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    Clinical Trial Results:
    Dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes

    Summary
    EudraCT number
    		 2014-003196-39
    Trial protocol
    		 GB   DE   CZ   AT  
    Global end of trial date
    13 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2017
    First version publication date
    27 Oct 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NN9535-4191
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02461589
    WHO universal trial number (UTN)
    		 U1111-1159-4923
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.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
    16 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of four dose-levels of semaglutide administered subcutaneously (s.c.) once daily (OD) versus placebo on glycaemic control after 26 weeks of treatment
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice and EN ISO 14155 Part 1 and 2, and 21 CFR 312.120.
    Background therapy
    		 Subjects continued the pre-trial stable diabetes treatment consisting of diet and exercise with or without metformin (≥ 1500 mg daily or maximum tolerated dose) during the trial.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    21 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 31
    Country: Number of subjects enrolled
    Canada: 39
    Country: Number of subjects enrolled
    Czech Republic: 53
    Country: Number of subjects enrolled
    Germany: 42
    Country: Number of subjects enrolled
    United Kingdom: 76
    Country: Number of subjects enrolled
    Malaysia: 31
    Country: Number of subjects enrolled
    Russian Federation: 50
    Country: Number of subjects enrolled
    Serbia: 84
    Country: Number of subjects enrolled
    United States: 239
    Country: Number of subjects enrolled
    South Africa: 60
    Worldwide total number of subjects
    705
    EEA total number of subjects
    202
    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)
    550
    From 65 to 84 years
    155
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The trial was conducted at 139 sites in 10 countries as follows: Austria: 3 sites; Canada: 8 sites; Czech Republic: 9 sites; Germany: 7 sites; Malaysia: 5 sites; Russian Federation: 7 sites; Serbia: 9 sites; South Africa: 7 sites; United Kingdom: 13 sites; United States: 71 sites.

    Pre-assignment
    Screening details
    		 Not applicable

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    A portion of this trial was double-blinded (sponsor, investigators, and subjects) within dose level in order to minimise bias during trial conduct. Semaglutide, liraglutide, and placebo were visually identical to fulfil the requirements for double-blind procedures. Furthermore, equal volumes of semaglutide, liraglutide, and placebo were administered during treatment ensuring blinding within dose-level. An open-label design was chosen for the semaglutide flexible dose arm of the trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Semaglutide 0.05 mg
    Arm description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered with semaglutide sc injection in the thigh, abdomen, or upper arm, using a durable pen injector (NovoPen® 4) preferably around the same time of the day irrespective of meals.

    Arm title
    		 Semaglutide 0.1 mg
    Arm description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered with semaglutide sc injection in the thigh, abdomen, or upper arm, using a durable pen injector (NovoPen® 4) preferably around the same time of the day irrespective of meals.

    Arm title
    		 Semaglutide 0.2 mg
    Arm description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered with semaglutide sc injection in the thigh, abdomen, or upper arm, using a durable pen injector (NovoPen® 4) preferably around the same time of the day irrespective of meals.

    Arm title
    		 Semaglutide 0.3 mg
    Arm description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks sequentially followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered with semaglutide sc injection in the thigh, abdomen, or upper arm, using a durable pen injector (NovoPen® 4) preferably around the same time of the day irrespective of meals.

    Arm title
    		 Liraglutide 0.3 mg
    Arm description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Victoza®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered with liraglutide sc injection in the thigh, abdomen, or upper arm, using a durable pen injector (NovoPen® 4) preferably around the same time of the day irrespective of meals.

    Arm title
    		 Liraglutide 0.6 mg
    Arm description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Victoza®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered with liraglutide sc injection in the thigh, abdomen, or upper arm, using a durable pen injector (NovoPen® 4) preferably around the same time of the day irrespective of meals.

    Arm title
    		 Liraglutide 1.2 mg
    Arm description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Victoza®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered with liraglutide sc injection in the thigh, abdomen, or upper arm, using a durable pen injector (NovoPen® 4) preferably around the same time of the day irrespective of meals.

    Arm title
    		 Liraglutide 1.8 mg
    Arm description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks sequentially followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Victoza®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered with liraglutide sc injection in the thigh, abdomen, or upper arm, using a durable pen injector (NovoPen® 4) preferably around the same time of the day irrespective of meals.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo (equal volumes as semaglutide or liraglutide) sc injection once daily upto 26 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered with placebo sc injection in the thigh, abdomen, or upper arm, using a durable pen injector (NovoPen® 4) preferably around the same time of the day irrespective of meals.

