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    Clinical Trial Results:
    Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes

    Summary
    EudraCT number
    		 2014-005375-91
    Trial protocol
    		 IE   FI   DE   GB   SK   LV   LT   GR   ES   PT   HR  
    Global end of trial date
    19 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 May 2018
    First version publication date
    30 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9535-4216
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02648204
    WHO universal trial number (UTN)
    		 U1111-1164-8495
    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
    30 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    o compare the effect of once-weekly dosing of two dose levels of subcutaneous semaglutide (0.5 mg and 1.0 mg) versus once-weekly dosing of two dose levels of subcutaneous dulaglutide (0.75 mg and 1.5 mg) on glycaemic control in subjects with type 2 diabetes on a background treatment with metformin.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice, EN ISO 14155 Parts 1 and 2 and FDA 21 CFR 312.120.
    Background therapy
    		 Subjects were to continue metformin at pre-trial dose and frequency during the whole treatment period unless rescue medication was needed.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    06 Jan 2016
    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: 60
    Country: Number of subjects enrolled
    Germany: 58
    Country: Number of subjects enrolled
    Spain: 63
    Country: Number of subjects enrolled
    Finland: 31
    Country: Number of subjects enrolled
    United Kingdom: 70
    Country: Number of subjects enrolled
    Greece: 73
    Country: Number of subjects enrolled
    Hong Kong: 30
    Country: Number of subjects enrolled
    Croatia: 27
    Country: Number of subjects enrolled
    India: 130
    Country: Number of subjects enrolled
    Ireland: 22
    Country: Number of subjects enrolled
    Lithuania: 40
    Country: Number of subjects enrolled
    Latvia: 35
    Country: Number of subjects enrolled
    Portugal: 14
    Country: Number of subjects enrolled
    Romania: 65
    Country: Number of subjects enrolled
    Slovakia: 40
    Country: Number of subjects enrolled
    United States: 441
    Worldwide total number of subjects
    1199
    EEA total number of subjects
    598
    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)
    939
    From 65 to 84 years
    260
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 210 sites were approved for recruiting subjects, of which 196 sites randomized the subjects: Bulgaria: 6; Croatia: 6; Finland: 6; Germany: 6; Greece: 8; Hong Kong: 1; India: 22; Ireland: 5; Latvia: 3; Lithuania: 5; Portugal: 4; Romania: 7; Slovakia: 6; Spain: 8; United Kingdom: 8; United States: 95.

    Pre-assignment
    Screening details
    		 A total of 1201 subjects were randomized in the trial: Semaglutide 0.5 mg-301 subjects, Semaglutide 1.0 mg-300 subjects, Dulaglutide 0.75 mg-300 subjects, Dulaglutide 1.5 mg-300 subjects. Of the 1201 subjects, 1199 were exposed to trial products and 2 randomised subjects withdrew prior to exposure (1 subject in each Dulaglutide arm).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Semaglutide 0.5 mg
    Arm description
    		 Subjects received subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). Subjects were followed for 5 weeks after completion of treatment period.
    Arm type
    		 Experimental

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

    Arm title
    		 Semaglutide 1.0 mg
    Arm description
    		 Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
    Arm type
    		 Experimental

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

    Arm title
    		 Dulaglutide 0.75 mg
    Arm description
    		 Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    Other name
    Trulicity®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dulaglutide solution for injection in a pre-filled pen was administered by s.c. injection either in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.

    Arm title
    		 Dulaglutide 1.5 mg
    Arm description
    		 Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    Other name
    Trulicity®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dulaglutide solution for injection in a pre-filled pen was administered by s.c. injection either in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.

    Number of subjects in period 1
    		Semaglutide 0.5 mg Semaglutide 1.0 mg Dulaglutide 0.75 mg Dulaglutide 1.5 mg
    Started
    301
    300
    299
    299
    Completed
    279
    279
    287
    284
    Not completed
    22
    21
    12
    15
         Adverse event, serious fatal
    1
    1
    2
    2
         Consent withdrawn by subject
    12
    8
    1
    5
         Adverse event, non-fatal
    -
    -
    1
    -
         Lost to follow-up
    5
    8
    4
    6
         Missing follow-up information
    4
    4
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 0.5 mg
    Reporting group description
    		 Subjects received subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). Subjects were followed for 5 weeks after completion of treatment period.

