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    Clinical Trial Results:
    Multiple dose trial examining dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2012-004994-16
    Trial protocol
    		 SE   IT   DE   GB   BG   AT   ES   DK  
    Global end of trial date
    11 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jul 2016
    First version publication date
    27 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NN9924-3790
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01923181
    WHO universal trial number (UTN)
    		 U1111-1136-4716
    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
    01 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy on glycaemic control of oral semaglutide in a SNAC formulation against placebo in subjects with T2D
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and International Conference on Harmonisation (ICH) Good Clinical Practice (1996) and 21 Code of Federal Regulations (CFR) 312.120 (2013).
    Background therapy
    		 The trial medication was given as add-on to previous metformin therapy or as monotherapy if subject was treated with diet and exercise alone.
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    02 Dec 2013
    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
    Spain: 44
    Country: Number of subjects enrolled
    Sweden: 28
    Country: Number of subjects enrolled
    United Kingdom: 62
    Country: Number of subjects enrolled
    Austria: 38
    Country: Number of subjects enrolled
    Bulgaria: 33
    Country: Number of subjects enrolled
    Denmark: 25
    Country: Number of subjects enrolled
    Germany: 37
    Country: Number of subjects enrolled
    Italy: 33
    Country: Number of subjects enrolled
    Canada: 35
    Country: Number of subjects enrolled
    Israel: 51
    Country: Number of subjects enrolled
    Malaysia: 33
    Country: Number of subjects enrolled
    Serbia: 26
    Country: Number of subjects enrolled
    South Africa: 16
    Country: Number of subjects enrolled
    United States: 171
    Worldwide total number of subjects
    632
    EEA total number of subjects
    300
    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)
    479
    From 65 to 84 years
    152
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The trial was conducted at 100 sites in 14 countries as follows: Austria: 6 sites; Bulgaria: 3 sites; Canada: 6 sites; Denmark: 6 sites; Germany: 6 sites; Israel: 6 sites; Italy: 4 sites; Malaysia: 4 sites; Serbia: 1 site; South Africa: 3 sites; Spain: 5 sites; Sweden: 3 sites; United Kingdom: 8 sites; United States: 39 sites.

    Pre-assignment
    Screening details
    		 Subjects attended a screening visit in order to assess their eligibility, which took place within 2 weeks prior to the randomisation visit. Subjects were randomised once all inclusion and exclusion criteria were confirmed. At this visit, data about the subjects already on metformin was documented, based on which the randomisation was stratified.

    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
    The study was partially blinded, where oral semaglutide and oral placebo arms were double-blinded, whereas subcutaneous (sc) semaglutide active comparator arm was open-labelled. An internal oral GLP-1 safety committee was constituted to perform ongoing blinded safety surveillance and in case this committee recommended unblinding of any data for further analysis, an independent ad hoc safety group was established to maintain the blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 The subjects in this arm were administered with placebo tablets once daily orally for 26 weeks. The placebo tablets did not contain sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The doses were administered according to the following rules: Fasting for at least 6 hours (e.g., in the morning following an overnight fast) before tablet ingestion. Water and oral concomitant medication was allowed up to 2 hours prior to dosing. Intake of maximum 120 mL of water was allowed when swallowing the tablet. Subjects were required to abstain from food and fluid intake for at least 30 minutes after ingestion of oral placebo tablet. Oral concomitant medication was allowed to be taken 2 hours post-dosing. If taken with food, concomitant medication was allowed to be administered 30 minutes after ingestion of the placebo tablet.

    Arm title
    		 Sema 2.5 mg
    Arm description
    		 The subjects in this group were administered with 2.5 mg of oral semaglutide once daily for 26 weeks. The semaglutide 2.5 mg tablet contained a fixed dose of 300 mg SNAC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide 2.5 mg
    Investigational medicinal product code
    Other name
    SEMAGLUTIDE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The doses were administered according to the following rules: Fasting for at least 6 hours (e.g., in the morning following an overnight fast) before tablet ingestion. Water and oral concomitant medication was allowed up to 2 hours prior to dosing. Intake of maximum 120 mL of water was allowed when swallowing the tablet. Subjects were required to abstain from food and fluid intake for at least 30 minutes after ingestion of oral semaglutide tablet. Oral concomitant medication was allowed to be taken 2 hours post-dosing. If taken with food, concomitant medication was allowed to be administered 30 minutes after ingestion of the semaglutide tablet.

    Arm title
    		 Sema 5 mg
    Arm description
    		 The subjects in this group were administered with once daily oral doses of 2.5 mg semaglutide for 4 weeks, then 5 mg of semaglutide for 22 weeks. The maintenance dose was 5 mg for subjects in this group. The semaglutide 5 mg tablet contained a fixed dose of 300 mg SNAC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide 5.0 mg
    Investigational medicinal product code
    Other name
    SEMAGLUTIDE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The doses were administered according to the following rules: Fasting for at least 6 hours (e.g., in the morning following an overnight fast) before tablet ingestion. Water and oral concomitant medication was allowed up to 2 hours prior to dosing. Intake of maximum 120 mL of water was allowed when swallowing the tablet. Subjects were required to abstain from food and fluid intake for at least 30 minutes after ingestion of oral semaglutide tablet. Oral concomitant medication was allowed to be taken 2 hours post-dosing. If taken with food, concomitant medication was allowed to be administered 30 minutes after ingestion of the semaglutide tablet.