    Arm title
    		 Semaglutide flexible
    Arm description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks sequentially followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Participants were allowed to follow a more flexible dose-escalation regimen. Semaglutide dose levels could be temporarily reduced in participants with poor gastrointestinal tolerability depending on investigator’s assessment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered with semaglutide sc injection in the thigh, abdomen, or upper arm, using a durable pen injector (NovoPen® 4) preferably around the same time of the day irrespective of meals.

    Number of subjects in period 1
    		Semaglutide 0.05 mg Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.3 mg Liraglutide 0.3 mg Liraglutide 0.6 mg Liraglutide 1.2 mg Liraglutide 1.8 mg Placebo Semaglutide flexible
    Started
    64
    63
    65
    63
    64
    64
    64
    65
    129
    64
    Completed
    58
    61
    60
    58
    62
    61
    58
    60
    123
    60
    Not completed
    6
    2
    5
    5
    2
    3
    6
    5
    6
    4
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
         Consent withdrawn by subject
    5
    1
    3
    2
    1
    2
    1
    3
    3
    1
         Unclassified
    -
    -
    -
    -
    -
    -
    1
    -
    -
    2
         Lost to follow-up
    -
    -
    2
    3
    1
    1
    3
    1
    3
    1
         Missing follow-up information
    1
    1
    -
    -
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 0.05 mg
    Reporting group description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 26 weeks.

    Reporting group title
    Semaglutide 0.1 mg
    Reporting group description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26.

    Reporting group title
    Semaglutide 0.2 mg
    Reporting group description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26.

    Reporting group title
    Semaglutide 0.3 mg
    Reporting group description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks sequentially followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26.

    Reporting group title
    Liraglutide 0.3 mg
    Reporting group description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks.

    Reporting group title
    Liraglutide 0.6 mg
    Reporting group description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26.

    Reporting group title
    Liraglutide 1.2 mg
    Reporting group description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26.

    Reporting group title
    Liraglutide 1.8 mg
    Reporting group description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks sequentially followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo (equal volumes as semaglutide or liraglutide) sc injection once daily upto 26 weeks.

    Reporting group title
    Semaglutide flexible
    Reporting group description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks sequentially followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Participants were allowed to follow a more flexible dose-escalation regimen. Semaglutide dose levels could be temporarily reduced in participants with poor gastrointestinal tolerability depending on investigator’s assessment.

    Reporting group values
    		 Semaglutide 0.05 mg Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.3 mg Liraglutide 0.3 mg Liraglutide 0.6 mg Liraglutide 1.2 mg Liraglutide 1.8 mg Placebo Semaglutide flexible Total
    Number of subjects
    		 64 63 65 63 64 64 64 65 129 64 705
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 49 45 44 54 47 46 54 51 105 55 550
        From 65-84 years
    		 15 18 21 9 17 18 10 14 24 9 155
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.53 ± 9.8 57.51 ± 10.0 58.37 ± 9.58 54.76 ± 9.66 57.20 ± 10.78 59.45 ± 9.77 53.73 ± 11.35 55.82 ± 9.19 57.08 ± 9.25 54.81 ± 9.70 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 31 28 22 31 35 32 30 32 57 28 326
        Male
    		 33 35 43 32 29 32 34 33 72 36 379
    Study Specific Characteristic | glycosylated haemoglobin (HbA1c)
    Units: percentage of HbA1c
        arithmetic mean (standard deviation)
    		 7.87 ± 0.71 7.91 ± 0.83 7.96 ± 0.82 8.23 ± 0.80 8.06 ± 0.86 8.12 ± 0.81 8.14 ± 0.87 8.07 ± 0.85 8.12 ± 0.87 8.10 ± 0.91 -
    Study Specific Characteristic | Fasting plasma glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 9.26 ± 2.60 8.97 ± 2.22 9.20 ± 2.28 9.67 ± 2.56 9.32 ± 2.54 9.34 ± 2.33 9.91 ± 2.70 9.18 ± 2.45 9.67 ± 2.98 9.82 ± 2.66 -
    Study Specific Characteristic | Body weight
    Units: kg
        arithmetic mean (standard deviation)
    		 93.44 ± 18.27 92.40 ± 17.20 98.07 ± 17.92 94.82 ± 17.84 92.25 ± 17.48 92.68 ± 16.46 96.67 ± 18.28 93.40 ± 19.34 93.98 ± 17.75 95.29 ± 15.43 -
    Study Specific Characteristic | Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 133.70 ± 15.14 130.97 ± 14.92 131.34 ± 12.55 132.08 ± 11.69 134.02 ± 11.30 132.41 ± 12.37 134.20 ± 12.73 131.02 ± 11.86 132.17 ± 14.26 132.70 ± 12.74 -
    Study Specific Characteristic | Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 80.06 ± 8.90 79.71 ± 8.56 80.48 ± 8.87 81.41 ± 8.05 81.83 ± 6.98 81.28 ± 6.90 82.98 ± 6.94 80.66 ± 7.62 80.98 ± 8.00 81.89 ± 8.40 -

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 0.05 mg
    Reporting group description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 26 weeks.

    Reporting group title
    Semaglutide 0.1 mg
    Reporting group description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26.

    Reporting group title
    Semaglutide 0.2 mg
    Reporting group description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26.

    Reporting group title
    Semaglutide 0.3 mg
    Reporting group description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks sequentially followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26.

    Reporting group title
    Liraglutide 0.3 mg
    Reporting group description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks.

    Reporting group title
    Liraglutide 0.6 mg
    Reporting group description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26.

    Reporting group title
    Liraglutide 1.2 mg
    Reporting group description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26.

    Reporting group title
    Liraglutide 1.8 mg
    Reporting group description
    		 Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks sequentially followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo (equal volumes as semaglutide or liraglutide) sc injection once daily upto 26 weeks.

    Reporting group title
    Semaglutide flexible
    Reporting group description
    		 Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks sequentially followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Participants were allowed to follow a more flexible dose-escalation regimen. Semaglutide dose levels could be temporarily reduced in participants with poor gastrointestinal tolerability depending on investigator’s assessment.

    Primary: Change in HbA1c (Glycosylated haemoglobin)

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    End point title
    		 Change in HbA1c (Glycosylated haemoglobin)
    End point description
    Mean change from baseline in HbA1c at week 26. The full analysis set (FAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the FAS would contribute to the evaluation “as randomised”. Analysis was performed using a mixed model for repeated measurements with treatment, region and stratum as fixed factors and baseline value as covariate, all nested within visit.
    End point type
    Primary
    End point timeframe
    Week 0, week 26
    End point values
    		 Semaglutide 0.05 mg Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.3 mg Liraglutide 0.3 mg Liraglutide 0.6 mg Liraglutide 1.2 mg Liraglutide 1.8 mg Placebo Semaglutide flexible
    Number of subjects analysed
    64
    63
    65
    63
    64
    64
    64
    65
    129
    64
    Units: percentage of HbA1c
        arithmetic mean (standard deviation)
    -0.97 ± 0.85
    -1.30 ± 1.03
    -1.65 ± 0.79
    -1.96 ± 0.95
    -0.50 ± 0.93
    -0.88 ± 0.90
    -0.86 ± 0.92
    -1.32 ± 0.78
    -0.05 ± 0.90
    -1.72 ± 0.97
    Statistical analysis title
    		 Semaglutide 0.05 vs placebo
    Statistical analysis description
    Analysis was performed using a mixed model for repeated measurements with treatment, region and stratum as fixed factors and baseline value as covariate, all nested within visit.
    Comparison groups
    Semaglutide 0.05 mg v Placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.77
    Statistical analysis title
    		 Semaglutide 0.1 vs placebo
    Statistical analysis description
    Analysis was performed using a mixed model for repeated measurements with treatment, region and stratum as fixed factors and baseline value as covariate, all nested within visit.
    Comparison groups
    Semaglutide 0.1 mg v Placebo
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -1.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.61
         upper limit
    		 -1.08
    Statistical analysis title
    		 Semaglutide 0.2 vs placebo
    Statistical analysis description
    Analysis was performed using a mixed model for repeated measurements with treatment, region and stratum as fixed factors and baseline value as covariate, all nested within visit.
    Comparison groups
    Semaglutide 0.2 mg v Placebo
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -1.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.95
         upper limit
    		 -1.42
    Statistical analysis title
    		 Semaglutide 0.3 vs placebo
    Statistical analysis description
    Analysis was performed using a mixed model for repeated measurements with treatment, region and stratum as fixed factors and baseline value as covariate, all nested within visit.
    Comparison groups
    Semaglutide 0.3 mg v Placebo
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -1.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.12
         upper limit
    		 -1.6

    Secondary: Change in Fasting plasma glucose (FPG)

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    End point title
    		 Change in Fasting plasma glucose (FPG)
    End point description
    Mean change from baseline in FPG at week 26. The FAS included all randomised subjects exposed to at least one dose of trial product. Subjects in the FAS would contribute to the evaluation “as randomised”. Analysis was performed using a mixed model for repeated measurements with treatment, region and stratum as fixed factors and baseline value as covariate, all nested within visit.
    End point type
    Secondary
    End point timeframe
    Week 0, Week 26
    End point values
    		 Semaglutide 0.05 mg Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.3 mg Liraglutide 0.3 mg Liraglutide 0.6 mg Liraglutide 1.2 mg Liraglutide 1.8 mg Placebo Semaglutide flexible
    Number of subjects analysed
    64
    63
    65
    63
    64
    64
    64
    65
    129
    63
    Units: mmol/L
        arithmetic mean (standard deviation)
    -2.09 ± 1.96
    -2.08 ± 2.23
    -2.64 ± 2.07
    -3.53 ± 2.20
    -1.33 ± 2.06
    -1.56 ± 1.74
    -1.51 ± 2.41
    -1.92 ± 2.34
    -0.54 ± 2.45
    -3.40 ± 2.84
    No statistical analyses for this end point

    Secondary: Body weight change

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    End point title
    		 Body weight change
    End point description
    Mean change from baseline in body weight at week 26. The FAS included all randomised subjects exposed to at least one dose of trial product. Subjects in the FAS would contribute to the evaluation “as randomised”. Missing data imputed from a mixed model for repeated measures with treatment, region and stratum as fixed factors and baseline value as covariate, all nested within visit.
    End point type
    Secondary
    End point timeframe
    Week 0, Week 26
    End point values
    		 Semaglutide 0.05 mg Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.3 mg Liraglutide 0.3 mg Liraglutide 0.6 mg Liraglutide 1.2 mg Liraglutide 1.8 mg Placebo Semaglutide flexible
    Number of subjects analysed
    64
    63
    65
    63
    64
    64
    64
    65
    129
    64
    Units: kg
        arithmetic mean (standard deviation)
    -2.75 ± 2.82
    -4.36 ± 4.24
    -6.70 ± 4.57
    -8.23 ± 5.34
    -1.48 ± 3.06
    -1.81 ± 3.06
    -1.78 ± 3.41
    -3.68 ± 4.26
    -1.22 ± 3.42
    -6.60 ± 4.98
    No statistical analyses for this end point

    Secondary: Change in Systolic and diastolic blood pressure

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    End point title
    		 Change in Systolic and diastolic blood pressure
    End point description
    Mean change from baseline in blood pressure (systolic and diastolic) at week 26. The FAS included all randomised subjects exposed to at least one dose of trial product. Subjects in the FAS would contribute to the evaluation “as randomised”. Missing data imputed from a mixed model for repeated measures with treatment, region and stratum as fixed factors and baseline value as covariate, all nested within visit.
    End point type
    Secondary
    End point timeframe
    Week 0, Week 26
    End point values
    		 Semaglutide 0.05 mg Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.3 mg Liraglutide 0.3 mg Liraglutide 0.6 mg Liraglutide 1.2 mg Liraglutide 1.8 mg Placebo Semaglutide flexible
    Number of subjects analysed
    64
    63
    65
    63
    64
    64
    64
    65
    129
    64
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolicblood pressure
    -5.74 ± 12.30
    -2.77 ± 13.21
    -4.25 ± 12.24
    -9.85 ± 11.58
    -3.77 ± 9.79
    -3.20 ± 10.89
    -4.69 ± 12.73
    -2.99 ± 11.94
    -2.34 ± 11.40
    -6.62 ± 14.02
        Diastolic blood pressure
    -0.60 ± 8.78
    0.66 ± 8.26
    -1.62 ± 9.38
    -4.02 ± 8.56
    -1.77 ± 7.37
    -1.89 ± 8.20
    -0.60 ± 6.78
    0.63 ± 8.13
    -0.61 ± 8.50
    -1.69 ± 8.25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline up to week 33.
    Adverse event reporting additional description
    Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation “as treated”. Treatment-emergent adverse events (TEAEs) were defined as events recorded from baseline and until completion of the post-treatment follow-up visit (7 weeks).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Sema 0.05 mg
    Reporting group description
    		 -

