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    Clinical Trial Results:
    Efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes

    Summary
    EudraCT number
    		 2013-000632-94
    Trial protocol
    		 IT   GB  
    Global end of trial date
    08 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 May 2016
    First version publication date
    20 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9535-3623
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02054897
    WHO universal trial number (UTN)
    		 U1111-1139-3090
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate superiority of once-weekly dosing of two dose levels of semaglutide versus placebo on glycaemic control after 30 weeks of treatment in drug-naïve subjects with type 2 diabetes
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice, EN ISO 14155 Part 1 and 2 and FDA 21 CFR 312.120
    Background therapy
    		 Not applicable.
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    03 Feb 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    Italy: 27
    Country: Number of subjects enrolled
    Canada: 39
    Country: Number of subjects enrolled
    Japan: 61
    Country: Number of subjects enrolled
    Mexico: 33
    Country: Number of subjects enrolled
    Russian Federation: 52
    Country: Number of subjects enrolled
    South Africa: 26
    Country: Number of subjects enrolled
    United States: 124
    Worldwide total number of subjects
    387
    EEA total number of subjects
    52
    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)
    317
    From 65 to 84 years
    69
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 There were 72 sites in 8 countries that randomised subjects: Canada: 7 sites; Italy: 6 sites; Japan: 5 sites; Mexico: 2 sites; Russian Federation: 8 sites; South Africa: 8 sites; United Kingdom: 4 sites; United States: 32 sites.

    Pre-assignment
    Screening details
    		 Not applicable.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Semaglutide and placebo were supplied in similar 1.5 mL pre-filled PDS290 pen-injector and were by all means visually identical and were packed and labelled to fulfil the requirements for double blind procedures. Furthermore, equal volumes of semaglutide and placebo were administered during treatment ensuring blinding within dose-level.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Semaglutide 0.5 mg
    Arm description
    		 Subjects were given 0.25 mg semaglutide once weekly for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide B 1.34 mg/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
    Subjects were given 0.25 mg semaglutide once weekly for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period. Administered subcutaneously (s.c., under the skin).

    Arm title
    		 Semaglutide 1.0 mg
    Arm description
    		 Subjects were given 0.25 mg semaglutide once weekly for 4 weeks, 0.5 mg semaglutide once weekly for the next 4 weeks followed by 1.0 mg semaglutide once weekly for the remaining 22 weeks of the treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide B 1.34 mg/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
    Subjects were given 0.25 mg semaglutide once weekly for 4 weeks, 0.5 mg semaglutide once weekly for the next 4 weeks followed by 1.0 mg semaglutide once weekly for the remaining 22 weeks of the treatment period. Administered subcutaneously (s.c., under the skin).

    Arm title
    		 Placebo
    Arm description
    		 Subjects randomised to either of the 2 different placebo arms, i.e., placebo 0.5 mg arm or placebo 1.0 mg arm. These 2 placebo arms were pooled together for data analysis. a. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly for 4 weeks followed by 0.5 mg placebo once weekly for the remaining 26 weeks of the treatment period. b. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly for 4 weeks, 0.5 mg placebo once weekly for the next 4 weeks followed by 1.0 mg placebo once weekly for the remaining 22 weeks of the treatment period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly for 4 weeks followed by 0.5 mg placebo once weekly for the remaining 26 weeks of the treatment period. Administered subcutaneously (s.c., under the skin). Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly for 4 weeks, 0.5 mg placebo once weekly for the next 4 weeks followed by 1.0 mg placebo once weekly for the remaining 22 weeks of the treatment period. Administered subcutaneously (s.c., under the skin).

    Number of subjects in period 1
    		Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
    Started
    128
    130
    129
    Completed
    119
    123
    117
    Not completed
    9
    7
    12
         Lost to follow-up
    4
    2
    7
         Missing follow-up information
    3
    5
    3
         Withdrawal by subject
    2
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 0.5 mg
    Reporting group description
    		 Subjects were given 0.25 mg semaglutide once weekly for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period.

