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    Clinical Trial Results:
    A 26-week trial comparing efficacy and safety of insulin degludec/insulin aspart BID and insulin degludec OD plus insulin aspart in subjects with type 2 Diabetes Mellitus treated with basal insulin in need of treatment intensification with mealtime insulin.

    Summary
    EudraCT number
    		 2012-002346-20
    Trial protocol
    		 AT   NO  
    Global end of trial date
    09 Jan 2014

    Results information
    Results version number
    		 v1
    This version publication date
    01 Apr 2016
    First version publication date
    31 Jul 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    NN5401-3996
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01713530
    WHO universal trial number (UTN)
    		 U1111-1130-7135
    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
    24 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial was to confirm the efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) in controlling glycaemia after 26 weeks of treatment.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical Practice (1996) and FDA 21 CFR 312.120.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    21 Feb 2013
    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
    Algeria: 36
    Country: Number of subjects enrolled
    United States: 140
    Country: Number of subjects enrolled
    France: 42
    Country: Number of subjects enrolled
    Norway: 33
    Country: Number of subjects enrolled
    Austria: 23
    Worldwide total number of subjects
    274
    EEA total number of subjects
    98
    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)
    204
    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 48 sites in five countries as follows: Algeria (4), Austria (6), France (8), Norway (6), United States (24). In addition, 3 sites (in Austria and US) screened but did not randomise any subjects, and one site in Norway was approved by the institutional review board (IRB) but did not screen any subjects.

    Pre-assignment
    Screening details
    		 For both treatment arms, diet and exercise counselling was continued as per the standard of care at the investigational site. During the screening and treatment period, it was not allowed to start any other antidiabetic treatment, change the pre-randomisation OAD (except for the SU/glinides which were to be discontinued at randomisation)or OAD dose

    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
    		 IDegAsp BID
    Arm description
    		 IDegAsp is the soluble co-formulation of IDeg (70%) and IAsp (30%). IDegAsp was administered twice daily (BID).
    Arm type
    		 Experimental

    Investigational medicinal product name
    IDegAsp
    Investigational medicinal product code
    Other name
    Insulin degludec, insulin aspart
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IDegAsp 100 U/mL, 3 mL prefilled pen PDS290, for subcutaneous injection. IDegAsp was administered twice daily (BID); either with breakfast and dinner or with lunch and dinner. IDegAsp was injected subcutaneously in the abdomen, upper arm (deltoid area) or thigh. The injection area was to remain the same throughout the trial, but the site within the area was to be changed for each injection.

    Arm title
    		 IDeg once daily (OD) + IAsp
    Arm description
    		 IDeg was administered once daily (OD) at any time of the day. IAsp was administered with the main meals 2−4 times daily in accordance with local labelling.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    IDeg
    Investigational medicinal product code
    Other name
    Insulin degludec
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IDeg 100 U/mL, 3 mL prefilled pen PDS290, for subcutaneous injection. IDeg was administered once daily (OD) subcutaneous injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial.

    Investigational medicinal product name
    IAsp
    Investigational medicinal product code
    Other name
    insulin aspart
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IAsp; NovoRapid®/NovoLog®, 100 U/mL, 3 mL, FlexPen®, for subcutaneous injection. IAsp was administered with the main meals 2−4 times daily in accordance with local labelling. The IAsp was injected subcutaneously preferably into the abdominal wall in accordance with local labelling.

    Number of subjects in period 1
    		IDegAsp BID IDeg once daily (OD) + IAsp
    Started
    138
    136
    Completed
    113
    117
    Not completed
    25
    19
         Adverse event, serious fatal
    -
    1
         Adverse event, non-fatal
    -
    4
         Unclassified
    4
    2
         Protocol deviation
    21
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IDegAsp BID
    Reporting group description
    		 IDegAsp is the soluble co-formulation of IDeg (70%) and IAsp (30%). IDegAsp was administered twice daily (BID).

