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    Clinical Trial Results:
    A Prospective, International, Multi-Centric, Open-Label Study to Assess the Efficacy of an Extended Injection Interval schedule of Lanreotide Autogel 120 Mg In Acromegalic Subjects who are Biochemically controlled on the Long Term Treatment with Octreotide Lar 10 or 20 mg

    Summary
    EudraCT number
    		 2007-005838-37
    Trial protocol
    		 SE   FR   DK   NL   FI   LV   GR  
    Global end of trial date
    20 May 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Mar 2016
    First version publication date
    16 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A-38-52030-214
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma
    Sponsor organisation address
    65 quai Georges Gorse, Boulogne Billancourt Cedex, France, 92650
    Public contact
    Medical Director, Clinical Endocrinology and Metabolism, Ipsen, 0033 158335000, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Clinical Endocrinology and Metabolism, Ipsen, 0033 158335000, clinical.trials@ipsen.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
    27 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of extended injection intervals (every 6 or 8 weeks) of lanreotide Autogel 120 mg in the control of insulin-like growth factor-1 (IGF-1) levels in adult subjects with acromegaly who are biochemically controlled with octreotide LAR (10 or 20 mg).
    Protection of trial subjects
    This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonisation (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 Adult subjects with acromegaly controlled with Octreotide long acting repeatable (Oct-LAR) 10 or 20 mg every 28 days for at least 6 months
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Oct 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 2 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Serbia: 15
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    Brazil: 15
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Greece: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 17
    Country: Number of subjects enrolled
    Latvia: 10
    Worldwide total number of subjects
    124
    EEA total number of subjects
    57
    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)
    105
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study initiation date: 06-Oct-2008. Study completion date: 20-May-2013. Screened subjects were 128 and screen failure subjects were 4. Subjects treated were 124 and subjects withdrawn early were 17. Subjects completed the study were 107.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 128 [1]
    Number of subjects completed
    		 124

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Does not meet Entry Criteria: 4
    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: Pre-assignment period includes screen failure subjects
    Period 1
    Period 1 title
    Treatment Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phase 1: Lanreotide Autogel 120 mg
    Arm description
    		 Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lanreotide Autogel
    Investigational medicinal product code
    Other name
    Oct-LAR
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg subcutaneous (SC) injection

    Arm title
    		 Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks
    Arm description
    		 Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lanreotide Autogel
    Investigational medicinal product code
    Other name
    Oct-LAR
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg subcutaneous (SC) injection

    Arm title
    		 Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks
    Arm description
    		 Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lanreotide Autogel
    Investigational medicinal product code
    Other name
    Oct-LAR
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg subcutaneous (SC) injection

    Arm title
    		 Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks
    Arm description
    		 Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lanreotide Autogel
    Investigational medicinal product code
    Other name
    Oct-LAR
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg subcutaneous (SC) injection

    Number of subjects in period 1
    		Phase 1: Lanreotide Autogel 120 mg Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks
    Started
    15
    13
    70
    26
    Completed
    0
    13
    68
    26
    Not completed
    15
    0
    2
    0
         Consent withdrawn by subject
    5
    -
    1
    -
         Adverse event, non-fatal
    7
    -
    1
    -
         Does not meet Entry Criteria
    1
    -
    -
    -
         Protocol deviation
    1
    -
    -
    -
         Lack of efficacy
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase 1: Lanreotide Autogel 120 mg
    Reporting group description
    		 Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.

    Reporting group title
    Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks
    Reporting group description
    		 Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.

    Reporting group title
    Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks
    Reporting group description
    		 Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.

    Reporting group title
    Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks
    Reporting group description
    		 Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.

    Reporting group values
    		 Phase 1: Lanreotide Autogel 120 mg Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks Total
    Number of subjects
    		 15 13 70 26 124
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 11 11 61 22 105
        Adults (65-84 years)
    		 4 2 9 4 19
    Age continuous
    Overall analysis (All subjects) for age continuous at baseline value is arithmetic mean (Standard Deviation) = 54.4 (± 10.9) years
    Units: years
        arithmetic mean (standard deviation)
    		 55.2 ( 15.3 ) 55 ( 10.1 ) 53.2 ( 10.4 ) 57 ( 9.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 8 41 20 78
        Male
    		 6 5 29 6 46
    BMI
    Overall analysis (All subjects) for BMI at baseline value is arithmetic mean (Standard Deviation) = 28.8 (± 5.6) kg/m^2
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 28.4 ( 2.9 ) 29.2 ( 4.1 ) 29.5 ( 6.5 ) 27 ( 4.3 ) -

    End points

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    End points reporting groups
    Reporting group title
    Phase 1: Lanreotide Autogel 120 mg
    Reporting group description
    		 Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.

    Reporting group title
    Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks
    Reporting group description
    		 Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.

    Reporting group title
    Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks
    Reporting group description
    		 Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.

    Reporting group title
    Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks
    Reporting group description
    		 Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.

    Subject analysis set title
    Overall Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Lanreotide Autogel 120 mg: Phase 1 and 2

    Subject analysis set title
    Phase 1 Only: Lanreotide Autogel 120 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Only 15 subjects participated only in phase 1 and did not move on to phase 2. The other entered in phase 2 according to IGF-1 level. Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.

    Subject analysis set title
    Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.

    Subject analysis set title
    Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.

    Subject analysis set title
    Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.

    Primary: Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)

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    End point title
    		 Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted) [1]
    End point description
    A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48) Intention to Treat (ITT) population: All patients having received ≥1 study drug dose. Modified ITT (MITT) population: All subjects in the ITT population for whom group allocation was performed (included in Phase 2) N = Number of subjects at the visit
    End point type
    Primary
    End point timeframe
    At week 48 (End of Study)
    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: Statistical anaylsis is not done for this endpoint
    End point values
    		 Overall Study
    Number of subjects analysed
    124
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Intention-to-Treat (N=124)
    75.8 (68.3 to 83.3)
        Modified Intention-to-Treat (N=109)
    86.2 (79.8 to 92.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Normalised IGF 1 Levels (Age and Sex Adjusted)

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    End point title
    		 Percentage of Subjects With Normalised IGF 1 Levels (Age and Sex Adjusted)
    End point description
    The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24. ITT population. N = Number of subjects at the visit.
    End point type
    Secondary
    End point timeframe
    At week 24
    End point values
    		 Overall Study
    Number of subjects analysed
    124
    Units: Percentage of subjects
    number (confidence interval 95%)
        Intention-to-Treat (N=124)
    88.7 (83.1 to 94.3)
        Modified intention-to-Treat (N=109)
    100 (100 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks

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    End point title
    		 Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks
    End point description
    The criterion for a subject is satisfied if he maintained an injection interval of six weeks or increasing his injection interval to eight weeks during Phase 2 of the study. ITT population. N= Number of subjects at the visit.
    End point type
    Secondary
    End point timeframe
    During phase 2 of the study (up to Week 48)
    End point values
    		 Overall Study
    Number of subjects analysed
    124
    Units: Percentage of subjects
    number (confidence interval 95%)
        Intention-to-Treat (N=124)
    78.2 (71 to 85.5)
        Modified Intention-to-Treat (N=109)
    88.1 (82 to 94.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels

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    End point title
    		 Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels
    End point description
    The criterion for a subject is satisfied if he extended his injection interval to eight weeks during Phase 2 of the study, whilst maintaining normalised IGF-1 levels at Week 48. ITT population. N = Number of subjects at the visit.
    End point type
    Secondary
    End point timeframe
    At week 48
    End point values
    		 Overall Study
    Number of subjects analysed
    124
    Units: Percentage of subjects
    number (confidence interval 95%)
        Intention-to-Treat (N=124)
    20.2 (13.1 to 27.2)
        Modified Intention-to-Treat (N=109)
    22.9 (15 to 30.8)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval

