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    Clinical Trial Results:
    A single-dose cross-over study to assess direct and indirect effects of dapagliflozin on pancreatic alpha and beta cells in patients with type 2 diabetes

    Summary
    EudraCT number
    		 2015-005549-30
    Trial protocol
    		 SE  
    Global end of trial date
    01 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Aug 2020
    First version publication date
    07 Aug 2020
    Other versions
    Summary report(s)
    		 A single-dose cross-over study to assess direct and indirect effects of dapagliflozin on pancreatic alpha and beta cells in patients with type 2 diabetes

    Trial information

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    Trial identification
    Sponsor protocol code
    ESR-15-11421
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02765204
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Uppsala University
    Sponsor organisation address
    Sjukhusvägen 1, Uppsala, Sweden, 75185
    Public contact
    Jan Eriksson, Dept of Medical Sciences, Clinical Diabetes and Metabolism, Uppsala University, 46 186114419, jan.eriksson@medsci.uu.se
    Scientific contact
    Jan Eriksson, Dept of Medical Sciences, Clinical Diabetes and Metabolism, Uppsala University, 46 186114419, jan.eriksson@medsci.uu.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 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if Dapagliflozin has direct effect on alpha cell glucagon release.
    Protection of trial subjects
    Heartrate, bloodpressure, bloodsamples taken as a standard procedure as in ordinary healthcare
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2016
    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: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    4
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Advertisment, studycenter patientlist

    Pre-assignment
    Screening details
    		 Age 18-75 years, BMI 20-35, diagnosis at least 6 months of T2D, Metformin treatment with stable dos for at least 1 month, HbA1c range 55-86mmol/mol

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dapa
    Arm description
    		 D=Dapagliflozin 10mg and Salin infusion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg dapagliflozin

    Arm title
    		 Dapa+Iso
    Arm description
    		 Dapagliflozin 10mg and isoglycemiclamp
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg Dapagliflozin

    Arm title
    		 Dapa + Saxa
    Arm description
    		 Dapagliflozin 10mg and saxagliptin 5mg and salininfusion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dapagliflozin and saxagluptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10mg Dapagliflozin 5mg saxagliptin

    Number of subjects in period 1
    		Dapa Dapa+Iso Dapa + Saxa
    Started
    5
    5
    5
    Completed
    3
    5
    4
    Not completed
    2
    0
    1
         Consent withdrawn by subject
    1
    -
    1
         Adverse event, non-fatal
    1
    -
    -

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Dapa
    Reporting group description
    		 D=Dapagliflozin 10mg and Salin infusion

    Reporting group title
    Dapa+Iso
    Reporting group description
    		 Dapagliflozin 10mg and isoglycemiclamp

    Reporting group title
    Dapa + Saxa
    Reporting group description
    		 Dapagliflozin 10mg and saxagliptin 5mg and salininfusion

    Primary: Plasma glucose and glucagon levels during experimental periods. Comparing experiments with spontaneous glycemia and isoglycemia respectively.

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    End point title
    		 Plasma glucose and glucagon levels during experimental periods. Comparing experiments with spontaneous glycemia and isoglycemia respectively.
    End point description
    This study will provide insight into SGLT2 action in beta and alpha cells, in particular with respect to direct and indirect effects on glucagon secretion. Furthermore, it explores the mechanisms of glucose control when combining SGLT2- and DPP4 inhibitors.
    End point type
    Primary
    End point timeframe
    10 month
    End point values
    		 Dapa Dapa+Iso Dapa + Saxa
    Number of subjects analysed
    3
    5
    4
    Units: mmol/mol
        number (not applicable)
    3
    5
    4
    Attachments
    		 Untitled (Filename: 2019 PL Dapa glucagon JCEM.pdf)
    Statistical analysis title
    		 Primary comparison: Effect of Dapagliflozin on glu
    Comparison groups
    Dapa v Dapa+Iso v Dapa + Saxa
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.001 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Hazard ratio (HR)
    Confidence interval
    Notes
    [1] - The study had 90% power to detect a 15% difference in the primary end point between the two conditions in the primary comparison. Based on previous work, this difference was judged to be clinically relevant and calculated to be 3 pmol/L (baseline level of about 20 pmol/L; SD, 3 pmol/L) (11). Thus, the sample size required for analysis of the primary end point was 12 evaluable patients. A maximum of three patients who did not complete the study (premature withdrawals) was expected. Thus, 15 patie
    [2] - The study had 90% power to detect a 15% difference in the primary end point between the two conditions in the primary comparison. Based on previous work, this difference was judged to be clinically relevant and calculated to be 3 pmol/L (baseline lev

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    10 month
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Tiredness
    Reporting group description
    		 Safety Ingeneral,thestudytreatmentswerewelltolerated;19 AEs were reported in six patients. No new and unexpected AEs were observed. The most commonly reportedeventswereheadache(sixeventsinthreepatients) andtiredness(fiveeventsinthreepatients).Fifteenevents were mild and two (ureteral stone and urticaria) were moderateinintensity.Oneevent,deepveinthrombosisof thearm,wasdeemedsevereinintensityandresultedinthe patient withdrawing from the study. The moderate and severe AEs required medication but none required hospitalization. Only one event (dizziness) was deemed as possibly related to the study drug. No deaths or serious AEs were reported during the study

    Serious adverse events
    		 Tiredness
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (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
    		 Tiredness
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    General disorders and administration site conditions
    Head banging
    Additional description: Safety Ingeneral,thestudytreatmentswerewelltolerated;19 AEs were reported in six patients. No new and unexpected AEs were observed. The most commonly reportedeventswereheadache(sixeventsinthreepatients) andtiredness(fiveeventsinthreepatients).Fifteen
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences all number
    5

    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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    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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