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    Clinical Trial Results:
    A double-blinded, randomised, three-period crossover euglycaemic clamp trial investigating the pharmacokinetics, glucodynamics and safety of BioChaperone human insulin, human insulin (Huminsulin® Normal) and insulin lispro (Humalog®) in subjects with type 1 diabetes

    Summary
    EudraCT number
    		 2014-001432-11
    Trial protocol
    		 DE  
    Global end of trial date
    10 Nov 2014

    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-CT010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02213146
    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 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare, in type 1 diabetes patients, the early insulin exposure after administration of a 0.2 U·kg BW-1 single dose of BioChaperone human insulin (BC Human insulin) and Huminsulin® Normal during euglycaemic clamps.
    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 Pharmaceuticals for Human Use (ICH) Good Clinical Practices.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Aug 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: 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
    		 Subjects with Type v1 Diabetes Mellitus for 12 months or more Treated with Multiple daily Insulin Injection for 12 months or more BMI between 18.5 and 28.0 Kg/m² HbA1C% equal or less than 9.0%

    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
    		 Investigator, Monitor, Subject
    Blinding implementation details
    This was a double-blind trial. An authorised person (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 and administration of the trial drug (these persons were not involved in any other clinical trial activities), everyone in the trial, including the PK laboratory, were blinded.

    Arms
    Arm title
    		 BC Human insulin / Human insulin / Insulin lispro
    Arm description
    		 Each subject were randomly allocated to a sequence of three treatments, i.e. with one single dose of BC human insulin containing 0.2 U·kg BW, and one single dose of Human insulin (Huminsulin Normal®), containing 0.2 U·kg BW human insulin, and one single dose of insulin lispro (Humalog®), containing 0.2 U·kg BW insulin lispro on three separate dosing visits and during euglycemic clamp procedures. The three dosing visits were separated by a wash-out period of 3 to 15 days.
    Arm type
    		 Cross-over (experimental & active comparator)

    Investigational medicinal product name
    BioChaperone Human Insulin
    Investigational medicinal product code
    Other name
    BC Human insulin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single injection of 0.2 U/Kg Body weight.

    Investigational medicinal product name
    Human insulin
    Investigational medicinal product code
    Other name
    Huminsulin® Normal
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single dose of 0.2 U/kg body weight.

    Investigational medicinal product name
    Insulin lispro
    Investigational medicinal product code
    Other name
    Humalog®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single dose of 0.2 U/kg body weight

    Number of subjects in period 1
    		BC Human insulin / Human insulin / Insulin lispro
    Started
    38
    Completed
    37
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 Overall population as it is a cross-over trial

    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
    		 0 0
        Male
    		 38 38
    Subject analysis sets

    Subject analysis set title
    Safety Analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received at least one dose of one of the IMP

    Subject analysis set title
    BC Human insulin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subject who received at least one dose of BC Human insulin

    Subject analysis set title
    Human insulin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    subject who received at least one dose of Human insulin

    Subject analysis set title
    Insulin lispro
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received at least one dose of insulin lispro

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

    End points

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    End points reporting groups
    Reporting group title
    BC Human insulin / Human insulin / Insulin lispro
    Reporting group description
    		 Each subject were randomly allocated to a sequence of three treatments, i.e. with one single dose of BC human insulin containing 0.2 U·kg BW, and one single dose of Human insulin (Huminsulin Normal®), containing 0.2 U·kg BW human insulin, and one single dose of insulin lispro (Humalog®), containing 0.2 U·kg BW insulin lispro on three separate dosing visits and during euglycemic clamp procedures. The three dosing visits were separated by a wash-out period of 3 to 15 days.