    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.

    Reporting group title
    Dulaglutide 0.75 mg
    Reporting group description
    		 Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.

    Reporting group title
    Dulaglutide 1.5 mg
    Reporting group description
    		 Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.

    Reporting group values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Dulaglutide 0.75 mg Dulaglutide 1.5 mg Total
    Number of subjects
    		 301 300 299 299 1199
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 222 247 238 232 939
        From 65-74 years
    		 67 45 53 60 225
        75-84 years
    		 12 8 8 7 35
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56 ± 10.9 55 ± 10.6 55 ± 10.4 56 ± 10.6 -
    Gender Categorical
    Units: Subjects
        Female
    		 169 162 160 171 662
        Male
    		 132 138 139 128 537
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 50 38 48 55 191
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 17 18 17 18 70
        White
    		 233 243 232 220 928
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 1 1 2 6 10
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 29 35 31 43 138
        Not Hispanic or Latino
    		 272 265 268 256 1061
    Glycosylated haemoglobin (Hb1Ac)
    Units: percentage of HbA1c
        arithmetic mean (standard deviation)
    		 8.3 ± 0.96 8.2 ± 0.92 8.2 ± 0.91 8.2 ± 0.89 -
    Body weight
    Units: kg
        arithmetic mean (standard deviation)
    		 96.4 ± 24.38 95.5 ± 20.90 95.6 ± 23.01 93.4 ± 21.79 -
    Fasting plasma glucose
    Number of subject analysed=298, 299, 297, 297 for semaglutide 0.5 mg, semaglutide 1.0 mg, dulaglutide 0.75 mg and dulaglutide 1.5 mg, respectively.
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 9.8 ± 2.54 9.8 ± 2.58 9.7 ± 2.65 9.6 ± 2.29 -

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 0.5 mg
    Reporting group description
    		 Subjects received subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). Subjects were followed for 5 weeks after completion of treatment period.

    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.

    Reporting group title
    Dulaglutide 0.75 mg
    Reporting group description
    		 Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.

    Reporting group title
    Dulaglutide 1.5 mg
    Reporting group description
    		 Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.

    Primary: Change in HbA1c

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    End point title
    		 Change in HbA1c
    End point description
    Results are based on HbA1c data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on-treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Analysis was based on FAS (all randomised subjects exposed to at least one dose of trial product).
    End point type
    Primary
    End point timeframe
    From baseline to week 40
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Dulaglutide 0.75 mg Dulaglutide 1.5 mg
    Number of subjects analysed
    301
    300
    299
    299
    Units: percentage of HbA1c
        least squares mean (standard error)
    -1.51 ± 0.06
    -1.78 ± 0.06
    -1.11 ± 0.05
    -1.37 ± 0.06
    Statistical analysis title
    		 Semaglutide 0.5 mg vs. Dulaglutide 0.75 mg
    Comparison groups
    Dulaglutide 0.75 mg v Semaglutide 0.5 mg
    Number of subjects included in analysis
    600
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 -0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    Notes
    [1] - Non-Inferiority margin: 0.4
    Statistical analysis title
    		 Semaglutide 0.5 mg vs. Dulaglutide 0.75 mg
    Comparison groups
    Semaglutide 0.5 mg v Dulaglutide 0.75 mg
    Number of subjects included in analysis
    600
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 -0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    Statistical analysis title
    		 Semaglutide 1.0 mg vs. Dulaglutide 1.5 mg
    Comparison groups
    Semaglutide 1.0 mg v Dulaglutide 1.5 mg
    Number of subjects included in analysis
    599
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 -0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    Notes
    [2] - Non-Inferiority margin: 0.04
    Statistical analysis title
    		 Semaglutide 1.0 mg vs. Dulaglutide 1.5 mg
    Comparison groups
    Semaglutide 1.0 mg v Dulaglutide 1.5 mg
    Number of subjects included in analysis
    599
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 -0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08