    Arm title
    		 Sema 10 mg
    Arm description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg of semaglutide for 22 weeks. The maintenance dose was 10 mg for subjects in this group. The semaglutide 10 mg tablet contained a fixed dose of 300 mg SNAC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide 10 mg
    Investigational medicinal product code
    Other name
    SEMAGLUTIDE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The doses were administered according to the following rules: Fasting for at least 6 hours (e.g., in the morning following an overnight fast) before tablet ingestion. Water and oral concomitant medication was allowed up to 2 hours prior to dosing. Intake of maximum 120 mL of water was allowed when swallowing the tablet. Subjects were required to abstain from food and fluid intake for at least 30 minutes after ingestion of oral semaglutide tablet. Oral concomitant medication was allowed to be taken 2 hours post-dosing. If taken with food, concomitant medication was allowed to be administered 30 minutes after ingestion of the semaglutide tablet.

    Arm title
    		 Sema 20 mg
    Arm description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. The maintenance dose was 20 mg for subjects in this group. The semaglutide 20 mg tablet contained a fixed dose of 300 mg SNAC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide 20 mg
    Investigational medicinal product code
    Other name
    SEMAGLUTIDE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The doses were administered according to the following rules: Fasting for at least 6 hours (e.g., in the morning following an overnight fast) before tablet ingestion. Water and oral concomitant medication was allowed up to 2 hours prior to dosing. Intake of maximum 120 mL of water was allowed when swallowing the tablet. Subjects were required to abstain from food and fluid intake for at least 30 minutes after ingestion of oral semaglutide tablet. Oral concomitant medication was allowed to be taken 2 hours post-dosing. If taken with food, concomitant medication was allowed to be administered 30 minutes after ingestion of the semaglutide tablet.

    Arm title
    		 Sema 40 mg
    Arm description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks. The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 4th week. The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide 40 mg
    Investigational medicinal product code
    Other name
    SEMAGLUTIDE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The doses were administered according to the following rules: Fasting for at least 6 hours (e.g., in the morning following an overnight fast) before tablet ingestion. Water and oral concomitant medication was allowed up to 2 hours prior to dosing. Intake of maximum 120 mL of water was allowed when swallowing the tablet. Subjects were required to abstain from food and fluid intake for at least 30 minutes after ingestion of oral semaglutide tablet. Oral concomitant medication was allowed to be taken 2 hours post-dosing. If taken with food, concomitant medication was allowed to be administered 30 minutes after ingestion of the semaglutide tablet.

    Arm title
    		 Sema 40 mg S
    Arm description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks. The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 8th week (slow dose escalation). The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide 40 mg
    Investigational medicinal product code
    Other name
    SEMAGLUTIDE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The doses were administered according to the following rules: Fasting for at least 6 hours (e.g., in the morning following an overnight fast) before tablet ingestion. Water and oral concomitant medication was allowed up to 2 hours prior to dosing. Intake of maximum 120 mL of water was allowed when swallowing the tablet. Subjects were required to abstain from food and fluid intake for at least 30 minutes after ingestion of oral semaglutide tablet. Oral concomitant medication was allowed to be taken 2 hours post-dosing. If taken with food, concomitant medication was allowed to be administered 30 minutes after ingestion of the semaglutide tablet.

    Arm title
    		 Sema 40 mg F
    Arm description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks. The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 2nd week (fast dose escalation). The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide 40 mg
    Investigational medicinal product code
    Other name
    SEMAGLUTIDE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The doses were administered according to the following rules: Fasting for at least 6 hours (e.g., in the morning following an overnight fast) before tablet ingestion. Water and oral concomitant medication was allowed up to 2 hours prior to dosing. Intake of maximum 120 mL of water was allowed when swallowing the tablet. Subjects were required to abstain from food and fluid intake for at least 30 minutes after ingestion of oral semaglutide tablet. Oral concomitant medication was allowed to be taken 2 hours post-dosing. If taken with food, concomitant medication was allowed to be administered 30 minutes after ingestion of the semaglutide tablet.

    Arm title
    		 Sema 1 mg SC
    Arm description
    		 The subjects in this group were administered with once weekly doses of 0.25 mg of sc semaglutide for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. The maintenance dose was 1.0 mg for subjects in this group.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Semaglutide B 1.34 mg/ml PDS290
    Investigational medicinal product code
    Other name
    SEMAGLUTIDE
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Semaglutide (sc administration) was available as 1.34 mg/mL, solution for injection, 1.5 mL pre-filled PDS290 pen-injector. The injections were administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were administered on the same day of the week during the trial.

