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    Clinical Trial Results:
    Efficacy and safety of semaglutide once-weekly versus placebo as add on to SGLT-2i in subjects with type 2 diabetes mellitus. A 30-week randomised, double-blind, placebo-controlled trial

    Summary
    EudraCT number
    		 2016-000904-27
    Trial protocol
    		 NO   AT  
    Global end of trial date
    06 Aug 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9535-4269
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03086330
    WHO universal trial number (UTN)
    		 U1111-1180-1213
    Other trial identifiers
    		 JapicCTI: 173542
    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
    18 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to SGLT-2 inhibitor monotherapy or in combination with either metformin or SU on glycaemic control after 30 weeks of treatment in subjects with T2D.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice, including archiving of essential documents, (1996) and 21 CFR 312.120.
    Background therapy
    		 Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, metformin and sulphonylurea (SU) were considered as background medications. All participants were to be on a SGLT-2 inhibitor treatment. Subjects were to continue their anti-diabetic background medication throughout the trial at the same dose level with the same frequency as at the trial entry unless rescue criteria were met, or a safety concern related to acute renal impairment or hospitalization for major surgical procedures or acute serious medical illnesses occurred. All background medications were to be used in accordance with standard of care in the individual country and were not to exceed the maximum approved dose in the individual country.
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    15 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 39
    Country: Number of subjects enrolled
    Canada: 47
    Country: Number of subjects enrolled
    Japan: 50
    Country: Number of subjects enrolled
    Norway: 27
    Country: Number of subjects enrolled
    Russian Federation: 40
    Country: Number of subjects enrolled
    United States: 99
    Worldwide total number of subjects
    302
    EEA total number of subjects
    66
    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)
    244
    From 65 to 84 years
    58
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 61 sites in 6 countries as follows: Austria (4 sites), Canada (8 sites), Japan (4 sites), Norway (4 sites), Russian Federation (5 sites), United States of America (USA) (36 sites). In addition, 1 site in Norway and 3 sites in the USA screened, but didn’t randomise any participant.

    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
    According to standard pharmacovigilance procedures, specific members of the Novo Nordisk A/S Global Safety department were not blinded to suspected unexpected serious adverse reaction (SUSARs; for reporting purpose), whereas the clinical study group and the investigator remained blinded throughout the trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Semaglutide 1.0 mg
    Arm description
    		 Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30).
    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
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Semaglutide was taken once weekly as subcutaneous (s.c.) injections.

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Dose escalation for placebo matched that for semaglutide with regards to volume.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was taken once weekly as s.c. injections.

    Number of subjects in period 1
    		Semaglutide 1.0 mg Placebo
    Started
    151
    151
    Completed
    147
    147
    Not completed
    4
    4
         Consent withdrawn by subject
    3
    2
         Lost to follow-up
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Dose escalation for placebo matched that for semaglutide with regards to volume.

    Reporting group values
    		 Semaglutide 1.0 mg Placebo Total
    Number of subjects
    		 151 151 302
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 123 121 244
        From 65-84 years
    		 28 30 58
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.5 ( 8.9 ) 56.6 ( 10.1 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 62 64 126
        Male
    		 89 87 176
    Glycosylated haemoglobin (HbA1c)
    Units: Percentage HbA1c
        arithmetic mean (standard deviation)
    		 8.0 ( 0.8 ) 8.1 ( 0.8 ) -

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Dose escalation for placebo matched that for semaglutide with regards to volume.

    Primary: Change in HbA1c

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    End point title
    		 Change in HbA1c
    End point description
    Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: 1) the last dose of trial product + 7 days or 2) initiation of rescue medication. Population description: 'Full analysis set (FAS)' included all randomised participants. Number of subjects analysed = number of participants with available data.
    End point type
    Primary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    120
    127
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    -1.6 ( 0.8 )
    -0.2 ( 0.9 )
    Statistical analysis title
    		 Semaglutide 1.0 mg versus Placebo
    Statistical analysis description
    The responses were analysed using an analysis of covariance (ANCOVA) with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    247
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.61
         upper limit
    		 -1.24

    Secondary: Change in body weight (kg)

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    End point title
    		 Change in body weight (kg)
    End point description
    Change from baseline (week 0) in body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. Population description: 'FAS' included all randomised participants. Number of subjects analysed = number of participants with available data.
    End point type
    Secondary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    121
    128
    Units: Kg
        arithmetic mean (standard deviation)
    -4.7 ( 4.3 )
    -1.0 ( 3.1 )
    Statistical analysis title
    		 Semaglutide 1.0 mg versus placebo
    Statistical analysis description
    The responses were analysed using an ANCOVA with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -3.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 -2.93

