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    Clinical Trial Results:
    Impact of liraglutide on cardiac function and structure in young adults with type 2 diabetes: an open label, randomised active-comparator trial.

    Summary
    EudraCT number
    		 2012-002422-78
    Trial protocol
    		 GB  
    Global end of trial date
    29 Sep 2017

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    UNOLE 0398
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02043054
    WHO universal trial number (UTN)
    		 U1111-1131-8802
    Sponsors
    Sponsor organisation name
    University of Leicester
    Sponsor organisation address
    Research & Enterprise Division, University of Leicester, Leicester General Hospital, Leicester , United Kingdom, LE5 4PW
    Public contact
    Professor Melanie Davies, University of Leicester, +44 01162586481, melanie.davies@uhl-tr.nhs.uk
    Scientific contact
    Professor Melanie Davies, University of Leicester, +44 01162586481, melanie.davies@uhl-tr.nhs.uk
    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
    13 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Sep 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal question is whether Lirgalutide improves cardiac function (as measured by left-ventricular function) to a greater extent than Sitagliptin in younger adults with type 2 diabetes who are likely to present with abnormalities.
    Protection of trial subjects
    All study participants were required to read a patient Information Sheet (PIS) about the trial (including trial treatments and any known side-effects) and sign an Informed Consent Form (ICF). Patients were monitored regularly throughout the trial duration.
    Background therapy
    		 None. Liraglutide was the Investigational Medicinal Product and Sitagliptin was the comparator product. There were no other products used in this CTIMP.
    Evidence for comparator
    		 At the time of writing the trial protocol, there were recent advances in therapies for the treatment of T2DM which included the GLP1 analogues and the DPP IV inhibitors. Both of these therapies target the incretin system using different methods to elevate/maintain circulating levels of GLP1 to subsequently achieve improved blood sugar control. Interestingly, GLP1 analogues were reported not only to improve blood sugar control but to additionally induce weight-loss and emerging experimental evidence at that time indicated that it may have beneficial effects on the heart's structure and function. Due to the profile of this condition being a lot worse and younger patients having greater CVD risk, a therapy offering multiple positive effects, in particular the potential cardiometabolic effects, made this line of therapy attractive in this patient population. Further, at that time, there were signals from secondary outcomes from other cardiovascular trials that Saxagliptin may have an adverse effect on Cardiovascular function measures. Consequently, the study Investigators chose to use Sitagliptin as the active comparator in this trial. The aim of this research was to investigate the cardiometabolic effects of Liraglutide (GLP1 analogue) compared to that of its clinically relevant comparator Sitagliptin (DPP IV inhibitor).
    Actual start date of recruitment
    08 Jul 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
    United Kingdom: 76
    Worldwide total number of subjects
    76
    EEA total number of subjects
    76
    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)
    76
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Sponsor Greenlight was issued on 28/01/2014. First Patient First Visit date was 18/02/2014 and Last Patient Last Visit date was 13/09/2017.

    Pre-assignment
    Screening details
    		 76 people (41 women and 35 men) who had obesity (average body mass index (BMI) 35 kg·m-2) and had been diagnosed with type 2 diabetes for an average of 4.4 years were enrolled into the study. Sixty-four people completed the study (31 in the liraglutide group and 33 in the sitagliptin group).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Liraglutide
    Arm description
    		 Participants received 1.8mg/daily Liraglutide. Liraglutide was administered using labelled 3ml prefilled pens (Victoza® 6mgml-1) supplied by the manufacturer.
    Arm type
    		 Investigational Medicinal Product

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Victoza
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide doses were self-administrated by the participant through daily subcutaneous injections, using labelled 3ml prefilled pens (Victoza® 6mgml-1) supplied by the manufacturer. Liraglutide doses were initiated at 0.6 mg and then increased to 1.2 mg in week two and 1.8mg in week three. The dose was then maintained at 1.8 mg. Where 1.8 mg doses were not tolerated by the patient, the dose was lowered to the maximum tolerated dose at the investigators discretion.

    Arm title
    		 Sitagliptin
    Arm description
    		 Sitagliptin 100mg/daily.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Januvia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sitagliptin doses were self-administered by the participant orally at 100mg/day throughout the 26 week period of the study.

    Number of subjects in period 1
    		Liraglutide Sitagliptin
    Started
    38
    38
    Completed
    24
    28
    Not completed
    14
    10
         Withdrawn
    3
    3
         Lost to follow-up
    11
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Participants received 1.8mg/daily Liraglutide. Liraglutide was administered using labelled 3ml prefilled pens (Victoza® 6mgml-1) supplied by the manufacturer.

    Reporting group title
    Sitagliptin
    Reporting group description
    		 Sitagliptin 100mg/daily.

