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    Clinical Trial Results:
    Effect of liraglutide on vascular inflammation in type-2 diabetes: A randomized, placebo-controlled, double-blind, parallel clinical PET/CT trial

    Summary
    EudraCT number
    		 2016-001523-31
    Trial protocol
    		 DK  
    Global end of trial date
    16 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2020
    First version publication date
    25 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    U1111-1181-4107
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03449654
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Steno Diabetes Center Copenhagen
    Sponsor organisation address
    Niels Steensens vej 2, Gentofte, Denmark,
    Public contact
    Peter Rossing, Steno Diabetes Center Copenhagen, +45 30913383, peter.rossing@regionh.dk
    Scientific contact
    Peter Rossing, Steno Diabetes Center Copenhagen, +45 30913383, peter.rossing@regionh.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
    01 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial is to determine whether 6 months Liraglutide treatment is associated with improvement in atherosclerotic phenotype through anti-inflammatory effects compared to placebo.
    Protection of trial subjects
    Regular blood suger measuring when starting liraglutide/placebo.
    Background therapy
    		 Standard of care.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Oct 2016
    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: 102
    Worldwide total number of subjects
    102
    EEA total number of subjects
    102
    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)
    44
    From 65 to 84 years
    57
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from the outpatient clinic at the Steno Diabetes Center Copenhagen in Denmark and through newspaper advertisements.

    Pre-assignment
    Screening details
    		 Patients were eligible if they met the inclusion criteria: type 2 diabetes (WHO criteria); age > 50 years; HbA1c ≥ 48 mmol/mol (6·5%); eGFR ≥ 30 mL/min/1·73 m2 (estimated by CKD-EPI formula); stable glucose- and cholesterol-lowering treatment for a minimum of 4 weeks prior to the baseline PET/CT. 147 were screened. 102 were randomized.

    Period 1
    Period 1 title
    Baseline (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
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosage and administration as for liraglutide.

    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
    Liraglutide will be introduced at a dose of 0.6 mg/day escalated to 1.2 mg/day after one week and after another week to 1.8 mg/day. Dose escalation can be postponed based on the subject’s tolerance to the trial medication. Further, the liraglutide dose can be reduced at any time during the trial if required by the subject’s tolerance to the product. If the dose of 1.8 mg/day is not tolerated by the patient, the patient will be allowed to continue in the study with a dose of 0.6 or 1.2 mg/day (maximal tolerated dose). Injection can be given at any time during the day. It is however recommended that the time of injection is consistent from day to day.

    Number of subjects in period 1
    		Placebo Liraglutide
    Started
    51
    51
    Completed
    49
    50
    Not completed
    2
    1
         Adverse event, serious fatal
    2
    -
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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

    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Liraglutide Total
    Number of subjects
    		 51 51 102
    Age categorical
    age
    Units: Subjects
        Adults (18-64 years)
    		 24 20 44
        From 65-84 years
    		 27 30 57
        85 years and over
    		 0 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.9 ( 8.6 ) 66.9 ( 7.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 10 16
        Male
    		 45 41 86

    End points

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

    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Primary: Arterial vascular inflammation

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    End point title
    		 Arterial vascular inflammation
    End point description
    Change in vascular inflammation over 26 weeks
    End point type
    Primary
    End point timeframe
    Arterial vascular inflammation assessed at baseline and after 26 weeks liraglutide / placebo treatment.
    End point values
    		 Placebo Liraglutide
    Number of subjects analysed
    50
    49
    Units: ratio
        arithmetic mean (confidence interval 95%)
    -0.04 (-0.17 to 0.08)
    -0.09 (-0.19 to 0.01)
    Statistical analysis title
    		 un-paired t-test
    Comparison groups
    Placebo v Liraglutide
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    screening until end-of-treatment at week 26.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 -

    Reporting group title
    liraglutide
    Reporting group description
    		 -

    Serious adverse events
    		 placebo liraglutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 51 (7.84%)
    4 / 51 (7.84%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery surgery
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mesenteric adenitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         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: 5%
    Non-serious adverse events
    		 placebo liraglutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 51 (68.63%)
    48 / 51 (94.12%)
    Investigations
    Investigations
         subjects affected / exposed
    0 / 51 (0.00%)
    7 / 51 (13.73%)
         occurrences all number
    0
    7
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    Cardiac disorders
    Dizziness
         subjects affected / exposed
    4 / 51 (7.84%)
    3 / 51 (5.88%)
         occurrences all number
    4
    3
    cardiac disorders
         subjects affected / exposed
    7 / 51 (13.73%)
    5 / 51 (9.80%)
         occurrences all number
    7
    5
    Surgical and medical procedures
    Surgical and medical procedures
         subjects affected / exposed
    3 / 51 (5.88%)
    2 / 51 (3.92%)
         occurrences all number
    3
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 51 (1.96%)
    5 / 51 (9.80%)
         occurrences all number
    1
    5
    General disorders and administration site conditions
    tiredness
         subjects affected / exposed
    5 / 51 (9.80%)
    5 / 51 (9.80%)
         occurrences all number
    5
    5
    Ear and labyrinth disorders
    Ear and labyrinth disorders
         subjects affected / exposed
    1 / 51 (1.96%)
    4 / 51 (7.84%)
         occurrences all number
    1
    4
    Eye disorders
    Eye disorders
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    gastrointestinal symptoms
         subjects affected / exposed
    18 / 51 (35.29%)
    41 / 51 (80.39%)
         occurrences all number
    18
    41
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    2 / 51 (3.92%)
    4 / 51 (7.84%)
         occurrences all number
    2
    4
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    6 / 51 (11.76%)
    1 / 51 (1.96%)
         occurrences all number
    6
    1
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    9 / 51 (17.65%)
    5 / 51 (9.80%)
         occurrences all number
    9
    5

    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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