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    Clinical Trial Results:
    Randomized, Double-blind, Placebo-controlled, Dose escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients with Type 2 Diabetes Mellitus not Adequately Controlled With Metformin and/or Basal Insulin

    Summary
    EudraCT number
    2015-005789-42
    Trial protocol
    ES   Outside EU/EEA  
    Global end of trial date
    27 Jan 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Aug 2020
    First version publication date
    01 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TDR14311
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02803918
    WHO universal trial number (UTN)
    U1111-1176-6142
    Sponsors
    Sponsor organisation name
    Sanofi-aventis Recherche & Développement
    Sponsor organisation address
    1, Avenue Pierre Brossolette, Chilly Mazarin, France, 91385
    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)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000916-PIP01-10
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate safety of 14-day repeated lixisenatide doses of 5 microgram [mcg], 10 mcg and 20 mcg as compared to placebo in paediatric subjects with Type 2 diabetes mellitus (T2DM).
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of paediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimised. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimise distress and discomfort.
    Background therapy
    Metformin and/or basal insulin was used as non-investigational medicinal product and were administered according to local label.
    Evidence for comparator
    -
    Actual start date of recruitment
    17 May 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
    South Africa: 1
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Turkey: 3
    Country: Number of subjects enrolled
    United States: 5
    Country: Number of subjects enrolled
    Mauritius: 5
    Country: Number of subjects enrolled
    Mexico: 8
    Worldwide total number of subjects
    23
    EEA total number of subjects
    1
    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)
    23
    Adults (18-64 years)
    0
    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 11 sites in 6 countries. A total of 23 subjects were screened between 17 May 2017 and 23 November 2019.

    Pre-assignment
    Screening details
    A total of 23 subjects were randomised and treated in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received a dose of placebo (matched to lixisenatide) as subcutaneous (SC) injection from Day 1 to Day 42.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo (matched to lixisenatide) was administered in abdominal area. Subjects were fasted for at least 1 hour prior to dosing.

    Arm title
    Lixisenatide
    Arm description
    Subjects received 3 doses of lixisenatide (5 mcg, 10 mcg and 20 mcg) as SC injection in incremental sequential dose escalation steps of 2 weeks from Day 1 to Day 42.
    Arm type
    Experimental

    Investigational medicinal product name
    Lixisenatide
    Investigational medicinal product code
    AVE0010
    Other name
    Lyxumia
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lixisenatide was administered in abdominal area. Each subject underwent a dose escalation according to the following paradigm: 5 mcg (Day 1 to 14), then 10 mcg (Day 15 to 28) and 20 mcg (Day 29 to 42). Subjects were fasted for at least 1 hour prior to dosing.

    Number of subjects in period 1
    Placebo Lixisenatide
    Started
    5
    18
    Completed
    5
    17
    Not completed
    0
    1
         Poor compliance to protocol
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received a dose of placebo (matched to lixisenatide) as subcutaneous (SC) injection from Day 1 to Day 42.

    Reporting group title
    Lixisenatide
    Reporting group description
    Subjects received 3 doses of lixisenatide (5 mcg, 10 mcg and 20 mcg) as SC injection in incremental sequential dose escalation steps of 2 weeks from Day 1 to Day 42.

    Reporting group values
    Placebo Lixisenatide Total
    Number of subjects
    5 18 23
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    15.4 ± 1.5 15.6 ± 1.0 -
    Gender categorical
    Units: Subjects
        Female
    3 13 16
        Male
    2 5 7
    Body mass index (BMI)
    Units: Kilogram per square meter (kg/m^2)
        arithmetic mean (standard deviation)
    37.4 ± 3.6 33.2 ± 4.8 -
    Duration of diabetes
    Units: years
        arithmetic mean (standard deviation)
    3.5 ± 2.2 1.6 ± 1.2 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received a dose of placebo (matched to lixisenatide) as subcutaneous (SC) injection from Day 1 to Day 42.

    Reporting group title
    Lixisenatide
    Reporting group description
    Subjects received 3 doses of lixisenatide (5 mcg, 10 mcg and 20 mcg) as SC injection in incremental sequential dose escalation steps of 2 weeks from Day 1 to Day 42.

    Subject analysis set title
    Lixisenatide 5 mcg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received a dose of lixisenatide 5 mcg as SC injection from Day 1 to Day 14.

    Subject analysis set title
    Lixisenatide 10 mcg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received a dose of lixisenatide 10 mcg as SC injection from Day 15 to Day 28.

