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    Clinical Trial Results:
    To evaluate if 24 weeks treatment with Lixisenatide, reduces arterial stiffness as measured by aortic pulse wave velocity (Ao-PWV) in T2DM patients with diabetic nephropathy (DN)

    Summary
    EudraCT number
    		 2016-001758-17
    Trial protocol
    		 GB  
    Global end of trial date
    15 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2026
    First version publication date
    08 May 2026
    Other versions
    Summary report(s)
    		 LAST CSR v3.0 Final Signed

    Trial information

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    Trial identification
    Sponsor protocol code
    LAST
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Janaka Karalliedde, King's College London, 44 02078484464, j.karalliedde@kcl.ac.uk
    Scientific contact
    Janaka Karalliedde, King's College London, 44 02078484464, j.karalliedde@kcl.ac.uk
    Sponsor organisation name
    Guy's and St Thomas NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE1 9RT
    Public contact
    Janaka Karalliedde, Guy's and St Thomas' NHS Foundation Trust, 44 02078484464, j.karalliedde@kcl.ac.uk
    Scientific contact
    Janaka Karalliedde, Guy's and St Thomas' NHS Foundation Trust, 44 02078484464, j.karalliedde@kcl.ac.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
    15 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if treatment with Lixisenatide for 24 weeks reduces Ao-PWV in T2DM with DN.
    Protection of trial subjects
    Participants have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw patients from the study drug in the event of inter- current illness, AEs, SAE’s, SUSAR’s, protocol violations, administrative reasons or other reasons.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jan 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 101
    Worldwide total number of subjects
    101
    EEA total number of subjects
    101
    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)
    77
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 143 [1]
    Number of subjects completed
    		 101

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 N/A: 42
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: We do not count screening participants as enrolled
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lixisenatide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    10mcg od increasing to 20mcg od within 14 days from the start of treatment

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    dosage of 10mcg od increasing to 20mcg od within 14 days from the start of treatment

    Number of subjects in period 1
    		Active Placebo
    Started
    51
    50
    Completed
    47
    43
    Not completed
    4
    7
         N/A
    4
    7

    Baseline characteristics

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 51 50 101
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.5 ( 10.2 ) 67.2 ( 11.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 16 35
        Male
    		 32 34 66

    End points

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Aortic Pulse Wave Velocity

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    End point title
    		 Aortic Pulse Wave Velocity [1]
    End point description
    End point type
    Primary
    End point timeframe
    Following 24-week treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see uploaded report
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    50
    Units: m/s
        arithmetic mean (confidence interval 95%)
    9.65 (9.17 to 10.13)
    9.96 (9.45 to 10.46)
    No statistical analyses for this end point

    Secondary: Albuminuria excretion rate

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    End point title
    		 Albuminuria excretion rate
    End point description
    End point type
    Secondary
    End point timeframe
    Following 24-week treatment
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    50
    Units: mcg/min
        arithmetic mean (confidence interval 95%)
    449.94 (253.54 to 646.34)
    208.26 (6.97 to 409.56)
    No statistical analyses for this end point

    Secondary: Central systolic blood pressure

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    End point title
    		 Central systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Following 24-week treatment
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    50
    Units: mm/Hg
        arithmetic mean (confidence interval 95%)
    121.95 (117.97 to 125.93)
    208.26 (6.97 to 409.56)
    No statistical analyses for this end point

    Secondary: Central diastolic blood pressure

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    End point title
    		 Central diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Following 24-week treatment
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    50
    Units: mm/Hg
        arithmetic mean (confidence interval 95%)
    78.83 (76.83 to 80.83)
    78.06 (75.97 to 80.15)
    No statistical analyses for this end point

    Secondary: Seated brachial systolic blood pressure

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    End point title
    		 Seated brachial systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Following 24-week treatment
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    50
    Units: mm/Hg
        arithmetic mean (confidence interval 95%)
    136.57 (132.28 to 140.86)
    133.45 (128.97 to 137.94)
    No statistical analyses for this end point

    Secondary: Seated brachial diastolic blood pressure

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    End point title
    		 Seated brachial diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Following 24-week treatment
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    50
    Units: mm/Hg
        arithmetic mean (confidence interval 95%)
    78.46 (76.48 to 80.43)
    77.43 (75.37 to 79.5)
    No statistical analyses for this end point

    Secondary: Weight

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    End point title
    		 Weight
    End point description
    End point type
    Secondary
    End point timeframe
    Following 24-week treatment
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    50
    Units: Kg
        arithmetic mean (confidence interval 95%)
    100.58 (98.63 to 102.52)
    100.58 (98.54 to 102.62)
    No statistical analyses for this end point

    Secondary: eGFR/1.73m2

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    End point title
    		 eGFR/1.73m2
    End point description
    End point type
    Secondary
    End point timeframe
    Following 24-week treatment
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    50
    Units: mL/min
        arithmetic mean (confidence interval 95%)
    67.83 (65.4 to 70.27)
    66.11 (63.56 to 68.66)
    No statistical analyses for this end point

    Secondary: HbA1c log transformed

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    End point title
    		 HbA1c log transformed
    End point description
    End point type
    Secondary
    End point timeframe
    Following 24-week treatment
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    50
    Units: %
        arithmetic mean (confidence interval 95%)
    8.94 (8.58 to 9.30)
    9.58 (9.12 to 9.97)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24-weeks following treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 21 (100.00%)
    23 / 23 (100.00%)
    Vascular disorders
    Other cardiovascular disorders
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Immune system disorders
    Immunological
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Reproductive system and breast disorders
    Genitourinary/Renal
         subjects affected / exposed
    0 / 21 (0.00%)
    6 / 23 (26.09%)
         occurrences all number
    0
    6
    Respiratory, thoracic and mediastinal disorders
    Respiratory/Virus/Flu/Chest infection/Lower respiratory tract infection
         subjects affected / exposed
    5 / 21 (23.81%)
    7 / 23 (30.43%)
         occurrences all number
    7
    7
    Injury, poisoning and procedural complications
    Forehead wound
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Other cardiovascular disorders
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 23 (4.35%)
         occurrences all number
    3
    2
    Nervous system disorders
    Neurological/Dizziness/Memory loss
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    Blood and lymphatic system disorders
    Hematological
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    3
    Eye disorders
    Eyes, ear, nose, throat
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gastrointestinal/ Tooth
         subjects affected / exposed
    4 / 21 (19.05%)
    7 / 23 (30.43%)
         occurrences all number
    6
    5
    Skin and subcutaneous tissue disorders
    Dermatological
         subjects affected / exposed
    3 / 21 (14.29%)
    4 / 23 (17.39%)
         occurrences all number
    4
    4
    Musculoskeletal and connective tissue disorders
    Musculoskeletal
         subjects affected / exposed
    8 / 21 (38.10%)
    2 / 23 (8.70%)
         occurrences all number
    6
    5
    Metabolism and nutrition disorders
    Endocrine
         subjects affected / exposed
    6 / 21 (28.57%)
    4 / 23 (17.39%)
         occurrences all number
    5
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jan 2018
    Protocol V5.0 30May2017, Invitation letter: Version 3.0 Jun2017 (PIC sites)
    19 Jan 2018
    Protocol V6.0 20 November 2017, SmPC: Lixisenatide 10 micrograms solution for injection 18Sep 2017, SmPC: Lixisenatide 20 micrograms solution for injection 18Sep 2017

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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