    Reporting group values
    		 Liraglutide Sitagliptin Total
    Number of subjects
    		 38 38 76
    Age categorical
    76 people (41 women and 35 men) with Type 2 Diabetes were enrolled. They had an average age of 44 years.
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 38 38 76
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    76 people (41 women and 35 men) with type 2 Diabetes were enrolled into the study. Participants had an average age of 44 years.
    Units: years
        arithmetic mean (standard deviation)
    		 43.4 ( 7.0 ) 44.8 ( 5.9 ) -
    Gender categorical
    We recruited 76 people (41 women and 35 men) with type 2 diabetes. 18 women were randomized to the IMP arm and 23 women to the active comparator arm. 20 men were randomized to the IMP arm and 15 men to the active comparator arm.
    Units: Subjects
        Female
    		 18 23 41
        Male
    		 20 15 35
    Smoking status
    There were 11 current smokers in the liraglutide group and 8 in the sitagliptin group.
    Units: Subjects
        Current smoker
    		 11 8 19
        Never Smoked
    		 19 18 37
        Ex smoker
    		 8 12 20
    Duration of diabetes
    The combined study population had a median T2DM duration of 3 years.
    Units: years
        arithmetic mean (standard deviation)
    		 4.5 ( 4.5 ) 4.4 ( 4.4 ) -
    Body weight
    The combined study population had a mean body weight of 100.7kg.
    Units: kg
        arithmetic mean (standard deviation)
    		 100.8 ( 18.8 ) 100.7 ( 21.1 ) -
    BMI
    The combined study population had a mean BMI of 35.3 kg/m^2.
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 35.7 ( 7 ) 34.9 ( 5.3 ) -
    Brachial systolic blood pressure
    The combined study population had an average systolic blood pressure of 125.8 mmHg.
    Units: mmHg
        arithmetic mean (standard deviation)
    		 129 ( 11.9 ) 128 ( 15.6 ) -
    Brachial diastolic blood pressure
    The combined study population had a mean diastolic blood pressure of 85.5 mmHg.
    Units: mmHg
        arithmetic mean (standard deviation)
    		 86 ( 9.0 ) 85 ( 9.8 ) -
    Heart rate
    Units: Beats per min
        arithmetic mean (standard deviation)
    		 81.0 ( 11.1 ) 76.5 ( 11.9 ) -
    HbA1c
    The combined study population had a mean baseline HbA1c of 7.5%.
    Units: Percentage %
        arithmetic mean (standard deviation)
    		 7.5 ( 0.8 ) 7.6 ( 0.8 ) -
    HbA1c
    The combined study population had a mean baseline HbA1c of 58.8 mmol/mol.
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 58.4 ( 9.3 ) 59.1 ( 9.1 ) -
    VO2 max
    Data were available for 32 people in the liraglutide group and 30 in the sitagliptin group.
    Units: ml per kg per min
        arithmetic mean (standard deviation)
    		 23.7 ( 6.1 ) 23.5 ( 5.0 ) -
    PEDSR Circumferential
    PEDSR = peak early diastolic strain rate Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: s^-1
        arithmetic mean (standard deviation)
    		 1.1 ( 0.3 ) 1.0 ( 0.3 ) -
    PEDSR Longitudinal
    PEDSR = peak early diastolic strain rate Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: s^-1
        arithmetic mean (standard deviation)
    		 0.9 ( 0.2 ) 0.9 ( 0.2 ) -
    LVEDMI
    LVEDMI = left ventricular end diastolic mass index Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: g/m^2
        arithmetic mean (standard deviation)
    		 55.3 ( 10.3 ) 54.5 ( 8.7 ) -
    LVEDVI
    LVEDVI = left ventricular end-diastolic volume index Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL/m^2
        arithmetic mean (standard deviation)
    		 69.9 ( 15.0 ) 70.8 ( 13.9 ) -
    LVESVI
    LVESVI = left ventricular end-systolic volume index Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL/m^2
        arithmetic mean (standard deviation)
    		 25.8 ( 13.3 ) 24.8 ( 8.8 ) -
    LVEF
    LVEF = left ventricular ejection fraction Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: Percentage %
        arithmetic mean (standard deviation)
    		 64.5 ( 10.4 ) 65.6 ( 6.2 ) -
    LVMV ratio
    LVMV = left ventricular mass volume
    Units: g/ml^3
        arithmetic mean (standard deviation)
