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    Clinical Trial Results:
    A Randomized, Open-label Study on the Effects of Insulin Pen Devices on Glycemic Control in Children, Adolescents and Adults with Type 1 Diabetes: Novel Pen with Memory Function (HumaPen Memoir) vs. Conventional Pen without Memory Function (HumaPen Luxura)

    Summary
    EudraCT number
    		 2008-007769-21
    Trial protocol
    		 DE  
    Global end of trial date
    18 Jul 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Apr 2019
    First version publication date
    03 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H9D-SB-ITAE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00985712
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 12704
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jul 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jul 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory function, when used over 24 weeks for prandial insulin injections achieves superior glycemic control, when compared to the conventional HumaPen Luxura without memory function.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Sep 2009
    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
    Germany: 257
    Worldwide total number of subjects
    257
    EEA total number of subjects
    257
    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)
    4
    Adolescents (12-17 years)
    25
    Adults (18-64 years)
    208
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Not applicable

    Period 1
    Period 1 title
    Overall Study
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HumaPen Luxura
    Arm description
    		 Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Huminsulin Regular
    Investigational medicinal product code
    Other name
    Huminsulin Normal, LY041001
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant's received insulin dose of Huminsulin Normal subcutaneously.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant's received insulin dose of Insulin Lispro through subcutaneous route.

    Arm title
    		 HumaPen Memoir
    Arm description
    		 Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Huminsulin Regular
    Investigational medicinal product code
    Other name
    Huminsulin Normal, LY041001
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant's received insulin dose of Huminsulin Normal subcutaneously.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant's received insulin dose of Insulin Lispro through subcutaneous route.

    Number of subjects in period 1
    		HumaPen Luxura HumaPen Memoir
    Started
    133
    130
    Received at Least One Dose of Study Drug
    131
    130
    Full Analysis Set (FAS)
    128
    129
    Completed
    127
    123
    Not completed
    6
    7
         Consent withdrawn by subject
    4
    1
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    2
    2
         Sponsor decision
    -
    2
         Protocol deviation
    -
    1
    Period 2
    Period 2 title
    Full Analysis Set (FAS)
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 HumaPen Luxura
    Arm description
    		 Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Huminsulin Regular
    Investigational medicinal product code
    Other name
    Huminsulin Normal, LY041001
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant's received insulin dose of Huminsulin Normal subcutaneously.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant's received insulin dose of Insulin Lispro through subcutaneous route.

    Arm title
    		 HumaPen Memoir
    Arm description
    		 Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Huminsulin Regular
    Investigational medicinal product code
    Other name
    Huminsulin Normal, LY041001
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant's received insulin dose of Huminsulin Normal subcutaneously.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant's received insulin dose of Insulin Lispro through subcutaneous route.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The baseline characteristics are calculated for Full Analysis Set (FAS) participants as per SAP.
    Number of subjects in period 2
    		HumaPen Luxura HumaPen Memoir
    Started
    128
    129
    Completed
    127
    123
    Not completed
    1
    6
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    -
    2
         Sponsor decision
    -
    2
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HumaPen Luxura
    Reporting group description
    		 Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks

    Reporting group title
    HumaPen Memoir
    Reporting group description
    		 Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

    Reporting group values
    		 HumaPen Luxura HumaPen Memoir Total
    Number of subjects
    		 128 129
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.2 ± 15.52 38.3 ± 17.37 -
    Gender, Male/Female
    Units: Participants
        Female
    		 52 56 108
        Male
    		 76 73 149
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 127 128 255
        Black or African American
    		 1 1 2
    Region of Enrollment
    Units: Subjects
        Germany
    		 128 129 257
    Hemoglobin A1c (HbA1c)
    HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
    Units: percentage of glycosylated hemoglobin
        arithmetic mean (standard deviation)
    		 9.06 ± 0.93 9.12 ± 1.04 -

    End points

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    End points reporting groups
    Reporting group title
    HumaPen Luxura
    Reporting group description
    		 Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks

    Reporting group title
    HumaPen Memoir
    Reporting group description
    		 Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
    Reporting group title
    HumaPen Luxura
    Reporting group description
    		 Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks

