Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomised trial comparing efficacy and safety after intensification with either insulin aspart once daily as add-on or changing to basal bolus treatment with insulin degludec and insulin aspart in subjects with type 2 diabetes previously treated with insulin degludec/insulin aspart twice daily

    Summary
    EudraCT number
    		 2012-003152-37
    Trial protocol
    		 DE  
    Global end of trial date
    07 Mar 2014

    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

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NN5401-4003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01814137
    WHO universal trial number (UTN)
    		 U1111-1132-2674
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Alle, 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
    11 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) vs. basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c)
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2009), International Conference on Harmonisation Good Clinical Practice (1996), EN ISO 14155 Part 1 and 2, and FDA 21 CFR 312.120.
    Background therapy
    		 DPP-4 inhibitor and/or metformin were the only allowed OAD treatments in trial NN5401-4003, and the dose and dosing frequency were not to be changed at any time during the 26-week treatment period, unless dose reductions were needed for safety reasons. Start of any new antidiabetic treatment was not allowed.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    12 Mar 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
    Germany: 2
    Country: Number of subjects enrolled
    Malaysia: 11
    Country: Number of subjects enrolled
    Turkey: 1
    Country: Number of subjects enrolled
    United States: 26
    Worldwide total number of subjects
    40
    EEA total number of subjects
    2
    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)
    32
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The trial was conducted at 20 sites in 4 countries as follows: Germany: 1 site; Malaysia: 2 sites; Turkey: 1 site; United States: 16 sites. The subjects in this trial were to continue from trial NN5401-3941.

    Pre-assignment
    Screening details
    		 Subjects who did not reach the HbA1c target < 7.0% on IDegAsp BID after 26 weeks of treatment in trial NN5401-3941 were enrolled in this trial.

    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 + IAsp
    Arm description
    		 Subjects randomised to IDegAsp BID + IAsp OD were, at the discretion of the investigator, to start the doses of IDegAsp taken with breakfast and main evening meal at Week 26 in trial NN5401-3941 and add 4 units of IAsp at lunch.
    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 was administered subcutaneously (s.c.) by 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. Rotation of injection sites within a given region was recommended. Titration (self-titration) of IDegAsp was performed once weekly.

    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 was injected s.c. with the main meal OD, depending on the treatment arm, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. Dose reduction had to be done based on the investigator’s discretion.

    Arm title
    		 IDeg OD + IAsp
    Arm description
    		 Subjects randomised to IDeg OD + IAsp TID were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into three doses.
    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 was administered s.c. by 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. Rotation of injection sites within a given region was recommended. When needed, the subjects had the option of changing the OD injection time from day to day. Titration (self-titration) of IDeg was performed once weekly.

    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 was injected s.c. with the main meals TID, depending on the treatment arm, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. Dose reduction had to be done based on the investigator’s discretion.

    Number of subjects in period 1
    		IDegAsp BID + IAsp IDeg OD + IAsp
    Started
    20
    20
    Completed
    15
    15
    Not completed
    5
    5
         Adverse event, non-fatal
    -
    1
         Withdrawal criteria
    3
    3
         Unclassified
    2
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    IDegAsp BID + IAsp
    Reporting group description
    		 Subjects randomised to IDegAsp BID + IAsp OD were, at the discretion of the investigator, to start the doses of IDegAsp taken with breakfast and main evening meal at Week 26 in trial NN5401-3941 and add 4 units of IAsp at lunch.

    Reporting group title
    IDeg OD + IAsp
    Reporting group description
    		 Subjects randomised to IDeg OD + IAsp TID were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into three doses.

    Reporting group values
    		 IDegAsp BID + IAsp IDeg OD + IAsp Total
    Number of subjects
    		 20 20 40
    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)
    		 16 16 32
        From 65-84 years
    		 4 4 8
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58 ± 8 56.9 ± 8.1 -
    Gender categorical
    Units: Subjects
        Female
    		 5 9 14
        Male
    		 15 11 26
    Body weight
    Units: Kg
        arithmetic mean (standard deviation)
    		 90.4 ± 20.7 85.3 ± 20.2 -
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 31.7 ± 5.3 31.1 ± 6.2 -
    Glycosylated haemoglobin (HbA1c)
    Units: Percentage (%)
        arithmetic mean (standard deviation)
    		 7.9 ± 0.7 7.7 ± 0.6 -
    Fasting plasma glucose (FPG)
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 7.3 ± 3.5 8.6 ± 2.8 -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    IDegAsp BID + IAsp
    Reporting group description
    		 Subjects randomised to IDegAsp BID + IAsp OD were, at the discretion of the investigator, to start the doses of IDegAsp taken with breakfast and main evening meal at Week 26 in trial NN5401-3941 and add 4 units of IAsp at lunch.

    Reporting group title
    IDeg OD + IAsp
    Reporting group description
    		 Subjects randomised to IDeg OD + IAsp TID were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into three doses.