    Subject analysis set title
    Lixisenatide 20 mcg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received a dose of lixisenatide 20 mcg as SC injection from Day 29 to Day 42.

    Primary: Safety profile: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Safety profile: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) [1] [2]
    End point description
    Adverse event (AE): any untoward medical occurrence in a subject who received study drug and did not necessarily had a causal relationship with study treatment. Serious AEs (SAEs): Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalisation, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. AE of special interest (AESI): AE (serious/nonserious) of scientific and medical concern, specific to study drug or program, which were monitored and immediately notified to Sponsor. TEAEs: AEs that occurred or worsened or became serious during on-treatment phase (time from first study drug administration up to 3 days after last study drug administration [i.e., up to 45 days]). Analysis was performed on safety population which included subjects who were exposed to study drug regardless of amount of treatment administered.
    End point type
    Primary
    End point timeframe
    From Baseline up to end-of-study (EOS; up to Day 45)
    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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data were planned to be collected and analysed for specified arms only.
    End point values
    Placebo Lixisenatide 5 mcg Lixisenatide 10 mcg Lixisenatide 20 mcg
    Number of subjects analysed
    5
    18
    18
    18
    Units: subjects
    number (not applicable)
        Any TEAE
    3
    6
    3
    4
        Severe TEAE
    0
    0
    0
    1
        Ant TESAE
    0
    0
    0
    1
        Any TEAE leading to death
    0
    0
    0
    0
        Any TEAE leading to permanent discontinuation
    0
    0
    0
    0
        Any TEAE of special interest (AESI)
    1
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects by Anti-lixisenatide Antibodies (ADAs) Status (Positive/Negative)

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    End point title
    Number of Subjects by Anti-lixisenatide Antibodies (ADAs) Status (Positive/Negative) [3] [4]
    End point description
    Number of subjects with ADAs status categorised as negative and positive were reported. Baseline was defined as the last values done on Baseline (Day -1) before first study drug administration. Analysis was performed on safety population.
    End point type
    Primary
    End point timeframe
    Baseline (Day -1), Day 14, Day 28 and Day 42
    Notes
    [3] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be collected and analysed for specified arms only.
    End point values
    Placebo Lixisenatide 5 mcg Lixisenatide 10 mcg Lixisenatide 20 mcg
    Number of subjects analysed
    5
    18
    18
    18
    Units: subjects
    number (not applicable)
        Baseline: Negative
    5
    17
    17
    17
        Baseline: Positive
    0
    1
    1
    1
        Day 14: Negative
    5
    16
    0
    0
        Day 14: Positive
    0
    2
    0
    0
        Day 28: Negative
    5
    0
    8
    0
        Day 28: Positive
    0
    0
    9
    0
        Day 42: Negative
    4
    0
    0
    4
        Day 42: Positive
    1
    0
    0
    14
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration Observed (Cmax) of Lixisenatide Following Repeated Dosing of 20 mcg Dose by Anti-lixisenatide Antibodies Status

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    End point title
    Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration Observed (Cmax) of Lixisenatide Following Repeated Dosing of 20 mcg Dose by Anti-lixisenatide Antibodies Status
    End point description
    Cmax was defined as maximum plasma concentration observed during the respective treatment period, evaluated as per subject ADA status. Analysis was performed on PK population which included all subjects without any major deviations related to study drug administration and provided at least one blood sample for drug concentration measurement. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0 hour), 0.5 hour, 1, 1.5, 2, 2.5, 3.5 and 4.5 hours post-dose on Day 42
    End point values
    Lixisenatide 20 mcg
    Number of subjects analysed
    18
    Units: picogram/millilitre (pg/mL)
    arithmetic mean (standard deviation)
        ADA Negative (n = 4)
    83.9 ± 25.2
        ADA Positive (n = 11)
    508 ± 453
    No statistical analyses for this end point

    Secondary: Pharmacokinetic Parameter : Time to Reach Maximum Plasma Concentration (tmax) of Lixisenatide Following Repeated Dosing of 20 mcg Dose by Anti-lixisenatide Antibodies Status

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    End point title
    Pharmacokinetic Parameter : Time to Reach Maximum Plasma Concentration (tmax) of Lixisenatide Following Repeated Dosing of 20 mcg Dose by Anti-lixisenatide Antibodies Status
    End point description
    tmax was defined as the time to reach Cmax, evaluated as per subject ADA status. Analysis was performed on the PK population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0 hour), 0.5 hour, 1, 1.5, 2, 2.5, 3.5 and 4.5 hours post-dose on Day 42
    End point values
    Lixisenatide 20 mcg
    Number of subjects analysed
    18
    Units: hours
    median (full range (min-max))
        ADA Negative (n = 4)
    1.24 (0.98 to 2.50)
        ADA Positive (n = 11)
    2.00 (0.50 to 4.50)
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration (AUC) From Time 0 Hour to 4.5 Hours (AUC0-4.5) of Lixisenatide Following Repeated Dosing of 20 mcg Dose by Anti-lixisenatide Antibodies Status