    		 0.68 ( 0.10 ) 0.66 ( 0.12 ) -
    PSS (circ)
    PSS (circ) = peak systolic strain (circumferential)
    Units: s^-1
        arithmetic mean (standard deviation)
    		 -22.98 ( 3.45 ) -23.20 ( 2.99 ) -
    Total cholesterol
    Units: mmol/l
        arithmetic mean (standard deviation)
    		 4.7 ( 1.2 ) 4.6 ( 0.9 ) -
    LDL cholesterol
    Data was available for 36 participants in each arm.
    Units: mmol/l
        arithmetic mean (standard deviation)
    		 2.3 ( 0.8 ) 2.4 ( 0.6 ) -
    HDL cholesterol
    Data were available for 37 participants in the sitagliptin group.
    Units: mmol/l
        arithmetic mean (standard deviation)
    		 1.1 ( 0.2 ) 1.2 ( 0.3 ) -
    Triglyceride
    Units: mmol/l
        arithmetic mean (standard deviation)
    		 2.6 ( 1.5 ) 2.4 ( 1.7 ) -
    Alanine Transaminase
    Units: IU/l
        arithmetic mean (standard deviation)
    		 39.6 ( 21.8 ) 33.1 ( 14.7 ) -
    eGFR
    Estimated Glomerular Filtration Rate
    Units: ml/min
        arithmetic mean (standard deviation)
    		 87.6 ( 4.6 ) 89.1 ( 3.3 ) -
    LV GCS
    LV GCS = left ventricular global circumferential strain Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: Percentage %
        arithmetic mean (standard deviation)
    		 -19.0 ( 3.3 ) -19.4 ( 2.8 ) -
    LV GLS
    LV GLS = left ventricular global longitudinal strain Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: Percentage %
        arithmetic mean (standard deviation)
    		 -15.8 ( 2.8 ) -16.4 ( 2.3 ) -
    LV EDV
    LV EDV = left ventricular end-diastolic volume Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL
        arithmetic mean (standard deviation)
    		 152.7 ( 41.3 ) 153.9 ( 43.8 ) -
    LV ESV
    LV ESV = left ventricular end-systolic volume Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL
        arithmetic mean (standard deviation)
    		 56.6 ( 32.1 ) 54.5 ( 24.1 ) -
    LVSV
    Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL
        arithmetic mean (standard deviation)
    		 96.1 ( 22.4 ) 99.5 ( 23.5 ) -
    LVCO
    LVCO = left ventricular cardiac output Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: L/min
        arithmetic mean (standard deviation)
    		 7.4 ( 1.4 ) 7.2 ( 1.6 ) -
    LVM
    LVM = left ventricular end diastolic mass Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: grams
        arithmetic mean (standard deviation)
    		 120.6 ( 28.7 ) 118 ( 27.8 ) -
    LV peak filling rate
    Data were available for 34 people in the liraglutide group and 34 in the sitagliptin group.
    Units: mL/s
        arithmetic mean (standard deviation)
    		 555.9 ( 109.4 ) 547.7 ( 108 ) -
    LMV/V
    Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: g/mL
        arithmetic mean (standard deviation)
    		 0.80 ( 0.13 ) 0.79 ( 0.14 ) -
    Min LA vol
    LA vol = left atrial volume Data were available for 32 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL
        arithmetic mean (standard deviation)
    		 30.6 ( 14.3 ) 32.5 ( 10.5 ) -
    Max LA vol
    Data were available for 32 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL
        arithmetic mean (standard deviation)
    		 68.3 ( 21.0 ) 73.7 ( 20.1 ) -
    LAEF
    LAEF = left atrial ejection fraction Data were available for 32 people in the liraglutide group and 35 in the sitagliptin group.
    Units: Percentage %
        arithmetic mean (standard deviation)
    		 56.0 ( 9.0 ) 55.8 ( 6.9 ) -
    Global stress MBF
    MBF = myocardial blood flow Data were available for 30 people in the liraglutide group and 34 in the sitagliptin group.
    Units: mL/min/g
        arithmetic mean (standard deviation)
    		 3.7 ( 1.2 ) 3.6 ( 0.9 ) -
    Global rest MBF
    Data were available for 30 people in the liraglutide group and 33 in the sitagliptin group.
    Units: mL/min/g
        arithmetic mean (standard deviation)
    		 1.4 ( 0.5 ) 1.4 ( 0.5 ) -
    MPR
    MPR = myocardial perfusion reserve Data were available for 30 people in the liraglutide group and 33 in the sitagliptin group.
    Units: None
        arithmetic mean (standard deviation)
    		 3.0 ( 1.2 ) 2.9 ( 1.0 ) -
    Subject analysis sets

