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    Clinical Trial Results:
    Study of the Effect of Vildagliptin versus Dapagliflozin on Glucagon Response to Mixed Meal in Metformin-treated Subjects with Type 2 Diabetes

    Summary
    EudraCT number
    		 2015-001334-21
    Trial protocol
    		 SE  
    Global end of trial date
    13 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Mar 2021
    First version publication date
    10 Mar 2021
    Other versions
    Summary report(s)
    		 2015-001334-21 Results

    Trial information

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    Trial identification
    Sponsor protocol code
    350A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02475070
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lund university
    Sponsor organisation address
    Sölvegatan 19, Lund, Sweden, 22184
    Public contact
    Bo Ahrén, Lund university, 46 462220758, Bo.Ahren@med.lu.se
    Scientific contact
    Bo Ahrén, Lund university, 46 462220758, Bo.Ahren@med.lu.se
    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
    15 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effects of vildagliptin versus dapagliflozin on glucagon response to mixed meal ingestion in metformin-treated patients with type 2 diabetes
    Protection of trial subjects
    Subjects with type 2 diabetes
    Background therapy
    		 Metformin
    Evidence for comparator
    		 Vildagliptin versus Dapagliflozin
    Actual start date of recruitment
    01 Sep 2015
    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
    Sweden: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    20
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 28 subjects were recruited through hospitals

    Pre-assignment
    Screening details
    		 Subjects were examined by physician and lab tests were taken

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Patients received vildagliptin or dapagliflozin first, then dapagliflozin or vildagliptin. Randomization and blinding were handled by the University hospital pharamcist.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vildagliptin
    Arm description
    		 Vildagliptin 50mg twice daily for two weeks followed by a meal test. This was followed by a 4 weeks wash-out period followed by two week treatment with Dapagliflozin 10 mg once daily followed by a meal test.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vildagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg twice daily

    Arm title
    		 Dapagliflozin
    Arm description
    		 Dapagliflozin 10 mg once daily for two weeks followed by a meal test. This was followed by a 4 weeks wash-out period followed by two week treatment with Vildagliptin 50 mg twice daily followed by a meal test.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg once daily

    Number of subjects in period 1
    		Vildagliptin Dapagliflozin
    Started
    14
    14
    Completed
    14
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 28 28
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.2 ( 7.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 20 20
    HbA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 50.4 ( 6.7 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 30.7 ( 5.6 ) -
    Diabetes duration
    Units: Years
        arithmetic mean (standard deviation)
    		 5.8 ( 3.0 ) -

    End points

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    End points reporting groups
    Reporting group title
    Vildagliptin
    Reporting group description
    		 Vildagliptin 50mg twice daily for two weeks followed by a meal test. This was followed by a 4 weeks wash-out period followed by two week treatment with Dapagliflozin 10 mg once daily followed by a meal test.

    Reporting group title
    Dapagliflozin
    Reporting group description
    		 Dapagliflozin 10 mg once daily for two weeks followed by a meal test. This was followed by a 4 weeks wash-out period followed by two week treatment with Vildagliptin 50 mg twice daily followed by a meal test.

    Primary: Glucagon response to mixed meal

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    End point title
    		 Glucagon response to mixed meal
    End point description
    Area under the glucagon curve (AUC) for glucagon after mixed meal ingestion
    End point type
    Primary
    End point timeframe
    4 hours
    End point values
    		 Vildagliptin Dapagliflozin
    Number of subjects analysed
    14
    14
    Units: nmol/l min
        arithmetic mean (standard error)
    32.1 ( 2.3 )
    37.5 ( 2.7 )
    Statistical analysis title
    		 t-test
    Statistical analysis description
    t-test for mean between the groups
    Comparison groups
    Vildagliptin v Dapagliflozin
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Secondary: Fasting glucagon

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    End point title
    		 Fasting glucagon
    End point description
    Fasting glucagon after two weeks of treatment with either vildagliptin or dapagliflozin
    End point type
    Secondary
    End point timeframe
    Two weeks
    End point values
    		 Vildagliptin Dapagliflozin
    Number of subjects analysed
    14
    14
    Units: pmol/L
        arithmetic mean (standard error)
    35.6 ( 2.5 )
    39.4 ( 3.4 )
    Statistical analysis title
    		 t-test
    Statistical analysis description
    t-test of difference in means
    Comparison groups
    Vildagliptin v Dapagliflozin
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.032
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Two weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Vildagliptin
    Reporting group description
    		 -

    Reporting group title
    Dapagliflozin
    Reporting group description
    		 -

    Serious adverse events
    		 Vildagliptin Dapagliflozin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Vildagliptin Dapagliflozin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 14 (28.57%)
    3 / 14 (21.43%)
    Nervous system disorders
    Fatigue
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Infections and infestations
    Common cold
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29498469
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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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