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    Clinical Trial Results:
    A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 years with Type 1 Diabetes on a Basal-Bolus Regimen with Insulin Aspart as Bolus Insulin Trial Phase: 3

    Summary
    EudraCT number
    2006-002478-23
    Trial protocol
    GB   FI   DK   HU   CZ   FR   BG  
    Global end of trial date
    07 Sep 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    NN304-1690
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00623194
    WHO universal trial number (UTN)
    -
    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)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000412-PIP01-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Feb 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Sep 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the development of insulin detemir-insulin aspart cross-reacting antibodies following a 104 week-period (52 weeks in NN304-1689 and 52 weeks in NN304-1690) of insulin detemir treatment in children and adolescents.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (October 2000, amended 2002 and 2004) and ICH Good Clinical Practice (01-May-1996).
    Background therapy
    The subjects were treated with insulin detemir and completed 52 weeks of treatment in the NN304-1689 trial.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    19 Feb 2008
    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
    Poland: 20
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Bulgaria: 19
    Country: Number of subjects enrolled
    Czech Republic: 18
    Country: Number of subjects enrolled
    Denmark: 6
    Country: Number of subjects enrolled
    Finland: 7
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Macedonia, the former Yugoslav Republic of: 11
    Country: Number of subjects enrolled
    Russian Federation: 40
    Country: Number of subjects enrolled
    Turkey: 11
    Worldwide total number of subjects
    146
    EEA total number of subjects
    84
    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)
    88
    Adolescents (12-17 years)
    58
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial sites included 29 sites in 11 countries: Bulgaria (3 sites), Czech Republic (3 sites), Denmark (2 sites), Finland (4 sites), France (1 site), Hungary (2 sites), Macedonia (1 site), Poland (4 sites), Russian Federation (4 sites), Turkey (4 sites) and United Kingdom (1 site).

    Pre-assignment
    Screening details
    At entry subjects had finalised 52-weeks treatment with insulin detemir (Trial NN304-1689, NCT00435019).The subjects continued treatment with insulin detemir and insulin aspart doses used in Trial NN304-1689.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Insulin Detemir
    Arm description
    Subjects received insulin detemir up to twice daily plus insulin aspart at larger meals. Doses were adjusted individually (treatment up to 104 weeks).
    Arm type
    Experimental

    Investigational medicinal product name
    Levemir
    Investigational medicinal product code
    Other name
    Insulin detemir
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin detemir was administered subcutaneously once or twice daily at the same time of the day as in Trial NN304-1689. All subjects also received insulin aspart as bolus insulin immediately before or after main meals. The dose of insulin was continuously and individually adjusted based on plasmaglucose (PG) measurements according to the NN304-1689 Titration Guideline.

    Investigational medicinal product name
    NovoRapid
    Investigational medicinal product code
    Other name
    Insulin aspart
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All subjects received insulin aspart as bolus insulin immediately before or after main meals. The dose of insulin was continuously and individually adjusted based on plasmaglucose (PG) measurements according to the NN304-1689 Titration Guideline.

    Number of subjects in period 1
    Insulin Detemir
    Started
    146
    Completed
    141
    Not completed
    5
         protocol violation
    3
         unclassified
    1
         Lack of efficacy
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)

    Reporting group values
    Overall Study Total
    Number of subjects
    146 146
    Age categorical
    Units: Subjects
        2 to 5 years
    37 37
        6 to 12 years
    59 59
        13 to 16 years
    50 50
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    10.1 ± 4.2 -
    Gender categorical
    Units: Subjects
        Female
    77 77
        Male
    69 69
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0
        Asian
    0 0
        Native Hawaiian or Other Pacific Islander
    0 0
        Black or African American
    0 0
        White
    144 144
        More than one race
    0 0
        Unknown or Not Reported
    2 2
    Pubertal Status
    Units: Subjects
        Tanner grade 1
    83 83
        Tanner grade 2+
    63 63
    Height
    Units: meters
        arithmetic mean (standard deviation)
    1.39 ± 0.26 -
    BMI
    Units: kg/m^2
        arithmetic mean (standard deviation)
    18.14 ± 2.81 -

    End points

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    End points reporting groups
    Reporting group title
    Insulin Detemir
    Reporting group description
    Subjects received insulin detemir up to twice daily plus insulin aspart at larger meals. Doses were adjusted individually (treatment up to 104 weeks).