    Subject analysis set title
    Liraglutide (imputed)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients allocated to liraglutide with missing outcome data imputed.

    Subject analysis set title
    Sitagliptin (imputed)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients allocated to sitagliptin with missing outcome data imputed.

    Subject analysis sets values
    		 Liraglutide (imputed) Sitagliptin (imputed)
    Number of subjects
    31
    33
    Age categorical
    76 people (41 women and 35 men) with Type 2 Diabetes were enrolled. They had an average age of 44 years.
    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)
    31
    33
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    76 people (41 women and 35 men) with type 2 Diabetes were enrolled into the study. Participants had an average age of 44 years.
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    We recruited 76 people (41 women and 35 men) with type 2 diabetes. 18 women were randomized to the IMP arm and 23 women to the active comparator arm. 20 men were randomized to the IMP arm and 15 men to the active comparator arm.
    Units: Subjects
        Female
        Male
    Smoking status
    There were 11 current smokers in the liraglutide group and 8 in the sitagliptin group.
    Units: Subjects
        Current smoker
        Never Smoked
        Ex smoker
    Duration of diabetes
    The combined study population had a median T2DM duration of 3 years.
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Body weight
    The combined study population had a mean body weight of 100.7kg.
    Units: kg
        arithmetic mean (standard deviation)
    ( )
    ( )
    BMI
    The combined study population had a mean BMI of 35.3 kg/m^2.
    Units: kg/m^2
        arithmetic mean (standard deviation)
    ( )
    ( )
    Brachial systolic blood pressure
    The combined study population had an average systolic blood pressure of 125.8 mmHg.
    Units: mmHg
        arithmetic mean (standard deviation)
    ( )
    ( )
    Brachial diastolic blood pressure
    The combined study population had a mean diastolic blood pressure of 85.5 mmHg.
    Units: mmHg
        arithmetic mean (standard deviation)
    ( )
    ( )
    Heart rate
    Units: Beats per min
        arithmetic mean (standard deviation)
    ( )
    ( )
    HbA1c
    The combined study population had a mean baseline HbA1c of 7.5%.
    Units: Percentage %
        arithmetic mean (standard deviation)
    ( )
    ( )
    HbA1c
    The combined study population had a mean baseline HbA1c of 58.8 mmol/mol.
    Units: mmol/mol
        arithmetic mean (standard deviation)
    ( )
    ( )
    VO2 max
    Data were available for 32 people in the liraglutide group and 30 in the sitagliptin group.
    Units: ml per kg per min
        arithmetic mean (standard deviation)
    ( )
    ( )
    PEDSR Circumferential
    PEDSR = peak early diastolic strain rate Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: s^-1
        arithmetic mean (standard deviation)
    ( )
    ( )
    PEDSR Longitudinal
    PEDSR = peak early diastolic strain rate Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: s^-1
        arithmetic mean (standard deviation)
    ( )
    ( )
    LVEDMI
    LVEDMI = left ventricular end diastolic mass index Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: g/m^2
        arithmetic mean (standard deviation)
    ( )
    ( )
    LVEDVI
    LVEDVI = left ventricular end-diastolic volume index Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL/m^2
        arithmetic mean (standard deviation)
    ( )
    ( )
    LVESVI
    LVESVI = left ventricular end-systolic volume index Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL/m^2
        arithmetic mean (standard deviation)
    ( )
    ( )
    LVEF
    LVEF = left ventricular ejection fraction Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: Percentage %
        arithmetic mean (standard deviation)
    ( )
    ( )
    LVMV ratio
    LVMV = left ventricular mass volume
    Units: g/ml^3
        arithmetic mean (standard deviation)
    ( )
    ( )
    PSS (circ)
    PSS (circ) = peak systolic strain (circumferential)
    Units: s^-1
        arithmetic mean (standard deviation)
    ( )
    ( )
    Total cholesterol
    Units: mmol/l
        arithmetic mean (standard deviation)
    ( )
    ( )
    LDL cholesterol
    Data was available for 36 participants in each arm.
    Units: mmol/l
        arithmetic mean (standard deviation)
    ( )
    ( )
    HDL cholesterol
    Data were available for 37 participants in the sitagliptin group.
    Units: mmol/l
        arithmetic mean (standard deviation)
    ( )
    ( )
    Triglyceride
    Units: mmol/l
        arithmetic mean (standard deviation)
    ( )
    ( )
    Alanine Transaminase
    Units: IU/l
        arithmetic mean (standard deviation)
    ( )
    ( )
    eGFR
    Estimated Glomerular Filtration Rate
    Units: ml/min
        arithmetic mean (standard deviation)
    ( )
    ( )
    LV GCS
    LV GCS = left ventricular global circumferential strain Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: Percentage %
        arithmetic mean (standard deviation)
    ( )
    ( )
    LV GLS
    LV GLS = left ventricular global longitudinal strain Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: Percentage %
        arithmetic mean (standard deviation)
    ( )
    ( )
    LV EDV
    LV EDV = left ventricular end-diastolic volume Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    LV ESV
    LV ESV = left ventricular end-systolic volume Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    LVSV
    Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    LVCO
    LVCO = left ventricular cardiac output Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: L/min
        arithmetic mean (standard deviation)
    ( )
    ( )
    LVM
    LVM = left ventricular end diastolic mass Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: grams
        arithmetic mean (standard deviation)
    ( )
    ( )
    LV peak filling rate
    Data were available for 34 people in the liraglutide group and 34 in the sitagliptin group.
    Units: mL/s
        arithmetic mean (standard deviation)
    ( )
    ( )
    LMV/V
    Data were available for 34 people in the liraglutide group and 35 in the sitagliptin group.
    Units: g/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Min LA vol
    LA vol = left atrial volume Data were available for 32 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Max LA vol
    Data were available for 32 people in the liraglutide group and 35 in the sitagliptin group.
    Units: mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    LAEF
    LAEF = left atrial ejection fraction Data were available for 32 people in the liraglutide group and 35 in the sitagliptin group.
    Units: Percentage %
        arithmetic mean (standard deviation)
    ( )
    ( )
    Global stress MBF
    MBF = myocardial blood flow Data were available for 30 people in the liraglutide group and 34 in the sitagliptin group.
    Units: mL/min/g
        arithmetic mean (standard deviation)
    ( )
    ( )
    Global rest MBF
    Data were available for 30 people in the liraglutide group and 33 in the sitagliptin group.
    Units: mL/min/g
        arithmetic mean (standard deviation)
    ( )
    ( )
    MPR
    MPR = myocardial perfusion reserve Data were available for 30 people in the liraglutide group and 33 in the sitagliptin group.
    Units: None
        arithmetic mean (standard deviation)
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Participants received 1.8mg/daily Liraglutide. Liraglutide was administered using labelled 3ml prefilled pens (Victoza® 6mgml-1) supplied by the manufacturer.

