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    Clinical Trial Results:
    A trial comparing the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart in subjects with type 2 diabetes mellitus previously treated with insulin glargine

    Summary
    EudraCT number
    		 2012-000373-23
    Trial protocol
    		 DE  
    Global end of trial date
    22 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2016
    First version publication date
    28 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN5401-3941
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01680341
    WHO universal trial number (UTN)
    		 U1111-1127-4114
    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
    26 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm the efficacy of the insulin degludec/insulin aspart (IDegAsp) twice daily (BID) simple titration algorithm in controlling glycaemia with respect to change from baseline in glycosylated haemoglobin (HbA1c) after 26 weeks of treatment.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki and ICH Good Clinical Practice and EN ISO 14155 Part 1 and 2.
    Background therapy
    		 While entering the treatment period the subjects discontinued IGlar and sulfonylurea (SU)/glinides (if administered) but continued treatment with other OADs as prescribed. i.e. metformin, DPP-4 inhibitor or alpha-glucosidase inhibitor.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    31 Aug 2012
    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: 39
    Country: Number of subjects enrolled
    Algeria: 35
    Country: Number of subjects enrolled
    Malaysia: 33
    Country: Number of subjects enrolled
    Turkey: 10
    Country: Number of subjects enrolled
    United States: 155
    Worldwide total number of subjects
    272
    EEA total number of subjects
    39
    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)
    202
    From 65 to 84 years
    70
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 43 sites in 5 countries as follows: 3 sites in Algeria, 5 sites in Germany, 3 sites in Malaysia, 3 sites in Turkey, 29 sites in United States.

    Pre-assignment
    Screening details
    		 At screening, subjects were on IGlar and up to 3 OADs (metformin, DPP-4 inhibitor, SU/glinides or alpha-glucosidase inhibitor) therapy. These pre-trial assignments were ongoing from ≥12 weeks prior to randomisation and doses were stabilised in this period of time.

    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
    This was an open-label trial. There was no blinding of investigators or subjects. An open label trial design was chosen since all subjects in both treatment arms were to receive insulin treatment with IDegAsp BID and since blinding of the different titration algorithms would not have been possible.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IDegAsp Simple
    Arm description
    		 Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the simple titration algorithm. IDegAsp doses were self-titrated, twice weekly (at intervals of 3-4 days) based upon a single pre-breakfast and single pre-dinner self-measured plasma glucose (SMPG) values. The titration of the morning dose was to be based on the previous evening's pre-dinner SMPG measurement and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurement taken on the day of titration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IDegAsp
    Investigational medicinal product code
    Other name
    Insulin degludec and Insulin aspart
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value, with subcutaneous (s.c., under the skin) administration.

    Arm title
    		 IDegAsp Stepwise
    Arm description
    		 Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the step-wise titration algorithm. IDegAsp doses were self-titrated, once weekly, based on lowest of 3 pre-breakfast and 3 pre-dinner self-measured plasma glucose (SMPG) values, (measurements on 3 consecutive days prior to titration). The titration of the morning dose was to be based on the pre-dinner SMPG measurements and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurements.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IDegAsp
    Investigational medicinal product code
    Other name
    Insulin degludec and Insulin aspart
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values, with subcutaneous (s.c., under the skin) administration.

    Number of subjects in period 1
    		IDegAsp Simple IDegAsp Stepwise
    Started
    136
    136
    Completed
    115
    119
    Not completed
    21
    17
         Adverse event, serious fatal
    1
    1
         Adverse event, non-fatal
    2
    1
         Unclassified
    18
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IDegAsp Simple
    Reporting group description
    		 Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the simple titration algorithm. IDegAsp doses were self-titrated, twice weekly (at intervals of 3-4 days) based upon a single pre-breakfast and single pre-dinner self-measured plasma glucose (SMPG) values. The titration of the morning dose was to be based on the previous evening's pre-dinner SMPG measurement and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurement taken on the day of titration.

    Reporting group title
    IDegAsp Stepwise
    Reporting group description
    		 Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the step-wise titration algorithm. IDegAsp doses were self-titrated, once weekly, based on lowest of 3 pre-breakfast and 3 pre-dinner self-measured plasma glucose (SMPG) values, (measurements on 3 consecutive days prior to titration). The titration of the morning dose was to be based on the pre-dinner SMPG measurements and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurements.

