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    Clinical Trial Results:
    In vivo molecular imaging of angiogenesis in type 2 diabetes

    Summary
    EudraCT number
    		 2019-003466-41
    Trial protocol
    		 DK  
    Global end of trial date
    06 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2022
    First version publication date
    01 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AK2019-10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Dr Rasmus Ripa, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, rasmus.ripa@regionh.dk
    Scientific contact
    Dr Rasmus Ripa, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, rasmus.ripa@regionh.dk
    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 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To use 68Ga-NODAGA-E[c(RGDyK)]2 PET/CT scans as a tool to image myocardial angiogenesis in persons with type 2 diabetes compares to controls without diabetes.
    Protection of trial subjects
    The study investigated a new i.v. radiotracer for detecting angiogenesis. There were no discomfort or pain associated with the study of the new tracer.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 2020
    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
    Denmark: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    6
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study population was recruited as a sub-group from the Rubin 2 (DOI: 10.1111/dme.14517) at a single center in Copenhagen, Denmark from January 23rd 2020 until October 5th 2020.

    Pre-assignment
    Screening details
    		 48 persons, 29 with type 2 diabetes and 19 controls participated included in the Rubin 2 study (DOI: 10.1111/dme.14517) was screened for inclusion. All 48 screened persons were eligible for inclusion. However due to the Covid19 pandemic, inclusion had to be terminated in October 2020 after inclusion of 30 participants.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Type 2 diabetes
    Arm description
    		 The type 2 diabetes was PET/CT scanned with RGD-PET at one time-point
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-NODAGA-E[c(RGDyK)]2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    At the scan the patient were injected with ~200 MBq of 68Ga-NODAGA-E[c(RGDyK)]2

    Arm title
    		 Non-diabetic controls
    Arm description
    		 The non-diabetic controls arm was PET/CT scanned with RGD-PET at one time-point.
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-NODAGA-E[c(RGDyK)]2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    At the scan the patient were injected with ~200 MBq of 68Ga-NODAGA-E[c(RGDyK)]2

    Number of subjects in period 1
    		Type 2 diabetes Non-diabetic controls
    Started
    20
    10
    Completed
    20
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Type 2 diabetes
    Reporting group description
    		 The type 2 diabetes was PET/CT scanned with RGD-PET at one time-point

    Reporting group title
    Non-diabetic controls
    Reporting group description
    		 The non-diabetic controls arm was PET/CT scanned with RGD-PET at one time-point.

    Reporting group values
    		 Type 2 diabetes Non-diabetic controls Total
    Number of subjects
    		 20 10 30
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61 ( 9 ) 62 ( 8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 4 10
        Male
    		 14 6 20

    End points

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    End points reporting groups
    Reporting group title
    Type 2 diabetes
    Reporting group description
    		 The type 2 diabetes was PET/CT scanned with RGD-PET at one time-point

    Reporting group title
    Non-diabetic controls
    Reporting group description
    		 The non-diabetic controls arm was PET/CT scanned with RGD-PET at one time-point.

    Primary: Cardiac 68Ga-RGD uptake in type 2 diabetes and non-diabetic controls

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    End point title
    		 Cardiac 68Ga-RGD uptake in type 2 diabetes and non-diabetic controls
    End point description
    End point type
    Primary
    End point timeframe
    cross section
    End point values
    		 Type 2 diabetes Non-diabetic controls
    Number of subjects analysed
    20
    10
    Units: SUV
        arithmetic mean (standard deviation)
    1.18 ( 0.15 )
    1.18 ( 0.11 )
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    Type 2 diabetes v Non-diabetic controls
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.99
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - We applied the Student’s t-tests for continuous variables to analyse differences in RGD uptake between the participants with type 2 diabetes and the non-diabetic controls.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All participants were monitored 24 hours after injection of the radiotracer for adverse eventa.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Type 2 diabetes
    Reporting group description
    		 The type 2 diabetes was PET/CT scanned with RGD-PET at one time-point

    Reporting group title
    Non-diabetic controls
    Reporting group description
    		 The non-diabetic controls arm was PET/CT scanned with RGD-PET at one time-point.

    Serious adverse events
    		 Type 2 diabetes Non-diabetic controls
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 10 (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: 0%
    Non-serious adverse events
    		 Type 2 diabetes Non-diabetic controls
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
    Gastrointestinal disorders
    Appetite disorder
    Additional description: few days with decreased appetite and insomnia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Infection
    Additional description: Participant reports self limiting dark color urine and febrilia.
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0

    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.
    The study was planned to include all participants in the re-examination who gave consent to this sub-study, however due to the Covid19 pandemic, inclusion had to be terminated in October 2020 after inclusion of 30 participants.
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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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