    Reporting group title
    Sitagliptin
    Reporting group description
    		 Sitagliptin 100mg/daily.

    Subject analysis set title
    Liraglutide (imputed)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients allocated to liraglutide with missing outcome data imputed.

    Subject analysis set title
    Sitagliptin (imputed)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients allocated to sitagliptin with missing outcome data imputed.

    Primary: PEDSR (circ.)

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    End point title
    		 PEDSR (circ.)
    End point description
    Peak early diastolic strain rate (circumferential), measured by cardiac MRI at baseline and 26-weeks.
    End point type
    Primary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin Liraglutide (imputed) Sitagliptin (imputed)
    Number of subjects analysed
    28
    33
    31
    33
    Units: s^-1
        least squares mean (confidence interval 95%)
    -0.06 (-0.10 to -0.01)
    -0.05 (-0.10 to -0.01)
    -0.07 (-0.12 to -0.02)
    -0.06 (-0.10 to -0.01)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Statistical analysis description
    Linear regression was used to compare treatment effects adjusted for baseline values (age, sex, HbA1c, weight) with results presented as mean between group differences (Liraglutide minus Sitagliptin) and 95% confidence intervals. The primary analysis was conducted on a complete case ITT basis.
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.874
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 0.61
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (imputed)
    Statistical analysis description
    Same as ITT analysis above, but given not all participants had outcome data available multiple imputation was used to perform a full intention to treat analysis for the primary outcome only.
    Comparison groups
    Liraglutide (imputed) v Sitagliptin (imputed)
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.707
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.05

    Secondary: LV GCS

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    End point title
    		 LV GCS
    End point description
    LV GCS = left ventricular global circumferential strain
    End point type
    Secondary
    End point timeframe
    Baseline to completion of study (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: Percentage %
        least squares mean (confidence interval 95%)
    0.66 (0.15 to 1.17)
    0.27 (-0.20 to 0.73)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.274
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 1.09

    Secondary: PEDSR (long.)

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    End point title
    		 PEDSR (long.)
    End point description
    PEDSR (long.) = peak early diastolic strain rate (longitudinal)
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: s^-1
        least squares mean (confidence interval 95%)
    -0.08 (-0.13 to -0.03)
    -0.04 (-0.08 to -0.01)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.254
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.03

    Secondary: LV GLS

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    End point title
    		 LV GLS
    End point description
    LV GLS = left ventriular global longitudinal strain
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: Percentage %
        least squares mean (confidence interval 95%)
    0.33 (-0.35 to 1.01)
    0.43 (-0.19 to 1.05)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.841
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 0.85

    Secondary: LV EDV

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    End point title
    		 LV EDV
    End point description
    LV EDV = left ventricular end-diastolic volume.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: mL
        least squares mean (confidence interval 95%)
    -3.74 (-8.75 to 1.26)
    -3.46 (-7.95 to 1.03)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.936
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.14
         upper limit
    		 6.58