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    End point title
    Area Under the Plasma Concentration (AUC) From Time 0 Hour to 4.5 Hours (AUC0-4.5) of Lixisenatide Following Repeated Dosing of 20 mcg Dose by Anti-lixisenatide Antibodies Status
    End point description
    AUC0-4.5 was defined as area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero (lixisenatide scale) to time 4.5 hours post-dose, evaluated as per subject ADA status. Analysis was performed on PK population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0 hour), 0.5 hour, 1, 1.5, 2, 2.5, 3.5 and 4.5 hours post-dose on Day 42
    End point values
    Lixisenatide 20 mcg
    Number of subjects analysed
    18
    Units: picogram*hour per millilitre (pg*h/mL)
    arithmetic mean (standard deviation)
        ADA Negative (n = 4)
    267 ± 96.1
        ADA Positive (n = 9)
    2300 ± 1940
    No statistical analyses for this end point

    Secondary: Change From Baseline in Area Under the Plasma Glucose Concentration From Time 0 Hour to 4.5 Hours (AUC0-4.5) at Day 42

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    End point title
    Change From Baseline in Area Under the Plasma Glucose Concentration From Time 0 Hour to 4.5 Hours (AUC0-4.5) at Day 42 [5]
    End point description
    AUC0-4.5 was defined as area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero (lixisenatide scale) to time 4.5 hours post-dose. Analysis was performed on pharmacodynamic (PD) population which included all randomised subjects without any important deviation related to study drug administration for whom the PD data was considered sufficient and interpretable. Here, 'number of subjects analysed' = subjects evaluable and had available data for this endpoint
    End point type
    Secondary
    End point timeframe
    0.5 hour (prior to standardised breakfast), 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), pre-dose (0 hour), 1, 1.5, 2, 2.5, 3.5, 4.5 hours post-dose on Day 42
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data were planned to be collected and analysed for specified arms only.
    End point values
    Placebo Lixisenatide 20 mcg
    Number of subjects analysed
    5
    17
    Units: millimoles*hour per litre (mmol*h/L)
        arithmetic mean (standard deviation)
    13.84 ± 18.93
    -17.33 ± 12.19
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14, Day 28 and Day 42

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    End point title
    Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14, Day 28 and Day 42 [6]
    End point description
    Change in FPG was calculated by subtracting baseline value from Day 14, Day 28 and Day 42 values. Baseline was defined as the last values done on Day -1 before first study drug administration. Analysis was performed on PD population. Here, 'n' = subjects with available data for each specified category and '99999' was used as a space filler and indicated that no subjects were involved in the PD analysis at the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 14, 28 and 42
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data were planned to be collected and analysed for specified arms only.
    End point values
    Placebo Lixisenatide 5 mcg Lixisenatide 10 mcg Lixisenatide 20 mcg
    Number of subjects analysed
    5
    18
    18
    18
    Units: millimoles per litre (mmol/L)
    arithmetic mean (standard deviation)
        Day 14 (n = 5, 17, 0, 0)
    1.73 ± 1.39
    -1.08 ± 1.84
    99999 ± 99999
    99999 ± 99999
        Day 28 (n = 5, 0, 18, 0)
    2.35 ± 2.27
    99999 ± 99999
    -0.69 ± 2.76
    99999 ± 99999
        Day 42 (n = 5, 0, 0, 18)
    2.91 ± 3.71
    99999 ± 99999
    99999 ± 99999
    -1.23 ± 2.11
    No statistical analyses for this end point

    Secondary: Change From Baseline in 1-Hour Postprandial Plasma Glucose (1-Hour-PPG) at Day 14, Day 28 and Day 42

