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    Clinical Trial Results:
    A trial to compare the injection site pain experience of 0.25 mg semaglutide sc administered by 2 different products

    Summary
    EudraCT number
    		 2019-002284-10
    Trial protocol
    		 NL  
    Global end of trial date
    04 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Sep 2020
    First version publication date
    04 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INS-4582
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04007107
    WHO universal trial number (UTN)
    		 U1111-1233-9590
    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, +1 866 8677178, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, +1 866 8677178, 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
    17 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to compare, in healthy subjects, the injection site pain experience of a single dose of 0.25 milligrams (mg) semaglutide subcutaneous (sc) given as the DV3396 product to that of the PDS290 product.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, adopted by the 18th World Medical Association (WMA) General Assembly, Helsinki, Finland, June 1964, and subsequent amendments and International Council for Harmonisation (ICH) Good Clinical Practice (GCP)(European Medicines Agency (EMA)/Committee for Medicinal Products for Human Use CHMP)/ICH/135/1995), including archiving of essential documents and the EU Clinical Trial Directive (CTD)2001/20/EC.
    Background therapy
    		 Not applicable.
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    27 Jun 2019
    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
    Netherlands: 103
    Worldwide total number of subjects
    103
    EEA total number of subjects
    103
    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)
    89
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at one site in the Netherlands.

    Pre-assignment
    Screening details
    		 Subjects were randomised in a 2x2 scheme evenly to 4 sequences (A,B,C and D) of either DV3396 or PDS290 and side of injection (right/left) on abdomen.

    Period 1
    Period 1 title
    Treatment Period 1 (Day 1)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject
    Blinding implementation details
    Investigator and subject were blinded to treatment. Qualified, unblinded members of study staff not otherwise involved in the trial procedures were responsible for trial drug administration in order to maintain blinding. To maintain blinding of subjects, a visual blind was in place during dose administration.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A: DV3396 (Right) then PDS290 (Left)
    Arm description
    		 Subjects were to receive a subcutaneous (s.c.) injection of DV3396 product (0.25 milligrams (mg) of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DV3396
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on right side of abdomen in treatment period 1 on Day 1.

    Investigational medicinal product name
    PDS290
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on left side of abdomen in treatment period 2 on Day 1.

    Arm title
    		 Sequence B: DV3396 (Left) then PDS290 (Right)
    Arm description
    		 Subjects were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PDS290
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on right side of abdomen in treatment period 2 on Day 1.

    Investigational medicinal product name
    DV3396
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on left side of abdomen in treatment period 1 on Day 1.

    Arm title
    		 Sequence C: PDS290 (Right) then DV3396 (Left)
    Arm description
    		 Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DV3396
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on left side of abdomen in treatment period 2 on Day 1.

    Investigational medicinal product name
    PDS290
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on right side of abdomen in treatment period 1 on Day 1.

    Arm title
    		 Sequence D: PDS290 (Left) then DV3396 (Right)
    Arm description
    		 Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DV3396
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive a s.c. injection of DV3396 product (0.25 mg of semaglutide) on right side of abdomen in treatment period 2 on Day 1.

    Investigational medicinal product name
    PDS290
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on left side of abdomen in treatment period 1 on Day 1.

    Number of subjects in period 1
    		Sequence A: DV3396 (Right) then PDS290 (Left) Sequence B: DV3396 (Left) then PDS290 (Right) Sequence C: PDS290 (Right) then DV3396 (Left) Sequence D: PDS290 (Left) then DV3396 (Right)
    Started
    26
    26
    25
    26
    Completed
    26
    26
    25
    26
    Period 2
    Period 2 title
    Treatment Period 2 (Day 1)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A: DV3396 (Right) then PDS290 (Left)
    Arm description
    		 Subjects were to receive a subcutaneous (s.c.) injection of DV3396 product (0.25 milligrams (mg) of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DV3396
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on right side of abdomen in treatment period 1 on Day 1.

    Investigational medicinal product name
    PDS290
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on left side of abdomen in treatment period 2 on Day 1.

    Arm title
    		 Sequence B: DV3396 (Left) then PDS290 (Right)
    Arm description
    		 Subjects were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DV3396
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on left side of abdomen in treatment period 1 on Day 1.

    Investigational medicinal product name
    PDS290
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on right side of abdomen in treatment period 2 on Day 1.

    Arm title
    		 Sequence C: PDS290 (Right) then DV3396 (Left)
    Arm description
    		 Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PDS290
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on right side of abdomen in treatment period 1 on Day 1.

    Investigational medicinal product name
    DV3396
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on left side of abdomen in treatment period 2 on Day 1.

