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    Clinical Trial Results:
    Efficacy and safety of semaglutide 1.0 mg once-weekly versus liraglutide 1.2 mg once-daily as add-on to 1–3 oral anti-diabetic drugs (OADs) in subjects with type 2 diabetes

    Summary
    EudraCT number
    		 2016-004965-22
    Trial protocol
    		 SI   HU   FR   FI   ES   SE   BG   GB   CZ   PL   IT  
    Global end of trial date
    13 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Aug 2019
    First version publication date
    22 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9535-4339
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03191396
    WHO universal trial number (UTN)
    		 U1111-1190-5868
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Anchor and Disclosure (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
    27 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of semaglutide s.c. 1.0 mg once-weekly versus liraglutide s.c. 1.2 mg once-daily on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996), including archiving of essential documents.
    Background therapy
    		 After screening, subjects were required to continue their oral anti-diabetic drug (OAD) pre-trial background medication (i.e. metformin, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulphonyl ureas, or combinations of these) throughout the entire trial.
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    27 Jun 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 91
    Country: Number of subjects enrolled
    Czech Republic: 29
    Country: Number of subjects enrolled
    Spain: 45
    Country: Number of subjects enrolled
    Finland: 54
    Country: Number of subjects enrolled
    France: 31
    Country: Number of subjects enrolled
    United Kingdom: 147
    Country: Number of subjects enrolled
    Hungary: 48
    Country: Number of subjects enrolled
    Italy: 35
    Country: Number of subjects enrolled
    Poland: 30
    Country: Number of subjects enrolled
    Slovenia: 30
    Country: Number of subjects enrolled
    Sweden: 37
    Worldwide total number of subjects
    577
    EEA total number of subjects
    577
    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)
    377
    From 65 to 84 years
    199
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 77 sites in 11 countries as follows (number of sites that screened subjects/ number of sites that randomised subjects): Bulgaria (9/ 9); Czech Republic (5/ 5); Finland (8/ 8); France (8/ 8); Hungary (8/ 8); Italy (4/ 4); Poland (3/ 3); Slovenia (4/ 4); Spain (5/ 5); Sweden (6/ 6); United Kingdom (17/ 17)

    Pre-assignment
    Screening details
    		 After screening, subjects were required to continue their oral anti-diabetic drug (OAD) pre-trial background medication (i.e. metformin, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulphonyl ureas, or combinations of these) throughout the entire trial.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Semaglutide 1.0 mg
    Arm description
    		 Subjects received 1.0 mg semaglutide once weekly for 30 weeks (including 8-week dose escalation period). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide B 1.34 mg/ml PDS290
    Investigational medicinal product code
    Other name
    Ozempic®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg once-daily was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30).

    Arm title
    		 Liraglutide 1.2 mg
    Arm description
    		 Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
    Arm type
    		 Active comparator

    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
    Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once daily and the time of injection recommended being consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg once-daily.

    Number of subjects in period 1
    		Semaglutide 1.0 mg Liraglutide 1.2 mg
    Started
    290
    287
    Completed
    287
    282
    Not completed
    3
    5
         Consent withdrawn by subject
    3
    2
         Lost to follow-up
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects received 1.0 mg semaglutide once weekly for 30 weeks (including 8-week dose escalation period). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).

    Reporting group title
    Liraglutide 1.2 mg
    Reporting group description
    		 Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).

    Reporting group values
    		 Semaglutide 1.0 mg Liraglutide 1.2 mg Total
    Number of subjects
    		 290 287 577
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 178 199 377
        From 65-74 years
    		 96 77 173
        From 75-84 years
    		 15 11 26
        85 years and over
    		 1 0 1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 60.1 ( 10.5 ) 58.9 ( 10.0 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 130 120 250
        Male
    		 160 167 327
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 5 3 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 2 1 3
        White
    		 264 268 532
        Other
    		 3 0 3
        Unknown or Not Reported
    		 16 15 31
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 6 3 9
        Not Hispanic or Latino
    		 268 269 537
        Unknown or Not Reported
    		 16 15 31

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects received 1.0 mg semaglutide once weekly for 30 weeks (including 8-week dose escalation period). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).

    Reporting group title
    Liraglutide 1.2 mg
    Reporting group description
    		 Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).