    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects were given 0.25 mg semaglutide once weekly for 4 weeks, 0.5 mg semaglutide once weekly for the next 4 weeks followed by 1.0 mg semaglutide once weekly for the remaining 22 weeks of the treatment period.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomised to either of the 2 different placebo arms, i.e., placebo 0.5 mg arm or placebo 1.0 mg arm. These 2 placebo arms were pooled together for data analysis. a. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly for 4 weeks followed by 0.5 mg placebo once weekly for the remaining 26 weeks of the treatment period. b. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly for 4 weeks, 0.5 mg placebo once weekly for the next 4 weeks followed by 1.0 mg placebo once weekly for the remaining 22 weeks of the treatment period.

    Reporting group values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo Total
    Number of subjects
    		 128 130 129 387
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.6 ( 11.1 ) 52.7 ( 11.9 ) 53.9 ( 11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 68 50 59 177
        Male
    		 60 80 70 210
    HbA1c
    Units: Percentage
        arithmetic mean (standard deviation)
    		 8.09 ( 0.89 ) 8.12 ( 0.81 ) 7.95 ( 0.85 ) -
    Fasting plasma glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 9.66 ( 2.77 ) 9.9 ( 2.5 ) 9.68 ( 2.77 ) -
    Body weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 89.81 ( 22.96 ) 96.87 ( 25.59 ) 89.05 ( 22.16 ) -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 79.52 ( 9.06 ) 79.25 ( 8.52 ) 79.14 ( 8.39 ) -
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 127.87 ( 13.15 ) 128.89 ( 12.92 ) 129.57 ( 13.5 ) -

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 0.5 mg
    Reporting group description
    		 Subjects were given 0.25 mg semaglutide once weekly for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period.

    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects were given 0.25 mg semaglutide once weekly for 4 weeks, 0.5 mg semaglutide once weekly for the next 4 weeks followed by 1.0 mg semaglutide once weekly for the remaining 22 weeks of the treatment period.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomised to either of the 2 different placebo arms, i.e., placebo 0.5 mg arm or placebo 1.0 mg arm. These 2 placebo arms were pooled together for data analysis. a. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly for 4 weeks followed by 0.5 mg placebo once weekly for the remaining 26 weeks of the treatment period. b. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly for 4 weeks, 0.5 mg placebo once weekly for the next 4 weeks followed by 1.0 mg placebo once weekly for the remaining 22 weeks of the treatment period.

    Primary: Change in HbA1c

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    End point title
    		 Change in HbA1c
    End point description
    Change in HbA1c from baseline to week 30. Full analysis set (FAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo. 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.
    End point type
    Primary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    128
    130
    129
    Units: Percentage
        arithmetic mean (standard deviation)
    -1.47 ( 1.02 )
    -1.56 ( 1.26 )
    0 ( 0.9 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 1.0 mg versus placebo. Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -1.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.81
         upper limit
    		 -1.25
    Notes
    [1] - The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 0.5 mg versus placebo, if superiority for semaglutide 1.0 mg was concluded. Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.
    Comparison groups
    Semaglutide 0.5 mg v Placebo
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.71
         upper limit
    		 -1.15
    Notes
    [2] - The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

    Secondary: Change in body weight.

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    End point title
    		 Change in body weight.
    End point description
    Change in body weight from baseline to week 30. Full analysis set (FAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo. 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.
    End point type
    Secondary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    128
    130
    129
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    -3.68 ( 4.03 )
    -4.67 ( 5.19 )
    -0.89 ( 3.46 )
    No statistical analyses for this end point

    Secondary: Change in Fasting plasma glucose

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    End point title
    		 Change in Fasting plasma glucose
    End point description
    Change in Fasting plasma glucose from baseline to week 30. Full analysis set (FAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo. 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.
    End point type
    Secondary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    125
    129
    127
    Units: mmol/L
        arithmetic mean (standard deviation)
    -2.41 ( 2.55 )
    -2.39 ( 2.74 )
    -0.55 ( 2.2 )
    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
    Change in systolic and diastolic blood pressure from baseline to week 30. Full analysis set (FAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo. 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.
    End point type
    Secondary
    End point timeframe
    From baseline to week 30.
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    128
    130
    129
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic blood pressure
    -2.29 ( 12.58 )
    -2.74 ( 11.58 )
    -2.01 ( 11.23 )
        Diastolic blood pressure
    -0.73 ( 6.88 )
    0.22 ( 7.6 )
    0.6 ( 7.59 )
    No statistical analyses for this end point