    Subject analysis set title
    Safety Analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received at least one dose of one of the IMP

    Subject analysis set title
    BC Human insulin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subject who received at least one dose of BC Human insulin

    Subject analysis set title
    Human insulin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    subject who received at least one dose of Human insulin

    Subject analysis set title
    Insulin lispro
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received at least one dose of insulin lispro

    Primary: AUCins(0-1h)

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    End point title
    		 AUCins(0-1h)
    End point description
    Area under the human insulin serum concentration - time curve from t=0 to 1 hour.
    End point type
    Primary
    End point timeframe
    From t=0 to t=1 hour after IMP administration.
    End point values
    		 BC Human insulin Human insulin
    Number of subjects analysed
    35
    36
    Units: h*mU/L
        arithmetic mean (standard deviation)
    26.0 ( 14.3 )
    15.5 ( 9.7 )
    Statistical analysis title
    		 BC Human insulin vs Human insulin
    Comparison groups
    Human insulin v BC Human insulin
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    1.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.47
         upper limit
    		 2.07
    Notes
    [1] - Difference

    Secondary: AUCins(0-last)

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    End point title
    		 AUCins(0-last)
    End point description
    Area under the human insulin / insulin lispro serum concentration - time curve from t=0 to the last measurable insulin / insulin lispro serum concentration
    End point type
    Secondary
    End point timeframe
    Time curve from t=0 to the last measurable insulin / insulin lispro serum concentration
    End point values
    		 BC Human insulin Human insulin Insulin lispro
    Number of subjects analysed
    35
    36
    37
    Units: h*mU/L
        arithmetic mean (standard deviation)
    158.33 ( 47.043 )
    152.47 ( 32.690 )
    183.08 ( 41.679 )
    Statistical analysis title
    		 BC Human insulin vs Human insulin
    Comparison groups
    BC Human insulin v Human insulin
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.6548
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    1.016
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9453
         upper limit
    		 1.0922
    Notes
    [2] - Difference
    Statistical analysis title
    		 BC Human insulin vs insulin lispro
    Comparison groups
    BC Human insulin v Insulin lispro
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.857
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.815
         upper limit
    		 0.9006
    Notes
    [3] - Absence of differences

    Secondary: Tonset of appearance

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    End point title
    		 Tonset of appearance
    End point description
    Time from t=0 to the first time human insulin / insulin lispro serum concentration is equal or superior to lower limit of quantification (LLOQ)
    End point type
    Secondary
    End point timeframe
    From t=0 to t=10 hours
    End point values
    		 BC Human insulin Human insulin Insulin lispro
    Number of subjects analysed
    35
    36
    37
    Units: Hour
        arithmetic mean (standard deviation)
    0.088 ( 0.0421 )
    0.211 ( 0.1416 )
    0.119 ( 0.0611 )
    Statistical analysis title
    		 BC Human insulin vs Human insulin
    Comparison groups
    Human insulin v BC Human insulin
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehman estimate
    Point estimate
    -0.067
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1333
         upper limit
    		 -0.0667
    Notes
    [4] - Difference
    Statistical analysis title
    		 BC Human insulin vs insulin lispro
    Comparison groups
    BC Human insulin v Insulin lispro
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehman estimate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0667
         upper limit
    		 0
    Notes
    [5] - Absence of differences

    Secondary: Cmax ins

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    End point title
    		 Cmax ins
    End point description
    Maximum observed human insulin / insulin lispro serum concentration
    End point type
    Secondary
    End point timeframe
    From t=0 to t=10 hours
    End point values
    		 BC Human insulin Human insulin Insulin lispro
    Number of subjects analysed
    34
    35
    36
    Units: mU/L
        arithmetic mean (standard deviation)
    44.270 ( 19.784 )
    39.492 ( 16.556 )
    83.078 ( 39.685 )
    Statistical analysis title
    		 BC Human insulin vs Human insulin
    Comparison groups
    BC Human insulin v Human insulin
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.0122
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    1.133
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.0296
         upper limit
    		 1.2458
    Notes
    [6] - Difference
    Statistical analysis title
    		 BC Human insulin vs insulin lispro
    Comparison groups
    BC Human insulin v Insulin lispro
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5179
         upper limit
    		 0.5849
    Notes
    [7] - Absence of differences