    Reporting group title
    HumaPen Memoir
    Reporting group description
    		 Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

    Primary: Change from baseline in hemoglobin A1c (HbA1c) at week 24 endpoint

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    End point title
    		 Change from baseline in hemoglobin A1c (HbA1c) at week 24 endpoint
    End point description
    HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c. Analysis Population Description: Participants in full analysis population set with missing values accounted for using mixed model repeated measures (MMRM).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    End point values
    		 HumaPen Luxura HumaPen Memoir
    Number of subjects analysed
    128
    129
    Units: percentage of glycosylated hemoglobin
        least squares mean (confidence interval 95%)
    -0.48 (-0.64 to -0.32)
    -0.43 (-0.59 to -0.28)
    Statistical analysis title
    		 Hemoglobin A1c (HbA1c)
    Statistical analysis description
    Superiority criterion is met if the upper limit of Confidence Interval (CI) is below zero.
    Comparison groups
    HumaPen Luxura v HumaPen Memoir
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6692
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11

    Secondary: Percentage of participants achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at week 24 endpoint

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    End point title
    		 Percentage of participants achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at week 24 endpoint
    End point description
    Analysis Population Description: Participants in full analysis population set who had Week 24 measurements.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 HumaPen Luxura HumaPen Memoir
    Number of subjects analysed
    127
    127
    Units: percentage of participants
    number (not applicable)
        HbA1c ≤7.0%
    5.5
    3.1
        HbA1c ≤7.5%
    16.5
    11.0
    Statistical analysis title
    		 Percentage of Participants Achieving HbA1c
    Comparison groups
    HumaPen Luxura v HumaPen Memoir
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3551 [1]
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
    Notes
    [1] - P-value is for HbA1c ≤7.0%.
    Statistical analysis title
    		 Percentage of Participants Achieving HbA1c
    Comparison groups
    HumaPen Luxura v HumaPen Memoir
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2026 [2]
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
    Notes
    [2] - P-value is for HbA1c ≤7.5%.

    Secondary: Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to continue at week 24 endpoint

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    End point title
    		 Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to continue at week 24 endpoint
    End point description
    IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score. Analysis Population Description: Participants in full analysis population set who had Week 24 measurements.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 HumaPen Luxura HumaPen Memoir
    Number of subjects analysed
    128
    126
    Units: units on a scale
        least squares mean (confidence interval 95%)
    4.06 (3.88 to 4.25)
    4.05 (3.86 to 4.23)
    Statistical analysis title
    		 Insulin Delivery System Questionnaire (IDSQ)
    Comparison groups
    HumaPen Luxura v HumaPen Memoir
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.907
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%

    Secondary: 30-Day adjusted rates of self-Reported hypoglycemic episodes at any time from baseline through week 24

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    End point title
    		 30-Day adjusted rates of self-Reported hypoglycemic episodes at any time from baseline through week 24
    End point description
    Hypoglycemic episode is defined as blood glucose measurement ≤3.9 millimoles/Liter (mmol/L; 70 milligrams/deciliter [mg/dL]). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30. Analysis Population Description: Randomized participants who took at least one dose of study drug with post-baseline hypoglycemia follow-up.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 24
    End point values
    		 HumaPen Luxura HumaPen Memoir
    Number of subjects analysed
    130
    130
    Units: number of events per 30 days
        arithmetic mean (standard deviation)
    2.68 ± 4.66
    2.46 ± 4.38
    Statistical analysis title
    		 Hypoglycemic Episodes
    Comparison groups
    HumaPen Luxura v HumaPen Memoir
    Number of subjects included in analysis
    260
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9817
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%

    Secondary: 30-Day adjusted rates of self-Reported hyperglycemic episodes at any time from baseline through week 24