    Primary: Change in HbA1c

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    End point title
    		 Change in HbA1c
    End point description
    Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
    End point type
    Primary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 1.0 mg Liraglutide 1.2 mg
    Number of subjects analysed
    290
    287
    Units: Percentage of glycosylated haemoglobin
        arithmetic mean (standard deviation)
    -1.7 ( 0.9 )
    -1.1 ( 1.0 )
    Statistical analysis title
    		 Analysis 1
    Statistical analysis description
    The responses are analysed using an ANCOVA with treatment and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
    Comparison groups
    Liraglutide 1.2 mg v Semaglutide 1.0 mg
    Number of subjects included in analysis
    577
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.0001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.82
         upper limit
    		 -0.56
    Notes
    [1] - HbA1c non-inferiority was tested using a non-inferiority margin of 0.3.
    [2] - The non-inferiority p-value is calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3.
    Statistical analysis title
    		 Analysis 2
    Comparison groups
    Semaglutide 1.0 mg v Liraglutide 1.2 mg
    Number of subjects included in analysis
    577
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.82
         upper limit
    		 -0.56

    Secondary: Change in body weight (kg)

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    End point title
    		 Change in body weight (kg)
    End point description
    Mean change from baseline (week 0) to week 30 in body weight measured in kilograms. Results are based on the 'on-treatment without rescue medication' observation period where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
    End point type
    Secondary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 1.0 mg Liraglutide 1.2 mg
    Number of subjects analysed
    290
    287
    Units: kg
        arithmetic mean (standard deviation)
    -5.8 ( 4.7 )
    -2.0 ( 4.1 )
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Semaglutide 1.0 mg v Liraglutide 1.2 mg
    Number of subjects included in analysis
    577
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -3.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.57
         upper limit
    		 -3.09

    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 fasting plasma glucose measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
    End point type
    Secondary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 1.0 mg Liraglutide 1.2 mg
    Number of subjects analysed
    286
    285
    Units: mmol/L
        arithmetic mean (standard deviation)
    -2.65 ( 2.19 )
    -1.46 ( 2.42 )
    No statistical analyses for this end point

    Secondary: Change in systolic blood pressure

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    End point title
    		 Change in systolic blood pressure
    End point description
    Change in systolic blood pressure from baseline (week 0) to week 30 . Results are based on the 'on-treatment without rescue medication' period where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
    End point type
    Secondary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 1.0 mg Liraglutide 1.2 mg
    Number of subjects analysed
    290
    287
    Units: mmHg
        arithmetic mean (standard deviation)
    -4.3 ( 13.4 )
    -3.7 ( 13.8 )
    No statistical analyses for this end point

    Secondary: Change in diastolic blood pressure

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    End point title
    		 Change in diastolic blood pressure
    End point description
    Change in diastolic blood pressure from baseline (week 0) to week 30 . Results are based on the 'on-treatment without rescue medication' period where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
    End point type
    Secondary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 1.0 mg Liraglutide 1.2 mg
    Number of subjects analysed
    290
    287
    Units: mmHg
        arithmetic mean (standard deviation)
    -1.5 ( 8.6 )
    -1.3 ( 8.4 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days.
    Adverse event reporting additional description
    Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects received 1.0 mg semaglutide once weekly for 30 weeks (including 8-week dose escalation period). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).

    Reporting group title
    Liraglutide 1.2 mg
    Reporting group description
    		 Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).

    Serious adverse events
    		 Semaglutide 1.0 mg Liraglutide 1.2 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 289 (5.88%)
    22 / 287 (7.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leiomyoma
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medullary thyroid cancer
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal neoplasm
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Facial pain
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menopausal symptoms
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Cardiovascular examination
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cognitive disorder
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal vein occlusion
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 289 (0.35%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 289 (0.35%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 289 (0.69%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 289 (0.35%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 289 (0.35%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Semaglutide 1.0 mg Liraglutide 1.2 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    139 / 289 (48.10%)
    113 / 287 (39.37%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    27 / 289 (9.34%)
    19 / 287 (6.62%)
         occurrences all number
    37
    32
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    15 / 289 (5.19%)
    6 / 287 (2.09%)
         occurrences all number
    18
    6
    Constipation
         subjects affected / exposed
    17 / 289 (5.88%)
    10 / 287 (3.48%)
         occurrences all number
    17
    13
    Diarrhoea
         subjects affected / exposed
    45 / 289 (15.57%)
    35 / 287 (12.20%)
         occurrences all number
    56
    43
    Nausea
         subjects affected / exposed
    62 / 289 (21.45%)
    45 / 287 (15.68%)
         occurrences all number
    88
    54
    Vomiting
         subjects affected / exposed
    29 / 289 (10.03%)
    23 / 287 (8.01%)
         occurrences all number
    43
    32
    Infections and infestations
    Influenza
         subjects affected / exposed
    9 / 289 (3.11%)
    15 / 287 (5.23%)
         occurrences all number
    12
    16
    Nasopharyngitis
         subjects affected / exposed
    27 / 289 (9.34%)
    30 / 287 (10.45%)
         occurrences all number
    30
    32
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    30 / 289 (10.38%)
    17 / 287 (5.92%)
         occurrences all number
    31
    18

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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