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    Clinical Trial Results:
    The effect of insulin degludec in combination with liraglutide and metformin in subjects with type 2 diabetes qualifying for treatment intensification

    Summary
    EudraCT number
    		 2011-004665-32
    Trial protocol
    		 DE   GB   IT  
    Global end of trial date
    31 Dec 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Apr 2016
    First version publication date
    28 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Results to be updated

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NN1250-3944
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01664247
    WHO universal trial number (UTN)
    		 U1111-1124-6612
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm the efficacy of IDeg compared to placebo, both in combination with liraglutide and metformin, in controlling glycaemia
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice and FDA 21 CFR 312.120.
    Background therapy
    		 Metformin in combination with sulphonylurea, glinides, dipeptidyl peptidase IV inhibitors or exenatide were the background medications and were therefore treated as non-investigational medicinal product.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    01 Oct 2012
    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
    Italy: 24
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    France: 24
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    Israel: 15
    Country: Number of subjects enrolled
    Serbia: 52
    Country: Number of subjects enrolled
    South Africa: 16
    Country: Number of subjects enrolled
    Ukraine: 29
    Country: Number of subjects enrolled
    United Arab Emirates: 7
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    United States: 124
    Worldwide total number of subjects
    346
    EEA total number of subjects
    94
    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)
    281
    From 65 to 84 years
    65
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The following sites in each country screened/randomised/assigned subjects in the trial: Canada:7, France: 10, Germany: 8, Israel: 6, Italy: 7, Serbia: 7, South Africa: 6, Ukraine: 4, United Arab Emirates: 3, United Kingdom: 6, and United States: 65.

    Pre-assignment
    Screening details
    		 Not applicable

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IDeg + liraglutide
    Arm description
    		 Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, IDeg treatment was recommended to be initiated with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    IDeg PDS290
    Investigational medicinal product code
    SUB25238
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Drug: insulin degludec administered subcutaneously (under the skin) once daily. Dose individually adjusted.

    Arm title
    		 Placebo + liraglutide
    Arm description
    		 Placebo treatment was recommended to be initiated with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    SUB25238
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Drug: Placebo administered subcutaneously (under the skin) once daily.

    Number of subjects in period 1
    		IDeg + liraglutide Placebo + liraglutide
    Started
    174
    172
    Completed
    160
    131
    Not completed
    14
    41
         Withdrawal Criteria
    1
    4
         Adverse event, non-fatal
    5
    3
         Unclassified
    5
    29
         Protocol deviation
    3
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 IDeg treatment was recommended to be initiated with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. Metformin was the background medications and was therefore treated as non-investigational medicinal product (non-IMP).

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 346 346
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 281 281
        From 65-84 years
    		 65 65
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.2 ( 9.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 144 144
        Male
    		 202 202

    End points

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    End points reporting groups
    Reporting group title
    IDeg + liraglutide
    Reporting group description
    		 Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, IDeg treatment was recommended to be initiated with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose.

    Reporting group title
    Placebo + liraglutide
    Reporting group description
    		 Placebo treatment was recommended to be initiated with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose.

    Primary: Change from baseline in glycosylated haemoglobin (HbA1c) (%) after 26 weeks of randomised treatment

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    End point title
    		 Change from baseline in glycosylated haemoglobin (HbA1c) (%) after 26 weeks of randomised treatment
    End point description
    End point type
    Primary
    End point timeframe
    Week 0-Week 26
    End point values
    		 IDeg + liraglutide Placebo + liraglutide
    Number of subjects analysed
    174
    172
    Units: %
        least squares mean (standard error)
    -0.99 ( 0.08 )
    -0.07 ( 0.08 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change from baseline in HbA1c after 26 weeks of randomised treatment was analysed using an analysis of variance (ANOVA) method with treatment, sex and region as fixed factors, and age and baseline HbA1c as covariates.
    Comparison groups
    IDeg + liraglutide v Placebo + liraglutide
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean treatment difference
    Point estimate
    -0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 -0.75

    Secondary: Change from baseline in fasting plasma glucose (FPG) after 26 weeks of randomised treatment