    Primary: Change from baseline in HbA1c (%)

    		 Close Top of page
    End point title
    		 Change from baseline in HbA1c (%)
    End point description
    Percentage point change in glycosylated haemoglobin A1c (HbA1c) during 26 weeks of treatment.
    End point type
    Primary
    End point timeframe
    Mean change from baseline in HbA1c during 26 weeks of treatment.
    End point values
    		 IDegAsp BID + IAsp IDeg OD + IAsp
    Number of subjects analysed
    20
    20
    Units: Percentage (%)
        least squares mean (standard error)
    0.05 ± 0.2
    -0.49 ± 0.19
    Statistical analysis title
    		 HbA1c (%) after 26 weeks of treatment
    Statistical analysis description
    Change from baseline in HbA1c after 26 weeks of treatment was to be analysed using an Analysis of Variance (ANOVA) method with treatment, sex and region as fixed factors, and age and baseline HbA1c as covariates. The region was a factor with four levels: 1. North America, 2. Europe, 3. Asia, and 4. Africa.
    Comparison groups
    IDegAsp BID + IAsp v IDeg OD + IAsp
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.021 [2]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (Change from Baseline)
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.09
         upper limit
    		 0.99
    Variability estimate
    Standard error of the mean
    Notes
    [1] - It is a comparison trial.
    [2] - P-values were only to be presented for the primary endpoint. The other endpoints were considered supportive and explorative in nature and, hence, no p-values were to be presented.

    Secondary: Incidence of treatment emergent adverse events (TEAEs)

    		 Close Top of page
    End point title
    		 Incidence of treatment emergent adverse events (TEAEs)
    End point description
    A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product.
    End point type
    Secondary
    End point timeframe
    During 26 weeks of treatment.
    End point values
    		 IDegAsp BID + IAsp IDeg OD + IAsp
    Number of subjects analysed
    20
    20
    Units: number of events
    33
    45
    No statistical analyses for this end point

    Secondary: Number of treatment emergent hypoglycaemic episodes both according to Novo Nordisk definition of confirmed hypoglycaemic episodes (severe hypoglycaemia and /or a measured plasma glucose (PG)< 3.1 mmol/L (56 mg/dL) as well as to the ADA definition.

    		 Close Top of page
    End point title
    		 Number of treatment emergent hypoglycaemic episodes both according to Novo Nordisk definition of confirmed hypoglycaemic episodes (severe hypoglycaemia and /or a measured plasma glucose (PG)< 3.1 mmol/L (56 mg/dL) as well as to the ADA definition.
    End point description
    Confirmed hypoglycaemic episodes were defined as episodes that are either: • severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or • biochemically confirmed by a PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
    End point type
    Secondary
    End point timeframe
    During 26 weeks of treatment.
    End point values
    		 IDegAsp BID + IAsp IDeg OD + IAsp
    Number of subjects analysed
    20
    20
    Units: Number of events
    54
    95
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes.
    End point description
    Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive.
    End point type
    Secondary
    End point timeframe
    During 26 weeks of treatment.
    End point values
    		 IDegAsp BID + IAsp IDeg OD + IAsp
    Number of subjects analysed
    20
    20
    Units: number of confirmed events
    13
    12
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Change from baseline in fasting plasma glucose (FPG)
    End point description
    FPG was analysed on blood samples from fasting subjects which were analysed centrally.
    End point type
    Secondary
    End point timeframe
    After 26 weeks of treatment.
    End point values
    		 IDegAsp BID + IAsp IDeg OD + IAsp
    Number of subjects analysed
    19
    19
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.8 ± 3.59
    -2.57 ± 2.73
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
    Adverse event reporting additional description
    Safety analysis set included all subjects receiving at least one dose of the investigational product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    IDegAsp BID + IAsp
    Reporting group description
    		 Subjects randomised to IDegAsp BID + IAsp OD were, at the discretion of the investigator, to start the doses of IDegAsp taken with breakfast and main evening meal at Week 26 in trial NN5401-3941 and add 4 units of IAsp at lunch.

    Reporting group title
    IDeg OD + IAsp
    Reporting group description
    		 Subjects randomised to IDeg OD + IAsp TID were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into three doses.

    Serious adverse events
    		 IDegAsp BID + IAsp IDeg OD + IAsp
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cholecystectomy
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Peptic ulcer haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         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
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (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
    		 IDegAsp BID + IAsp IDeg OD + IAsp
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 20 (75.00%)
    16 / 20 (80.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    1 / 20 (5.00%)
    4 / 20 (20.00%)
         occurrences all number
    1
    6
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Cough
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Dyspnoea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Tendon rupture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Thermal burn
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Wrong drug administered
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Diabetic retinopathy
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Eye swelling
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Macular oedema
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Retinal aneurysm
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    3
    Diarrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    2
    Lip swelling
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Hidradenitis
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Back pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Acute sinusitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Dengue fever
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Eye infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Otitis media
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Tinea pedis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 20 (5.00%)
    5 / 20 (25.00%)
         occurrences all number
    1
    5
    Urinary tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    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.
    Due to the highly selected trial population randomised in this trial (N=40), the results should be interpreted with caution.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 03:25:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA