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    Clinical Trial Results:
    Influence of liraglutide on diastolic cardiac function and myocardial perfusion as determined by magnetic resonance imaging in patients with type 2 diabetes: a double-blind randomized parallel-group trial

    Summary
    EudraCT number
    		 2015-000410-22
    Trial protocol
    		 DK  
    Global end of trial date
    31 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Apr 2021
    First version publication date
    23 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    U1111-1140-6242
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02655770
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Cardiovascular MR Group, Dept. 2011, Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen Ø, Denmark, 2100
    Public contact
    Att: Niels Vejlstrup, The Cardiovascular MR Group, Dept. 2011, Rigshospitalet, +45 26114145, niels.vejlstrup@regionh.dk
    Scientific contact
    Att: Niels Vejlstrup, The Cardiovascular MR Group, Dept. 2011, Rigshospitalet, +45 26114145, niels.vejlstrup@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
    05 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to test if 18 weeks of treatment with liraglutide (up to 1.8 mg s.c. once daily) improves (or worsens) diastolic performance in T2DM patients with diastolic dysfunction, compared to placebo.
    Protection of trial subjects
    Overall we aimed at minimizing the trial subjects pain and distress as much as possible
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2016
    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
    Denmark: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    23
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the Department of Endocrinology and Cardiology at NSR Hospital in Denmark between May 2016 and August 2019. Patients with type 2 diabetes were identified in the endocrinology or cardiology outpatient clinic by a nurse or a physician responsible for their treatment.

    Pre-assignment
    Screening details
    		 372 patients were invited to participate either by letter or in person. After written patient information about the study and information about patient’s rights, and if they expressed interest in participating in the study, pre-screening interviews by telephone were conducted. Forty-two eligible patients were invited to the first in-person screenin

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Liraglutide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Victoza
    Investigational medicinal product code
    EU/1/09/529/001-005
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of 1.8 mg/per day

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1.8mg/day

    Number of subjects in period 1
    		Liraglutide Placebo
    Started
    20
    20
    Completed
    20
    19
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1

    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
    		 20 20 40
    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
        median (inter-quartile range (Q1-Q3))
    		 64 (55 to 68) 63 (58 to 67) -
    Gender categorical
    Units: Subjects
        Female
    		 2 6 8
        Male
    		 18 14 32
    Weight
    Units: kilogram(s)
        median (inter-quartile range (Q1-Q3))
    		 96 (88 to 102) 91 (80 to 96) -
    Body mass index
    Units: kilogram(s)/square meterm
        arithmetic mean (standard deviation)
    		 30.8 ± 4.5 30.8 ± 5.1 -
    Heart rate
    Units: beats per minut
        arithmetic mean (standard deviation)
    		 71 ± 11 70 ± 11 -
    Systolic blood pressure
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 133 (129 to 138) 134 (126 to 140) -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 82 ± 7 79 ± 11 -
    Diabetes duration
    Units: Years
        median (inter-quartile range (Q1-Q3))
    		 9.5 (4.8 to 13.5) 5.5 (2.0 to 14.5) -

    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: Early peak filling rate at rest

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    End point title
    		 Early peak filling rate at rest
    End point description
    End point type
    Primary
    End point timeframe
    18 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    20
    20
    Units: mL/sec
        arithmetic mean (standard deviation)
    -24 ± 60
    -6 ± 46
    Statistical analysis title
    		 Treatment effect
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -53
         upper limit
    		 16

    Primary: Early peak filling rate during stress

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    End point title
    		 Early peak filling rate during stress
    End point description
    End point type
    Primary
    End point timeframe
    18 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    20
    20
    Units: mL/sec
        arithmetic mean (standard deviation)
    2 ± 58
    -2 ± 38
    Statistical analysis title
    		 Treatment effect
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30
         upper limit
    		 37

    Primary: LA passive emptying fraction at rest

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    End point title
    		 LA passive emptying fraction at rest
    End point description
    End point type
    Primary
    End point timeframe
    18 weeks change
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    20
    20
    Units: Precentage
        median (inter-quartile range (Q1-Q3))
    -4.3 (-7.9 to 1.9)
    -0.6 (-3.1 to 2.2)
    Statistical analysis title
    		 Treatment effect
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.2
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    -3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 1.5

    Primary: LA passive emptying fraction during stress

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    End point title
    		 LA passive emptying fraction during stress
    End point description
    End point type
    Primary
    End point timeframe
    18 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    20
    20
    Units: Precentage
        median (inter-quartile range (Q1-Q3))
    -3.1 (-9.0 to 1.1)
    1.0 (-2.9 to 6.1)
    Statistical analysis title
    		 Treatment effect
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.049
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    -4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.98
         upper limit
    		 -0.07

    Secondary: Average E/e'

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    End point title
    		 Average E/e'
    End point description
    End point type
    Secondary
    End point timeframe
    18 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    20
    20
    Units: Ratio
        median (inter-quartile range (Q1-Q3))
    0.7 (-0.1 to 1.5)
    0.1 (-1.3 to 2.4)
    Statistical analysis title
    		 Treatment effect
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.6
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 1.9

    Secondary: Myocardial perfusion index

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    End point title
    		 Myocardial perfusion index
    End point description
    End point type
    Secondary
    End point timeframe
    18 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    20
    20
    Units: noon unit
        median (inter-quartile range (Q1-Q3))
    -0.41 (-0.71 to -0.15)
    -0.15 (-0.22 to 0.28)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 0.28

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    20 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    March 2021
    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
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         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)
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         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
    		 Liraglutide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 20 (80.00%)
    14 / 20 (70.00%)
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Angina pectoris
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Nausea
         subjects affected / exposed
    6 / 20 (30.00%)
    3 / 20 (15.00%)
         occurrences all number
    6
    3
    Dyspnoea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    poor appetite
         subjects affected / exposed
    6 / 20 (30.00%)
    3 / 20 (15.00%)
         occurrences all number
    6
    3
    Dry mouth
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    1
    Blood glucose abnormal
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    emotionally labile
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    leucocytosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    meteorism
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    Abdominal discomfort
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    pain of joint of knee
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Dizzinesss
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Administration site discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    thoracic facet joint pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 20 (15.00%)
    2 / 20 (10.00%)
         occurrences all number
    3
    2
    Constipation
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    heartburn
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Skin and subcutaneous tissue disorders
    Hot sweats
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Rash erythematous
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hypoglycaemia
         subjects affected / exposed
    2 / 20 (10.00%)
    3 / 20 (15.00%)
         occurrences all number
    2
    3
    Musculoskeletal and connective tissue disorders
    muscle cramp
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Infections and infestations
    acute nasopharyngitis
         subjects affected / exposed
    5 / 20 (25.00%)
    0 / 20 (0.00%)
         occurrences all number
    5
    0
    Pneumonia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1

    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.
    MPRI was only analysable in 16 patients
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