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    End point title
    		 Change from baseline in fasting plasma glucose (FPG) after 26 weeks of randomised treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0-Week 26
    End point values
    		 IDeg + liraglutide Placebo + liraglutide
    Number of subjects analysed
    172
    168
    Units: mmol/L
        arithmetic mean (standard deviation)
    -2.6 ( 2.91 )
    -0.28 ( 2.44 )
    No statistical analyses for this end point

    Secondary: Number of responders for HbA1c (below 7.0 %) after 26 weeks of randomised treatment

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    End point title
    		 Number of responders for HbA1c (below 7.0 %) after 26 weeks of randomised treatment
    End point description
    The end point values reflect percentage of subjects
    End point type
    Secondary
    End point timeframe
    After 26 weeks of randomised treatment
    End point values
    		 IDeg + liraglutide Placebo + liraglutide
    Number of subjects analysed
    174
    172
    Units: % of subjects
        number (not applicable)
    77.6
    35.5
    No statistical analyses for this end point

    Secondary: Change from baseline in mean pre-breakfast measurements used for titration after 26 weeks of randomised treatment

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    End point title
    		 Change from baseline in mean pre-breakfast measurements used for titration after 26 weeks of randomised treatment
    End point description
    Change from baseline after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.
    End point type
    Secondary
    End point timeframe
    Week 0-Week 26
    End point values
    		 IDeg + liraglutide Placebo + liraglutide
    Number of subjects analysed
    171
    167
    Units: mmol/L
        least squares mean (standard error)
    5.88 ( 0.14 )
    8.23 ( 0.15 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The pre-breakfast measures of SMPG values after 26 weeks of treatment were analysed an ANOVA method with treatment, region and sex as fixed effects, and age and baseline response as covariates.
    Comparison groups
    IDeg + liraglutide v Placebo + liraglutide
    Number of subjects included in analysis
    338
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.67
         upper limit
    		 -2.01

    Secondary: Change from baseline in 8-point profile after 26 weeks of randomised treatment

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    End point title
    		 Change from baseline in 8-point profile after 26 weeks of randomised treatment
    End point description
    The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.
    End point type
    Secondary
    End point timeframe
    Week 0-Week 26
    End point values
    		 IDeg + liraglutide Placebo + liraglutide
    Number of subjects analysed
    172
    169
    Units: mmol/L
    least squares mean (standard error)
        Before breakfast, N=170, 164
    5.85 ( 0.15 )
    8.54 ( 0.16 )
        90 min after breakfast, N=153, 148
    7.65 ( 0.24 )
    9.75 ( 0.25 )
        Before lunch, N=151,149
    6.33 ( 0.18 )
    8.34 ( 0.19 )
        90 min after lunch, N=152,150
    7.73 ( 0.21 )
    9.67 ( 0.21 )
        Before evening meal, N=154,148
    6.77 ( 0.2 )
    9.51 ( 0.21 )
        90 mins after evening meal, N=147,145
    7.93 ( 0.21 )
    9.65 ( 0.22 )
        Before bedtime, N=148, 142
    7.21 ( 0.2 )
    8.95 ( 0.21 )
        Before breakfast the next day, N=164,161
    6.05 ( 0.17 )
    8.55 ( 0.18 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast.
    Comparison groups
    IDeg + liraglutide v Placebo + liraglutide
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.04
         upper limit
    		 -2.34
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after breakfast.
    Comparison groups
    IDeg + liraglutide v Placebo + liraglutide
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.71
         upper limit
    		 -1.48
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before lunch.
    Comparison groups
    IDeg + liraglutide v Placebo + liraglutide
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.47
         upper limit
    		 -1.56
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after start of lunch.
    Comparison groups
    IDeg + liraglutide v Placebo + liraglutide
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.46
         upper limit
    		 -1.4
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point main evening meal.
    Comparison groups
    IDeg + liraglutide v Placebo + liraglutide
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.25
         upper limit
    		 -1.23
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after main evening meal.
    Comparison groups
    IDeg + liraglutide v Placebo + liraglutide
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.26
         upper limit
    		 -1.18
    Statistical analysis title
    		 Statistical Analysis 7
    Statistical analysis description
    The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before bedtime.
    Comparison groups
    IDeg + liraglutide v Placebo + liraglutide
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.27
         upper limit
    		 -1.23
    Statistical analysis title
    		 Statistical Analysis 8
    Statistical analysis description
    The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast the following day.
    Comparison groups
    IDeg + liraglutide v Placebo + liraglutide
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.91
         upper limit
    		 -2.09