    Primary: Insulin detemir-insulin aspart cross-reacting antibodies.

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    End point title
    Insulin detemir-insulin aspart cross-reacting antibodies. [1]
    End point description
    Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection. For all subjects the difference between the individual subject’s antibody measurements at Visit 10 and Visit 1 exension were calculated. This individual difference was used to adjust the antibody measurements. These corrected values were used for all analyses
    End point type
    Primary
    End point timeframe
    week 0, 52 and 104.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: In order to clarify if the antibody measurements stabilised or decreased the parameter of interest was the estimated slope of the model. No other statistical analysis was provided for Insulin Detemir-insulin Aspart Cross-reacting Antibodies.
    End point values
    Insulin Detemir
    Number of subjects analysed
    146
    Units: Percent bound of total
    least squares mean (standard error)
        Week 0 (3 hours)
    31.11 ± 1.25
        Week 52 (3 hours)
    43.99 ± 1.02
        Week 104 (3 hours)
    35.96 ± 1.14
        Week 0 (2.5 hours)
    31.22 ± 1.23
        Week 52 (2.5 hours)
    44.09 ± 1.01
        Week 104 (2.5 hours)
    35.92 ± 1.13
    No statistical analyses for this end point

    Secondary: Development of insulin detemir specific antibodies and insulin aspart specific antibodies

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    End point title
    Development of insulin detemir specific antibodies and insulin aspart specific antibodies
    End point description
    Amount of insulin detemir and insulin aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks. The blood samples analysed were taken before insulin detemir and less than 3 hours after insulin aspart injection.
    End point type
    Secondary
    End point timeframe
    At 0, 52 and 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    146
    Units: Percent bound of total
    least squares mean (standard error)
        Insulin Detemir specific, week 0
    2.81 ± 1.28
        Insulin Detemir specific, week 52
    4.4 ± 1.27
        Insulin Detemir specific, week 104
    3.05 ± 1.27
        Insulin Aspart specific, week 0
    1.32 ± 0.67
        Insulin Aspart specific, week 52
    2.79 ± 0.64
        Insulin Aspart specific, week 104
    1.99 ± 0.65
    No statistical analyses for this end point

    Secondary: BMI (Body Mass Index)

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    End point title
    BMI (Body Mass Index)
    End point description
    BMI (Body Mass Index) after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: kg/m^2
        arithmetic mean (standard deviation)
    18.88 ± 3.19
    No statistical analyses for this end point

    Secondary: SD-score (Z-score) for Body Weight

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    End point title
    SD-score (Z-score) for Body Weight
    End point description
    Standard deviation-score (SD-score or z-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: SD-scores
        arithmetic mean (standard deviation)
    0.13 ± 0.97
    No statistical analyses for this end point

    Secondary: Occurrence of ketoacidosis requiring hospitalisation during treatment

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    End point title
    Occurrence of ketoacidosis requiring hospitalisation during treatment
    End point description
    Number of diabetic ketoacidosis events requiring hospitalisation.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    146
    Units: Number
    3
    No statistical analyses for this end point

    Secondary: Insulin Dose

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    End point title
    Insulin Dose
    End point description
    Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: U/kg
    arithmetic mean (standard deviation)
        Insulin Detemir dose (Basal)
    0.66 ± 0.29
        Insulin Aspart dose (Bolus)
    0.51 ± 0.19
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Biochemistry - Albumin Serum (g/dL)

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    End point title
    Laboratory safety parameters: Biochemistry - Albumin Serum (g/dL)
    End point description
    Albumin Serum after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: g/dL
        arithmetic mean (standard deviation)
    4.32 ± 0.25
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Biochemistry- Creatinine Serum umol/L

