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    Clinical Trial Results:
    Effects of GLP-1 Receptor Agonist Lixisenatide on Post-prandial Lipid Profile in Obese Type 2 Diabetic Patients

    Summary
    EudraCT number
    		 2014-002263-15
    Trial protocol
    		 IT  
    Global end of trial date
    04 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Aug 2016
    First version publication date
    19 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LIXISL07016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02274740
    WHO universal trial number (UTN)
    		 U1111-1153-3774
    Sponsors
    Sponsor organisation name
    Sanofi S.pA
    Sponsor organisation address
    Viale Bodio 37/b, Milan, Italy, 20158
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    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 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Aug 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the ability of lixisenatide to modulate post-prandial hyperlipidemia as an add-on treatment to metformin in comparison to the control group (i.e . metformin therapy): in particular the effects on plasma changes in triglycerides in obese Type II diabetes subjects.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 Metformin was administered at a stable dose throughout the study unless there was a specific safety issue related to this treatment.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2015
    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
    Italy: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at a single center in Italy between April 30, 2015 and August 04, 2015.

    Pre-assignment
    Screening details
    		 A total of 3 subjects were screened, of which 1 subject was screen failure due to HbA1c and triglycerides out of required range. 2 subjects were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lixisenatide + Metformin
    Arm description
    		 Lixisenatide 10 mcg once daily (QD) subcutaneously for 2 weeks, then at a maintenance dose of 20 mcg up to 10 weeks on top of metformin.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lixisenatide
    Investigational medicinal product code
    AVE0010
    Other name
    Lyxumia®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lixisenatide was self-administered QD by subcutaneous injection over 60 minutes before breakfast.

    Arm title
    		 Metformin
    Arm description
    		 Metformin at a stable dose of ≥1.5 g/day as background therapy up to 10 weeks.
    Arm type
    		 Control Group

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Lixisenatide + Metformin Metformin
    Started
    1
    1
    Completed
    1
    0
    Not completed
    0
    1
         Study interruption
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lixisenatide + Metformin
    Reporting group description
    		 Lixisenatide 10 mcg once daily (QD) subcutaneously for 2 weeks, then at a maintenance dose of 20 mcg up to 10 weeks on top of metformin.

    Reporting group title
    Metformin
    Reporting group description
    		 Metformin at a stable dose of ≥1.5 g/day as background therapy up to 10 weeks.

    Reporting group values
    		 Lixisenatide + Metformin Metformin Total
    Number of subjects
    		 1 1 2
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1 2
    Gender categorical
    Units: Subjects
        Female
    		 1 1 2
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Lixisenatide + Metformin
    Reporting group description
    		 Lixisenatide 10 mcg once daily (QD) subcutaneously for 2 weeks, then at a maintenance dose of 20 mcg up to 10 weeks on top of metformin.

    Reporting group title
    Metformin
    Reporting group description
    		 Metformin at a stable dose of ≥1.5 g/day as background therapy up to 10 weeks.

    Primary: Change From Baseline in Triglycerides Area Under the Curve (AUC0-480 min) to Week 10

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    End point title
    		 Change From Baseline in Triglycerides Area Under the Curve (AUC0-480 min) to Week 10 [1]
    End point description
    AUC (0-480) was defined as the area under plasma concentration versus time curve from time 0 to 480 min after the meal.
    End point type
    Primary
    End point timeframe
    0 (pre-prandial) to 480 minutes after meal test at Baseline and Week 10
    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: Due to premature study interruption, none of the planned efficacy analysis was performed.
    End point values
    		 Lixisenatide + Metformin Metformin
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Not applicable
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [2] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    [3] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Triglycerides AUC0-480 min to Day 2

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    End point title
    		 Change From Baseline in Triglycerides AUC0-480 min to Day 2
    End point description
    AUC (0-480) was defined as the area under plasma concentration versus time curve from time 0 to 480 min after the meal.
    End point type
    Secondary
    End point timeframe
    0 (pre-prandial) to 480 minutes after meal test at Baseline and Day 2
    End point values
    		 Lixisenatide + Metformin Metformin
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Not applicable
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [4] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    [5] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Plasma Cholesterol, Apo B48, Free Fatty Acid, Lipoprotein to Day 2 and Week 10

