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    Clinical Trial Results:
    A clinical trial comparing efficacy and safety of insulin degludec/liraglutide (IDegLira) in subjects with type 2 diabetes mellitus using two different titration algorithms (DUAL™ VI)

    Summary
    EudraCT number
    2012-004625-25
    Trial protocol
    HU   BG   AT   SK   CZ  
    Global end of trial date
    23 Dec 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Jan 2017
    First version publication date
    07 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9068-4056
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02298192
    WHO universal trial number (UTN)
    U1111-1135-6634
    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@novnordisk.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
    15 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2015
    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), using a once weekly titration algorithm, in controlling glycaemia in insulin-naïve subjects with type 2 diabetes (T2DM), inadequately controlled on metformin alone or in combination with pioglitazone. This is done by comparing the difference in change from baseline HbA1c (glycosylated haemoglobin) after 32 weeks of treatment to a non-inferiority limit of 0.30 % for once weekly titration vs. twice weekly titration.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (64th WMA Assembly, October 2013) and ICH Good Clinical Practice (May 1996) and 21 CFR 312.120.
    Background therapy
    -
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    21 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 30
    Country: Number of subjects enrolled
    Bulgaria: 40
    Country: Number of subjects enrolled
    Canada: 30
    Country: Number of subjects enrolled
    Czech Republic: 35
    Country: Number of subjects enrolled
    Hungary: 42
    Country: Number of subjects enrolled
    Serbia: 39
    Country: Number of subjects enrolled
    Russian Federation: 35
    Country: Number of subjects enrolled
    Slovakia: 60
    Country: Number of subjects enrolled
    United States: 109
    Worldwide total number of subjects
    420
    EEA total number of subjects
    207
    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)
    328
    From 65 to 84 years
    92
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial was conducted at 80 sites in 9 countries as follows: Austria: 6 sites; Bulgaria: 5 sites; Canada: 7 sites, Czech Republic: 5 sites; Hungary: 4 sites, Russian Federation: 6 sites; Serbia: 4 sites, Slovakia: 7 sites; United States: 36 sites.

    Pre-assignment
    Screening details
    Stable daily treatment with metformin (≥1500 mg or max tolerated dose) ± pioglitazone (≥30 mg) 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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    IDegLira 1WT
    Arm description
    Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50 units/1.8mg liraglutide). The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured prebreakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
    Arm type
    Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    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 insulin degludec/liraglutide ratio of 100 units/3.6 mg per mL solution subcutaneously in the thigh, upper arm(deltoid) or abdomen approximately at the same time everyday.

    Investigational medicinal product name
    Insulin Degludec
    Investigational medicinal product code
    Other name
    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 insulin degludec/liraglutide ratio of 100 units/3.6 mg per mL solution subcutaneously in the thigh, upper arm(deltoid) or abdomen approximately at the same time everyday.

    Arm title
    IDegLira
    Arm description
    Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group, the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured prebreakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
    Arm type
    Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    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 insulin degludec/liraglutide ratio of 100 units/3.6 mg per mL solution subcutaneously in the thigh, upper arm(deltoid) or abdomen approximately at the same time everyday.

    Investigational medicinal product name
    Insulin Degludec
    Investigational medicinal product code
    Other name
    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 insulin degludec/liraglutide ratio of 100 units/3.6 mg per mL solution subcutaneously in the thigh, upper arm(deltoid) or abdomen approximately at the same time everyday.

    Number of subjects in period 1
    IDegLira 1WT IDegLira
    Started
    210
    210
    Completed
    191
    204
    Not completed
    19
    6
         Adverse event, non-fatal
    6
    2
         withdrawal critera
    2
    -
         Consent withdrawn by subject
    6
    1
         unclassifed
    3
    2
         Lost to follow-up
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IDegLira 1WT
    Reporting group description
    Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50 units/1.8mg liraglutide). The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured prebreakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.

    Reporting group title
    IDegLira
    Reporting group description
    Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group, the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured prebreakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.

    Reporting group values
    IDegLira 1WT IDegLira Total
    Number of subjects
    210 210 420
    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)
    162 166 328
        From 65-84 years
    48 44 92
        85 years and over
    0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    56.6 ± 10.3 57 ± 9.6 -
    Gender Categorical
    Units: Subjects
        Female
    99 98 197
        Male
    111 112 223
    HbA1C
    Units: percentage
        arithmetic mean (standard deviation)
    8.2 ± 0.9 8.1 ± 0.9 -

    End points

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    End points reporting groups
    Reporting group title
    IDegLira 1WT
    Reporting group description
    Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50 units/1.8mg liraglutide). The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured prebreakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.

    Reporting group title
    IDegLira
    Reporting group description
    Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group, the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured prebreakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.

    Primary: Change from baseline in HbA1c

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    End point title
    Change from baseline in HbA1c
    End point description
    Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment. Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.
    End point type
    Primary
    End point timeframe
    Week 0, week 32
    End point values
    IDegLira 1WT IDegLira
    Number of subjects analysed
    189
    200
    Units: percentage
        arithmetic mean (standard deviation)
    -2.01 ± 1.09
    -2.02 ± 0.98
    Statistical analysis title
    Statistical analysis
    Statistical analysis description
    A standard MMRM model was applied for primary endpoint. The model included treatment, visit, region and previous OAD treatment as fixed factors and the corresponding baseline value as a covariate with an unstructured covariance structure. Interactions between visit and all factors and covariates were also included in the model. In the following, this model will be referred to as the standard MMRM model.
    Comparison groups
    IDegLira v IDegLira 1WT
    Number of subjects included in analysis
    389
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.012
    Method
    Mixed models analysis
    Parameter type
    Treatment-Contrast
    Point estimate
    0.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.04
         upper limit
    0.28

    Secondary: HbA1c below 7.0%

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    End point title
    HbA1c below 7.0%
    End point description
    Responders to HbA1c below 7% after 32 weeks of treatment. Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 0, week 32
    End point values
    IDegLira 1WT IDegLira
    Number of subjects analysed
    189
    200
    Units: Participants
    number (not applicable)
        Yes
    170
    179
        No
    19
    21
    No statistical analyses for this end point

    Secondary: HbA1c below or equal to 6.5%

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    End point title
    HbA1c below or equal to 6.5%
    End point description
    Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment. Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 0, week 32
    End point values
    IDegLira 1WT IDegLira
    Number of subjects analysed
    189
    200
    Units: Participants
    number (not applicable)
        Yes
    158
    170
        No
    31
    30
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
    Adverse event reporting additional description
    Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated”.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    IDegLira
    Reporting group description
    Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group, the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured prebreakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.

    Reporting group title
    IDegLira (1WT)
    Reporting group description
    Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50 units/1.8mg liraglutide). The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured prebreakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.

    Serious adverse events
    IDegLira IDegLira (1WT)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 210 (6.67%)
    7 / 209 (3.35%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Endometrial adenocarcinoma
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         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
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (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
    Haematuria
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    2 / 210 (0.95%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal pain
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (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
    Hyperglycaemia
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    2 / 210 (0.95%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (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 IDegLira (1WT)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 210 (9.05%)
    24 / 209 (11.48%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    11 / 210 (5.24%)
    11 / 209 (5.26%)
         occurrences all number
    20
    16
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 210 (4.29%)
    13 / 209 (6.22%)
         occurrences all number
    13
    16

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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