    Number of subjects in period 1
    		Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 40 mg S Sema 40 mg F Sema 1 mg SC
    Started
    71
    70
    70
    70
    70
    71
    70
    70
    70
    Exposed
    71
    70
    70
    69
    70
    71
    70
    70
    69
    Completed
    65
    61
    60
    59
    48
    48
    53
    45
    53
    Not completed
    6
    9
    10
    11
    22
    23
    17
    25
    17
         Consent withdrawn by subject
    1
    -
    1
    -
    -
    1
    1
    3
    1
         Adverse event, non-fatal
    1
    6
    4
    8
    19
    16
    10
    18
    10
         Other, unclassified
    3
    1
    3
    2
    1
    4
    4
    4
    3
         Pregnancy
    -
    -
    -
    -
    -
    -
    1
    -
    -
         Protocol deviation
    1
    2
    2
    1
    2
    2
    1
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 The subjects in this arm were administered with placebo tablets once daily orally for 26 weeks. The placebo tablets did not contain sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC).

    Reporting group title
    Sema 2.5 mg
    Reporting group description
    		 The subjects in this group were administered with 2.5 mg of oral semaglutide once daily for 26 weeks. The semaglutide 2.5 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 5 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 2.5 mg semaglutide for 4 weeks, then 5 mg of semaglutide for 22 weeks. The maintenance dose was 5 mg for subjects in this group. The semaglutide 5 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 10 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg of semaglutide for 22 weeks. The maintenance dose was 10 mg for subjects in this group. The semaglutide 10 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 20 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. The maintenance dose was 20 mg for subjects in this group. The semaglutide 20 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 40 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks. The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 4th week. The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 40 mg S
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks. The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 8th week (slow dose escalation). The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 40 mg F
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks. The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 2nd week (fast dose escalation). The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 1 mg SC
    Reporting group description
    		 The subjects in this group were administered with once weekly doses of 0.25 mg of sc semaglutide for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. The maintenance dose was 1.0 mg for subjects in this group.

    Reporting group values
    		 Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 40 mg S Sema 40 mg F Sema 1 mg SC Total
    Number of subjects
    		 71 70 70 70 70 71 70 70 70 632
    Age categorical
    The total number of subjects include 2 subjects who were randomised but not exposed and not included in any of the analysis sets (1 subject in the Sema 10 mg arm and 1 subjects in the Sema 1 mg SC arm).
    Units: Subjects
        Adults (18-64 years)
    		 48 55 57 57 50 52 55 50 55 479
        From 65-84 years
    		 23 15 12 13 20 19 15 20 15 152
        85 years and over
    		 0 0 1 0 0 0 0 0 0 1
    Age continuous
    In the treatment arms, Sema 10 mg and Sema 1 mg SC, the mean values include only the data from 69 subjects in each arm since 1 subject each in these arms were not exposed to any treatment and hence should not be counted for any data under the respective arms. The total subjects enrolled/randomised are auto calculated by the system.
    Units: years
        arithmetic mean (standard deviation)
    		 58.9 ± 10.3 56.7 ± 9.9 55.7 ± 11 56.5 ± 10.1 58.3 ± 10.4 56.5 ± 10.2 57.1 ± 10.5 57.7 ± 10.8 56.8 ± 11.8 -
    Gender categorical
    The total number of subjects include 2 subjects who were randomised but not exposed and not included in any of the analysis sets (1 subject in the Sema 10 mg arm and 1 subjects in the Sema 1 mg SC arm).
    Units: Subjects
        Female
    		 31 25 23 26 26 28 29 26 21 235
        Male
    		 40 45 47 44 44 43 41 44 49 397
    HbA1c
    In the treatment arms, Sema 10 mg and Sema 1 mg SC, the mean values include only the data from 69 subjects in each arm since 1 subject each in these arms were not exposed to any treatment and hence should not be counted for any data under the respective arms. The total subjects enrolled/randomised are auto calculated by the system. Note: The mean and SD are reported with the precision of two decimals. However, zeros at the end of a value is deleted by the system, e.g. 8.00 is presented as 8.
    Units: percentage of haemoglobin
        arithmetic mean (standard deviation)
    		 8 ± 0.8 7.99 ± 0.72 7.8 ± 0.62 7.8 ± 0.7 7.86 ± 0.69 8.05 ± 0.75 7.96 ± 0.73 7.77 ± 0.75 7.77 ± 0.71 -
    Body weight
    In the treatment arms, Sema 10 mg and Sema 1 mg SC, the mean values include only the data from 69 subjects in each arm since 1 subject each in these arms were not exposed to any treatment and hence should not be counted for any data under the respective arms. The total subjects enrolled/randomised are auto calculated by the system.
    Units: kg
        arithmetic mean (standard deviation)
    		 93.76 ± 18.14 93.62 ± 15.63 93.09 ± 19.03 91.76 ± 14.02 93.81 ± 17.91 90.85 ± 16.51 93.25 ± 18.76 91.98 ± 15.37 88.8 ± 15.42 -
    Waist circumference
    In the treatment arms, Sema 10 mg and Sema 1 mg SC, the mean values include only the data from 69 subjects in each arm since 1 subject each in these arms were not exposed to any treatment and hence should not be counted for any data under the respective arms. The total subjects enrolled/randomised are auto calculated by the system. Note: The mean and SD are reported with the precision of one and two decimals, respectively. However, zeros at the end of the value is deleted by the system, e.g. 108.0 is presented as 108 and 13.30 is presented as 13.3.
    Units: centimeter
        arithmetic mean (standard deviation)
    		 111.1 ± 13.56 108.5 ± 11.87 106.1 ± 13.73 107.8 ± 12.28 108 ± 13.3 105.4 ± 12.78 107.9 ± 12.46 106.3 ± 11.66 105 ± 11.27 -
    BMI
    In the treatment arms, Sema 10 mg and Sema 1 mg SC, the mean values include only the data from 69 subjects in each arm since 1 subject each in these arms were not exposed to any treatment and hence should not be counted for any data under the respective arms. The total subjects enrolled/randomised are auto calculated by the system.
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 32.58 ± 4.53 31.74 ± 4.14 31.6 ± 4.86 31.89 ± 4.42 31.97 ± 4.52 31.12 ± 4.06 32.26 ± 4.46 31.66 ± 3.82 30.72 ± 4.03 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 The subjects in this arm were administered with placebo tablets once daily orally for 26 weeks. The placebo tablets did not contain sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC).