    Secondary: AUC-GIR 0-Last

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    End point title
    		 AUC-GIR 0-Last
    End point description
    Area under the glucose infusion rate time curve from 0 hours until the end of clamp.
    End point type
    Secondary
    End point timeframe
    From t=0 up to t=10 hours
    End point values
    		 BC Human insulin Human insulin Insulin lispro
    Number of subjects analysed
    36
    36
    37
    Units: mg/kg
        arithmetic mean (standard deviation)
    1294.2 ( 610.90 )
    1255.8 ( 612.64 )
    1295.3 ( 464.40 )
    Statistical analysis title
    		 BC Human insulin vs Human insulin
    Comparison groups
    Human insulin v BC Human insulin
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 = 0.5814
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    1.027
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9306
         upper limit
    		 1.1343
    Notes
    [8] - Difference
    Statistical analysis title
    		 BC Human insulin vs insulin lispro
    Comparison groups
    Insulin lispro v BC Human insulin
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.3622
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.959
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8894
         upper limit
    		 1.035
    Notes
    [9] - Absence of difference

    Secondary: T onset of Action

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    End point title
    		 T onset of Action
    End point description
    Time from t=0 hours until blood glucose concentration has decreased by 5 mg·dL 1 (0.3 mmol·L 1) from baseline
    End point type
    Secondary
    End point timeframe
    From t=0 up to 10 hours
    End point values
    		 BC Human insulin Human insulin Insulin lispro
    Number of subjects analysed
    35
    36
    37
    Units: Hour
        arithmetic mean (standard deviation)
    0.469 ( 0.1744 )
    0.822 ( 0.3369 )
    0.555 ( 0.1721 )
    Statistical analysis title
    		 BC Human insulin vs Human insulin
    Comparison groups
    BC Human insulin v Human insulin
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehman estimate
    Point estimate
    -0.333
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 -0.2167
    Notes
    [10] - Difference
    Statistical analysis title
    		 BC Human insulin vs insulin lispro
    Comparison groups
    BC Human insulin v Insulin lispro
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.0024
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehman estimate
    Point estimate
    -0.083
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1667
         upper limit
    		 -0.0333
    Notes
    [11] - Absence of differences

    Secondary: GIRmax

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    End point title
    		 GIRmax
    End point description
    Maximum glucose infusion rate
    End point type
    Secondary
    End point timeframe
    From t=0 up to t=10 hours
    End point values
    		 BC Human insulin Human insulin Insulin lispro
    Number of subjects analysed
    36
    36
    37
    Units: mg/kg/min
        arithmetic mean (standard deviation)
    4.622 ( 2.4718 )
    4.209 ( 2.4950 )
    6.487 ( 2.5341 )
    Statistical analysis title
    		 BC Human insulin vs Human insulin
    Comparison groups
    BC Human insulin v Human insulin
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    P-value
    		 < 0.023
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    1.124
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.0173
         upper limit
    		 1.2413
    Notes
    [12] - Difference
    Statistical analysis title
    		 BC Human insulin vs insulin lispro
    Comparison groups
    BC Human insulin v Insulin lispro
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 [13]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.682
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6281
         upper limit
    		 0.7411
    Notes
    [13] - Absence of difference

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first IMP (study drug) dose to safety follow-up visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    BC Human Insulin
    Reporting group description
    		 -

    Reporting group title
    Human insulin
    Reporting group description
    		 -

    Reporting group title
    Insulin lispro
    Reporting group description
    		 -

    Serious adverse events
    		 BC Human Insulin Human insulin Insulin lispro
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 37 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 BC Human Insulin Human insulin Insulin lispro
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 37 (8.11%)
    5 / 37 (13.51%)
    4 / 37 (10.81%)
    Injury, poisoning and procedural complications
    Phlebitis
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    1
    Injection site erythema
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 37 (5.41%)
    4 / 37 (10.81%)
         occurrences all number
    2
    2
    4
    Vision blurred
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Hyperventilation
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 37 (0.00%)
    2 / 37 (5.41%)
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    2
    0
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Aug 2014
    Two additionnal arms with different doses of BC Human insulin at different doses were cancelled. This amendment was in place before the start of study recruitment / study.

    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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