    Secondary: Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment

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    End point title
    		 Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0-Week 26
    End point values
    		 IDeg + liraglutide Placebo + liraglutide
    Number of subjects analysed
    169
    166
    Units: mmol/L
        arithmetic mean (standard deviation)
    -2.3 ( 1.8 )
    -0.5 ( 1.7 )
    No statistical analyses for this end point

    Secondary: Number of hypoglycaemic episodes (confirmed) during 26 weeks of randomised treatment

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    End point title
    		 Number of hypoglycaemic episodes (confirmed) during 26 weeks of randomised treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0-Week 26
    End point values
    		 IDeg + liraglutide Placebo + liraglutide
    Number of subjects analysed
    173
    170
    Units: Event rate/100 patient years of exposure
    57
    12
    No statistical analyses for this end point

    Secondary: Number of adverse events during 26 weeks of randomised treatment

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    End point title
    		 Number of adverse events during 26 weeks of randomised treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Time Frame: Weeks 0-Week 26
    End point values
    		 IDeg + liraglutide Placebo + liraglutide
    Number of subjects analysed
    173
    170
    Units: Event rate/100 patient years of exposure
    344
    335
    No statistical analyses for this end point

    Secondary: Change from baseline in patient reported health-related quality of life using the Short-Form 36 Health Survey version 2 after 26 weeks of randomised treatment

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    End point title
    		 Change from baseline in patient reported health-related quality of life using the Short-Form 36 Health Survey version 2 after 26 weeks of randomised treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0-Week 26
    End point values
    		 IDeg + liraglutide Placebo + liraglutide
    Number of subjects analysed
    174
    169
    Units: Not applicable
    arithmetic mean (standard deviation)
        Physical health
    0.5 ( 6.3 )
    0 ( 6.2 )
        Mental health
    0.6 ( 8.1 )
    -0.7 ( 8.8 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event with an onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Placebo + liraglutide
    Reporting group description
    		 The placebo treatment was recommended to be initiated with 10 units. Liraglutide treatment was initiated on 0.6 mg daily for one week.

    Reporting group title
    IDeg + liraglutide
    Reporting group description
    		 IDeg treatment was recommended to be initiated with 10 units. After that it was titrated once weekly. Liraglutide treatment was initiated on 0.6 mg daily for one week.

    Serious adverse events
    		 Placebo + liraglutide IDeg + liraglutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 170 (5.29%)
    6 / 173 (3.47%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lentigo maligna stage II
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery occlusion
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cholecystectomy
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device removal
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus management
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 173 (0.58%)
         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 / 170 (0.59%)
    0 / 173 (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 / 170 (0.59%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 173 (0.58%)
         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
    Pleural effusion
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 173 (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
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 173 (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
    		 Placebo + liraglutide IDeg + liraglutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 170 (18.82%)
    33 / 173 (19.08%)
    Investigations
    Lipase increased
         subjects affected / exposed
    13 / 170 (7.65%)
    10 / 173 (5.78%)
         occurrences all number
    15
    11
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    13 / 170 (7.65%)
    10 / 173 (5.78%)
         occurrences all number
    17
    10
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    11 / 170 (6.47%)
    14 / 173 (8.09%)
         occurrences all number
    12
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Sep 2013
    • Update of the trial flow chart and phone table to question subjects about technical complaints. • Update of trial schedule with updated LPLV date. • Update of Event adjudication section. • Clarification that the PP analysis set consisted of subjects that have not violated any inclusion or randomisation criteria • Update minor editorial and formatting issues.

    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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    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
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