    Reporting group title
    Sema 2.5 mg
    Reporting group description
    		 The subjects in this group were administered with 2.5 mg of oral semaglutide once daily for 26 weeks. The semaglutide 2.5 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 5 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 2.5 mg semaglutide for 4 weeks, then 5 mg of semaglutide for 22 weeks. The maintenance dose was 5 mg for subjects in this group. The semaglutide 5 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 10 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg of semaglutide for 22 weeks. The maintenance dose was 10 mg for subjects in this group. The semaglutide 10 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 20 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. The maintenance dose was 20 mg for subjects in this group. The semaglutide 20 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 40 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks. The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 4th week. The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 40 mg S
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks. The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 8th week (slow dose escalation). The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 40 mg F
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks. The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 2nd week (fast dose escalation). The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 1 mg SC
    Reporting group description
    		 The subjects in this group were administered with once weekly doses of 0.25 mg of sc semaglutide for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. The maintenance dose was 1.0 mg for subjects in this group.

    Primary: Change in HbA1c

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    End point title
    		 Change in HbA1c
    End point description
    Change in HbA1c from baseline to after 26 weeks of treatment. Subjects in the full analysis set (FAS) and only measurements belonging to the on-treatment without rescue medication observation period (the primary observation period for examination of efficacy endpoints) were included in the analysis. This observation period included observations recorded at or after date of first dose of trial product and not after the first occurrence of the following: 1) The end-date of the on-treatment observation period. 2) Initiation of rescue medication. The total number of subjects included in this period were 463. FAS included subjects who had received at least 1 dose of randomised semaglutide (oral or sc) or placebo. Subjects in FAS contributed to the evaluation based on their randomised treatment. Note: The mean and SD are reported with the precision of two decimals. However, zeros at the end of a value is deleted by the system, e.g. 0.10 is presented as 0.1.
    End point type
    Primary
    End point timeframe
    From baseline to after 26 weeks of treatment
    End point values
    		 Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 40 mg S Sema 40 mg F Sema 1 mg SC
    Number of subjects analysed
    51
    56
    58
    57
    48
    46
    52
    44
    48
    Units: percentage of HbA1c
    least squares mean (standard error)
        Change from baseline
    -0.31 ± 0.1
    -0.71 ± 0.1
    -1.2 ± 0.1
    -1.49 ± 0.1
    -1.69 ± 0.11
    -1.91 ± 0.11
    -1.74 ± 0.1
    -1.65 ± 0.11
    -1.87 ± 0.11
    Statistical analysis title
    		 Primary statistical analysis
    Statistical analysis description
    The post-baseline responses were analysed using a mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution. Subjects in the FAS and only measurements belonging to the on-treatment without rescue medication observation period were included in the analysis.
    Comparison groups
    Placebo v Sema 2.5 mg
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0069
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.69
         upper limit
    		 -0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [1] - The estimated treatment difference with corresponding two-sided p-value and 95% confidence interval at 26 weeks was presented, and efficacy of oral semaglutide was considered confirmed if the upper limit of the confidence interval was strictly less than zero.
    Statistical analysis title
    		 Primary statistical analysis
    Statistical analysis description
    The post-baseline responses were analysed using a mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution. Subjects in the FAS and only measurements belonging to the on-treatment without rescue medication observation period were included in the analysis.
    Comparison groups
    Placebo v Sema 5 mg
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 -0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [2] - The estimated treatment difference with corresponding two-sided p-value and 95% confidence interval at 26 weeks was presented, and efficacy of oral semaglutide was considered confirmed if the upper limit of the confidence interval was strictly less than zero.
    Statistical analysis title
    		 Primary statistical analysis
    Statistical analysis description
    The post-baseline responses were analysed using a mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution. Subjects in the FAS and only measurements belonging to the on-treatment without rescue medication observation period were included in the analysis.
    Comparison groups
    Placebo v Sema 10 mg
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.47
         upper limit
    		 -0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [3] - The estimated treatment difference with corresponding two-sided p-value and 95% confidence interval at 26 weeks was presented, and efficacy of oral semaglutide was considered confirmed if the upper limit of the confidence interval was strictly less than zero.
    Statistical analysis title
    		 Primary statistical analysis
    Statistical analysis description
    The post-baseline responses were analysed using a mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution. Subjects in the FAS and only measurements belonging to the on-treatment without rescue medication observation period were included in the analysis.
    Comparison groups
    Placebo v Sema 20 mg
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.68
         upper limit
    		 -1.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [4] - The estimated treatment difference with corresponding two-sided p-value and 95% confidence interval at 26 weeks was presented, and efficacy of oral semaglutide was considered confirmed if the upper limit of the confidence interval was strictly less than zero.
    Statistical analysis title
    		 Primary statistical analysis
    Statistical analysis description
    The post-baseline responses were analysed using a mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution. Subjects in the FAS and only measurements belonging to the on-treatment without rescue medication observation period were included in the analysis.
    Comparison groups
    Placebo v Sema 40 mg
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.89
         upper limit
    		 -1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [5] - The estimated treatment difference with corresponding two-sided p-value and 95% confidence interval at 26 weeks was presented, and efficacy of oral semaglutide was considered confirmed if the upper limit of the confidence interval was strictly less than zero.

