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    Clinical Trial Results:
    A 32-week randomised, multinational, treat-to-target, open label, parallel group comparison of stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy

    Summary
    EudraCT number
    		 2014-003708-62
    Trial protocol
    		 BG   HU  
    Global end of trial date
    21 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BIAsp-4157
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02453685
    WHO universal trial number (UTN)
    		 U1111-1158-7280
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.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
    22 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of intensification with BIAsp 30 versus intensification with basal bolus insulin analogues (insulin glargine [IGlar] and insulin aspart [IAsp]) on glycaemic control.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996) and FDA 21 CFR 312.120.
    Background therapy
    		 Pre-trial treatment with metformin and sulphonylurea (SU) were continued as background treatment throughout the entire trial.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    01 Sep 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
    United Arab Emirates: 31
    Country: Number of subjects enrolled
    Australia: 15
    Country: Number of subjects enrolled
    Bulgaria: 42
    Country: Number of subjects enrolled
    Hungary: 35
    Country: Number of subjects enrolled
    India: 66
    Country: Number of subjects enrolled
    Korea, Republic of: 31
    Country: Number of subjects enrolled
    Serbia: 52
    Country: Number of subjects enrolled
    Thailand: 23
    Country: Number of subjects enrolled
    Turkey: 40
    Worldwide total number of subjects
    335
    EEA total number of subjects
    77
    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)
    257
    From 65 to 84 years
    78
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 41 sites in 9 countries, as follows: Australia: 4 sites; Bulgaria: 5 sites; Hungary: 3 sites; India: 7 sites; Korea, Republic of: 4 sites; Serbia: 5 sites; Thailand: 4 sites; Turkey: 5 sites; United Arab Emirates: 4 sites.

    Pre-assignment
    Screening details
    		 Not applicable

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BIAsp 30
    Arm description
    		 Subjects received subcutaneous (s.c.) injection of biphasic insulin aspart 30 (BIAsp 30 - a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal self-measured plasma glucose (SMPG) target of 4.4−6.1 mmol/L (80−110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (haemoglobin A1c [HbA1c]) <7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Biphasic insulin aspart 30
    Investigational medicinal product code
    Other name
    NovoMix®30
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BIAsp 30 was administered as s.c. injections according to the locally approved label. The chosen region of the body where the injections were administered should remain the same throughout the trial. However, the injection site within the chosen body region should rotate or change for each administration.

    Arm title
    		 Basal-bolus
    Arm description
    		 Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin aspart
    Investigational medicinal product code
    Other name
    NovoRapid®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IAsp was administered as s.c. injections according to the locally approved label. The chosen region of the body where the injections were administered should remain the same throughout the trial. However, the injection site within the chosen body region should rotate or change for each administration.

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    Other name
    Lantus®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IGlar was administered as s.c. injections according to the locally approved label. The chosen region of the body where the injections were administered should remain the same throughout the trial. However, the injection site within the chosen body region should rotate or change for each administration.

    Number of subjects in period 1
    		BIAsp 30 Basal-bolus
    Started
    168
    167
    Exposed
    166
    166
    Completed
    149
    155
    Not completed
    19
    12
         Consent withdrawn by subject
    8
    4
         Adverse event, non-fatal
    -
    1
         Unclassified
    4
    2
         Lost to follow-up
    -
    1
         Protocol deviation
    7
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BIAsp 30
    Reporting group description
    		 Subjects received subcutaneous (s.c.) injection of biphasic insulin aspart 30 (BIAsp 30 - a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal self-measured plasma glucose (SMPG) target of 4.4−6.1 mmol/L (80−110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (haemoglobin A1c [HbA1c]) <7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.

    Reporting group title
    Basal-bolus
    Reporting group description
    		 Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.

    Reporting group values
    		 BIAsp 30 Basal-bolus Total
    Number of subjects
    		 168 167 335
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 131 126 257
        From 65-84 years
    		 37 41 78
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.6 ± 10.4 56.5 ± 10.1 -
    Gender Categorical
    Units: Subjects
        Female
    		 79 90 169
        Male
    		 89 77 166
    HbA1c
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    		 8.31 ± 0.73 8.23 ± 0.69 -

    End points

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    End points reporting groups
    Reporting group title
    BIAsp 30
    Reporting group description
    		 Subjects received subcutaneous (s.c.) injection of biphasic insulin aspart 30 (BIAsp 30 - a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal self-measured plasma glucose (SMPG) target of 4.4−6.1 mmol/L (80−110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (haemoglobin A1c [HbA1c]) <7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.