    Secondary: Change in fasting plasma glucose

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    End point title
    		 Change in fasting plasma glucose
    End point description
    Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 30. Results are based on the ‘on-treatment without rescue medication’ observation period. Population description: 'FAS' included all randomised participants. Number of subjects analysed = number of participants with available data.
    End point type
    Secondary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    120
    128
    Units: mmol/L
        arithmetic mean (standard deviation)
    -2.26 ( 2.05 )
    0.07 ( 2.07 )
    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 from baseline (week 0) in systolic and diastolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. Population description: 'FAS' included all randomised participants. Number of subjects analysed = number of participants with available data.
    End point type
    Secondary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    121
    128
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic blood pressure
    -4.3 ( 14.5 )
    1.1 ( 12.3 )
        Diastolic blood pressure
    -0.1 ( 8.1 )
    -0.1 ( 6.7 )
    No statistical analyses for this end point

    Secondary: Change in scores for selected patient reported outcomes (PRO): Diabetes Treatment Satisfaction Questionnaire (DTSQ)

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    End point title
    		 Change in scores for selected patient reported outcomes (PRO): Diabetes Treatment Satisfaction Questionnaire (DTSQ)
    End point description
    Change from baseline (week 0) in PRO questionnaire, DTSQ was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. The DTSQ measures satisfaction with diabetes treatment. The DTSQ consists of 8 items evaluating 6 aspects of treatment satisfaction and 2 perceived recent event rates of hyperglycemia/hypoglycemia. Each item is scored on a 7- point Likert scale ranging from 0 (very dissatisfied) to 6 (very satisfied). Items evaluating 6 aspects (items 3-8) of treatment satisfaction are summed to produce a total treatment satisfaction score; DTSQ status total scores range from 0-36, with higher scores indicating greater satisfaction; the perceived frequency of hyperglycemia/hypoglycemia items are scored separately, with lower scores indicating better perceived blood glucose control. Population description: ‘FAS’ included all randomised participants. Number of subjects analysed = number of participants with available data.
    End point type
    Secondary
    End point timeframe
    From baseline to week 30
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    119
    125
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        1) Feeling of unacceptably high blood sugars
    -2.2 ( 1.9 )
    -0.8 ( 2.2 )
        2) Feeling of unacceptably low blood sugars
    0.3 ( 1.5 )
    -0.4 ( 1.5 )
        Total treatment satisfaction score (Sum of 3-8)
    4.2 ( 6.6 )
    1.9 ( 7.0 )
        3) Satisfaction with current treatment
    0.8 ( 1.6 )
    0.2 ( 1.4 )
        4) Convenience of current treatment
    0.7 ( 1.3 )
    0.5 ( 1.3 )
        5) Flexibility of current treatment
    0.7 ( 1.5 )
    0.4 ( 1.7 )
        6) Satisfaction with understanding of diabetes
    0.5 ( 1.2 )
    0.5 ( 1.5 )
        7) Recommending treatment to others
    0.8 ( 1.3 )
    0.2 ( 1.8 )
        8) Satisfaction to continue with present treatment
    0.8 ( 1.7 )
    0.2 ( 1.7 )
    No statistical analyses for this end point

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

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    End point title
    		 Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists target (yes/no)
    End point description
    Percentage of participants with HbA1c equal to or below 6.5% (48 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. Population description: 'FAS' included all randomised participants. Number of subjects analysed = number of participants with available data.
    End point type
    Secondary
    End point timeframe
    After 30 weeks' treatment
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    120
    127
    Units: Percentage of participants
        number (not applicable)
    60.0
    3.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 0 to week 30 (treatment period) + 42 days (follow-up period).
    Adverse event reporting additional description
    Results are based on the safety analysis set (SAS), which included all participants exposed to at least one dose of trial product (semaglutide or placebo). 'Number of deaths causally related to treatment’ is the data considered to present under ‘total number of deaths resulting from adverse events'.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Dose escalation for placebo matched that for semaglutide with regards to volume.

    Serious adverse events
    		 Semaglutide 1.0 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 150 (4.67%)
    6 / 151 (3.97%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Thyroidectomy
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal artery occlusion
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ischaemic
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurocysticercosis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Semaglutide 1.0 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 150 (32.67%)
    28 / 151 (18.54%)
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    2 / 150 (1.33%)
    8 / 151 (5.30%)
         occurrences all number
    2
    9
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    10 / 150 (6.67%)
    0 / 151 (0.00%)
         occurrences all number
    10
    0
    Diarrhoea
         subjects affected / exposed
    17 / 150 (11.33%)
    9 / 151 (5.96%)
         occurrences all number
    21
    11
    Nausea
         subjects affected / exposed
    29 / 150 (19.33%)
    5 / 151 (3.31%)
         occurrences all number
    37
    7
    Vomiting
         subjects affected / exposed
    14 / 150 (9.33%)
    3 / 151 (1.99%)
         occurrences all number
    21
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 150 (5.33%)
    8 / 151 (5.30%)
         occurrences all number
    9
    11

    More information

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

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

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

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