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    Clinical Trial Results:
    DUAL™VII - Insulin degludec/liraglutide (IDegLira) vs. basal-bolus therapy: A clinical trial comparing efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in subjects with type 2 diabetes mellitus

    Summary
    EudraCT number
    2014-003621-18
    Trial protocol
    HU   SK   GR   ES   CZ   FR  
    Global end of trial date
    05 Oct 2016

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

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9068-4185
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02420262
    WHO universal trial number (UTN)
    U1111-1160-6923
    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)
    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
    30 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm the efficacy of insulin degludec/liraglutide (IDegLira) in terms of glycaemic control in subjects with type 2 diabetes mellitus on previous treatment with insulin glargine (IGlar) and metformin. This was done by comparing the difference in change in HbA1c from baseline after 26 weeks of treatment to a non-inferiority limit of 0.30% for once daily IDegLira versus basal-bolus therapy with once daily IGlar plus prandial insulin aspart (IAsp), both arms in combination with metformin.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (64th WMA Assembly) and ICH Good Clinical Practice (May 1996) and 21 CFR 312.120.
    Background therapy
    All subjects were to continue with metformin at the stable pre-trial dose level, unless there was a safety concern.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    26 Jul 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
    Argentina: 45
    Country: Number of subjects enrolled
    Czech Republic: 37
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Greece: 44
    Country: Number of subjects enrolled
    Hungary: 37
    Country: Number of subjects enrolled
    Israel: 30
    Country: Number of subjects enrolled
    Mexico: 46
    Country: Number of subjects enrolled
    Russian Federation: 50
    Country: Number of subjects enrolled
    Slovakia: 36
    Country: Number of subjects enrolled
    Spain: 45
    Country: Number of subjects enrolled
    Turkey: 40
    Country: Number of subjects enrolled
    United States: 80
    Worldwide total number of subjects
    506
    EEA total number of subjects
    215
    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)
    382
    From 65 to 84 years
    123
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    The trial was conducted at 89 sites in 12 countries: Argentina (3 sites), Czech Republic (5 sites), France (3 sites), Greece (6 sites), Hungary (3 sites), Israel (6 sites), Mexico (3 sites), Russia (7 sites), Slovakia (5 sites), Spain (6 sites), Turkey (5 sites) and United States (37 sites).

    Pre-assignment
    Screening details
    Subjects with type 2 diabetes mellitus were on treatment with stable daily dose of insulin glargine (IGlar) between 20 units and 50 units (both inclusive) for at least 56 days prior to screening in combination with a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) for at least 90 days prior to screening.

    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
    IDegLira
    Arm description
    Insulin Degludec/Liraglutide (IDegLira) was administered once daily (OD) for a duration of 26 weeks. IDegLira treatment was initiated at starting dose 16 dose steps and was titrated according to a predefined titration algorithm. The maximum daily dose was 50 dose steps. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
    Arm type
    Experimental

    Investigational medicinal product name
    Insulin degludec liraglutide
    Investigational medicinal product code
    Other name
    Xultophy®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira).

    Arm title
    IGlar + IAsp
    Arm description
    Subjects received insulin glargine plus prandial insulin aspart (IGlar + IAsp) for a duration of 26 weeks. A stable pre-trial OD dose of IGlar was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U as prandial insulin treatment before each main meal and was titrated in a treat-to-target fashion in accordance with a predefined titration algorithm. There was no maximum dose specified for IGlar or IAsp.
    Arm type
    Active comparator

    Investigational medicinal product name
    Insulin Glargine
    Investigational medicinal product code
    Other name
    Lantus®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).

    Investigational medicinal product name
    Insulin Aspart
    Investigational medicinal product code
    Other name
    NovoRapid®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 – 6.0 mmol/L).

    Number of subjects in period 1
    IDegLira IGlar + IAsp
    Started
    252
    254
    Exposed
    252
    253
    Completed
    250
    249
    Not completed
    2
    5
         Adverse event, non-fatal
    1
    -
         Consent withdrawn by subject
    1
    4
         Unclassified
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IDegLira
    Reporting group description
    Insulin Degludec/Liraglutide (IDegLira) was administered once daily (OD) for a duration of 26 weeks. IDegLira treatment was initiated at starting dose 16 dose steps and was titrated according to a predefined titration algorithm. The maximum daily dose was 50 dose steps. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.