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    End point title
    Laboratory safety parameters: Biochemistry- Creatinine Serum umol/L
    End point description
    Creatine serum after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: umol/L
        arithmetic mean (standard deviation)
    51.08 ± 13.55
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Biochemistry - Sodium Serum (mmol/L)

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    End point title
    Laboratory safety parameters: Biochemistry - Sodium Serum (mmol/L)
    End point description
    Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: mmol/L
        arithmetic mean (standard deviation)
    141.6 ± 3.11
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Biochemistry- Alkaline Phosphatase Serum (U/L)

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    End point title
    Laboratory safety parameters: Biochemistry- Alkaline Phosphatase Serum (U/L)
    End point description
    Alkaline phosphatase serum after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: U/L
        arithmetic mean (standard deviation)
    226.7 ± 197.1
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Haematology - Leukocytes

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    End point title
    Laboratory safety parameters: Haematology - Leukocytes
    End point description
    Leukocytes after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: 10^9/L
        arithmetic mean (standard deviation)
    6.72 ± 1.85
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Fundoscopy/Fundus Photography

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    End point title
    Laboratory safety parameters: Fundoscopy/Fundus Photography
    End point description
    Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant; Abn. NCS = Abnormal, Not clinically significant; Abn. CS = Abnormal, clinically significant; Abn. NCS = Abnormal, Not clinically significant.
    End point type
    Secondary
    End point timeframe
    At 52 weeks and at 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    146
    Units: participants
        Abnormal, clinically significant
    1
        Abnormal, not clinically significant
    8
        Normal
    131
        Missing
    6
        Abn CS baseline and 104 weeks
    1
    No statistical analyses for this end point

    Secondary: Vital Signs: Blood Pressure

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    End point title
    Vital Signs: Blood Pressure
    End point description
    Blood pressure (Systolic and Diastolic) after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    143
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic Blood Pressure
    109.5 ± 13.6
        Diastolic Blood Pressure
    66.6 ± 8.9
    No statistical analyses for this end point

    Secondary: Vital Signs: Pulse

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    End point title
    Vital Signs: Pulse
    End point description
    Pulse at week 104, measured after resting in a sitting position for 5 minutes.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    141
    Units: beats/minute
        arithmetic mean (standard deviation)
    82.6 ± 9
    No statistical analyses for this end point

    Secondary: Incidence of hypoglycaemia (mild, moderate, severe and biochemical)

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    End point title
    Incidence of hypoglycaemia (mild, moderate, severe and biochemical)
    End point description
    Incidence of hypoglycaemia (mild, moderate, severe and biochemical) – total, daytime and night time during treatment. Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment. Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment. Biochemical: Plasma glucose < 3.6mmol/L with no signs or symptoms.
    End point type
    Secondary
    End point timeframe
    Weeks 0 - 104
    End point values
    Insulin Detemir
    Number of subjects analysed
    146
    Units: Episodes
        Total hypoglycaemic episodes
    16074
        Total hypoglycaemic episodes, daytime
    13605
        Total hypoglycaemic episodes, night-time
    2469
        Daytime, Mild
    9080
        Daytime, Moderate
    396
        Daytime, Severe
    3
        Daytime, Biochemical
    4122
        Daytime, Unclassified
    4
        Night-time, Mild
    1450
        Night-time, Moderate
    54
        Night-time, Severe
    4
        Night-time, Biochemical
    958
        Night-time, unclassified
    3
    No statistical analyses for this end point

    Secondary: Adverse events during treatment

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    End point title
    Adverse events during treatment
    End point description
    Adverse events during the treatment period expressed as number of events per 100 exposure years.
    End point type
    Secondary
    End point timeframe
    Adverse events from the first day on trial product (Visit 1 + 1 day) to one week after last day on trial product (Visit 5Ext + 7 days at most).
    End point values
    Insulin Detemir
    Number of subjects analysed
    146
    Units: Number of events per 100 exposure years
        number (not applicable)
    246.9
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Biochemistry - Total protein serum (g/dL)