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    End point title
    		 Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval [2]
    End point description
    IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline. MITT population. One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.
    End point type
    Secondary
    End point timeframe
    At baseline (visit 1) and week 48
    Notes
    [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: Comparisons are done only in phase 2 groups [Phae 2 Groups A,B and C]
    End point values
    		 Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks
    Number of subjects analysed
    12
    67
    25
    Units: Percentage of ULN
        arithmetic mean (standard deviation)
    -1.7 ( 18.55 )
    5.74 ( 30.48 )
    -4.33 ( 28.14 )
    Statistical analysis title
    		 Phase 2: Group A versus B
    Statistical analysis description
    Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.
    Comparison groups
    Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks v Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0013 [3]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [3] - Adjusted mean difference [95% CI] = 18.69 [7.46 to 29.91]
    Statistical analysis title
    		 Phase2: Group C versus B
    Statistical analysis description
    Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
    Comparison groups
    Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks v Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [4] - Adjusted mean difference [95% CI] = -23.97 [-32.12 to [-15.81]
    Statistical analysis title
    		 Phase2: Group A versus C
    Statistical analysis description
    Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
    Comparison groups
    Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks v Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [5] - Adjusted mean difference [95% CI] = 42.65 [29.48 to 55.82]

    Secondary: Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C

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    End point title
    		 Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C [6]
    End point description
    MITT population. One subject in Group A had missing IGF-1 value at baseline. One subject in Group B had missing IGF-1 value at week 48 and two subjects did not attend week 48 (early withdrawal). One subject in Group C had missing IGF-1 value at week 48.
    End point type
    Secondary
    End point timeframe
    At baseline (visit 1)
    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: Comparisons are done only in phase 2 groups [A versus B, A versus C, A versus (B+C) and B versus C]
    End point values
    		 Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks
    Number of subjects analysed
    12
    67
    25
    Units: Percentage of ULN
        arithmetic mean (confidence interval 95%)
    98.69 (89.4 to 108)
    67.75 (60.4 to 75.1)
    51.3 (41.1 to 61.5)
    Statistical analysis title
    		 Phase 2: Group A versus Group B
    Statistical analysis description
    Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
    Comparison groups
    Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks v Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0009 [7]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [7] - Difference (95% CI) = 30.94% (13.12% to 48.75%)
    Statistical analysis title
    		 Phase 2: Group A versus Group C
    Statistical analysis description
    Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
    Comparison groups
    Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks v Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [8] - Difference (95% CI) = 47.40% (31.67% to 63.12%)
    Statistical analysis title
    		 Group A versus (B + C)
    Statistical analysis description
    Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
    Comparison groups
    Phase 2 (Group A): Lanreotide Autogel 120 mg every 4 weeks v Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks v Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [9]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [9] - Difference (95% CI) = 35.41% (18.11% to 52.71%)
    Statistical analysis title
    		 Phase 2: Group B versus C
    Statistical analysis description
    Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
    Comparison groups
    Phase 2 (Group B): Lanreotide Autogel 120 mg every 6 weeks v Phase 2 (Group C): Lanreotide Autogel 120 mg every 8 weeks
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017 [10]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [10] - Difference (95% CI) = 16.46% (3.01% to 29.91%)

    Secondary: Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24

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    End point title
    		 Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24
    End point description
    ITT population. n = Number of subjects at the visit. These subjects entered in phase 2. One subject was not included in this analysis because IGF-1 was lower than 130% at week 24 but not in the second phase and one subject in group A had missing IGF-1 value at baseline.
    End point type
    Secondary
    End point timeframe
    At baseline (Visit 1)
    End point values
    		 Overall Study
    Number of subjects analysed
    122
    Units: Percentage of ULN
    number (confidence interval 95%)
        Uncontrolled IGF-1 levels at Week 24 (n=14)
    95.92 (50.3 to 141.5)
        Normalized IGF-1 levels at Week 24 (A+B+C) (n=108)
    67.49 (61.8 to 73.2)
        Difference in Mean Baseline
    28.43 (6.83 to 50.03)
    No statistical analyses for this end point

    Secondary: Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)