    Reporting group title
    IGlar + IAsp
    Reporting group description
    Subjects received insulin glargine plus prandial insulin aspart (IGlar + IAsp) for a duration of 26 weeks. A stable pre-trial OD dose of IGlar was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U as prandial insulin treatment before each main meal and was titrated in a treat-to-target fashion in accordance with a predefined titration algorithm. There was no maximum dose specified for IGlar or IAsp.

    Reporting group values
    IDegLira IGlar + IAsp Total
    Number of subjects
    252 254 506
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    182 200 382
        From 65-84 years
    70 53 123
        85 years and over
    0 1 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    58.6 ± 9.0 58.0 ± 8.6 -
    Gender, Male/Female
    Units: Subjects
        Female
    142 137 279
        Male
    110 117 227
    Study Specific Characteristic | Glycosylated haemoglobin (HbA1c)
    Units: percentage of glycosylated haemoglobin
        arithmetic mean (standard deviation)
    8.21 ± 0.76 8.24 ± 0.81 -
    Study Specific Characteristic | Body Weight
    Units: kg
        arithmetic mean (standard deviation)
    87.2 ± 16.0 88.2 ± 17.2 -

    End points

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    End points reporting groups
    Reporting group title
    IDegLira
    Reporting group description
    Insulin Degludec/Liraglutide (IDegLira) was administered once daily (OD) for a duration of 26 weeks. IDegLira treatment was initiated at starting dose 16 dose steps and was titrated according to a predefined titration algorithm. The maximum daily dose was 50 dose steps. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.

    Reporting group title
    IGlar + IAsp
    Reporting group description
    Subjects received insulin glargine plus prandial insulin aspart (IGlar + IAsp) for a duration of 26 weeks. A stable pre-trial OD dose of IGlar was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U as prandial insulin treatment before each main meal and was titrated in a treat-to-target fashion in accordance with a predefined titration algorithm. There was no maximum dose specified for IGlar or IAsp.

    Primary: Change from baseline in HbA1c (glycosylated haemoglobin)

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    End point title
    Change from baseline in HbA1c (glycosylated haemoglobin)
    End point description
    Change from baseline in HbA1c values after 26 weeks of treatment. The analysis of this efficacy endpoint was based on the full analysis set (FAS). The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 14 subjects in IDegLira and 21 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.
    End point type
    Primary
    End point timeframe
    After 26 weeks of treatment
    End point values
    IDegLira IGlar + IAsp
    Number of subjects analysed
    244
    245
    Units: Percentage of glycosylated haemoglobin
        least squares mean (standard error)
    -1.48 ± 0.05
    -1.46 ± 0.05
    Statistical analysis title
    Primary statistical analysis
    Statistical analysis description
    Change from baseline in HbA1c was analysed using a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline HbA1c as covariate. Interactions between visit and all factors and the covariate were also included in the model.
    Comparison groups
    IGlar + IAsp v IDegLira
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Treatment contrast
    Point estimate
    -0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.16
         upper limit
    0.12
    Notes
    [1] - Non-inferiority for IDegLira vs basal-bolus (IGlar + IAsp) was considered confirmed if the upper boundary of the two-sided 95% confidence interval was strictly below 0.30% or equivalent for non-inferiority using one-sided test for null hypothesis (H0): D ≥0.30% against alternative hypothesis (HA): D <0.30% was less than or equal to 2.5%, where D is the mean treatment difference (IDegLira minus basal-bolus).

    Secondary: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes

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    End point title
    Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
    End point description
    Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”. One subject in IGlar + IAsp arm did not contribute to the analysis for this endpoint.
    End point type
    Secondary
    End point timeframe
    During 26 weeks of treatment
    End point values
    IDegLira IGlar + IAsp
    Number of subjects analysed
    252
    253
    Units: Number of episodes
    129
    975
    Statistical analysis title
    Confirmatory secondary statistical analysis
    Statistical analysis description
    Hypoglycaemic episodes were analysed using a negative binomial regression. The model included treatment and region as fixed factors and logarithm of the time period in which a hypoglycaemic episode considered treatment emergent as offset.
    Comparison groups
    IDegLira v IGlar + IAsp
    Number of subjects included in analysis
    505
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    < 0.0001
    Method
    Negative binomial regression model
    Parameter type
    Treatment ratio
    Point estimate
    0.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.08
         upper limit
    0.17
    Notes
    [2] - Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment rate ratio was entirely below 1.0. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.

