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    Clinical Trial Results:
    Blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®) after ingestion of a standardised meal.

    Summary
    EudraCT number
    		 2014-005028-92
    Trial protocol
    		 DE  
    Global end of trial date
    13 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Sep 2020
    First version publication date
    16 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BC3-CT011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02344992
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Adocia
    Sponsor organisation address
    115 Avenue Lacassagne, LYON, France, 69003
    Public contact
    Deputy General Manager, Adocia, +33 472610610, o.soula@adocia.com
    Scientific contact
    Director of Clinical Development, Adocia, +33 472610610, g.meiffren@adocia.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
    11 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparison of postprandial blood glucose (BG) control after administration of BioChaperone insulin lispro (BC Lispro) and Humalog® at the start (t=0) of a standardised meal ingestion.
    Protection of trial subjects
    The trial was conducted in accordance with the declaration of Helsinki and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical use (ICH) Good Clinical Practices.
    Background therapy
    		 l
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jan 2015
    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: 38
    Worldwide total number of subjects
    38
    EEA total number of subjects
    38
    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)
    38
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at one site in Germany

    Pre-assignment
    Screening details
    		 MAle or Female subjects aged from 18 to 64 years with type 1 diabetes mellitus for at least 1 year. HbA1C% equal or less than 9.0% BMI between 18.5 and 28.0 kg/m²

    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
    Blinding implementation details
    An authorised unblinded person prepared and administered the trial drug according to the randomisation based assignment to one of the predefined treatment sequences. Except for the unblinded persons involved in the preparation & administration of the trial drug (persons not involved in any other clinical trial activities), everyone in the trial inclusive the PK laboratory was blinded until after completion of the trial and the final data review.

    Arms
    Arm title
    		 BC Lispro / Humalog®
    Arm description
    		 Each subject was randomly allocated to a sequence of two treatments applied at two separate dosing visits, i.e. with one single dose (0.2U·kg-1BW) of Humalog® injected immediately prior to the start of meal ingestion (0 minutes), or a single dose (0.2U·kg-1BW) of BC Lispro injected immediately prior to the start of meal ingestion (0 minutes). Subjects stayed at the clinical trial centre until the 8-hour standardised test-meal procedure was terminated. The two dosing visits will be separated by a wash-out period of 3-15 days.
    Arm type
    		 Cross-over (experimental & active comparator)

    Investigational medicinal product name
    Biochaperone insulin lispro
    Investigational medicinal product code
    Other name
    BC lispro
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of 0.2 U/kg body weight was administered subcutaneously with a disposable syringe.

    Investigational medicinal product name
    Humalog®
    Investigational medicinal product code
    Other name
    Insulin lispro
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of 0.2 U/kg body weight was administered subcutaneously with a disposable syringe.

    Number of subjects in period 1
    		BC Lispro / Humalog®
    Started
    38
    Completed
    38

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 38 38
    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)
    		 38 38
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 35 35
    Subject analysis sets

    Subject analysis set title
    BC Lispro
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received at least one dose of BC Lispro

    Subject analysis set title
    Humalog®
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received at least one dose of Humalog®

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjeects who received at least one dose of IMP (study drug)

    Subject analysis sets values
    		 BC Lispro Humalog® Safety population
    Number of subjects
    38
    38
    38
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    38
    38
    38
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    3
    3
    3
        Male
    35
    35
    35

    End points

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    End points reporting groups
    Reporting group title
    BC Lispro / Humalog®
    Reporting group description
    		 Each subject was randomly allocated to a sequence of two treatments applied at two separate dosing visits, i.e. with one single dose (0.2U·kg-1BW) of Humalog® injected immediately prior to the start of meal ingestion (0 minutes), or a single dose (0.2U·kg-1BW) of BC Lispro injected immediately prior to the start of meal ingestion (0 minutes). Subjects stayed at the clinical trial centre until the 8-hour standardised test-meal procedure was terminated. The two dosing visits will be separated by a wash-out period of 3-15 days.