    Secondary: LV EDVi

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    End point title
    		 LV EDVi
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: mL/m^2
        least squares mean (confidence interval 95%)
    -0.23 (-2.90 to 2.44)
    -1.50 (-3.93 to 0.92)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.497
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 4.94

    Secondary: LV ESV

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    End point title
    		 LV ESV
    End point description
    LV ESV = left ventricular end-systolic volume
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: mL
        least squares mean (confidence interval 95%)
    -1.20 (-4.76 to 2.35)
    -3.67 (-6.86 to -0.47)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Sitagliptin v Liraglutide
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.322
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    2.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.41
         upper limit
    		 7.33

    Secondary: LV ESVi

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    End point title
    		 LV ESVi
    End point description
    LV ESVi = left ventricular end-systolic volume index.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: mL/m^2
        least squares mean (confidence interval 95%)
    0.01 (-1.69 to 1.69)
    -1.55 (-3.09 to -0.01)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Sitagliptin v Liraglutide
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.19
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.77
         upper limit
    		 3.88

    Secondary: LVEF

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    End point title
    		 LVEF
    End point description
    LVEF = left ventricular ejection fraction.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: Percentage %
        least squares mean (confidence interval 95%)
    -0.60 (-2.72 to 1.53)
    1.39 (-0.52 to 3.30)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.183
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -1.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 0.94

    Secondary: LVSV

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    End point title
    		 LVSV
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: mL
        least squares mean (confidence interval 95%)
    -2.59 (-7.53 to 2.34)
    0.22 (-4.19 to 4.63)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.421
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -2.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.66
         upper limit
    		 4.03

    Secondary: LVCO

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    End point title
    		 LVCO
    End point description
    LVCO = left ventricular cardiac output.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: L/min
        least squares mean (confidence interval 95%)
    -0.10 (-0.49 to 0.29)
    0.12 (-0.23 to 0.48)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.421
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.76
         upper limit
    		 0.32

    Secondary: LVM

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    End point title
    		 LVM
    End point description
    LVM = left ventricular end-diastolic mass.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: grams
        least squares mean (confidence interval 95%)
    0.72 (-3.94 to 5.37)
    -0.43 (-4.59 to 3.75)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.726
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.23
         upper limit
    		 7.5

    Secondary: LVMi

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    End point title
    		 LVMi
    End point description
    LVMi = left ventricular end-diastolic mass index.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: g/m^2
        least squares mean (confidence interval 95%)
    1.27 (-0.88 to 3.42)
    -0.26 (-2.22 to 1.69)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.308
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.41
         upper limit
    		 4.49

    Secondary: LV peak filling rate

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    End point title
    		 LV peak filling rate
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    33
    Units: mL/s
        least squares mean (confidence interval 95%)
    10.87 (-18.0 to 39.7)
    -18.72 (-44.90 to 7.46)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.145
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    29.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.15
         upper limit
    		 69.32

    Secondary: LMV/V

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    End point title
    		 LMV/V
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    32
    Units: g/mL
        least squares mean (confidence interval 95%)
    0.03 (-0.11 to 0.07)
    0.01 (-0.03 to 0.05)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.51
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.07

    Secondary: Min LA vol

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    End point title
    		 Min LA vol
    End point description
    LA vol = left atrial volume.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    32
    Units: mL
        least squares mean (confidence interval 95%)
    -0.81 (-3.52 to 1.89)
    1.89 (-0.61 to 4.38)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.161
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.47
         upper limit
    		 1.07

    Secondary: Max LA vol

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    End point title
    		 Max LA vol
    End point description
    LA vol = left atrial volume.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    32
    Units: mL
        least squares mean (confidence interval 95%)
    -3.82 (-8.88 to 1.23)
    -0.81 (-5.49 to 3.85)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.406
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -3.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 4.09

    Secondary: LAEF

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    End point title
    		 LAEF
    End point description
    LAEF = left atrial ejection fraction.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    32
    Units: Percentage %
        least squares mean (confidence interval 95%)
    -1.65 (-3.46 to 0.17)
    -2.80 (-4.48 to -1.12)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.37
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.37
         upper limit
    		 3.67

    Secondary: Global stress MBF

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    End point title
    		 Global stress MBF
    End point description
    MBF = myocardial blood flow.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    25
    30
    Units: mL/min/g
        least squares mean (confidence interval 95%)
    -0.21 (-0.49 to 0.06)
    -0.15 (-0.40 to 0.97)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Sitagliptin v Liraglutide
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.748
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.44
         upper limit
    		 0.32