    Secondary: Change in body weight (kg)

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    End point title
    		 Change in body weight (kg)
    End point description
    Results are based on body weight data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Analysis was based on FAS. Number of subjects analysed=number of subjects with available data for body weight.
    End point type
    Secondary
    End point timeframe
    From baseline to week 40
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Dulaglutide 0.75 mg Dulaglutide 1.5 mg
    Number of subjects analysed
    301
    300
    299
    298
    Units: kg
        least squares mean (standard error)
    -4.56 ± 0.28
    -6.53 ± 0.28
    -2.30 ± 0.27
    -2.98 ± 0.27
    Statistical analysis title
    		 Semaglutide 1.0 mg vs. Dulaglutide 1.5 mg
    Comparison groups
    Semaglutide 1.0 mg v Dulaglutide 1.5 mg
    Number of subjects included in analysis
    598
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -3.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.32
         upper limit
    		 -2.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.39
    Statistical analysis title
    		 Semaglutide 0.5 mg vs. Dulaglutide 0.75 mg
    Comparison groups
    Semaglutide 0.5 mg v Dulaglutide 0.75 mg
    Number of subjects included in analysis
    600
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -2.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.02
         upper limit
    		 -1.51
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.39

    Secondary: Change in fasting plasma glucose

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    End point title
    		 Change in fasting plasma glucose
    End point description
    Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Analysis was based on FAS. Number of participants analysed=number of participants with available data for fasting plasma glucose.
    End point type
    Secondary
    End point timeframe
    From baseline to week 40
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Dulaglutide 0.75 mg Dulaglutide 1.5 mg
    Number of subjects analysed
    298
    299
    297
    297
    Units: mmol/L
        least squares mean (standard error)
    -2.18 ± 0.12
    -2.83 ± 0.12
    -1.87 ± 0.12
    -2.25 ± 0.12
    No statistical analyses for this end point

    Secondary: Change in systolic and diastolic blood pressure

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    End point title
    		 Change in systolic and diastolic blood pressure
    End point description
    Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Analysis was based on FAS.
    End point type
    Secondary
    End point timeframe
    From baseline to week 40
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Dulaglutide 0.75 mg Dulaglutide 1.5 mg
    Number of subjects analysed
    301
    300
    299
    299
    Units: mmHg
    least squares mean (standard error)
        Diastolic BP
    -0.57 ± 0.48
    -2.05 ± 0.49
    -0.35 ± 0.47
    -0.03 ± 0.47
        Systolic BP
    -2.44 ± 0.76
    -4.88 ± 0.77
    -2.16 ± 0.75
    -2.86 ± 0.75
    No statistical analyses for this end point

    Secondary: Overall scores for patient reported outcomes: Diabetes Treatment Satisfaction Questionnaire

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    End point title
    		 Overall scores for patient reported outcomes: Diabetes Treatment Satisfaction Questionnaire
    End point description
    The questionnaire contains 8 items and evaluates subjects’ diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was period where subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: end-date of the ‘on-treatment’ observation period or initiation of rescue medication
    End point type
    Secondary
    End point timeframe
    From baseline to week 40
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Dulaglutide 0.75 mg Dulaglutide 1.5 mg
    Number of subjects analysed
    301 [3]
    299 [4]
    299 [5]
    298 [6]
    Units: units on a scale
        least squares mean (standard error)
    4.60 ± 0.28
    4.55 ± 0.29
    4.52 ± 0.28
    4.65 ± 0.28
    Notes
    [3] - Number of participants with available data for diabetes treatment satisfaction questionnaire.
    [4] - Number of participants with available data for diabetes treatment satisfaction questionnaire
    [5] - Number of participants with available data for diabetes treatment satisfaction questionnaire
    [6] - Number of participants with available data for diabetes treatment satisfaction questionnaire
    No statistical analyses for this end point

    Secondary: Subjects who achieve (yes/no) HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists target