    Reporting group title
    Basal-bolus
    Reporting group description
    		 Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.

    Primary: Change from baseline in HbA1c

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    End point title
    		 Change from baseline in HbA1c
    End point description
    Change in HbA1c from baseline (week 0) to week 32. Analysis was performed on the full analysis set.
    End point type
    Primary
    End point timeframe
    After 32 weeks of treatment
    End point values
    		 BIAsp 30 Basal-bolus
    Number of subjects analysed
    164 [1]
    164 [2]
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    -1.16 ± 0.98
    -1.3 ± 0.9
    Notes
    [1] - Week 32 data after application of Last observation carried forward; 164 subjects contributed
    [2] - Week 32 data after application of Last observation carried forward; 164 subjects contributed
    Statistical analysis title
    		 BIAsp 30 vs Basal-bolus
    Statistical analysis description
    Analysis was performed using mixed model repeated measurements (MMRM) including treatment, region, and strata as fixed effects, HbA1c at baseline as covariate, interactions between all fixed effects and visit and using an unstructured residual covariance matrix. Below, 'treatment difference' refers to "BIAsp 30 minus Basal-bolus.
    Comparison groups
    BIAsp 30 v Basal-bolus
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0435
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.36

    Secondary: HbA1c < 7.0% without severe hypoglycaemic episodes (yes/no)

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    End point title
    		 HbA1c < 7.0% without severe hypoglycaemic episodes (yes/no)
    End point description
    Percentage of subjects with HbA1c below 7.0% after 32 weeks of randomised treatment without treatment emergent severe hypoglycaemic episodes during the last 12 weeks of treatment. Subjects withdrawn before 32 weeks were handled as non-responders. Severe hypoglycaemic episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Analysis was performed on the full analysis set.
    End point type
    Secondary
    End point timeframe
    After 32 weeks of treatment
    End point values
    		 BIAsp 30 Basal-bolus
    Number of subjects analysed
    168
    167
    Units: Percentage of subjects
    number (not applicable)
        Yes
    42.3
    56.3
        No
    57.7
    43.7
    No statistical analyses for this end point

    Secondary: Number of treatment emergent hypoglycaemic episodes classified according to the ADA and the Novo Nordisk definitions

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    End point title
    		 Number of treatment emergent hypoglycaemic episodes classified according to the ADA and the Novo Nordisk definitions
    End point description
    Hypoglycaemic episodes were classified as severe, Asymptomatic, Documented symptomatic, Pseudo, and Probable symptomatic as per ADA classification. As symptoms of hypoglycaemia occur below a PG level of 3.1 mmol/L, (56 mg/dL) Novo Nordisk classification included hypoglycaemia with plasma glucose (PG) levels below 3.1 mmol/L (56 mg/dL) in the definition of blood glucose confirmed hypoglycaemia. Hence, Novo Nordisk classification included following types of hypoglycaemia in addition to ADA classification: Severe hypoglycaemia, Symptomatic blood glucose confirmed hypoglycaemia, Asymptomatic blood glucose confirmed hypoglycaemia, Severe or blood glucose confirmed symptomatic hypoglycaemia, Blood glucose confirmed hypoglycaemia, and Severe or blood glucose confirmed hypoglycaemia. Reported data represents total of all hypoglycaemic episodes. Analysis was performed on the safety analysis set (all subjects receiving at least one dose of the investigational product or its comparator).
    End point type
    Secondary
    End point timeframe
    During 32 weeks of treatment
    End point values
    		 BIAsp 30 Basal-bolus
    Number of subjects analysed
    166
    166
    Units: Hypoglycaemic episodes
        ADA classification
    1650
    1841
        Novo Nordisk classification
    1650
    1841
    No statistical analyses for this end point