    Arm title
    		 Sequence D: PDS290 (Left) then DV3396 (Right)
    Arm description
    		 Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PDS290
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on left side of abdomen in treatment period 1 on Day 1.

    Investigational medicinal product name
    DV3396
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive a s.c. injection of DV3396 product (0.25 mg of semaglutide) on right side of abdomen in treatment period 2 on Day 1.

    Number of subjects in period 2
    		Sequence A: DV3396 (Right) then PDS290 (Left) Sequence B: DV3396 (Left) then PDS290 (Right) Sequence C: PDS290 (Right) then DV3396 (Left) Sequence D: PDS290 (Left) then DV3396 (Right)
    Started
    26
    26
    25
    26
    Completed
    26
    25
    25
    26
    Not completed
    0
    1
    0
    0
         Withdrawal by Subject
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period 1 (Day 1)
    Reporting group description
    		 Subjects were to receive 2 s.c. injections of 0.25 mg semaglutide; 1 each of PDS290 product and DV3396 product from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.

    Reporting group values
    		 Treatment Period 1 (Day 1) Total
    Number of subjects
    		 103 103
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.9 ( 18.1 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 66 66
        Male
    		 37 37

    End points

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    End points reporting groups
    Reporting group title
    Sequence A: DV3396 (Right) then PDS290 (Left)
    Reporting group description
    		 Subjects were to receive a subcutaneous (s.c.) injection of DV3396 product (0.25 milligrams (mg) of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.

    Reporting group title
    Sequence B: DV3396 (Left) then PDS290 (Right)
    Reporting group description
    		 Subjects were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.

    Reporting group title
    Sequence C: PDS290 (Right) then DV3396 (Left)
    Reporting group description
    		 Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.

    Reporting group title
    Sequence D: PDS290 (Left) then DV3396 (Right)
    Reporting group description
    		 Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
    Reporting group title
    Sequence A: DV3396 (Right) then PDS290 (Left)
    Reporting group description
    		 Subjects were to receive a subcutaneous (s.c.) injection of DV3396 product (0.25 milligrams (mg) of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.

    Reporting group title
    Sequence B: DV3396 (Left) then PDS290 (Right)
    Reporting group description
    		 Subjects were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.

    Reporting group title
    Sequence C: PDS290 (Right) then DV3396 (Left)
    Reporting group description
    		 Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.

    Reporting group title
    Sequence D: PDS290 (Left) then DV3396 (Right)
    Reporting group description
    		 Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.

    Subject analysis set title
    DV3396
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) from any of the sequences A/B/C/D on Day 1.

    Subject analysis set title
    PDS290
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) from any of the sequences A/B/C/D on Day 1.

    Primary: Intensity of Injection Site Pain

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    End point title
    		 Intensity of Injection Site Pain
    End point description
    The intensity of pain was measured on a visual analogue scale (VAS). The VAS consists of a horizontal 100 millimetres (mm) line where 0 mm corresponded to no pain and 100 mm corresponded to unbearable pain. After each injection, the participants rated their pain perception at the VAS by marking a vertical line across the 100 mm line. The distance (mm) between the endpoint “no pain” and the vertical line on the VAS was recorded and analysed. The per protocol (PP) set included all subjects who had received both injections of semaglutide and had completed both intensity of injection site pain assessments.
    End point type
    Primary
    End point timeframe
    1 minute after each injection (Day 1)
    End point values
    		 DV3396 PDS290
    Number of subjects analysed
    102
    102
    Units: score on a scale
        arithmetic mean (standard deviation)
    35.1 ( 23.1 )
    4.4 ( 7.5 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The intensity of pain was analysed by a fixed analysis of variance model with VAS score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.
    Comparison groups
    DV3396 v PDS290
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Estimated treatment difference
    Point estimate
    30.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.6
         upper limit
    		 34.8
    Notes
    [1] - Due to cross-over design of the study, the following “number of subjects included in analysis” is being erroneously displayed as 204. The actual “number of subjects included in analysis” is 102.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Day 28. Results are based on safety analysis set which included all subjects who had received at least 1 injection of semaglutide (included any skin contact with trial product whether the injection was completed or not).
    Adverse event reporting additional description
    Treatment emergent AE was defined as an event that had onset date on or after the day of first injection and no later than 28 days after the day of last injection. Trial was crossover and injections were given only 30 minutes apart, so it was not possible to say which product the AE was related to. Hence, AE data are presented for overall study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 Subjects were to receive 2 s.c. injections of 0.25 mg semaglutide; 1 each of PDS290 product and DV3396 product from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.

    Serious adverse events
    		 Overall Study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 103 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall Study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 103 (14.56%)
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    15 / 103 (14.56%)
         occurrences all number
    15

    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
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