    Reporting group values
    		 IDegAsp Simple IDegAsp Stepwise Total
    Number of subjects
    		 136 136 272
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 105 97 202
        From 65-84 years
    		 31 39 70
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.8 ( 9.8 ) 59.1 ( 9.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 60 53 113
        Male
    		 76 83 159
    Body Weight
    Units: Kg
        arithmetic mean (standard deviation)
    		 89.4 ( 19.3 ) 89.4 ( 17.4 ) -
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 31.7 ( 4.8 ) 31.5 ( 4.7 ) -
    Duration of Diabetes
    Units: Years
        arithmetic mean (standard deviation)
    		 13 ( 7 ) 11.2 ( 6.7 ) -
    HbA1c
    Units: Percentage (%)
        arithmetic mean (standard deviation)
    		 8.2 ( 0.9 ) 8.2 ( 0.9 ) -
    Fasting Plasma Glucose (FPG)
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 7.8 ( 2.3 ) 8.1 ( 3 ) -

    End points

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    End points reporting groups
    Reporting group title
    IDegAsp Simple
    Reporting group description
    		 Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the simple titration algorithm. IDegAsp doses were self-titrated, twice weekly (at intervals of 3-4 days) based upon a single pre-breakfast and single pre-dinner self-measured plasma glucose (SMPG) values. The titration of the morning dose was to be based on the previous evening's pre-dinner SMPG measurement and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurement taken on the day of titration.

    Reporting group title
    IDegAsp Stepwise
    Reporting group description
    		 Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the step-wise titration algorithm. IDegAsp doses were self-titrated, once weekly, based on lowest of 3 pre-breakfast and 3 pre-dinner self-measured plasma glucose (SMPG) values, (measurements on 3 consecutive days prior to titration). The titration of the morning dose was to be based on the pre-dinner SMPG measurements and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurements.

    Primary: Change from baseline in HbA1c (%)

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    End point title
    		 Change from baseline in HbA1c (%)
    End point description
    Change from baseline in HbA1c (%) after 26 weeks of treatment.
    End point type
    Primary
    End point timeframe
    At end of 26 weeks of treatment
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    136
    136
    Units: Percentage
        least squares mean (standard error)
    -1.45 ( 0.09 )
    -1.33 ( 0.09 )
    Statistical analysis title
    		 Change from baseline in HbA1c (%).
    Statistical analysis description
    Change from baseline in HbA1c after 26 weeks of treatments is analysed using an ANOVA method with treatment, sex and region as fixed effects, and age and baseline HbA1c as covariates.
    Comparison groups
    IDegAsp Simple v IDegAsp Stepwise
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0.11
    Variability estimate
    Standard error of the mean

    Secondary: Change from baseline in fasting plasma glucose (FPG)

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    End point title
    		 Change from baseline in fasting plasma glucose (FPG)
    End point description
    Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    At end of 26 weeks of treatment
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    136
    136
    Units: mmol/L
        least squares mean (standard error)
    -1.68 ( 0.23 )
    -1.98 ( 0.23 )
    No statistical analyses for this end point

    Secondary: Proportion of subjects achieving HbA1c< 7.0%

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    End point title
    		 Proportion of subjects achieving HbA1c< 7.0%
    End point description
    Proportion of subjects achieving HbA1c< 7.0% at end of 26 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    At end of 26 weeks of treatment
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    136
    136
    Units: Number of subjects
    91
    85
    No statistical analyses for this end point

    Secondary: Proportion of subjects with HbA1c< 7.0% without confirmed hypoglycaemic episodes

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    End point title
    		 Proportion of subjects with HbA1c< 7.0% without confirmed hypoglycaemic episodes
    End point description
    Proportion of subjects with HbA1c< 7.0% without confirmed hypoglycaemic episodes during the last 12 weeks of treatment or within 7 days from last randomised treatment including only subjects exposed for at least 12 weeks.
    End point type
    Secondary
    End point timeframe
    At end of 26 weeks of treatment.
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    122
    125
    Units: Number of subjects
    31
    40
    No statistical analyses for this end point

    Secondary: Self-measured plasma glucose measurements (SMPGs) of the 8-point profiles