    Reporting group title
    Sema 0.10 mg
    Reporting group description
    		 -

    Reporting group title
    Sema 0.20 mg
    Reporting group description
    		 -

    Reporting group title
    Sema 0.30 mg
    Reporting group description
    		 -

    Reporting group title
    Lira 0.30 mg
    Reporting group description
    		 -

    Reporting group title
    Lira 0.60 mg
    Reporting group description
    		 -

    Reporting group title
    Lira 1.20 mg
    Reporting group description
    		 -

    Reporting group title
    Lira 1.80 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Sema flexible
    Reporting group description
    		 -

    Serious adverse events
    		 Sema 0.05 mg Sema 0.10 mg Sema 0.20 mg Sema 0.30 mg Lira 0.30 mg Lira 0.60 mg Lira 1.20 mg Lira 1.80 mg Placebo Sema flexible
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 64 (10.94%)
    3 / 63 (4.76%)
    2 / 65 (3.08%)
    2 / 63 (3.17%)
    1 / 64 (1.56%)
    2 / 64 (3.13%)
    2 / 64 (3.13%)
    7 / 65 (10.77%)
    4 / 129 (3.10%)
    4 / 64 (6.25%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal meningioma benign
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 129 (0.78%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Coronary revascularisation
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endarterectomy
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Percutaneous coronary intervention
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stent placement
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular graft
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 129 (0.78%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Catheterisation cardiac
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 65 (1.54%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystoscopy
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    1 / 65 (1.54%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 65 (1.54%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiploic appendagitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 129 (0.78%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 129 (0.78%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 129 (0.78%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 129 (0.78%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Sema 0.05 mg Sema 0.10 mg Sema 0.20 mg Sema 0.30 mg Lira 0.30 mg Lira 0.60 mg Lira 1.20 mg Lira 1.80 mg Placebo Sema flexible
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 64 (50.00%)
    34 / 63 (53.97%)
    39 / 65 (60.00%)
    42 / 63 (66.67%)
    35 / 64 (54.69%)
    28 / 64 (43.75%)
    38 / 64 (59.38%)
    35 / 65 (53.85%)
    61 / 129 (47.29%)
    44 / 64 (68.75%)
    Investigations
    Lipase increased
         subjects affected / exposed
    3 / 64 (4.69%)
    3 / 63 (4.76%)
    3 / 65 (4.62%)
    3 / 63 (4.76%)
    3 / 64 (4.69%)
    3 / 64 (4.69%)
    4 / 64 (6.25%)
    7 / 65 (10.77%)
    4 / 129 (3.10%)
    5 / 64 (7.81%)
         occurrences all number
    3
    3
    3
    3
    4
    5
    5
    7
    4
    5
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 64 (3.13%)
    4 / 63 (6.35%)
    2 / 65 (3.08%)
    0 / 63 (0.00%)
    3 / 64 (4.69%)
    0 / 64 (0.00%)
    3 / 64 (4.69%)
    3 / 65 (4.62%)
    3 / 129 (2.33%)
    1 / 64 (1.56%)
         occurrences all number
    2
    4
    2
    0
    3
    0
    3
    3
    3
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 64 (3.13%)
    4 / 63 (6.35%)
    2 / 65 (3.08%)
    3 / 63 (4.76%)
    0 / 64 (0.00%)
    3 / 64 (4.69%)
    1 / 64 (1.56%)
    4 / 65 (6.15%)
    3 / 129 (2.33%)
    6 / 64 (9.38%)
         occurrences all number
    4
    6
    2
    4
    0
    4
    1
    5
    3
    8
    Headache
         subjects affected / exposed
    7 / 64 (10.94%)
    8 / 63 (12.70%)
    4 / 65 (6.15%)