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    End point title
    		 Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
    End point description
    Acromegaly symptoms were assessed by the patients using the Patient Assessed Acromegaly Symptom Questionnaire (PASQ) scale ranging from 0 (No symptoms) to 8 (Severe, incapacitating symptoms). Phase 1 in week 24: 3 Phase 2 (Group A) in week 24: 13 Phase 2 (Group B) in week 24: 69 Phase 2 (Group C) in week 24: 25 Phase 2 (Group A) in week 48: 13 Phase 2 (Group B) in week 48: 68 Phase 2 (Group C) in week 48: 26
    End point type
    Secondary
    End point timeframe
    At baseline, week 24 and week 48
    End point values
    		 Overall Study
    Number of subjects analysed
    124
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline - Headache
    2 ( 1.95 )
        Baseline - Excessive perspiration
    2.34 ( 2.3 )
        Baseline - Fatigue
    3.4 ( 2.4 )
        Baseline - Soft tissue swelling
    1.75 ( 2.01 )
        Baseline - Arthralgia
    3.39 ( 2.53 )
        Week 24 - Headache
    1.91 ( 1.84 )
        Week 24 - Excessive perspiration
    2.31 ( 2.2 )
        Week 24 - Fatigue
    3.55 ( 2.43 )
        Week 24 - Soft tissue swelling
    1.8 ( 2.11 )
        Week 24 - Arthralgia
    3.25 ( 2.63 )
        Week 48 - Headache
    2.33 ( 2.15 )
        Week 48 - Excessive perspiration
    2.48 ( 2.17 )
        Week 48 - Fatigue
    3.42 ( 2.31 )
        Week 48 - Soft tissue swelling
    2.07 ( 2.28 )
        Week 48 - Arthralgia
    3.69 ( 2.5 )
    No statistical analyses for this end point

    Secondary: Mean Changes From Baseline in Quality of Life Scores (AcroQoL)

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    End point title
    		 Mean Changes From Baseline in Quality of Life Scores (AcroQoL)
    End point description
    ITT population. AcroQoL score groups 22 components: Eight physical, Seven psychological appearance and Seven psychological personal relations, adjusted to a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst. Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included
    End point type
    Secondary
    End point timeframe
    At weeks 24 and 48
    End point values
    		 Overall Study
    Number of subjects analysed
    124
    Units: Units on a scale
    arithmetic mean (standard deviation)
        At week 24 (N=86)
    -0.35 ( 11.43 )
        At week 48 (N=83)
    -1.08 ( 10.15 )
    No statistical analyses for this end point

    Secondary: Mean Changes From Baseline in Quality of Life Scores (SF-36)

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    End point title
    		 Mean Changes From Baseline in Quality of Life Scores (SF-36)
    End point description
    ITT population. Short Form-36 questionnaire (SF-36) score comprises eight components: Physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health on a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst. N = Number of subjects at the visit. Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2.
    End point type
    Secondary
    End point timeframe
    At weeks 24 and 48
    End point values
    		 Overall Study
    Number of subjects analysed
    124
    Units: Units on a scale
    arithmetic mean (standard deviation)
        At week 24 (N=112)
    1.03 ( 15.89 )
        At week 48 (N=107)
    0.06 ( 13.93 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48

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    End point title
    		 Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48
    End point description
    MITT population. The criterion for a subject is satisfied if he had a IGF-1 level (age and sex adjusted) without any worsening of the AcroQoL change score between Inclusion and Week 48. Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included.
    End point type
    Secondary
    End point timeframe
    At week 48 (End of Study)
    End point values
    		 Overall Study
    Number of subjects analysed
    85
    Units: Percentage of subjects
    number (confidence interval 95%)
        Phase I / Group A (N=9)
    44.4 (12 to 76.9)
        Phase I / Group B (N=55)
    47.2 (33.7 to 60.6)
        Phase I / Group C (N=21)
    38.1 (17.3 to 58.9)
        Overall study (N=85)
    44.6 (33.9 to 55.3)
    No statistical analyses for this end point