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    End point title
    Change From Baseline in 1-Hour Postprandial Plasma Glucose (1-Hour-PPG) at Day 14, Day 28 and Day 42 [7]
    End point description
    1-Hour PPG excursion was calculated as the difference between the plasma glucose value 1 hour post meal test (T1.5) and the plasma glucose value before time of injection (T0): 1-Hour-PPG excursion = PG-T1.5 - PG-T0. Baseline was defined as the last values done on Day -1 before first study drug administration. Analysis was performed on PD population. Here, 'n' = subjects with available data for each specified category and '99999' was used as a space filler and indicated that no subjects were involved in the PD analysis at the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 14, 28 and 42
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data were planned to be collected and analysed for specified arms only.
    End point values
    Placebo Lixisenatide 5 mcg Lixisenatide 10 mcg Lixisenatide 20 mcg
    Number of subjects analysed
    5
    18
    18
    18
    Units: mmol/L
    arithmetic mean (standard deviation)
        Day 14 (n = 5, 17, 0, 0)
    0.42 ± 2.12
    -1.28 ± 2.36
    99999 ± 99999
    99999 ± 99999
        Day 28 (n = 5, 0, 18, 0)
    -0.76 ± 3.45
    99999 ± 99999
    -3.12 ± 2.24
    99999 ± 99999
        Day 42 (n = 5, 0, 0, 16)
    0.59 ± 2.33
    99999 ± 99999
    99999 ± 99999
    -3.19 ± 3.12
    No statistical analyses for this end point

    Secondary: Change From Baseline in 2-Hours Postprandial Plasma Glucose (2-Hours-PPG) at Day 14, Day 28 and Day 42

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    End point title
    Change From Baseline in 2-Hours Postprandial Plasma Glucose (2-Hours-PPG) at Day 14, Day 28 and Day 42 [8]
    End point description
    2-Hours PPG excursion was calculated as the difference between the plasma glucose value 2 hours post meal test (T2.5) and the plasma glucose value before time of injection (T0): 2-Hours-PPG excursion = PG-T2.5 - PG-T0. Baseline was defined as the last values done on Day -1 before first study drug administration. Analysis was performed on PD population. Here, 'n' = subjects with available data for each specified category and '99999' was used as a space filler at fields and indicated that no subjects were involved in the PD analysis at the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 14, 28 and 42
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data were planned to be collected and analysed for specified arms only.
    End point values
    Placebo Lixisenatide 5 mcg Lixisenatide 10 mcg Lixisenatide 20 mcg
    Number of subjects analysed
    5
    18
    18
    18
    Units: mmol/L
    arithmetic mean (standard deviation)
        Day 14 (n = 5, 17, 0, 0)
    -1.43 ± 2.24
    -1.12 ± 1.73
    99999 ± 99999
    99999 ± 99999
        Day 28 (n = 5, 0, 18, 0)
    -0.57 ± 2.36
    99999 ± 99999
    -2.75 ± 2.09
    99999 ± 99999
        Day 42 (n = 5, 0, 0, 17)
    -0.08 ± 1.17
    99999 ± 99999
    99999 ± 99999
    -3.96 ± 3.17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE data were collected from signature of the informed consent form up to end-of-study (i.e. up to Day 45)
    Adverse event reporting additional description
    TEAEs were defined as AEs that occurred or worsened or became serious during the on-treatment phase (the time from the first study drug administration up to 3 days after last study drug administration [i.e. up to Day 45]). Analysis was performed on safety population.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received a dose of placebo (matched to lixisenatide) as SC injection from Day 1 to Day 42.

    Reporting group title
    Lixisenatide
    Reporting group description
    Subjects received 3 doses of lixisenatide (5 mcg, 10 mcg and 20 mcg) as SC injection in incremental sequential dose escalation steps of 2 weeks from Day 1 to Day 42.

    Serious adverse events
    Placebo Lixisenatide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo Lixisenatide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    7 / 18 (38.89%)
    Injury, poisoning and procedural complications
    Limb Injury
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Weight Increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    3
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Eye disorders
    Chalazion
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Influenza Like Illness
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Injection Site Pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 18 (11.11%)
         occurrences all number
    1
    8
    Vomiting
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    11
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Urinary Tract Infection Bacterial
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Sep 2016
    Following changes were made: -A part of the standard reporting text was deleted for unknown technical reasons in the finalisation procedure of the document. The reason for this Amendment was to re-include the standard reporting text. -Guidelines for reporting SAEs was updated.
    19 Jul 2017
    Following changes were made: - Inclusion Criterion: In order to accommodate local medical paediatric practice and clinical guidelines the global protocol did not specify the exact metformin dose. The other aspects of the Inclusion Criterion would not be changed as they were requirements. - Exclusion Criterion: Based on the local paediatric medical practice and clinical necessity, the utilisation of psychotropic agents would be accepted as long as the subjects were stabilised for at least three months on this therapy.

    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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