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    End point title
    		 Subjects who achieve (yes/no) HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists target
    End point description
    Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Results are based on the FAS.
    End point type
    Secondary
    End point timeframe
    After 40 weeks treatment
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Dulaglutide 0.75 mg Dulaglutide 1.5 mg
    Number of subjects analysed
    301
    300
    299
    299
    Units: percentage of subjects
    number (not applicable)
        Yes
    49.2
    66.7
    34.1
    47.2
        No
    50.8
    33.3
    65.9
    52.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days)
    Adverse event reporting additional description
    A TEAE was defined as an AE with onset in the ‘on-treatment’ period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Semaglutide 0.5 mg
    Reporting group description
    		 Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).

    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.

    Reporting group title
    Dulaglutide 0.75 mg
    Reporting group description
    		 Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.

    Reporting group title
    Dulaglutide 1.5 mg
    Reporting group description
    		 Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.

    Serious adverse events
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Dulaglutide 0.75 mg Dulaglutide 1.5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 301 (5.65%)
    23 / 300 (7.67%)
    24 / 299 (8.03%)
    22 / 299 (7.36%)
         number of deaths (all causes)
    0
    1
    2
    2
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of ampulla of Vater
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardioversion
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrectomy
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hospitalisation
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hysterectomy
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchidectomy
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drowning
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cystocele
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Lipase increased
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Face injury
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural myocardial infarction
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    2 / 299 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    2 / 299 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    2 / 299 (0.67%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemic unconsciousness
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatolithiasis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    2 / 299 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder pain
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 301 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    2 / 299 (0.67%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HIV infection
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Postoperative wound infection
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic complication
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 301 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Dulaglutide 0.75 mg Dulaglutide 1.5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    132 / 301 (43.85%)
    134 / 300 (44.67%)
    106 / 299 (35.45%)
    139 / 299 (46.49%)
    Investigations
    Lipase increased
         subjects affected / exposed
    19 / 301 (6.31%)
    17 / 300 (5.67%)
    16 / 299 (5.35%)
    17 / 299 (5.69%)
         occurrences all number
    23
    17
    17
    20
    Nervous system disorders
    Headache
         subjects affected / exposed
    25 / 301 (8.31%)
    22 / 300 (7.33%)
    12 / 299 (4.01%)
    19 / 299 (6.35%)
         occurrences all number
    35
    30
    20
    30
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    16 / 301 (5.32%)
    14 / 300 (4.67%)
    10 / 299 (3.34%)
    15 / 299 (5.02%)
         occurrences all number
    18
    14
    10
    18
    Diarrhoea
         subjects affected / exposed
    43 / 301 (14.29%)
    41 / 300 (13.67%)
    23 / 299 (7.69%)
    53 / 299 (17.73%)
         occurrences all number
    79
    96
    42
    75
    Nausea
         subjects affected / exposed
    67 / 301 (22.26%)
    63 / 300 (21.00%)
    39 / 299 (13.04%)
    60 / 299 (20.07%)
         occurrences all number
    144
    192
    66
    108
    Vomiting
         subjects affected / exposed
    30 / 301 (9.97%)
    31 / 300 (10.33%)
    12 / 299 (4.01%)
    29 / 299 (9.70%)
         occurrences all number
    50
    48
    16
    40
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    15 / 301 (4.98%)
    14 / 300 (4.67%)
    17 / 299 (5.69%)
    20 / 299 (6.69%)
         occurrences all number
    16
    16
    20
    24
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 301 (4.32%)
    10 / 300 (3.33%)
    21 / 299 (7.02%)
    16 / 299 (5.35%)
         occurrences all number
    18
    11
    26
    21
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    25 / 301 (8.31%)
    27 / 300 (9.00%)
    9 / 299 (3.01%)
    31 / 299 (10.37%)
         occurrences all number
    26
    27
    12
    36

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Oct 2016
    The protocol was updated to include diabetic retinopathy complications in the risk-benefit assessment of semaglutide based on clinical findings from the phase 3a programme. Other minor language corrections and updates were also included for general clarification.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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