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    Clinical Trial Results:
    Effects of Linagliptin on Renal Endothelium Function in Patients with Type 2 Diabetes.

    Summary
    EudraCT number
    		 2012-002278-30
    Trial protocol
    		 DE  
    Global end of trial date
    06 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2021
    First version publication date
    28 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CRC2012LINA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Erlangen
    Sponsor organisation address
    Maximiliansplatz 2, Erlangen, Germany,
    Public contact
    Clinical Research Center, Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, 0049 91318536245, roland.schmieder@uk-erlangen.de
    Scientific contact
    Clinical Research Center, Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, 0049 91318536245, roland.schmieder@uk-erlangen.de
    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 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the effect of linagliptin compared to placebo on basal production and release of nitric oxide (NO) from renal vasculature, as assessed by changes of renal plasma flow due to L-NMMA infusion.
    Protection of trial subjects
    Physical examinations, vital signs, checking concomitant medication, assessment of adverse events, measurement of safety laboratory markers (including glucose levels, biochemistry, haematology and urinanalsis) were done regularly in the course of the study. Home blood glucose measurements (Home Blood Glucose Monitoring) were performed by the study participants during the whole duration of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jul 2012
    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
    Germany: 66
    Worldwide total number of subjects
    66
    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)
    53
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited via advertising in local newspapers, by our G.P. / local network in Erlangen/Nürnberg/Fürth and by our University Outpatient Clinic. Participants were included after study physician has evaluated in- and exclusion criteria and after the participant has given his/her oral and written informed consent.

    Pre-assignment
    Screening details
    		 we screened female and male patients, aged between 18 and 70 years with type 2 diabetes, without diabetic nephropathy. Eligible patients entered a 4 week run-in/wash-out phase, if pretreated with any blood glucose lowering agent, or a 2 week run-in/wash-out phase, if not pretreated.

    Period 1
    Period 1 title
    Treatment Period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Linagliptin
    Arm description
    		 The study followed randomized cross-over-design, i.e. subjects underwent both treatment arms in randomized order for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg once daily

    Arm title
    		 Placebo
    Arm description
    		 This study followed randomized cross-over-design, e.e. subjects underwent both treatment arms in randomized order for 4 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily

    Number of subjects in period 1
    		Linagliptin Placebo
    Started
    66
    66
    Completed
    62
    62
    Not completed
    4
    4
         Adverse event, non-fatal
    3
    3
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Period 1 Total
    Number of subjects
    		 66 66
    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)
    		 53 53
        From 65-84 years
    		 13 13
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 23 23
        Male
    		 43 43

    End points

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    End points reporting groups
    Reporting group title
    Linagliptin
    Reporting group description
    		 The study followed randomized cross-over-design, i.e. subjects underwent both treatment arms in randomized order for 4 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 This study followed randomized cross-over-design, e.e. subjects underwent both treatment arms in randomized order for 4 weeks

    Primary: Effect of Linagliptin compared to placebo by change of renal plasma flow due to L-NMMA infusion

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    End point title
    		 Effect of Linagliptin compared to placebo by change of renal plasma flow due to L-NMMA infusion
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    		 Linagliptin Placebo
    Number of subjects analysed
    62
    62
    Units: ml/min
        arithmetic mean (standard deviation)
    -50.9 ( 34 )
    -54.2 ( 30 )
    Statistical analysis title
    		 effect of linagliptin on RPF compared to placebo
    Comparison groups
    Linagliptin v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 2.5

    Secondary: Effect of Linagliptin compared to placebo on RPF

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    End point title
    		 Effect of Linagliptin compared to placebo on RPF
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Linagliptin Placebo
    Number of subjects analysed
    62
    62
    Units: ml/min
        arithmetic mean (standard deviation)
    612 ( 106 )
    621 ( 91 )
    No statistical analyses for this end point

    Secondary: Effect of Linagliptin compared to placebo on GFR

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    End point title
    		 Effect of Linagliptin compared to placebo on GFR
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Linagliptin Placebo
    Number of subjects analysed
    62
    62
    Units: ml/min
        arithmetic mean (standard deviation)
    142 ( 16 )
    142 ( 15 )
    No statistical analyses for this end point

    Secondary: Effect of Linagliptin compared to placebo on RVR (renal vessel resistance)

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    End point title
    		 Effect of Linagliptin compared to placebo on RVR (renal vessel resistance)
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Linagliptin Placebo
    Number of subjects analysed
    62
    62
    Units: ml/min
        arithmetic mean (standard deviation)
    88.4 ( 18 )
    92.1 ( 21 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    In the course of the intire study , each adverse event had to be reported on an Adverse Event Case Report Form as soon as known, in general at the subsequent study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    all patients treated with IMP
    Reporting group description
    		 -

    Serious adverse events
    		 all patients treated with IMP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 66 (1.52%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 all patients treated with IMP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 66 (100.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 66 (28.79%)
         occurrences all number
    19
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 66 (4.55%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 66 (7.58%)
         occurrences all number
    5
    Infections and infestations
    Cough
         subjects affected / exposed
    4 / 66 (6.06%)
         occurrences all number
    4
    Cystitis
         subjects affected / exposed
    3 / 66 (4.55%)
         occurrences all number
    3
    Nasopharyngitis
         subjects affected / exposed
    35 / 66 (53.03%)
         occurrences all number
    35

    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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