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    Clinical Trial Results:
    A trial to compare the pharmacokinetics and pharmacodynamics of insulin lispro administered s.c. into lipohypertrophic or normal abdominal adipose tissue in subjects with diabetes mellitus type 1

    Summary
    EudraCT number
    		 2014-003144-12
    Trial protocol
    		 DE  
    Global end of trial date
    25 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2020
    First version publication date
    31 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DBC-14LIPOINJ01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02221323
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Profil Institut für Stoffwechselforschung GmbH
    Sponsor organisation address
    Hellersbergstr. 9, Neuss, Germany, 41460
    Public contact
    Regulatory Affairs Manager, Profil Institut für Stoffwechselforschung GmbH, +49 21314018145, regulatory@profil.com
    Scientific contact
    Regulatory Affairs Manager, Profil Institut für Stoffwechselforschung GmbH, +49 21314018145, regulatory@profil.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
    18 Nov 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the pharmacokinetic and pharmacodynamic effects of insulin lispro during the first 4 hours after s.c. administration into either lipohypertrophic or normal adipose tissue during a euglycaemic clamp examination.
    Protection of trial subjects
    A common risk of all available insulin preparations will be that subjects participating in this study may experience hypoglycaemia. In order to minimize the risk of hypoglycaemia after insulin injection close monitoring of subjects’ blood glucose level will occur in a medically supervised environment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Sep 2014
    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: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Screening occured in one trial site.

    Pre-assignment
    Screening details
    		 Eighteen (18) subjects were screened and 13 were considered eligible and randomised. All 13 randomised subjects completed the trial.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 1st arm - lipohypertrophic adipose tissue
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin lispro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Six dose administrations within 16 days; 0.9 IU/kg international unit(s)/kilogram

    Arm title
    		 2nd arm - normal adipose tissue
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin lispro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Six dose administrations within 16 days; 0.9 IU/kg international unit(s)/kilogram

    Number of subjects in period 1
    		1st arm - lipohypertrophic adipose tissue 2nd arm - normal adipose tissue
    Started
    13
    13
    Completed
    13
    13

    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
    		 13 13
    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)
    		 13 13
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 50.1 (32 to 62) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    1st arm - lipohypertrophic adipose tissue
    Reporting group description
    		 -

    Reporting group title
    2nd arm - normal adipose tissue
    Reporting group description
    		 -

    Primary: Summary statistics of pooled primary PK endpoint

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    End point title
    		 Summary statistics of pooled primary PK endpoint
    End point description
    End point type
    Primary
    End point timeframe
    0-4h
    End point values
    		 1st arm - lipohypertrophic adipose tissue 2nd arm - normal adipose tissue
    Number of subjects analysed
    13
    13
    Units: h*mU/L
        arithmetic mean (full range (min-max))
    131.10 (2.50 to 271.65)
    164.90 (68.88 to 312.74)
    Statistical analysis title
    		 PK analysis
    Comparison groups
    1st arm - lipohypertrophic adipose tissue v 2nd arm - normal adipose tissue
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0021
    Method
    		 ANOVA
    Confidence interval

    Primary: Summary statistics of pooled primary PD endpoint

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    End point title
    		 Summary statistics of pooled primary PD endpoint
    End point description
    End point type
    Primary
    End point timeframe
    0-4h
    End point values
    		 1st arm - lipohypertrophic adipose tissue 2nd arm - normal adipose tissue
    Number of subjects analysed
    13
    13
    Units: mg/kg
        arithmetic mean (full range (min-max))
    625.13 (41.01 to 1727.8)
    775.07 (356.26 to 1475.3)
    Statistical analysis title
    		 PD analysis
    Comparison groups
    1st arm - lipohypertrophic adipose tissue v 2nd arm - normal adipose tissue
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.039
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (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 trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 13 (7.69%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Chest pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    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
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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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