    Subject analysis set title
    BC Lispro
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received at least one dose of BC Lispro

    Subject analysis set title
    Humalog®
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received at least one dose of Humalog®

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjeects who received at least one dose of IMP (study drug)

    Primary: ∆AUCBG,0-2h

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    End point title
    		 ∆AUCBG,0-2h
    End point description
    Area under the blood glucose concentration-time curve from 0-2 hours after a standardised liquid meal
    End point type
    Primary
    End point timeframe
    From t=0 to t=2 hour after the standardised liquid meal
    End point values
    		 BC Lispro Humalog®
    Number of subjects analysed
    38
    38
    Units: mg.h/dL
        arithmetic mean (standard deviation)
    54.402 ( 56.981 )
    109.97 ( 62.498 )
    Statistical analysis title
    		 BC Lispro vs Humalog®
    Comparison groups
    Humalog® v BC Lispro
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.284
         upper limit
    		 0.524
    Notes
    [1] - Differences

    Secondary: BG1h

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    End point title
    		 BG1h
    End point description
    Blood glucose concentration at 1 hour after a standardised liquid meal.
    End point type
    Secondary
    End point timeframe
    From t=0 to t=1h after the standardised liquid meal.
    End point values
    		 BC Lispro Humalog®
    Number of subjects analysed
    38
    38
    Units: mg/dL
        arithmetic mean (standard deviation)
    135.2 ( 37.30 )
    176.7 ( 40.09 )
    Statistical analysis title
    		 BC Lispro vs Humalog®
    Comparison groups
    BC Lispro v Humalog®
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.692
         upper limit
    		 0.831
    Notes
    [2] - Differences

    Secondary: BG2h

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    End point title
    		 BG2h
    End point description
    blood glucose concentration at 2 hours after a standardised meal
    End point type
    Secondary
    End point timeframe
    From t=0 to t=2h after the standardised meal
    End point values
    		 BC Lispro Humalog®
    Number of subjects analysed
    38
    38
    Units: mg/dL
        arithmetic mean (standard deviation)
    126.1 ( 48.13 )
    153.3 ( 55.72 )
    Statistical analysis title
    		 BC Lispro vs Humalog®
    Comparison groups
    BC Lispro v Humalog®
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.0006
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.737
         upper limit
    		 0.913
    Notes
    [3] - Differences

    Secondary: AUCIns(0-30min)

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    End point title
    		 AUCIns(0-30min)
    End point description
    Area under the serum insulin lispro concentration-time curve from 0-30 min
    End point type
    Secondary
    End point timeframe
    From t=0 to t=30min after dosing
    End point values
    		 BC Lispro Humalog®
    Number of subjects analysed
    38
    38
    Units: h.mU/L
        arithmetic mean (standard deviation)
    25.190 ( 11.026 )
    10.629 ( 5.5779 )
    Statistical analysis title
    		 BC Lispro vs Humalog®
    Comparison groups
    BC Lispro v Humalog®
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    2.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.18
         upper limit
    		 3.303
    Notes
    [4] - Differences

    Secondary: AUCins(0-1h)

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    End point title
    		 AUCins(0-1h)
    End point description
    Area under the serum insulin lispro concentration-time curve from 0-1 hour
    End point type
    Secondary
    End point timeframe
    From T=0 to t=1h after dosing
    End point values
    		 BC Lispro Humalog®
    Number of subjects analysed
    38
    38
    Units: h.mU/L
        arithmetic mean (standard deviation)
    81.430 ( 32.224 )
    55.179 ( 22.125 )
    Statistical analysis title
    		 BC Lispro vs Humalog®
    Comparison groups
    Humalog® v BC Lispro
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.371
         upper limit
    		 1.675
    Notes
    [5] - Differences

    Secondary: AUCins(0-8h)