    Secondary: Global rest MBF

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    End point title
    		 Global rest MBF
    End point description
    MBF = myocardial blood flow.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    25
    30
    Units: mL/min/g
        least squares mean (confidence interval 95%)
    -0.14 (-0.26 to -0.02)
    -0.21 (-0.32 to -0.10)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.412
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.23

    Secondary: MPR

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    End point title
    		 MPR
    End point description
    MPR = myocardial perfusion reserve.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    25
    30
    Units: None
        least squares mean (confidence interval 95%)
    -0.09 (-0.46 to 0.28)
    0.19 (-0.15 to 0.53)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.291
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.79
         upper limit
    		 0.24

    Secondary: HbA1c (%)

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    End point title
    		 HbA1c (%)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    31
    33
    Units: Percentage %
        least squares mean (confidence interval 95%)
    -0.89 (-1.18 to -0.60)
    -0.48 (-0.76 to -0.18)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.048
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.83
         upper limit
    		 -0.01

    Secondary: HbA1c (mmol/mol)

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    End point title
    		 HbA1c (mmol/mol)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    31
    33
    Units: mmol/mol
        least squares mean (confidence interval 95%)
    -9.90 (-13.12 to -6.67)
    -5.32 (-8.46 to -2.19)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.048
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -4.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.1
         upper limit
    		 -0.37

    Secondary: Weight

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    End point title
    		 Weight
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    31
    33
    Units: kg
        least squares mean (confidence interval 95%)
    -4.51 (-5.84 to -3.19)
    -0.63 (-1.92 to 0.66)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -3.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.74
         upper limit
    		 -2.01

    Secondary: BMI

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    End point title
    		 BMI
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    31
    33
    Units: kg/m^2
        least squares mean (confidence interval 95%)
    -1.60 (-2.10 to -1.10)
    -0.28 (-0.77 to 0.20)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.03
         upper limit
    		 -0.62

    Secondary: Systolic blood pressure

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    End point title
    		 Systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    31
    33
    Units: mmHg
        least squares mean (confidence interval 95%)
    -8.90 (-12.02 to -5.78)
    -8.73 (-11.77 to -5.69)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.939
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.56
         upper limit
    		 4.22

    Secondary: Diastolic blood pressure

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    End point title
    		 Diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    31
    33
    Units: mmHg
        least squares mean (confidence interval 95%)
    -5.15 (-7.61 to -2.70)
    -3.88 (-6.27 to -1.50)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.473
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.07
         upper limit
    		 2.09

    Secondary: Heart rate

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    End point title
    		 Heart rate
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    31
    33
    Units: Beats per min
        least squares mean (confidence interval 95%)
    13.49 (9.57 to 17.41)
    7.96 (4.15 to 11.78)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.052
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    5.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 11.12

    Secondary: Total cholesterol

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    End point title
    		 Total cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    31
    33
    Units: mmol/l
        least squares mean (confidence interval 95%)
    0.11 (-0.11 to 0.34)
    -0.23 (-0.45 to -0.01)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 0.67

    Secondary: LDL cholesterol

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    End point title
    		 LDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    28
    31
    Units: mmol/l
        least squares mean (confidence interval 95%)
    0.21 (0.02 to 0.40)
    -0.09 (-0.27 to 0.09)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Sitagliptin v Liraglutide
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 0.57

    Secondary: HDL cholesterol

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    End point title
    		 HDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    30
    32
    Units: mmol/l
        least squares mean (confidence interval 95%)
    0.03 (-0.02 to 0.08)
    0.01 (-0.04 to 0.07)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.62
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.1

    Secondary: Triglycerides

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    End point title
    		 Triglycerides
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    31
    33
    Units: mmol/l
        least squares mean (confidence interval 95%)
    -0.32 (-0.57 to -0.06)
    -0.35 (-0.60 to -0.10)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.833
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.32
         upper limit
    		 0.39

    Secondary: Alanine Transaminase

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    End point title
    		 Alanine Transaminase
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    31
    33
    Units: IU/l
        least squares mean (confidence interval 95%)
    -4.92 (-11.22 to 1.37)
    6.35 (-0.23 to 12.46)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    -11.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.17
         upper limit
    		 -2.37

    Secondary: eGFR

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    End point title
    		 eGFR
    End point description
    eGFR = estimated glomerular filtration rate.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    31
    33
    Units: ml/min
        least squares mean (confidence interval 95%)
    -0.58 (-2.47 to 1.31)
    -3.02 (-4.85 to -1.18)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.08
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    2.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 5.16