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    End point title
    Laboratory safety parameters: Biochemistry - Total protein serum (g/dL)
    End point description
    Total protein serum after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: g/dL
        arithmetic mean (standard deviation)
    7.09 ± 0.45
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Biochemistry - Pottassium Serum (mmol/L)

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    End point title
    Laboratory safety parameters: Biochemistry - Pottassium Serum (mmol/L)
    End point description
    Potassium Serum after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    137
    Units: mmol/L
        arithmetic mean (standard deviation)
    4.38 ± 0.5
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Haematology - Haemoglobin (mmol/L)

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    End point title
    Laboratory safety parameters: Haematology - Haemoglobin (mmol/L)
    End point description
    Haemoglobin after 104 weeks
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: mmol/L
        arithmetic mean (standard deviation)
    8.28 ± 0.65
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Biochemistry -Alanine Aminotransferase Serum (U/L)

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    End point title
    Laboratory safety parameters: Biochemistry -Alanine Aminotransferase Serum (U/L)
    End point description
    Alanine Aminotransferase serum after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: U/L
        arithmetic mean (standard deviation)
    19 ± 8.26
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Biochemistry - Lactate Dehydrogenase Serum (U/L)

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    End point title
    Laboratory safety parameters: Biochemistry - Lactate Dehydrogenase Serum (U/L)
    End point description
    Lactate Dehydrogenase serum after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    137
    Units: U/L
        arithmetic mean (standard deviation)
    199.6 ± 40.34
    No statistical analyses for this end point

    Secondary: Laboratory safety parameters: Haematology - Thrombocytes

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    End point title
    Laboratory safety parameters: Haematology - Thrombocytes
    End point description
    Thrombocytes after 104 weeks.
    End point type
    Secondary
    End point timeframe
    At 104 weeks
    End point values
    Insulin Detemir
    Number of subjects analysed
    144
    Units: 10^9/L
        arithmetic mean (standard deviation)
    301.9 ± 76.55
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse events were collected over a period of 104 weeks.
    Adverse event reporting additional description
    The safety analysis set is all subjects exposed to at least one dose of trial drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Insulin Detemir
    Reporting group description
    Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)

    Serious adverse events
    Insulin Detemir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 146 (8.22%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Burns second degrees
         subjects affected / exposed
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis shigella
         subjects affected / exposed
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia unconsciousness
         subjects affected / exposed
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Insulin Detemir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    106 / 146 (72.60%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    25 / 146 (17.12%)
         occurrences all number
    84
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    8 / 146 (5.48%)
         occurrences all number
    13
    Abdominal pain
         subjects affected / exposed
    9 / 146 (6.16%)
         occurrences all number
    10
    Vomiting
         subjects affected / exposed
    10 / 146 (6.85%)
         occurrences all number
    10
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    71 / 146 (48.63%)
         occurrences all number
    164
    Upper Respiratory Tract Infection
         subjects affected / exposed
    21 / 146 (14.38%)
         occurrences all number
    44
    Pharyngitis
         subjects affected / exposed
    20 / 146 (13.70%)
         occurrences all number
    41
    Influenza
         subjects affected / exposed
    17 / 146 (11.64%)
         occurrences all number
    38
    Gastroenteritis
         subjects affected / exposed
    15 / 146 (10.27%)
         occurrences all number
    21
    Bronchitis
         subjects affected / exposed
    9 / 146 (6.16%)
         occurrences all number
    16
    Viral infection
         subjects affected / exposed
    10 / 146 (6.85%)
         occurrences all number
    12
    Rhinitis
         subjects affected / exposed
    9 / 146 (6.16%)
         occurrences all number
    11
    Acute Tonsilliitis
         subjects affected / exposed
    8 / 146 (5.48%)
         occurrences all number
    8

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Feb 2008
    Substantial amendment no. 1, dated 28 January 2008, was prepared to implement the decision to use a paper-based diary in the trial.

    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.
    Not applicable
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    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.

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