    Secondary: Subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target

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    End point title
    		 Subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target
    End point description
    Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Full analysis set (FAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo. 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.
    End point type
    Secondary
    End point timeframe
    After 30 weeks' treatment
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    128
    130
    129
    Units: percentage
    number (not applicable)
        Yes
    74.2
    72.3
    24.8
        No
    25.8
    27.7
    75.2
    No statistical analyses for this end point

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

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    End point title
    		 Subjects who achieve (yes/no): HbA1c equal to or below 6.5% (48 mmol/mol) American Association of Clinical Endocrinologists target
    End point description
    Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Full analysis set (FAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo. 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.
    End point type
    Secondary
    End point timeframe
    After 30 weeks' treatment
    End point values
    		 Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    128
    130
    129
    Units: Percentage
    number (not applicable)
        Yes
    59.4
    60
    13.2
        No
    40.6
    40
    86.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first trial product dose (visit 2) till the date of the end-of-treatment follow-up visit (visit 11) or on the date of the last trial product dose plus 42 days (5 weeks plus the 7 days visit window).
    Adverse event reporting additional description
    Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Semaglutide 0.5 mg
    Reporting group description
    		 Subjects were given 0.25 mg semaglutide once weekly for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomised to either of the 2 different placebo arms, i.e., placebo 0.5 mg arm or placebo 1.0 mg arm. These 2 placebo arms were pooled together for data analysis. a. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly for 4 weeks followed by 0.5 mg placebo once weekly for the remaining 26 weeks of the treatment period. b. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly for 4 weeks, 0.5 mg placebo once weekly for the next 4 weeks followed by 1.0 mg placebo once weekly for the remaining 22 weeks of the treatment period.

    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects were given 0.25 mg semaglutide once weekly for 4 weeks, 0.5 mg semaglutide once weekly for the next 4 weeks followed by 1.0 mg semaglutide once weekly for the remaining 22 weeks of the treatment period.

    Serious adverse events
    		 Semaglutide 0.5 mg Placebo Semaglutide 1.0 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 128 (5.47%)
    5 / 129 (3.88%)
    7 / 130 (5.38%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Coronary revascularisation
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric bypass
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 129 (0.00%)
    2 / 130 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Inflammation
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 129 (0.78%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental disorder
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Wound
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 129 (0.78%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric haemorrhage
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 129 (0.78%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 129 (0.78%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 129 (0.78%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Semaglutide 0.5 mg Placebo Semaglutide 1.0 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 128 (41.41%)
    27 / 129 (20.93%)
    47 / 130 (36.15%)
    Investigations
    Lipase increased
         subjects affected / exposed
    8 / 128 (6.25%)
    5 / 129 (3.88%)
    5 / 130 (3.85%)
         occurrences all number
    10
    5
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 128 (11.72%)
    8 / 129 (6.20%)
    9 / 130 (6.92%)
         occurrences all number
    43
    13
    18
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    8 / 128 (6.25%)
    1 / 129 (0.78%)
    5 / 130 (3.85%)
         occurrences all number
    9
    2
    5
    Diarrhoea
         subjects affected / exposed
    16 / 128 (12.50%)
    3 / 129 (2.33%)
    14 / 130 (10.77%)
         occurrences all number
    27
    3
    19
    Dyspepsia
         subjects affected / exposed
    7 / 128 (5.47%)
    3 / 129 (2.33%)
    5 / 130 (3.85%)
         occurrences all number
    13
    3
    5
    Nausea
         subjects affected / exposed
    26 / 128 (20.31%)
    10 / 129 (7.75%)
    31 / 130 (23.85%)
         occurrences all number
    44
    12
    46
    Vomiting
         subjects affected / exposed
    5 / 128 (3.91%)
    2 / 129 (1.55%)
    9 / 130 (6.92%)
         occurrences all number
    11
    2
    15
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 128 (4.69%)
    7 / 129 (5.43%)
    6 / 130 (4.62%)
         occurrences all number
    7
    9
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Mar 2014
    The main objective was to update the definition of hypoglycaemia and to include an additional hypoglycaemic endpoint on severe or BG-confirmed symptomatic hypoglycaemic episodes and associated statistical analysis and minor updates 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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