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    End point title
    		 Change From Baseline in Plasma Cholesterol, Apo B48, Free Fatty Acid, Lipoprotein to Day 2 and Week 10
    End point description
    Change was to be calculated by subtracting baseline values from Day 2 and Week 10 values.
    End point type
    Secondary
    End point timeframe
    0 (pre-prandial) to 480 minutes after meal test at Baseline, Day 2 and Week 10
    End point values
    		 Lixisenatide + Metformin Metformin
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Not applicable
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [6] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    [7] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Low Density Lipoprotein (LDL) Oxidation to Day 2 and Week 10

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    End point title
    		 Change From Baseline in Low Density Lipoprotein (LDL) Oxidation to Day 2 and Week 10
    End point description
    End point type
    Secondary
    End point timeframe
    0 (pre-prandial) to 480 minutes after meal test at Baseline, Day 2 and Week 10
    End point values
    		 Lixisenatide + Metformin Metformin
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: Not applicable
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [8] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    [9] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Post Prandial Plasma Glucose AUC0-480 min, Post Prandial Insulin AUC0-480 min; Post Prandial C-peptide AUC0-480 min to Day 2 and Week 10

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    End point title
    		 Change From Baseline in Post Prandial Plasma Glucose AUC0-480 min, Post Prandial Insulin AUC0-480 min; Post Prandial C-peptide AUC0-480 min to Day 2 and Week 10
    End point description
    End point type
    Secondary
    End point timeframe
    0 (pre-prandial) to 480 minutes after meal test at Baseline, Day 2 and Week 10
    End point values
    		 Lixisenatide + Metformin Metformin
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: Not applicable
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [10] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    [11] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Cytokines and Stress Oxidative Markers to Day 2 and Week 10

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    End point title
    		 Change From Baseline in Cytokines and Stress Oxidative Markers to Day 2 and Week 10
    End point description
    Cytokines and stress oxidative markers are indication of low grade inflammation.
    End point type
    Secondary
    End point timeframe
    0 (pre-prandial) to 480 minutes after meal test at Baseline, Day 2 and Week 10
    End point values
    		 Lixisenatide + Metformin Metformin
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: Not applicable
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [12] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    [13] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Coronary Flow Reserve (CFR) to Day 2 and Week 10

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    End point title
    		 Change From Baseline in Coronary Flow Reserve (CFR) to Day 2 and Week 10
    End point description
    CFR was a ratio of coronary blood flow velocity before and after adenosine.
    End point type
    Secondary
    End point timeframe
    0 (pre-prandial) to 480 minutes after meal test at Baseline, Day 2 and Week 10
    End point values
    		 Lixisenatide + Metformin Metformin
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: Not applicable
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [14] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    [15] - Due to premature study interruption, none of the planned efficacy analysis was performed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 73) regardless of seriousness or relationship to investigational product
    Adverse event reporting additional description
    No adverse event was reported during the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Lixisenatide + Metformin
    Reporting group description
    		 Lixisenatide 10 mcg once daily (QD) subcutaneously for 2 weeks, then at a maintenance dose of 20 mcg up to 10 weeks on top of metformin.

    Reporting group title
    Metformin
    Reporting group description
    		 Metformin at a stable dose of ≥1.5 g/day as background therapy up to 10 weeks.

    Serious adverse events
    		 Lixisenatide + Metformin Metformin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Lixisenatide + Metformin Metformin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse event was reported during the trial.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Sep 2014
    - Changes in sections relative to the primary objective and primary endpoint sections were made for major clarity and internal consistency. - Changes in sections relative to the statistical analysis and pertinent to comparisons between groups were made for major clarity and internal consistency. - Changes in sections relative to the management of concomitant diabetes therapy were made to better clarify the procedures for the management of rescue therapy. - Exclusion criterion referring to renal disease was modified and the reference parameter and value was reworded according to estimated creatinine clearance ≤ 50 ml/min.

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

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