    Secondary: Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit

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    End point title
    		 Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit
    End point description
    ITT population. Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included. AcroQoL change from Baseline to Week 24 (48) = AcroQoL at Week 24 (48) - AcroQoL at Baseline. IGF-1 change from Baseline to Week 24 (48) = IGF-1 at Week 24 (48) - IGF-1 at Baseline. Correlation presented is a Spearman correlation (non parametric). N = Number of subjects at the visit. Measure Type = Correlation
    End point type
    Secondary
    End point timeframe
    At weeks 24 and 48
    End point values
    		 Overall Study
    Number of subjects analysed
    88
    Units: NA
    number (confidence interval 95%)
        Week 24: Phase I / Group A (n=8)
    0.43 (-0.42 to 0.86)
        Week 24: Phase I / Group B (n=55)
    -0.02 (-0.28 to 0.25)
        Week 24: Phase I / Group C (n=21)
    -0.41 (-0.71 to 0.04)
        Week 24: Overall study (n=85)
    -0.01 (-0.23 to 0.2)
        Week 48: Phase I / Group A (n=8)
    0.69 (-0.08 to 0.93)
        Week 48: Phase I / Group B (n=53)
    -0.06 (-0.32 to 0.22)
        Week 48: Phase I / Group C (n=21)
    -0.09 (-0.5 to 0.35)
        Week 48: Overall study (n=82)
    -0.01 (-0.22 to 0.21)
    No statistical analyses for this end point

    Secondary: Serum Growth Hormone (GH) Levels

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    End point title
    		 Serum Growth Hormone (GH) Levels
    End point description
    ITT population. N= Number of subjects at the visit. Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2.
    End point type
    Secondary
    End point timeframe
    At baseline, week 24 and week 48
    End point values
    		 Overall Study
    Number of subjects analysed
    124
    Units: ng/mL
    arithmetic mean (standard deviation)
        ITT - Baseline (N=124)
    0.97 ( 1.09 )
        ITT - Week 24 (N=112)
    0.99 ( 1.42 )
        ITT - Week 48 (N=107)
    0.92 ( 0.87 )
        MITT - Baseline (N=109)
    0.96 ( 1.11 )
        MITT - Week 24 (N=109)
    0.88 ( 0.78 )
        MITT - Week 48 (N=107)
    0.92 ( 0.87 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL

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    End point title
    		 Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
    End point description
    End point type
    Secondary
    End point timeframe
    At weeks 24 and 48
    End point values
    		 Overall Study
    Number of subjects analysed
    124
    Units: Percentage of subjects
    number (confidence interval 95%)
        ITT: Week 24 - Phase I only (n=15)
    66.7 (13.3 to 100)
        ITT: Week 24 - Phase I / Group A (n=13)
    100 (100 to 100)
        ITT: Week 24 - Phase I / Group B (n=70)
    91.4 (84.9 to 98)
        ITT: Week 24 - Phase I / Group C (n=26)
    100 (100 to 100)
        ITT: Week 24 - Overall study (n=124)
    93.8 (89.3 to 98.2)
        ITT: Week 48 - Phase I / Group A (n=13)
    100 (100 to 100)
        ITT: Week 48 - Phase I / Group B (n=70)
    92.6 (86.4 to 98.9)
        ITT: Week 48 - Phase I / Group C (n=26)
    96.2 (88.8 to 100)
        ITT: Week 48 - Overall study (n=124)
    94.4 (90 to 98.8)
        MITT: Week 24 - Phase I / Group A (n=13)
    100 (100 to 100)
        MITT: Week 24 - Phase I / Group B (n=70)
    91.4 (84.9 to 98)
        MITT: Week 24 - Phase I / Group C (n=26)
    100 (100 to 100)
        MITT: Week 24 - Overall study (n=109)
    94.5 (90.2 to 98.8)
        MITT: Week 48 - Phase I / Group A (n=13)
    100 (100 to 100)
        MITT: Week 48 - Phase I / Group B (n=70)
    92.6 (86.4 to 98.9)
        MITT: Week 48 - Phase I / Group C (n=26)
    96.2 (88.8 to 100)
        MITT: Week 48 - Overall study (n=109)
    94.4 (90 to 98.8)
    No statistical analyses for this end point