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    End point title
    		 Self-measured plasma glucose measurements (SMPGs) of the 8-point profiles
    End point description
    Self-measured plasma glucose measurements (SMPGs) of the 8-point profiles at the end of 26 weeks of treatment. (N: Number of subjects) 1. Before breakfast: N in IDegAsp Simple = 134, IDegAsp Step wise = 131 2. 90 minutes after start of breakfast : N in IDegAsp Simple = 129, IDegAsp Step wise = 126 3. Before lunch: N in IDegAsp Simple = 131, IDegAsp Step wise = 126 4. 90 minutes after start of lunch: N in IDegAsp Simple = 128, IDegAsp Step wise = 127 5. Before main evening meal: N in IDegAsp Simple = 133, IDegAsp Step wise = 128 6. 90 minutes after main evening meal: N in IDegAsp Simple = 127, IDegAsp Step wise = 128 7. Before bedtime: N in IDegAsp Simple = 121, IDegAsp Step wise = 116 8. Before breakfast the following day: N in IDegAsp Simple = 135, IDegAsp Step wise = 131
    End point type
    Secondary
    End point timeframe
    At the end of 26 weeks of treatment
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    136
    136
    Units: mmol/L
    least squares mean (standard error)
        Before breakfast
    6.55 ( 0.2 )
    6.61 ( 0.2 )
        90 minutes after start of breakfast
    8.18 ( 0.28 )
    8.07 ( 0.29 )
        Before lunch
    6.8 ( 0.26 )
    6.48 ( 0.26 )
        90 minutes after start of lunch
    8.91 ( 0.27 )
    8.57 ( 0.27 )
        Before main evening meal
    7.59 ( 0.26 )
    7.27 ( 0.27 )
        90 minutes after main evening meal
    8.74 ( 0.31 )
    8.89 ( 0.31 )
        Before bedtime
    7.89 ( 0.3 )
    8.17 ( 0.31 )
        Before breakfast the following day
    6.41 ( 0.19 )
    6.51 ( 0.2 )
    No statistical analyses for this end point

    Secondary: Self-measured plasma glucose measurements (SMPGs) of the Mean of the 8-point profile

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    End point title
    		 Self-measured plasma glucose measurements (SMPGs) of the Mean of the 8-point profile
    End point description
    Self-measured plasma glucose measurements (SMPGs) of the mean of the 8-point profile at end of 26 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    At end of 26 weeks of treatment.
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    136
    132
    Units: mmol/L
        least squares mean (standard error)
    7.69 ( 0.19 )
    7.72 ( 0.19 )
    No statistical analyses for this end point

    Secondary: Self-measured Prandial plasma glucose (SMPGs) increment from 8-point profile

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    End point title
    		 Self-measured Prandial plasma glucose (SMPGs) increment from 8-point profile
    End point description
    Self-measured Prandial plasma glucose (SMPGs) increment from 8-point profile at end of 26 weeks of treatment. (N: Number of subjects) 1. Mean of SMPG increment-All Meal: N in IDegAsp Simple = 130, N in IDegAsp Step wise = 129 2. SMPG increment-Breakfast: N in IDegAsp Simple = 131, N in IDegAsp Step wise = 129 3. SMPG increment-Lunch: N in IDegAsp Simple = 132, N in IDegAsp Step wise = 129 4. SMPG increment-Evening Meal: N in IDegAsp Simple = 130, N in IDegAsp Step wise = 127
    End point type
    Secondary
    End point timeframe
    At end of 26 weeks of treatment
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    136
    136
    Units: mmol/L
    least squares mean (standard error)
        Mean of SMPG increment: All Meal
    2.21 ( 0.18 )
    2.26 ( 0.19 )
        SMPG increment - Breakfast
    2.61 ( 0.29 )
    2.28 ( 0.29 )
        SMPG increment - Lunch
    2.7 ( 0.3 )
    2.42 ( 0.31 )
        SMPG increment: Evening Meal
    1.62 ( 0.31 )
    2.04 ( 0.32 )
    No statistical analyses for this end point

    Secondary: Incidence of treatment emergent adverse events (TEAEs)

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    End point title
    		 Incidence of treatment emergent adverse events (TEAEs)
    End point description
    A treatment emergent adverse event (TEAE) was defined as an event that has 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.
    End point type
    Secondary
    End point timeframe
    During 28 weeks of trial
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    135 [1]
    134 [2]
    Units: Number
    242
    286
    Notes
    [1] - 242 adverse events were reported in 87 subjects.
    [2] - 286 adverse events were reported in 89 subjects.
    No statistical analyses for this end point

    Secondary: Number of treatment emergent confirmed hypoglycaemic episodes according to the Novo Nordisk definition for confirmed hypoglycaemic episodes

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    End point title
    		 Number of treatment emergent confirmed hypoglycaemic episodes according to the Novo Nordisk definition for confirmed hypoglycaemic episodes
    End point description
    Number of treatment emergent confirmed hypoglycaemic episodes according to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured PG < 3.1 mmol/L (< 56 mg/dL) during 28 weeks of trial.
    End point type
    Secondary
    End point timeframe
    During 28 weeks of trial
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    135 [3]
    134 [4]
    Units: Number
    552
    323
    Notes
    [3] - 552 confirmed hypoglycaemic episodes were reported by 93 subjects.
    [4] - 323 confirmed hypoglycaemic episodes were reported by 78 subjects.
    No statistical analyses for this end point