    Secondary: Subjects who achieve (yes/no) HbA1c <7% (53 mmol/mol)

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    End point title
    		 Subjects who achieve (yes/no) HbA1c <7% (53 mmol/mol)
    End point description
    The proportion of subjects who achieved HbA1c <7% after 26 weeks of treatment. The data presented is summary of on-treatment without rescue data with missing data imputed from a mixed model for repeated measures with treatment, country, stratum and baseline value, all nested within visit. The FAS was used in all analyses of the supportive secondary efficacy endpoints. Subjects in the FAS contributed to the evaluation based on their randomised treatment.
    End point type
    Secondary
    End point timeframe
    After 26 weeks of treatment.
    End point values
    		 Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 40 mg S Sema 40 mg F Sema 1 mg SC
    Number of subjects analysed
    71
    70
    70
    69
    70
    71
    70
    70
    69
    Units: Percentage of subjects
    number (not applicable)
        Yes
    27.54
    44.12
    81.16
    83.58
    85.71
    89.71
    86.57
    87.69
    92.65
        No
    72.46
    55.88
    18.84
    16.42
    14.29
    10.29
    13.43
    12.31
    7.35
    No statistical analyses for this end point

    Secondary: Change in body weight

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    End point title
    		 Change in body weight
    End point description
    Change in body weight from baseline to after 26 weeks of treatment. Analysis of observed on-treatment without rescue data. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
    End point type
    Secondary
    End point timeframe
    From baseline to after 26 weeks of treatment
    End point values
    		 Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 40 mg S Sema 40 mg F Sema 1 mg SC
    Number of subjects analysed
    51
    56
    57
    57
    47
    46
    51
    44
    46
    Units: kg
    least squares mean (standard error)
        Change from baseline
    -1.18 ± 0.55
    -2.06 ± 0.53
    -2.65 ± 0.53
    -4.8 ± 0.54
    -6.14 ± 0.57
    -6.89 ± 0.56
    -6.05 ± 0.54
    -8.16 ± 0.58
    -6.43 ± 0.55
    No statistical analyses for this end point

    Secondary: Change in waist circumference

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    End point title
    		 Change in waist circumference
    End point description
    Change in waist circumference from baseline to after 26 weeks of treatment. Analysis of observed on-treatment without rescue data. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
    End point type
    Secondary
    End point timeframe
    From baseline to after 26 weeks of treatment
    End point values
    		 Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 40 mg S Sema 40 mg F Sema 1 mg SC
    Number of subjects analysed
    51
    56
    56
    57
    47
    46
    51
    44
    46
    Units: centimeter
    least squares mean (standard error)
        Change from baseline
    -1.66 ± 0.62
    -1.84 ± 0.6
    -2.21 ± 0.61
    -4.48 ± 0.6
    -4.47 ± 0.63
    -5.78 ± 0.63
    -5.06 ± 0.61
    -6.27 ± 0.65
    -6.21 ± 0.63
    No statistical analyses for this end point