    Reporting group title
    IDeg once daily (OD) + IAsp
    Reporting group description
    		 IDeg was administered once daily (OD) at any time of the day. IAsp was administered with the main meals 2−4 times daily in accordance with local labelling.

    Reporting group values
    		 IDegAsp BID IDeg once daily (OD) + IAsp Total
    Number of subjects
    		 138 136 274
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 104 100 204
        From 65-84 years
    		 34 36 70
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.6 ( 8.3 ) 59.6 ( 9.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 65 50 115
        Male
    		 73 86 159
    Body weight
    Units: Kg
        arithmetic mean (standard deviation)
    		 91.2 ( 17.7 ) 93.3 ( 15.2 ) -

    End points

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    End points reporting groups
    Reporting group title
    IDegAsp BID
    Reporting group description
    		 IDegAsp is the soluble co-formulation of IDeg (70%) and IAsp (30%). IDegAsp was administered twice daily (BID).

    Reporting group title
    IDeg once daily (OD) + IAsp
    Reporting group description
    		 IDeg was administered once daily (OD) at any time of the day. IAsp was administered with the main meals 2−4 times daily in accordance with local labelling.

    Primary: Change from baseline in HbA1c (%)

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    End point title
    		 Change from baseline in HbA1c (%)
    End point description
    End point type
    Primary
    End point timeframe
    After 26 weeks of treatment
    End point values
    		 IDegAsp BID IDeg once daily (OD) + IAsp
    Number of subjects analysed
    138
    136
    Units: percentage
        least squares mean (standard error)
    -1.23 ( 0.13 )
    -1.42 ( 0.12 )
    Statistical analysis title
    		 HbA1c (%) after 26 weeks of treatment
    Statistical analysis description
    Change from baseline in HbA1c after 26 weeks of treatment was analysed using an Analysis of Variance (ANOVA) method with treatment, anti-diabetic therapy at screening, sex and region as fixed factors, and age and baseline HbA1c as covariates.
    Comparison groups
    IDegAsp BID v IDeg once daily (OD) + IAsp
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.029 [2]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.41
    Notes
    [1] - The test of mean treatment difference is greater than 0.4%.
    [2] - Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%. This was equivalent to using a one-sided test of size 2.5%.

    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
    After 26 weeks of treatment.
    End point values
    		 IDegAsp BID IDeg once daily (OD) + IAsp
    Number of subjects analysed
    136
    136
    Units: mmol/L
        least squares mean (standard error)
    -2.22 ( 0.38 )
    -1.9 ( 0.36 )
    No statistical analyses for this end point

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

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    End point title
    		 Number of treatment emergent hypoglycaemic episodes according to Novo Nordisk definition of confirmed hypoglycaemic episodes.
    End point description
    Novo Nordisk definition for confirmed hypoglycaemic episodes: severe hypoglycaemia and /or a measured plasma glucose (PG)< 3.1 mmol/L (56 mg/dL).
    End point type
    Secondary
    End point timeframe
    During 26 weeks of treatment
    End point values
    		 IDegAsp BID IDeg once daily (OD) + IAsp
    Number of subjects analysed
    136
    135
    Units: Number of episodes
    706
    841
    No statistical analyses for this end point

    Secondary: Number of treatment emergent hypoglycaemic episodes according to the American Diabetes Association (ADA) definition

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    End point title
    		 Number of treatment emergent hypoglycaemic episodes according to the American Diabetes Association (ADA) definition
    End point description
    Categories of hypoglycaemic episode as per ADA definition: Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL). Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL). Relative hypoglycaemia: An episode during which the person with diabetes mellitus reports any of the typical symptoms of hypoglycaemia, and interprets those as indicative of hypoglycaemia, but with a measured PG concentration > 3.9 mmol/L (70 mg/dL). Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination (but that was presumably caused by a PG concentration ≤ 3.9 mmol/L [70 m
    End point type
    Secondary
    End point timeframe
    During 26 weeks of treatment
    End point values
    		 IDegAsp BID IDeg once daily (OD) + IAsp
    Number of subjects analysed
    136
    135
    Units: events
        American Diabetes Association (ADA)
    2894
    2685
        Severe
    29
    15
        Documented symptomatic
    1818
    1843
        Asymptomatic
    930
    728
        Probable symptomatic
    26
    33
        Relative
    91
    66
    No statistical analyses for this end point