    Secondary: Total daily insulin dose

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    End point title
    		 Total daily insulin dose
    End point description
    Total daily insulin dose in the basal bolus treatment group and in BIAsp 30 treatment group at each week of each treatment. Analysis was performed on the safety analysis set.
    End point type
    Secondary
    End point timeframe
    During 32 weeks of treatment
    End point values
    		 BIAsp 30 Basal-bolus
    Number of subjects analysed
    166
    166
    Units: U/kg
    arithmetic mean (standard deviation)
        Week 1 (n=164, 165)
    0.157 ± 0.038
    0.127 ± 0.026
        Week 2 (n=162, 165)
    0.187 ± 0.053
    0.167 ± 0.042
        Week 3 (n=163, 164)
    0.214 ± 0.07
    0.197 ± 0.061
        Week 4 (n=160, 161)
    0.238 ± 0.088
    0.224 ± 0.076
        Week 5 (n=158, 158)
    0.259 ± 0.102
    0.244 ± 0.088
        Week 6 (n=157, 161)
    0.28 ± 0.114
    0.264 ± 0.1
        Week 7 (n=155, 161)
    0.296 ± 0.131
    0.281 ± 0.11
        Week 8 (n=155, 161)
    0.308 ± 0.145
    0.296 ± 0.119
        Week 9 (n=154, 159)
    0.369 ± 0.172
    0.339 ± 0.137
        Week 10 (n=154, 159)
    0.397 ± 0.199
    0.365 ± 0.16
        Week 11 (n=154, 159)
    0.421 ± 0.224
    0.391 ± 0.182
        Week 12 (n=153, 160)
    0.443 ± 0.245
    0.413 ± 0.202
        Week 13 (n=150, 158)
    0.456 ± 0.267
    0.425 ± 0.214
        Week 14 (n=151, 158)
    0.472 ± 0.277
    0.439 ± 0.228
        Week 15 (n=151, 159)
    0.487 ± 0.295
    0.455 ± 0.237
        Week 16 (n=151, 159)
    0.501 ± 0.308
    0.468 ± 0.248
        Week 17 (n=149, 156)
    0.528 ± 0.324
    0.496 ± 0.27
        Week 18 (n=150, 157)
    0.546 ± 0.334
    0.516 ± 0.294
        Week 19 (n=149, 157)
    0.557 ± 0.353
    0.532 ± 0.316
        Week 20 (n=148, 155)
    0.569 ± 0.367
    0.544 ± 0.32
        Week 21 (n=149, 155)
    0.588 ± 0.387
    0.563 ± 0.347
        Week 22 (n=149, 156)
    0.602 ± 0.401
    0.58 ± 0.359
        Week 23 (n=148, 156)
    0.607 ± 0.411
    0.59 ± 0.373
        Week 24 (n=148, 156)
    0.615 ± 0.426
    0.605 ± 0.386
        Week 25 (n=147, 154)
    0.628 ± 0.435
    0.618 ± 0.398
        Week 26 (n=147, 156)
    0.643 ± 0.454
    0.643 ± 0.434
        Week 27 (n=149, 155)
    0.661 ± 0.472
    0.653 ± 0.452
        Week 28 (n=149, 155)
    0.671 ± 0.487
    0.664 ± 0.466
        Week 29 (n=149, 155)
    0.688 ± 0.509
    0.674 ± 0.484
        Week 30 (n=149, 155)
    0.692 ± 0.511
    0.682 ± 0.497
        Week 31 (n=149, 155)
    0.703 ± 0.525
    0.693 ± 0.515
        Week 32 (n=153, 155)
    0.7 ± 0.542
    0.708 ± 0.537
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
    Adverse event reporting additional description
    Safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All the adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    BIAsp 30
    Reporting group description
    		 Subjects received s.c. injection of BIAsp 30 (a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.

    Reporting group title
    Basal-bolus
    Reporting group description
    		 Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c <7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.

    Serious adverse events
    		 BIAsp 30 Basal-bolus
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 166 (8.43%)
    12 / 166 (7.23%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    2 / 166 (1.20%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebellar infarction
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic neuropathy
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic seizure
         subjects affected / exposed
    0 / 166 (0.00%)
    3 / 166 (1.81%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic unconsciousness
         subjects affected / exposed
    0 / 166 (0.00%)
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis erosive
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restrictive pulmonary disease
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    0 / 166 (0.00%)
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    2 / 166 (1.20%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BIAsp 30 Basal-bolus
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 166 (22.29%)
    40 / 166 (24.10%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 166 (7.23%)
    15 / 166 (9.04%)
         occurrences all number
    24
    27
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 166 (6.02%)
    11 / 166 (6.63%)
         occurrences all number
    19
    12
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 166 (6.63%)
    6 / 166 (3.61%)
         occurrences all number
    16
    7
    Back pain
         subjects affected / exposed
    11 / 166 (6.63%)
    8 / 166 (4.82%)
         occurrences all number
    13
    9
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    21 / 166 (12.65%)
    18 / 166 (10.84%)
         occurrences all number
    31
    27
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 166 (6.63%)
    11 / 166 (6.63%)
         occurrences all number
    15
    13

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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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