    Secondary: Change in body mass index (BMI)

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    End point title
    		 Change in body mass index (BMI)
    End point description
    Change in BMI from baseline to after 26 weeks of treatment. Analysis of observed on-treatment without rescue data. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
    End point type
    Secondary
    End point timeframe
    From baseline to after 26 weeks of treatment
    End point values
    		 Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 40 mg S Sema 40 mg F Sema 1 mg SC
    Number of subjects analysed
    51
    56
    57
    57
    47
    46
    51
    44
    46
    Units: kg/m2
    least squares mean (standard error)
        Change from baseline
    -0.41 ± 0.19
    -0.7 ± 0.18
    -0.91 ± 0.18
    -1.69 ± 0.19
    -2.11 ± 0.2
    -2.38 ± 0.19
    -2.1 ± 0.19
    -2.86 ± 0.2
    -2.25 ± 0.19
    No statistical analyses for this end point

    Secondary: Number of treatment emergent adverse events (TEAEs)

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    End point title
    		 Number of treatment emergent adverse events (TEAEs)
    End point description
    The on-treatment summary of adverse events included treatment emergent events with onset on or after the day of first randomised dose and not after the follow-up visit scheduled 5 weeks after end of treatment. This endpoint was summarised and analysed using the safety analysis set. The on-treatment observation period was the primary observation period for examination of all safety endpoints. Subjects in the safety analysis set contributed to the evaluation ‘as treated’.
    End point type
    Secondary
    End point timeframe
    Recorded from baseline until week 31
    End point values
    		 Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 40 mg S Sema 40 mg F Sema 1 mg SC
    Number of subjects analysed
    71
    70
    70
    69
    70
    71
    70
    70
    69
    Units: Number of events
        Number of events
    127
    142
    169
    233
    289
    230
    233
    245
    218
    No statistical analyses for this end point

    Secondary: Number of confirmed hypoglycaemic episodes

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    End point title
    		 Number of confirmed hypoglycaemic episodes
    End point description
    Confirmed hypoglycaemic episodes were defined as episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.
    End point type
    Secondary
    End point timeframe
    Recorded from baseline until week 31
    End point values
    		 Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 40 mg S Sema 40 mg F Sema 1 mg SC
    Number of subjects analysed
    71
    70
    70
    69
    70
    71
    70
    70
    69
    Units: Number of episodes
        Number of episodes
    5
    4
    4
    6
    1
    1
    3
    1
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) either observed by the investigator or reported spontaneously by the subjects were recorded. This included events from when the subject had signed the informed consent until the end of the post-treatment follow-up period.
    Adverse event reporting additional description
    Safety analysis set was used for the assessment of safety including AEs. Safety analysis set included 630 subjects who had been exposed to at least 1 dose of semaglutide (oral or sc) or placebo and excluded 2 subjects who were randomised but not exposed to treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 The subjects in this arm were administered with placebo tablets once daily orally for 26 weeks. The placebo tablets did not contain sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC).

    Reporting group title
    Sema 2.5 mg
    Reporting group description
    		 The subjects in this group were administered with 2.5 mg of oral semaglutide once daily for 26 weeks. The semaglutide 2.5 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 5 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 2.5 mg semaglutide for 4 weeks, then 5 mg of semaglutide for 22 weeks. The maintenance dose was 5 mg for subjects in this group. The semaglutide 5 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 10 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg of semaglutide for 22 weeks. The maintenance dose was 10 mg for subjects in this group. The semaglutide 10 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 20 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. The maintenance dose was 20 mg for subjects in this group. The semaglutide 20 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 40 mg
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks. The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 4th week. The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 40 mg S
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks.The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 8th week (slow dose escalation). The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 40 mg F
    Reporting group description
    		 The subjects in this group were administered with once daily oral doses of 5 mg semaglutide for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks. The maintenance dose was 40 mg for subjects in this group. In this arm, the dose-escalation occurred every 2nd week (fast dose escalation). The semaglutide 40 mg tablet contained a fixed dose of 300 mg SNAC.

    Reporting group title
    Sema 1 mg SC
    Reporting group description
    		 The subjects in this group were administered with once weekly doses of 0.25 mg of subcutaneous (sc) semaglutide for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. The maintenance dose was 1.0 mg for subjects in this group.