    Secondary: VO2 max

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    End point title
    		 VO2 max
    End point description
    VO2 max = maximal oxygen consumption.
    End point type
    Secondary
    End point timeframe
    Baseline to study completion (26 weeks).
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    22
    24
    Units: ml/kg/min
        least squares mean (confidence interval 95%)
    0.46 (-0.40 to 1.33)
    -0.47 (-1.30 to 0.35)
    Statistical analysis title
    		 Liraglutide vs Sitagliptin (ITT)
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.135
    Method
    		 Regression, Linear
    Parameter type
    		 LS Mean difference
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 2.17

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Consent to last dose of drug.
    Adverse event reporting additional description
    At each visit, the investigator documented adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. All SAEs and non-serious AEs classified as severe or possibly/probably related were followed up until resolution.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Liraglutide was administered using labelled 3ml prefilled pens (Victoza® 6mgml-1) supplied by the manufacturer. Starting at a dose of 0.6mg daily, a weekly 0.6mg incremental dose escalation protocol was followed at the investigator’s discretion towards a maintenance dose of 1.8mg weekly.

    Reporting group title
    Sitagliptin
    Reporting group description
    		 Sitagliptin was obtained from the manufacturer and prescribed at a dose of 100mg daily from the point of treatment initiation.

    Serious adverse events
    		 Liraglutide Sitagliptin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 38 (0.00%)
    4 / 38 (10.53%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Myocardial Infarction
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal Injury
    Additional description: Participant stepped off the pavement and twisted her ankle and hyperextended her knee causing serious knee injury.
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Chest infection
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         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: 0.05%
    Non-serious adverse events
    		 Liraglutide Sitagliptin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 38 (92.11%)
    38 / 38 (100.00%)
    Vascular disorders
    Haemorrhoids
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Hypertension
    Additional description: Worsening of blood pressure
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Dental problem
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 38 (7.89%)
         occurrences all number
    2
    3
    General disorders and administration site conditions
    Tiredness
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 38 (5.26%)
         occurrences all number
    1
    2
    Hot flush
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Lethargy
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Swelling of feet
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    2
    Immune system disorders
    Hay fever
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 38 (15.79%)
    8 / 38 (21.05%)
         occurrences all number
    6
    8
    Cough
         subjects affected / exposed
    1 / 38 (2.63%)
    7 / 38 (18.42%)
         occurrences all number
    1
    7
    Asthma attack
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Sinus pain
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Sore throat
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    low mood
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Stress
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Cardiac murmur
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Cholesterol levels raised
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Abnormal ECG
    Additional description: Abnormal ECG result (exercise)
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Injection site reaction
         subjects affected / exposed
    3 / 38 (7.89%)
    0 / 38 (0.00%)
         occurrences all number
    3
    0
    Wasp sting
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 38 (5.26%)
         occurrences all number
    2
    2
    Chest pain
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 38 (21.05%)
    9 / 38 (23.68%)
         occurrences all number
    8
    9
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Neuropathic pain
    Additional description: Worsening of neuropathic pain
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Faint
    Additional description: Fainted during VO2 exercise test
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    4 / 38 (10.53%)
    5 / 38 (13.16%)
         occurrences all number
    5
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    19 / 38 (50.00%)
    9 / 38 (23.68%)
         occurrences all number
    23
    9
    Vomiting
         subjects affected / exposed
    6 / 38 (15.79%)
    2 / 38 (5.26%)
         occurrences all number
    7
    3
    Abdominal pain
         subjects affected / exposed
    4 / 38 (10.53%)
    5 / 38 (13.16%)
         occurrences all number
    4
    5
    Diarrhoea
         subjects affected / exposed
    15 / 38 (39.47%)
    8 / 38 (21.05%)
         occurrences all number
    17
    8
    Constipation
         subjects affected / exposed
    5 / 38 (13.16%)
    2 / 38 (5.26%)
         occurrences all number
    5
    2
    Flatulence
         subjects affected / exposed
    6 / 38 (15.79%)
    2 / 38 (5.26%)
         occurrences all number
    6
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 38 (13.16%)
    1 / 38 (2.63%)
         occurrences all number
    6
    1
    Taste disorder
    Additional description: Strange taste
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dry skin
    Additional description: Dry skin on knees
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Excess Sweating
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Hard skin
    Additional description: Hard skin on right foot
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    itchy skin
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal injury
         subjects affected / exposed
    6 / 38 (15.79%)
    8 / 38 (21.05%)
         occurrences all number
    6
    8
    Swelling of knees
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Ear infection
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Thrush
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Appetite disorder
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemic event
         subjects affected / exposed
    2 / 38 (5.26%)
    4 / 38 (10.53%)
         occurrences all number
    3
    5
    Excessive Thirst
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         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.
    Unfortunately, despite the best efforts of the research team, this study did not recruit to target. After a challenging recruitment period, the study team managed to recruit 76 participants of an overall recruitment target of 90 participants.
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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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