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

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    End point title
    		 Number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes.
    End point description
    Nocturnal period is defined as the period between 00:01 and 05:59 a.m. (both included) in which hypoglycaemia can occur.
    End point type
    Secondary
    End point timeframe
    During 26 weeks of treatment
    End point values
    		 IDegAsp BID IDeg once daily (OD) + IAsp
    Number of subjects analysed
    136
    135
    Units: Number of episodes
    75
    96
    No statistical analyses for this end point

    Secondary: Incidence of treatment emergent adverse events (TEAE).

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    End point title
    		 Incidence of treatment emergent adverse events (TEAE).
    End point description
    A 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 26 weeks of treatment.
    End point values
    		 IDegAsp BID IDeg once daily (OD) + IAsp
    Number of subjects analysed
    136
    135
    Units: Event
    330
    298
    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 (visit 29).
    Adverse event reporting additional description
    Safety analysis set included all the subjects receiving at least one dose of the investigational product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0, 16.1
    Reporting groups
    Reporting group title
    IDegAsp PDS290
    Reporting group description
    		 IDegAsp was to be administered either with breakfast and dinner or with lunch and dinner. IDegAsp was to be injected subcutaneously in the abdomen, upper arm (deltoid area) or thigh.

    Reporting group title
    IDeg OD + IAsp
    Reporting group description
    		 IDeg was to be administered OD at any time of the day. It was to be injected subcutaneously in the abdomen, upper arm (deltoid area) or thigh. IAsp was to be administered with the main meals 2−4 times daily in accordance with local labelling.

    Serious adverse events
    		 IDegAsp PDS290 IDeg OD + IAsp
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 136 (5.15%)
    13 / 135 (9.63%)
         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)
    Pituitary tumour benign
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 136 (0.00%)
    2 / 135 (1.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rib fracture
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrong drug administered
         subjects affected / exposed
    0 / 136 (0.00%)
    2 / 135 (1.48%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (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
    Hypersomnia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic unconsciousness
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Ocular hypertension
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumomediastinum
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         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
    1 / 136 (0.74%)
    2 / 135 (1.48%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IDegAsp PDS290 IDeg OD + IAsp
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 136 (33.82%)
    38 / 135 (28.15%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 136 (7.35%)
    8 / 135 (5.93%)
         occurrences all number
    12
    12
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    10 / 136 (7.35%)
    2 / 135 (1.48%)
         occurrences all number
    10
    2
    Fatigue
         subjects affected / exposed
    7 / 136 (5.15%)
    1 / 135 (0.74%)
         occurrences all number
    7
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 136 (6.62%)
    9 / 135 (6.67%)
         occurrences all number
    9
    9
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 136 (3.68%)
    7 / 135 (5.19%)
         occurrences all number
    5
    8
    Pain in extremity
         subjects affected / exposed
    8 / 136 (5.88%)
    3 / 135 (2.22%)
         occurrences all number
    8
    3
    Infections and infestations
    Influenza
         subjects affected / exposed
    9 / 136 (6.62%)
    5 / 135 (3.70%)
         occurrences all number
    9
    7
    Nasopharyngitis
         subjects affected / exposed
    11 / 136 (8.09%)
    12 / 135 (8.89%)
         occurrences all number
    11
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Dec 2012
    Due to unforeseen changes in the regulatory environment, India was removed as a participating country and Quintiles Laboratory in Mumbai was removed from Protocol Attachment I. In order to reflect real life practice, it was clarified that 11 days from visit 1 to visit 2 were allowed. The timing of fundoscopy/fundus photography and that subjects were not to discard unused trial products was clarified. Due to a change in international trial manager, Protocol Attachment I was updated. Minor inconsistencies in Appendix A were corrected

    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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