end of trial date changed to 31-Aug-2017
    29 Sep 2016
    Four new trial sites included

    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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