    7 / 63 (11.11%)
    5 / 64 (7.81%)
    3 / 64 (4.69%)
    10 / 64 (15.63%)
    4 / 65 (6.15%)
    3 / 129 (2.33%)
    7 / 64 (10.94%)
         occurrences all number
    17
    30
    13
    11
    7
    11
    16
    8
    3
    14
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 63 (1.59%)
    4 / 65 (6.15%)
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    4 / 64 (6.25%)
    1 / 64 (1.56%)
    2 / 65 (3.08%)
    3 / 129 (2.33%)
    4 / 64 (6.25%)
         occurrences all number
    2
    1
    4
    1
    0
    5
    1
    2
    3
    4
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    2 / 64 (3.13%)
    3 / 63 (4.76%)
    1 / 65 (1.54%)
    2 / 63 (3.17%)
    1 / 64 (1.56%)
    3 / 64 (4.69%)
    2 / 64 (3.13%)
    4 / 65 (6.15%)
    3 / 129 (2.33%)
    4 / 64 (6.25%)
         occurrences all number
    2
    4
    1
    3
    1
    5
    2
    13
    4
    4
    Abdominal pain
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 63 (3.17%)
    3 / 65 (4.62%)
    5 / 63 (7.94%)
    3 / 64 (4.69%)
    0 / 64 (0.00%)
    4 / 64 (6.25%)
    0 / 65 (0.00%)
    1 / 129 (0.78%)
    4 / 64 (6.25%)
         occurrences all number
    4
    4
    7
    6
    3
    0
    4
    0
    1
    7
    Abdominal pain upper
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    4 / 65 (6.15%)
    4 / 63 (6.35%)
    1 / 64 (1.56%)
    2 / 64 (3.13%)
    2 / 64 (3.13%)
    3 / 65 (4.62%)
    3 / 129 (2.33%)
    6 / 64 (9.38%)
         occurrences all number
    0
    1
    5
    4
    2
    2
    2
    4
    3
    8
    Constipation
         subjects affected / exposed
    2 / 64 (3.13%)
    4 / 63 (6.35%)
    6 / 65 (9.23%)
    5 / 63 (7.94%)
    0 / 64 (0.00%)
    3 / 64 (4.69%)
    1 / 64 (1.56%)
    7 / 65 (10.77%)
    4 / 129 (3.10%)
    4 / 64 (6.25%)
         occurrences all number
    2
    4
    11
    7
    0
    3
    2
    7
    4
    6
    Diarrhoea
         subjects affected / exposed
    7 / 64 (10.94%)
    10 / 63 (15.87%)
    10 / 65 (15.38%)
    16 / 63 (25.40%)
    5 / 64 (7.81%)
    5 / 64 (7.81%)
    5 / 64 (7.81%)
    8 / 65 (12.31%)
    14 / 129 (10.85%)
    11 / 64 (17.19%)
         occurrences all number
    10
    13
    15
    29
    5
    9
    8
    16
    18
    22
    Dyspepsia
         subjects affected / exposed
    1 / 64 (1.56%)
    5 / 63 (7.94%)
    5 / 65 (7.69%)
    6 / 63 (9.52%)
    2 / 64 (3.13%)
    3 / 64 (4.69%)
    1 / 64 (1.56%)
    3 / 65 (4.62%)
    1 / 129 (0.78%)
    4 / 64 (6.25%)
         occurrences all number
    6
    7
    8
    6
    2
    3
    1
    3
    1
    4
    Flatulence
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 63 (1.59%)
    4 / 65 (6.15%)
    1 / 63 (1.59%)
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    2 / 64 (3.13%)
    1 / 65 (1.54%)
    1 / 129 (0.78%)
    6 / 64 (9.38%)
         occurrences all number
    2
    5
    6
    1
    0
    3
    3
    2
    1
    9
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 64 (0.00%)
    4 / 63 (6.35%)
    3 / 65 (4.62%)
    3 / 63 (4.76%)
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    1 / 64 (1.56%)
    1 / 65 (1.54%)
    1 / 129 (0.78%)
    4 / 64 (6.25%)
         occurrences all number
    0
    8
    3
    3
    0
    2
    1
    1
    1
    5
    Nausea
         subjects affected / exposed
    11 / 64 (17.19%)
    12 / 63 (19.05%)
    14 / 65 (21.54%)
    16 / 63 (25.40%)
    6 / 64 (9.38%)
    7 / 64 (10.94%)
    7 / 64 (10.94%)
    13 / 65 (20.00%)
    6 / 129 (4.65%)
    25 / 64 (39.06%)
         occurrences all number
    16
    20
    22
    22
    7
    11
    11
    18
    7
    35
    Vomiting
         subjects affected / exposed
    6 / 64 (9.38%)
    4 / 63 (6.35%)
    6 / 65 (9.23%)
    6 / 63 (9.52%)
    1 / 64 (1.56%)
    7 / 64 (10.94%)
    1 / 64 (1.56%)
    5 / 65 (7.69%)
    3 / 129 (2.33%)