    Serious adverse events
    		 Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 40 mg S Sema 40 mg F Sema 1 mg SC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 71 (7.04%)
    1 / 70 (1.43%)
    2 / 70 (2.86%)
    2 / 69 (2.90%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
    3 / 70 (4.29%)
    5 / 70 (7.14%)
    2 / 69 (2.90%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenal neoplasm
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    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
    Investigations
    Pancreatic enzymes increased
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 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
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative adhesion
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 69 (1.45%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    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
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Pterygium
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    Nausea
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 69 (1.45%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    Vomiting
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 69 (1.45%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    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
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 69 (1.45%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    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
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint abscess
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (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
         deaths causally related to treatment / all
    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
    		 Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 40 mg S Sema 40 mg F Sema 1 mg SC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 71 (47.89%)
    35 / 70 (50.00%)
    32 / 70 (45.71%)
    37 / 69 (53.62%)
    49 / 70 (70.00%)
    49 / 71 (69.01%)
    42 / 70 (60.00%)
    55 / 70 (78.57%)
    44 / 69 (63.77%)
    Investigations
    Lipase increased
         subjects affected / exposed
    2 / 71 (2.82%)
    2 / 70 (2.86%)
    1 / 70 (1.43%)
    1 / 69 (1.45%)
    3 / 70 (4.29%)
    3 / 71 (4.23%)
    4 / 70 (5.71%)
    4 / 70 (5.71%)
    2 / 69 (2.90%)
         occurrences all number
    2
    2
    1
    1
    3
    3
    4
    4
    2
    Weight decreased
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    2 / 70 (2.86%)
    4 / 71 (5.63%)
    0 / 70 (0.00%)
    3 / 70 (4.29%)
    1 / 69 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    4
    0
    3
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 71 (1.41%)
    4 / 70 (5.71%)
    3 / 70 (4.29%)
    2 / 69 (2.90%)
    6 / 70 (8.57%)
    1 / 71 (1.41%)
    2 / 70 (2.86%)
    2 / 70 (2.86%)
    3 / 69 (4.35%)
         occurrences all number
    1
    4
    3
    2
    6
    1
    2
    2
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 71 (0.00%)
    5 / 70 (7.14%)
    3 / 70 (4.29%)
    3 / 69 (4.35%)
    3 / 70 (4.29%)
    4 / 71 (5.63%)
    0 / 70 (0.00%)
    5 / 70 (7.14%)
    2 / 69 (2.90%)
         occurrences all number
    0
    5
    3
    3
    3
    4
    0
    5
    2
    Headache
         subjects affected / exposed
    4 / 71 (5.63%)
    4 / 70 (5.71%)
    9 / 70 (12.86%)
    8 / 69 (11.59%)
    10 / 70 (14.29%)
    4 / 71 (5.63%)
    8 / 70 (11.43%)
    7 / 70 (10.00%)
    10 / 69 (14.49%)
         occurrences all number
    4
    6
    9
    10
    18
    7
    10
    7
    21
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 71 (2.82%)
    3 / 70 (4.29%)
    3 / 70 (4.29%)
    3 / 69 (4.35%)
    5 / 70 (7.14%)
    1 / 71 (1.41%)
    1 / 70 (1.43%)
    3 / 70 (4.29%)
    2 / 69 (2.90%)
         occurrences all number
    2
    3
    3
    3
    6
    1
    1
    3
    3
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    2 / 69 (2.90%)
    3 / 70 (4.29%)
    2 / 71 (2.82%)
    1 / 70 (1.43%)
    4 / 70 (5.71%)
    5 / 69 (7.25%)
         occurrences all number
    0
    0
    1
    2
    3
    2
    1
    5
    7
    Abdominal distension
         subjects affected / exposed
    5 / 71 (7.04%)
    0 / 70 (0.00%)
    3 / 70 (4.29%)
    1 / 69 (1.45%)
    2 / 70 (2.86%)
    6 / 71 (8.45%)
    1 / 70 (1.43%)
    3 / 70 (4.29%)
    3 / 69 (4.35%)
         occurrences all number
    5
    0
    3
    1
    2
    6
    1
    3
    4
    Abdominal pain
         subjects affected / exposed
    0 / 71 (0.00%)
    3 / 70 (4.29%)
    1 / 70 (1.43%)
    1 / 69 (1.45%)
    4 / 70 (5.71%)
    3 / 71 (4.23%)
    4 / 70 (5.71%)
    3 / 70 (4.29%)
    4 / 69 (5.80%)
         occurrences all number
    0
    3
    1
    1
    7
    3
    4
    3
    4
    Abdominal pain upper