    Secondary: Number of treatment emergent hypoglycaemic episodes according to the American Diabetes Association (ADA) definition ≤ 3.9 mmol/L (≤ 70 mg/dL)

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    End point title
    		 Number of treatment emergent hypoglycaemic episodes according to the American Diabetes Association (ADA) definition ≤ 3.9 mmol/L (≤ 70 mg/dL)
    End point description
    Number of treatment emergent hypoglycaemic episodes according to the American Diabetes Association (ADA) definition ≤ 3.9 mmol/L (≤ 70 mg/dL).
    End point type
    Secondary
    End point timeframe
    During 28 weeks of trial
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    135 [5]
    134 [6]
    Units: Number
    2226
    1270
    Notes
    [5] - 2226 hypoglycaemic episodes were reported by 122 subjects.
    [6] - 1270 hypoglycaemic episodes were reported by 113 subjects.
    No statistical analyses for this end point

    Secondary: Number of treatment emergent confirmed hypoglycaemic episodes in the maintenance period

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    End point title
    		 Number of treatment emergent confirmed hypoglycaemic episodes in the maintenance period
    End point description
    Number of treatment emergent confirmed hypoglycaemic episodes in the maintenance period (from week 16 to end of trial including follow-up). N = Number of subjects 1. Confirmed episodes: N in IDegAsp Simple = 64, N in IDegAsp Step wise = 50 2. ADA classified episodes: N in IDegAsp Simple = 109, N in IDegAsp Step wise = 94 3. ADA unclassifiable episodes: N in IDegAsp Simple = 3, N in IDegAsp Step wise = 4
    End point type
    Secondary
    End point timeframe
    From week 16 to end of trial including follow-up
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    121
    124
    Units: Number
        Confirmed episodes
    230
    143
        ADA classified episodes
    902
    529
        ADA unclassifiable episodes
    6
    5
    No statistical analyses for this end point

    Secondary: Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes

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    End point title
    		 Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes
    End point description
    Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes during 28 weeks of trial. (N: Number of subjects) 1. Confirmed episodes: N in IDegAsp Simple = 37, N in IDegAsp Step wise = 24 2. ADA classifiable episodes: N in IDegAsp Simple = 71, N in IDegAsp Step wise = 46 3. ADA Unclassifiable episodes: N in IDegAsp Simple = 0, N in IDegAsp Step wise = 0
    End point type
    Secondary
    End point timeframe
    During 28 weeks of trial
    End point values
    		 IDegAsp Simple IDegAsp Stepwise
    Number of subjects analysed
    135
    134
    Units: Number
        Confirmed episodes
    82
    49
        ADA classifiable episodes
    245
    128
        ADA unclassifiable episodes
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period.
    Adverse event reporting additional description
    An adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    IDegAsp Simple
    Reporting group description
    		 Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the simple titration algorithm. IDegAsp doses were self-titrated, twice weekly (at intervals of 3-4 days) based on single pre-breakfast and single pre-dinner self-measured plasma glucose (SMPG) levels, with subcutaneous (s.c., under the skin) administration.

    Reporting group title
    IDegAsp Stepwise
    Reporting group description
    		 Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the step-wise titration algorithm. IDegAsp doses were self-titrated, once weekly, based on lowest of 3 pre-breakfast and 3 pre-dinner self-measured plasma glucose (SMPG) levels, with subcutaneous (s.c., under the skin) administration.

    Serious adverse events
    		 IDegAsp Simple IDegAsp Stepwise
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 135 (5.19%)
    10 / 134 (7.46%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 135 (0.74%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 134 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 134 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 134 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 134 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    2 / 135 (1.48%)
    0 / 134 (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
    		 IDegAsp Simple IDegAsp Stepwise
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 135 (33.33%)
    53 / 134 (39.55%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 135 (6.67%)
    8 / 134 (5.97%)
         occurrences all number
    10
    8
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 135 (3.70%)
    8 / 134 (5.97%)
         occurrences all number
    7
    12
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 135 (4.44%)
    8 / 134 (5.97%)
         occurrences all number
    6
    9
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    6 / 135 (4.44%)
    7 / 134 (5.22%)
         occurrences all number
    6
    7
    Influenza
         subjects affected / exposed
    5 / 135 (3.70%)
    12 / 134 (8.96%)
         occurrences all number
    5
    12
    Nasopharyngitis
         subjects affected / exposed
    12 / 135 (8.89%)
    20 / 134 (14.93%)
         occurrences all number
    16
    23
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 135 (10.37%)
    10 / 134 (7.46%)
         occurrences all number
    16
    12

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23710902
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