    6 / 64 (9.38%)
         occurrences all number
    10
    13
    9
    8
    1
    10
    1
    8
    3
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    0 / 65 (0.00%)
    1 / 63 (1.59%)
    3 / 64 (4.69%)
    4 / 64 (6.25%)
    3 / 64 (4.69%)
    1 / 65 (1.54%)
    5 / 129 (3.88%)
    3 / 64 (4.69%)
         occurrences all number
    1
    1
    0
    1
    4
    5
    3
    2
    6
    3
    Oropharyngeal pain
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 63 (3.17%)
    0 / 65 (0.00%)
    1 / 63 (1.59%)
    2 / 64 (3.13%)
    4 / 64 (6.25%)
    2 / 64 (3.13%)
    0 / 65 (0.00%)
    2 / 129 (1.55%)
    3 / 64 (4.69%)
         occurrences all number
    3
    2
    0
    1
    2
    4
    2
    0
    2
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 64 (4.69%)
    0 / 63 (0.00%)
    3 / 65 (4.62%)
    4 / 63 (6.35%)
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    1 / 65 (1.54%)
    6 / 129 (4.65%)
    1 / 64 (1.56%)
         occurrences all number
    3
    0
    3
    4
    1
    0
    2
    1
    7
    1
    Back pain
         subjects affected / exposed
    3 / 64 (4.69%)
    4 / 63 (6.35%)
    2 / 65 (3.08%)
    2 / 63 (3.17%)
    3 / 64 (4.69%)
    2 / 64 (3.13%)
    3 / 64 (4.69%)
    4 / 65 (6.15%)
    3 / 129 (2.33%)
    4 / 64 (6.25%)
         occurrences all number
    3
    4
    2
    4
    3
    2
    3
    4
    3
    5
    Muscle spasms
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
    0 / 65 (0.00%)
    0 / 63 (0.00%)
    0 / 64 (0.00%)
    4 / 64 (6.25%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    2 / 129 (1.55%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    0
    0
    0
    4
    0
    1
    2
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 65 (1.54%)
    2 / 63 (3.17%)
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    2 / 64 (3.13%)
    4 / 65 (6.15%)
    3 / 129 (2.33%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    1
    2
    1
    1
    2
    4
    3
    1
    Nasopharyngitis
         subjects affected / exposed
    7 / 64 (10.94%)
    6 / 63 (9.52%)
    4 / 65 (6.15%)
    5 / 63 (7.94%)
    4 / 64 (6.25%)
    3 / 64 (4.69%)
    5 / 64 (7.81%)
    5 / 65 (7.69%)
    7 / 129 (5.43%)
    10 / 64 (15.63%)
         occurrences all number
    12
    7
    4
    6
    5
    3
    7
    6
    9
    11
    Sinusitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 65 (1.54%)
    1 / 63 (1.59%)
    5 / 64 (7.81%)
    2 / 64 (3.13%)
    2 / 64 (3.13%)
    1 / 65 (1.54%)
    2 / 129 (1.55%)
    0 / 64 (0.00%)
         occurrences all number
    0
    0
    1
    1
    5
    2
    2
    1
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 64 (10.94%)
    2 / 63 (3.17%)
    1 / 65 (1.54%)
    7 / 63 (11.11%)
    6 / 64 (9.38%)
    1 / 64 (1.56%)
    2 / 64 (3.13%)
    5 / 65 (7.69%)
    9 / 129 (6.98%)
    4 / 64 (6.25%)
         occurrences all number
    8
    2
    1
    7
    6
    1
    3
    6
    11
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 64 (4.69%)
    7 / 63 (11.11%)
    6 / 65 (9.23%)
    8 / 63 (12.70%)
    2 / 64 (3.13%)
    1 / 64 (1.56%)
    3 / 64 (4.69%)
    3 / 65 (4.62%)
    1 / 129 (0.78%)
    9 / 64 (14.06%)
         occurrences all number
    3
    7
    6
    8
    3
    1
    3
    3
    1
    9
    Hyperglycaemia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    1 / 65 (1.54%)
    0 / 63 (0.00%)
    2 / 64 (3.13%)
    3 / 64 (4.69%)
    3 / 64 (4.69%)
    0 / 65 (0.00%)
    11 / 129 (8.53%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    1
    0
    3
    6
    3
    0
    11
    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.
    Not applicable
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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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