    Secondary: Subject Treatment Schedule Preference

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    End point title
    		 Subject Treatment Schedule Preference
    End point description
    ITT population. At week 24, the preference assessed between Octreotide Long Acting Repeatable intramuscular injection (Oct-LAR IM) every 4 weeks and Lanreotide Autogel 120 mg subcutaneous injection (SC) every 6 weeks. At week 48, the preference is assessed between Oct-LAR IM every 4 weeks and Lanreotide Autogel 120 mg SC either injected every 4, 6 or 8 weeks (as injected during Phase II of the study). Lan: Lanreotide W: Week Inj: Injection Wks: Weeks Phs: Phase Grp: Group evy: every
    End point type
    Secondary
    End point timeframe
    At weeks 24 and 48
    End point values
    		 Overall Study
    Number of subjects analysed
    124
    Units: Percentage of subjects
    number (not applicable)
        W24:Oct-LAR IM inj evy 4 wks Phs 1 only (n=15)
    20
        W24:Lan Autogel inj evy 6 wks Phs 1 only (n=15)
    80
        W24:Oct-LAR IM inj evy 4 wks Phs 1/Grp A(n=13)
    7.7
        W24:Lan Autogel inj evy 6 wks Phs 1/Grp A(n=13)
    92.3
        W24:Oct-LAR IM inj evy 4 wks Phs 1/Grp B(n=70)
    10.3
        W24:Lan Autogel inj evy 6 wks Phs 1/Grp B(n=70)
    85.3
        W24:Non precised Phs 1/Grp B (n=70)
    4.4
        W24:Oct-LAR IM inj evy 4 wks Phs 1/Grp C(n=26)
    3.8
        W24:Lan Autogel inj every 6 wks Phs 1/Grp C (n=26)
    96.2
        W24:Oct-LAR IM inj evy 4 wks-Overall study(n=124)
    8.9
        W24:Lan Autogel inj evy 6 wks-Overall study(n=124)
    88.4
        W24: Non precised - Overall study (n=124)
    2.7
        W48:Oct-LAR IM inj evy 4 wks Phs 1/Grp A(n=13)
    15.4
        W48:Lan Autogel inj evy 6 wks Phs 1/Grp A(n=13)
    76.9
        W48:Non precised Phs 1/Grp A (n=13)
    7.7
        W48:Oct-LAR IM inj evy 4 wks Phs 1/Grp B(n=70)
    14.7
        W48:Lan Autogel inj evy 4 wks Phs 1/Grp B(n=70)
    1.5
        W48:Lan Autogel inj evy 6 wks Phs 1/Grp B(n=70)
    77.9
        W48:Non precised Phs 1/Grp B (n=70)
    5.9
        W48:Oct-LAR IM inj evy 4 wks Phs 1/Grp C(n=26)
    7.7
        W48:Lan Autogel inj evy 8 wks Phs 1/Grp C(n=26)
    92.3
        W48:Oct-LAR IM inj evy 4 wks-Overall study(n=124)
    13.1
        W48:Lan Autogel inj evy 4 wks-Overall study(n=124)
    10.3
        W48:Lan Autogel inj evy 6 wks-Overall study(n=124)
    49.5
        W48:Lan Autogel inj evy 8 wks-Overall study(n=124)
    22.4
        W48:Non precised-Overall study (n=124)
    4.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to week 48
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Phase 1: Lanreotide Autogel 120 mg
    Reporting group description
    		 -

    Reporting group title
    Phase 2 (Group A): Lanreotide Autogel 120 mg
    Reporting group description
    		 -

    Reporting group title
    Phase 2 (Group B): Lanreotide Autogel 120 mg
    Reporting group description
    		 -

