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    Clinical Trial Results:
    Comparison of the impact of biphasic insulin aspart 30(BiAsp30), biphasic insulin aspart 70 (BiAsp 70) and insulin aspart on postprandial glucose and lipid metabolism during two consecutive meals in type 2 diabetics.

    Summary
    EudraCT number
    		 2008-008486-35
    Trial protocol
    		 AT  
    Global end of trial date
    28 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Apr 2020
    First version publication date
    02 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ENM-DA-008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01293396
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Weidenweg 12, Kumberg, Austria, 8062
    Public contact
    Assoc.-Prof. Dr. Harald Sourij, Medical University of Graz, ha.sourij@medunigraz.at
    Scientific contact
    Assoc.Prof. Dr. Harald Sourij, Medical University of Graz, 43 316 81310, ha.sourij@medunigraz.at
    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
    05 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the impact of 3 insulin preparations on postprandial glucose and lipid metabolism in two consecutive meals in patients with type 2 diabetes.
    Protection of trial subjects
    All laboratory results will be reviewed and the reports signed by the study physician who will record whether it is normal, abnormal but not clinically significant, or abnormal and clinically significant. In the latter case, the eligibility of the subject will be reviewed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2010
    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
    Austria: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    3
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 50 patients were screened and in total 20 randomizations were performed. After randomization 20 randomized subjects finished all three study visits.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Insulin Aspart
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Novo Rapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

    Investigational medicinal product name
    Novo Mix 30
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

    Investigational medicinal product name
    Novo Mix 70
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

    Arm title
    		 Biphasic insulin aspart 30
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NovoMix 30
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

    Arm title
    		 Biphasic insulin aspart 70
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NovoMix 70
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

    Number of subjects in period 1
    		Insulin Aspart Biphasic insulin aspart 30 Biphasic insulin aspart 70
    Started
    20
    20
    20
    Completed
    20
    20
    20

    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
    		 20 20
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65 ± 6 -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    Insulin Aspart
    Reporting group description
    		 -

    Reporting group title
    Biphasic insulin aspart 30
    Reporting group description
    		 -

    Reporting group title
    Biphasic insulin aspart 70
    Reporting group description
    		 -

    Primary: AOB postprandial glucose

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    End point title
    		 AOB postprandial glucose
    End point description
    End point type
    Primary
    End point timeframe
    after premixed Insulin Aspart 30, Insulin Aspart 70 and Insulin Aspart
    End point values
    		 Insulin Aspart Biphasic insulin aspart 30 Biphasic insulin aspart 70
    Number of subjects analysed
    20
    20
    20
    Units: mg/dL
        arithmetic mean (standard deviation)
    197 ± 550
    591 ± 681
    220 ± 617
    Statistical analysis title
    		 student´s t-test
    Statistical analysis description
    student´s t-test for group comparison
    Comparison groups
    Insulin Aspart v Biphasic insulin aspart 30 v Biphasic insulin aspart 70
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: AOB postprandial triglycerides

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    End point title
    		 AOB postprandial triglycerides
    End point description
    End point type
    Primary
    End point timeframe
    either after Insulin Aspart 30, Insulin Aspart 70 and Insulin Aspart
    End point values
    		 Insulin Aspart Biphasic insulin aspart 30 Biphasic insulin aspart 70
    Number of subjects analysed
    20
    20
    20
    Units: mg/dL
        arithmetic mean (standard deviation)
    412 ± 831
    484 ± 342
    358 ± 544
    Statistical analysis title
    		 student´s t-test
    Statistical analysis description
    student´s t-test for group comparison
    Comparison groups
    Insulin Aspart v Biphasic insulin aspart 30 v Biphasic insulin aspart 70
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: AOB postprandial free fatty acids

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    End point title
    		 AOB postprandial free fatty acids
    End point description
    End point type
    Primary
    End point timeframe
    either after premixed insulin aspart 30, insulin aspart 70 and insulin aspart
    End point values
    		 Insulin Aspart Biphasic insulin aspart 30 Biphasic insulin aspart 70
    Number of subjects analysed
    20
    20
    20
    Units: µmol/L
        arithmetic mean (standard deviation)
    -5.54 ± 5.42
    -4.81 ± 4.96
    -3.91 ± 3.31
    Statistical analysis title
    		 student´s t-test
    Statistical analysis description
    student´s t-test for group comparison
    Comparison groups
    Insulin Aspart v Biphasic insulin aspart 30 v Biphasic insulin aspart 70
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: AOB postprandial insulin

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    End point title
    		 AOB postprandial insulin
    End point description
    End point type
    Secondary
    End point timeframe
    either after premixed insulin aspart 30, insulin aspart 70 and insulin aspart
    End point values
    		 Insulin Aspart Biphasic insulin aspart 30 Biphasic insulin aspart 70
    Number of subjects analysed
    20
    20
    20
    Units: µU/L
        arithmetic mean (standard deviation)
    128.6 ± 106.7
    211.2 ± 149.7
    141.2 ± 155.3
    No statistical analyses for this end point

    Secondary: Maximum glucose increase

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    End point title
    		 Maximum glucose increase
    End point description
    End point type
    Secondary
    End point timeframe
    either after premixed insulin aspart 30, insulin aspart 70 and insulin aspart
    End point values
    		 Insulin Aspart Biphasic insulin aspart 30 Biphasic insulin aspart 70
    Number of subjects analysed
    20
    20
    20
    Units: mg/dL
        arithmetic mean (standard deviation)
    60.25 ± 40.45
    89.25 ± 57.85
    55.95 ± 42.44
    No statistical analyses for this end point

    Secondary: Maximum triglycerides increase

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    End point title
    		 Maximum triglycerides increase
    End point description
    End point type
    Secondary
    End point timeframe
    either after premixed insulin aspart 30, insulin aspart 70 and insulin aspart
    End point values
    		 Insulin Aspart Biphasic insulin aspart 30 Biphasic insulin aspart 70
    Number of subjects analysed
    20
    20
    20
    Units: mg/dL
        arithmetic mean (standard deviation)
    69 ± 88.75
    61.95 ± 53.36
    60.74 ± 56.38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the study visits
    Adverse event reporting additional description
    Reporting of hypoglycemic events during study visits
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Insulin Aspart
    Reporting group description
    		 -

    Reporting group title
    Biphasic insulin aspart 30
    Reporting group description
    		 -

    Reporting group title
    Biphasic insulin aspart 70
    Reporting group description
    		 -

    Serious adverse events
    		 Insulin Aspart Biphasic insulin aspart 30 Biphasic insulin aspart 70
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (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: 0%
    Non-serious adverse events
    		 Insulin Aspart Biphasic insulin aspart 30 Biphasic insulin aspart 70
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    Endocrine disorders
    Hypoglycaemia
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    5

    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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