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    End point title
    		 AUCins(0-8h)
    End point description
    Area under the serum insulin lispro concentration-time curve from 0-8 hours
    End point type
    Secondary
    End point timeframe
    From t=0 to t=8h after dosing
    End point values
    		 BC Lispro Humalog®
    Number of subjects analysed
    38
    38
    Units: h.mU/L
        arithmetic mean (standard deviation)
    275.31 ( 131.28 )
    270.76 ( 128.55 )
    Statistical analysis title
    		 BC Lispro vs Humalog®
    Comparison groups
    BC Lispro v Humalog®
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.6099
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.971
         upper limit
    		 1.051
    Notes
    [6] - Difference

    Secondary: Cmax ins

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    End point title
    		 Cmax ins
    End point description
    Maximum observed serum insulin lispro concentration
    End point type
    Secondary
    End point timeframe
    From t=0 to t=8h after dosing
    End point values
    		 BC Lispro Humalog®
    Number of subjects analysed
    38
    38
    Units: mU/L
        arithmetic mean (standard deviation)
    125.69 ( 53.013 )
    110.57 ( 42.921 )
    Statistical analysis title
    		 BC Lispro vs Humalog®
    Comparison groups
    BC Lispro v Humalog®
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.0003
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.061
         upper limit
    		 1.198
    Notes
    [7] - Differences

    Secondary: Tmax ins

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    End point title
    		 Tmax ins
    End point description
    Time to maximum observed serum insulin lispro concentration
    End point type
    Secondary
    End point timeframe
    From t=0 up to t=8h after dosing
    End point values
    		 BC Lispro Humalog®
    Number of subjects analysed
    38
    38
    Units: Hour
        arithmetic mean (standard deviation)
    0.818 ( 0.2866 )
    1.089 ( 0.3935 )
    Statistical analysis title
    		 BC Lispro vs Humalog®
    Comparison groups
    BC Lispro v Humalog®
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.686
         upper limit
    		 0.826
    Notes
    [8] - Differences

    Secondary: T50% early

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    End point title
    		 T50% early
    End point description
    Time to first observed half maximum serum insulin lispro concentration
    End point type
    Secondary
    End point timeframe
    From t=0 up to t=8 hour after dosing
    End point values
    		 BC Lispro Humalog®
    Number of subjects analysed
    38
    38
    Units: hour
        arithmetic mean (standard deviation)
    0.318 ( 0.0957 )
    0.498 ( 0.1443 )
    Statistical analysis title
    		 BC Lispro vs Humalog®
    Comparison groups
    BC Lispro v Humalog®
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.567
         upper limit
    		 0.705
    Notes
    [9] - Differences

    Secondary: T50% late

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    End point title
    		 T50% late
    End point description
    Time to last observed half maximum serum insulin lispro concentration
    End point type
    Secondary
    End point timeframe
    From t=0 up to t=8 hour after dosing
    End point values
    		 BC Lispro Humalog®
    Number of subjects analysed
    38
    38
    Units: hour
        arithmetic mean (standard deviation)
    2.367 ( 0.7948 )
    2.784 ( 0.9348 )
    Statistical analysis title
    		 BC Lispro vs Humalog®
    Comparison groups
    BC Lispro v Humalog®
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.785
         upper limit
    		 0.911
    Notes
    [10] - Differences

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first IMP (study drug) administration to the safety follow-up visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    BC Lispro
    Reporting group description
    		 -

    Reporting group title
    Humalog®
    Reporting group description
    		 -

    Serious adverse events
    		 BC Lispro Humalog®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 38 (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: 1%
    Non-serious adverse events
    		 BC Lispro Humalog®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 38 (52.63%)
    20 / 38 (52.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 38 (7.89%)
    2 / 38 (5.26%)
         occurrences all number
    3
    2
    Infections and infestations
    nasopharyngitis
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 38 (2.63%)
         occurrences all number
    1
    1
    Otitis media
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    18 / 38 (47.37%)
    19 / 38 (50.00%)
         occurrences all number
    22
    23

    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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