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    2 / 70 (2.86%)
    1 / 69 (1.45%)
    6 / 70 (8.57%)
    2 / 71 (2.82%)
    4 / 70 (5.71%)
    1 / 70 (1.43%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    2
    1
    8
    2
    6
    1
    0
    Constipation
         subjects affected / exposed
    4 / 71 (5.63%)
    4 / 70 (5.71%)
    4 / 70 (5.71%)
    6 / 69 (8.70%)
    5 / 70 (7.14%)
    9 / 71 (12.68%)
    7 / 70 (10.00%)
    8 / 70 (11.43%)
    7 / 69 (10.14%)
         occurrences all number
    5
    4
    4
    8
    8
    11
    7
    9
    7
    Diarrhoea
         subjects affected / exposed
    7 / 71 (9.86%)
    5 / 70 (7.14%)
    7 / 70 (10.00%)
    16 / 69 (23.19%)
    14 / 70 (20.00%)
    10 / 71 (14.08%)
    14 / 70 (20.00%)
    12 / 70 (17.14%)
    10 / 69 (14.49%)
         occurrences all number
    10
    6
    7
    20
    18
    15
    27
    15
    14
    Dyspepsia
         subjects affected / exposed
    3 / 71 (4.23%)
    2 / 70 (2.86%)
    5 / 70 (7.14%)
    6 / 69 (8.70%)
    8 / 70 (11.43%)
    6 / 71 (8.45%)
    6 / 70 (8.57%)
    5 / 70 (7.14%)
    10 / 69 (14.49%)
         occurrences all number
    3
    6
    7
    6
    8
    8
    8
    5
    11
    Eructation
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 69 (1.45%)
    2 / 70 (2.86%)
    5 / 71 (7.04%)
    1 / 70 (1.43%)
    2 / 70 (2.86%)
    2 / 69 (2.90%)
         occurrences all number
    0
    0
    0
    1
    2
    5
    1
    2
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 71 (1.41%)
    2 / 70 (2.86%)
    2 / 70 (2.86%)
    4 / 69 (5.80%)
    5 / 70 (7.14%)
    4 / 71 (5.63%)
    4 / 70 (5.71%)
    4 / 70 (5.71%)
    1 / 69 (1.45%)
         occurrences all number
    1
    2
    2
    4
    7
    4
    4
    4
    1
    Nausea
         subjects affected / exposed
    1 / 71 (1.41%)
    9 / 70 (12.86%)
    10 / 70 (14.29%)
    23 / 69 (33.33%)
    24 / 70 (34.29%)
    24 / 71 (33.80%)
    23 / 70 (32.86%)
    25 / 70 (35.71%)
    22 / 69 (31.88%)
         occurrences all number
    1
    12
    13
    27
    36
    37
    29
    27
    23
    Vomiting
         subjects affected / exposed
    3 / 71 (4.23%)
    4 / 70 (5.71%)
    4 / 70 (5.71%)
    14 / 69 (20.29%)
    11 / 70 (15.71%)
    14 / 71 (19.72%)
    11 / 70 (15.71%)
    16 / 70 (22.86%)
    6 / 69 (8.70%)
         occurrences all number
    3
    8
    5
    18
    14
    25
    22
    20
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 71 (1.41%)
    2 / 70 (2.86%)
    2 / 70 (2.86%)
    4 / 69 (5.80%)
    1 / 70 (1.43%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    3 / 69 (4.35%)
         occurrences all number
    1
    2
    2
    4
    1
    0
    0
    2
    3
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
    2 / 69 (2.90%)
    2 / 70 (2.86%)
    2 / 71 (2.82%)
    2 / 70 (2.86%)
    4 / 70 (5.71%)
    2 / 69 (2.90%)
         occurrences all number
    0
    1
    0
    3
    2
    2
    2
    6
    2
    Influenza
         subjects affected / exposed
    5 / 71 (7.04%)
    2 / 70 (2.86%)
    0 / 70 (0.00%)
    3 / 69 (4.35%)
    3 / 70 (4.29%)
    2 / 71 (2.82%)
    1 / 70 (1.43%)
    1 / 70 (1.43%)
    1 / 69 (1.45%)
         occurrences all number
    7
    2
    0
    5
    4
    2
    1
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    9 / 71 (12.68%)
    6 / 70 (8.57%)
    3 / 70 (4.29%)
    3 / 69 (4.35%)
    5 / 70 (7.14%)
    5 / 71 (7.04%)
    3 / 70 (4.29%)
    4 / 70 (5.71%)
    2 / 69 (2.90%)
         occurrences all number
    9
    7
    4
    3
    6
    5
    4
    5
    3
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 71 (1.41%)
    3 / 70 (4.29%)
    4 / 70 (5.71%)
    1 / 69 (1.45%)
    6 / 70 (8.57%)
    1 / 71 (1.41%)
    2 / 70 (2.86%)
    0 / 70 (0.00%)
    4 / 69 (5.80%)
         occurrences all number
    1
    3
    5
    1
    7
    1
    2
    0
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 71 (1.41%)
    3 / 70 (4.29%)
    2 / 70 (2.86%)
    10 / 69 (14.49%)
    8 / 70 (11.43%)
    10 / 71 (14.08%)
    3 / 70 (4.29%)
    10 / 70 (14.29%)
    9 / 69 (13.04%)
         occurrences all number
    1
    4
    2
    10
    8
    11
    4
    10
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Feb 2014
    The HbA1c criterion was removed as part of the rescue criteria during the treatment period. The process of reporting central electrocardiogram (ECG) evaluation back to investigator was changed. The ADA classification of hypoglycaemia was recently been updated. The definition of thyroid events for adjudication was updated. Minor inconsistencies were updated and amendment number 1 (local amendment for Sweden) was included.

    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
    For support, Contact us.
    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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