    Reporting group title
    Phase 2 (Group C): Lanreotide Autogel 120 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Phase 1: Lanreotide Autogel 120 mg Phase 2 (Group A): Lanreotide Autogel 120 mg Phase 2 (Group B): Lanreotide Autogel 120 mg Phase 2 (Group C): Lanreotide Autogel 120 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 13 (15.38%)
    4 / 70 (5.71%)
    2 / 26 (7.69%)
         number of deaths (all causes)
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Brain contusion
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Varicose vein
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash papular
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Phase 1: Lanreotide Autogel 120 mg Phase 2 (Group A): Lanreotide Autogel 120 mg Phase 2 (Group B): Lanreotide Autogel 120 mg Phase 2 (Group C): Lanreotide Autogel 120 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 15 (80.00%)
    10 / 13 (76.92%)
    49 / 70 (70.00%)
    20 / 26 (76.92%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma of liver
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Leiomyoma
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 13 (7.69%)
    1 / 70 (1.43%)
    2 / 26 (7.69%)
         occurrences all number
    1
    1
    1
    2
    Hypotension
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Flushing
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lymphangiectasia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    6 / 70 (8.57%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    15
    7
    Application site pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    3 / 70 (4.29%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    4
    1
    Injection site induration
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    2 / 26 (7.69%)
         occurrences all number
    1
    0
    2
    2
    Nodule
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    1 / 26 (3.85%)
         occurrences all number
    2
    0
    3
    2
    Influenza like illness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    2 / 70 (2.86%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Injection site nodule
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    1
    Asthenia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Facial pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Feeling cold
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection site haematoma
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injection site swelling
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    2
    Malaise
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Medical device pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Thirst
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Metrorrhagia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Asthma
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasal disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pleurisy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anxiety
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Depression
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Stress
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Blood pressure systolic decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    High density lipoprotein increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Transaminases increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tachycardia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 13 (15.38%)
    2 / 70 (2.86%)
    2 / 26 (7.69%)
         occurrences all number
    1
    2
    2
    5
    Dizziness
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Migraine
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    3
    0
    0
    1
    Carotid artery stenosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dysgeusia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Intercostal neuralgia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Bicytopenia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Leukopenia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    1
    Eye disorders
    Cataract cortical
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diplopia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Eye swelling
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Presbyopia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Visual acuity reduced
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    11 / 70 (15.71%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    21
    4
    Abdominal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    4 / 70 (5.71%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    8
    4
    Flatulence
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 13 (0.00%)
    2 / 70 (2.86%)
    1 / 26 (3.85%)
         occurrences all number
    2
    0
    2
    1
    Abdominal discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    3 / 26 (11.54%)
         occurrences all number
    0
    0
    3
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    2 / 70 (2.86%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Dyspepsia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    2 / 70 (2.86%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Nausea
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    1 / 26 (3.85%)
         occurrences all number
    1
    0
    1
    1
    Constipation
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Dental caries
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gingivitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Hiatus hernia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Proctitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Steatorrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    7
    Vomiting
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 13 (15.38%)
    7 / 70 (10.00%)
    4 / 26 (15.38%)
         occurrences all number
    2
    3
    7
    5
    Gallbladder polyp
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 13 (15.38%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    2
    0
    1
    Hepatomegaly
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hepatic cyst
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Hepatic steatosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    2 / 70 (2.86%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    1 / 26 (3.85%)
         occurrences all number
    1
    0
    1
    1
    Increased tendency to bruise
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Rash pruritic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Rosacea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Seborrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Swelling face
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    2
    Renal cyst
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    1
    Calculus ureteric
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haematuria
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nephrocalcinosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    0
    1
    Hypogonadism
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypothyroidism
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    3 / 70 (4.29%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    5
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 13 (15.38%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Back pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscular weakness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 13 (15.38%)
    3 / 70 (4.29%)
    0 / 26 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    3 / 70 (4.29%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    5
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    1
    Bronchitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Cervicitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Dengue fever
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fungal infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Furuncle
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    6 / 70 (8.57%)
    3 / 26 (11.54%)
         occurrences all number
    1
    0
    7
    3
    Impaired fasting glucose
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    5 / 70 (7.14%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    5
    0
    Diabetes mellitus
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    2 / 70 (2.86%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    2 / 70 (2.86%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Decreased appetite
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diabetes mellitus inadequate contr
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 70 (1.43%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fluid retention
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Podagra
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 70 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0

    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.
    None reported
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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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