    Secondary: Change from baseline in body weight

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    End point title
    Change from baseline in body weight
    End point description
    Change from baseline in body weight after 26 weeks of treatment. The analysis of this efficacy endpoint was based on the full analysis set (FAS). The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 08 subjects in both IDegLira and IGlar + IAsp arm did not contribute to the analysis for this endpoint.
    End point type
    Secondary
    End point timeframe
    After 26 weeks of treatment
    End point values
    IDegLira IGlar + IAsp
    Number of subjects analysed
    244
    246
    Units: kg
        least squares mean (standard error)
    -0.93 ± 0.22
    2.64 ± 0.22
    Statistical analysis title
    Confirmatory secondary statistical analysis
    Statistical analysis description
    Body weight measurements were analysed using a linear mixed model with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline bodyweight as covariate. Interactions between visit and all factors and the covariate were also included in the model.
    Comparison groups
    IDegLira v IGlar + IAsp
    Number of subjects included in analysis
    490
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Treatment difference
    Point estimate
    -3.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.19
         upper limit
    -2.95
    Notes
    [3] - Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment difference was below 0 or equal to 0.

    Secondary: Responder for HbA1c below 7.0%

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    End point title
    Responder for HbA1c below 7.0%
    End point description
    Number of subjects with HbA1c below 7% after 26 weeks of treatment. The analysis of this efficacy endpoint was based on the full analysis set (FAS). The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 14 subjects in IDegLira and 21 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.
    End point type
    Secondary
    End point timeframe
    After 26 weeks of treatment
    End point values
    IDegLira IGlar + IAsp
    Number of subjects analysed
    238
    233
    Units: Participants
        Yes
    157
    156
        No
    81
    77
    No statistical analyses for this end point

    Secondary: Responder for HbA1c below or equal to 6.5 %

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    End point title
    Responder for HbA1c below or equal to 6.5 %
    End point description
    Number of subjects with HbA1c below 7% after 26 weeks of treatment. The analysis of this efficacy endpoint was based on the full analysis set (FAS). The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 14 subjects in IDegLira and 21 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.
    End point type
    Secondary
    End point timeframe
    After 26 weeks of treatment
    End point values
    IDegLira IGlar + IAsp
    Number of subjects analysed
    238
    233
    Units: Participants
        Yes
    118
    104
        No
    120
    129
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until 26 weeks+ follow-up contact (comprising of 7 days) after end of randomised treatment.
    Adverse event reporting additional description
    A treatment emergent adverse event was defined as an event that had onset time after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). Analysis was performed using SAS, included all subjects receiving at least one dose of trial product.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    IDegLira
    Reporting group description
    Insulin Degludec/Liraglutide (IDegLira) was administered once daily (OD) for a duration of 26 weeks. IDegLira treatment was initiated at starting dose 16 dose steps and was titrated according to a predefined titration algorithm. The maximum daily dose was 50 dose steps. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.

    Reporting group title
    IGlar + IAsp
    Reporting group description
    Subjects received insulin glargine plus prandial insulin aspart (IGlar + IAsp) for a duration of 26 weeks. A stable pre-trial OD dose of IGlar was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U as prandial insulin treatment before each main meal and was titrated in a treat-to-target fashion in accordance with a predefined titration algorithm. There was no maximum dose specified for IGlar or IAsp.

    Serious adverse events
    IDegLira IGlar + IAsp
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 252 (4.76%)
    10 / 253 (3.95%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Embolism arterial
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Silent myocardial infarction
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic cyst
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Stag horn calculus
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 253 (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 / 252 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 253 (0.40%)
         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 / 252 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diabetic foot infection
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 252 (0.40%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    IDegLira IGlar + IAsp
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    84 / 252 (33.33%)
    79 / 253 (31.23%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 252 (5.56%)
    18 / 253 (7.11%)
         occurrences all number
    17
    23
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    9 / 252 (3.57%)
    14 / 253 (5.53%)
         occurrences all number
    9
    15
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    16 / 252 (6.35%)
    10 / 253 (3.95%)
         occurrences all number
    24
    17
    Nausea
         subjects affected / exposed
    28 / 252 (11.11%)
    4 / 253 (1.58%)
         occurrences all number
    37
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 252 (4.76%)
    30 / 253 (11.86%)
         occurrences all number
    12
    35
    Influenza
         subjects affected / exposed
    18 / 252 (7.14%)
    12 / 253 (4.74%)
         occurrences all number
    21
    13
    Upper respiratory tract infection
         subjects affected / exposed
    15 / 252 (5.95%)
    17 / 253 (6.72%)
         occurrences all number
    15
    19

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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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