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    Clinical Trial Results:
    A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients with Type 2 Diabetes

    Summary
    EudraCT number
    		 2017-001061-24
    Trial protocol
    		 DK   CZ   PL   GB  
    Global end of trial date
    09 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jul 2019
    First version publication date
    25 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KBP042/CD/003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03230786
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    KeyBioscience AG
    Sponsor organisation address
    Spichermatt 30, Stans, Switzerland, 6370
    Public contact
    Regulatory Affairs and Safety Dpt. , Nordic Bioscience Clinical Development, regulatory@nordicbioscience.com
    Scientific contact
    Regulatory Affairs and Safety Dpt. , Nordic Bioscience Clinical Development, regulatory@nordicbioscience.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
    31 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial is to evaluate the efficacy of three months of KBP-042 in Type 2 diabetic patients, in terms of glycaemic control.
    Protection of trial subjects
    Safeguard the interests of the trial subjects by providing an independent review of safety data or recommendations relating to the medical management of study subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Moldova, Republic of: 21
    Country: Number of subjects enrolled
    Romania: 73
    Country: Number of subjects enrolled
    Poland: 34
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Czech Republic: 50
    Country: Number of subjects enrolled
    Denmark: 57
    Worldwide total number of subjects
    255
    EEA total number of subjects
    234
    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)
    177
    From 65 to 84 years
    78
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 397 [1]
    Number of subjects completed
    		 255

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening failure: 142
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 397 subjects with T2DM were screened for the trial of which 255 subjects were found eligible.
    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 15 µg KBP-042
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    KBP-042
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The IMP was self-injected in the morning by daily s.c. injections in the abdominal region.

    Arm title
    		 30 µg KBP-042
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    KBP-042
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The IMP was self-injected in the morning by daily s.c. injections in the abdominal region.

    Arm title
    		 50 µg KBP-042
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    KBP-042
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The IMP was self-injected in the morning by daily s.c. injections in the abdominal region.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The placebo was a solution of 0.9% NaCl in water for s.c. injection. The placebo was self-injected in the morning by daily s.c. injections in the abdominal region.

    Number of subjects in period 1
    		15 µg KBP-042 30 µg KBP-042 50 µg KBP-042 Placebo
    Started
    63
    65
    63
    64
    Completed
    59
    60
    54
    59
    Not completed
    4
    5
    9
    5
         Consent withdrawn by subject
    1
    2
    3
    2
         Physician decision
    -
    -
    2
    1
         Adverse event, non-fatal
    2
    1
    3
    -
         Pregnancy
    -
    -
    -
    1
         Lost to follow-up
    1
    -
    1
    -
         Protocol deviation
    -
    2
    -
    1

    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
    		 255 255
    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)
    		 166 166
        From 65-84 years
    		 89 89
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 120 120
        Male
    		 135 135

    End points

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    End points reporting groups
    Reporting group title
    15 µg KBP-042
    Reporting group description
    		 -

    Reporting group title
    30 µg KBP-042
    Reporting group description
    		 -

    Reporting group title
    50 µg KBP-042
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Intention-to-treat population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT analysis set was defined as all subjects from the ITT analysis set who had a baseline and at least one post-treatment HbA1c measurement.

    Primary: Change from baseline in blood HbA1c at 12 weeks versus placebo

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    End point title
    		 Change from baseline in blood HbA1c at 12 weeks versus placebo
    End point description
    End point type
    Primary
    End point timeframe
    The blood HbA1c was performed at different time-points during the trial, from the screening visit, until week 12.
    End point values
    		 15 µg KBP-042 30 µg KBP-042 50 µg KBP-042 Placebo
    Number of subjects analysed
    61
    65
    61
    62
    Units: mmol/mol
        least squares mean (confidence interval 95%)
    -3.069 (-4.548 to -1.590)
    -2.890 (-4.327 to -1.453)
    -5.008 (-6.500 to -3.516)
    -4.032 (-5.504 to -2.559)
    Statistical analysis title
    		 Primary efficacy analysis
    Statistical analysis description
    The blood HbA1c was performed at different timepoints during the trial, from the screening visit, until week 12.
    Comparison groups
    30 µg KBP-042 v 50 µg KBP-042 v Placebo v 15 µg KBP-042
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1506
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events, including serious adverse events were evaluated and recorded at each clinical visit, from Visit 1 - at the time of consenting to participate in the trial, until the end of the post-treatment safety follow-up period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    15 µg daily of KBP-042
    Reporting group description
    		 -

    Reporting group title
    30 µg daily of KBP-042
    Reporting group description
    		 -

    Reporting group title
    50 µg daily of KBP-042
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 15 µg daily of KBP-042 30 µg daily of KBP-042 50 µg daily of KBP-042 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 61 (0.00%)
    3 / 50 (6.00%)
    1 / 63 (1.59%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Wound necrosis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 61 (0.00%)
    1 / 50 (2.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 61 (0.00%)
    1 / 50 (2.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 61 (0.00%)
    0 / 50 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 61 (0.00%)
    1 / 50 (2.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 15 µg daily of KBP-042 30 µg daily of KBP-042 50 µg daily of KBP-042 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 79 (68.35%)
    31 / 61 (50.82%)
    31 / 50 (62.00%)
    33 / 63 (52.38%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    7 / 79 (8.86%)
    4 / 61 (6.56%)
    1 / 50 (2.00%)
    0 / 63 (0.00%)
         occurrences all number
    12
    5
    2
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 61 (0.00%)
    3 / 50 (6.00%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Headache
         subjects affected / exposed
    4 / 79 (5.06%)
    1 / 61 (1.64%)
    1 / 50 (2.00%)
    3 / 63 (4.76%)
         occurrences all number
    5
    1
    2
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    15 / 79 (18.99%)
    6 / 61 (9.84%)
    6 / 50 (12.00%)
    5 / 63 (7.94%)
         occurrences all number
    20
    8
    13
    5
    Nausea
         subjects affected / exposed
    9 / 79 (11.39%)
    9 / 61 (14.75%)
    8 / 50 (16.00%)
    6 / 63 (9.52%)
         occurrences all number
    13
    11
    14
    7
    Vomiting
         subjects affected / exposed
    5 / 79 (6.33%)
    4 / 61 (6.56%)
    4 / 50 (8.00%)
    1 / 63 (1.59%)
         occurrences all number
    5
    11
    6
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    6 / 79 (7.59%)
    0 / 61 (0.00%)
    2 / 50 (4.00%)
    0 / 63 (0.00%)
         occurrences all number
    20
    0
    2
    0
    Rash
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 61 (1.64%)
    3 / 50 (6.00%)
    0 / 63 (0.00%)
         occurrences all number
    1
    1
    4
    0
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    6 / 79 (7.59%)
    5 / 61 (8.20%)
    7 / 50 (14.00%)
    3 / 63 (4.76%)
         occurrences all number
    6
    6
    7
    3
    Bronchitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 61 (1.64%)
    3 / 50 (6.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    1
    3
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 79 (0.00%)
    4 / 61 (6.56%)
    1 / 50 (2.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    5
    1
    0
    Viral infection
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 61 (0.00%)
    4 / 50 (8.00%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    4
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 79 (1.27%)
    3 / 61 (4.92%)
    7 / 50 (14.00%)
    0 / 63 (0.00%)
         occurrences all number
    1
    3
    7
    0
    Hyperlipidaemia
         subjects affected / exposed
    5 / 79 (6.33%)
    2 / 61 (3.28%)
    1 / 50 (2.00%)
    4 / 63 (6.35%)
         occurrences all number
    5
    2
    1
    4

    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
    For support, Contact us.
    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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