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    End point title
    		 30-Day adjusted rates of self-Reported hyperglycemic episodes at any time from baseline through week 24
    End point description
    Hyperglycemic episode is defined as blood glucose measurement >18 mmol/L (324 mg/dL). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30. Analysis Population Description: Randomized participants who took at least one dose of study drug with post-baseline hyperglycemia follow-up.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 24
    End point values
    		 HumaPen Luxura HumaPen Memoir
    Number of subjects analysed
    130
    130
    Units: number of events per 30 days
        arithmetic mean (standard deviation)
    2.56 ± 5.50
    3.92 ± 9.82
    Statistical analysis title
    		 Hypoglycemic Episodes
    Comparison groups
    HumaPen Luxura v HumaPen Memoir
    Number of subjects included in analysis
    260
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1187
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    H9D-SB-ITAE
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    HumaPen Luxura
    Reporting group description
    		 -

    Reporting group title
    HumaPen Memoir
    Reporting group description
    		 -

    Serious adverse events
    		 HumaPen Luxura HumaPen Memoir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 131 (5.34%)
    8 / 130 (6.15%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    glycosylated haemoglobin increased
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    road traffic accident
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    upper limb fracture
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    cerebrovascular accident
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    gastritis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    cervical spinal stenosis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    cystitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    salpingo-oophoritis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    diabetic foot
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    2 / 130 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic ketoacidosis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperglycaemia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoglycaemia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 HumaPen Luxura HumaPen Memoir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 131 (39.69%)
    50 / 130 (38.46%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    benign ovarian tumour
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    Vascular disorders
    haematoma
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    hypertension
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    peripheral arterial occlusive disease
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    injection site pain
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    oedema
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    oedema peripheral
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 130 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    erectile dysfunction
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 130 (0.77%)
         occurrences all number
    1
    1
    dyspnoea
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    epistaxis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    rhinitis allergic
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    burnout syndrome
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    depression
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 130 (0.00%)
         occurrences all number
    2
    0
    Investigations
    liver function test abnormal
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    contusion
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    joint sprain
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 131 (1.53%)
    1 / 130 (0.77%)
         occurrences all number
    2
    1
    thermal burn
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 130 (0.77%)
         occurrences all number
    1
    1
    wound
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 130 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    supraventricular tachycardia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 130 (0.00%)
         occurrences all number
    2
    0
    migraine
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    polyneuropathy
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    ear pain
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    tinnitus
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 130 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    conjunctivitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    glaucoma
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    2 / 130 (1.54%)
         occurrences all number
    1
    2
    dyspepsia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    gastritis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    nausea
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    tooth disorder
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    toothache
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    vomiting
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 130 (0.77%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    dermatitis allergic
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    eczema
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    ingrowing nail
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    intertrigo
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    lipodystrophy acquired
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 130 (0.00%)
         occurrences all number
    2
    0
    lipohypertrophy
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    neuropathic ulcer
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    skin ulcer
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    cystitis noninfective
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    nephropathy
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    renal failure
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    renal impairment
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    arthritis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    back pain
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    3 / 131 (2.29%)
    0 / 130 (0.00%)
         occurrences all number
    3
    0
    joint effusion
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    muscle spasms
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    osteochondrosis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    tendon pain
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    tenosynovitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    acute sinusitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    bronchitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 130 (0.77%)
         occurrences all number
    1
    1
    cystitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 130 (0.00%)
         occurrences all number
    2
    0
    ear infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    2
    epstein-barr virus infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    fungal infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    gastroenteritis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    2 / 130 (1.54%)
         occurrences all number
    1
    2
    infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    influenza
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 130 (0.77%)
         occurrences all number
    1
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    15 / 131 (11.45%)
    12 / 130 (9.23%)
         occurrences all number
    18
    13
    pneumonia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    pyelonephritis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    scarlet fever
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
         occurrences all number
    1
    0
    sinobronchitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    tonsillitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 131 (1.53%)
    1 / 130 (0.77%)
         occurrences all number
    2
    1
    urinary tract infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    3 / 131 (2.29%)
    2 / 130 (1.54%)
         occurrences all number
    3
    2
    viral infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 130 (0.77%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    diabetic foot
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    2 / 130 (1.54%)
         occurrences all number
    1
    2
    hypercholesterolaemia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 130 (0.77%)
         occurrences all number
    1
    1
    hyperlipidaemia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 130 (0.77%)
         occurrences all number
    1
    1
    hypoglycaemia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    iron deficiency
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1
    obesity
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    0
    1

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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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