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    Clinical Trial Results:
    A randomised, cross-over, open-label, multi-centre trial comparing the effect of insulin degludec and insulin glargine 100 Units per milliliter (U/mL), with or without OADs in subjects with type 2 diabetes using flash glucose monitoring

    Summary
    EudraCT number
    		 2017-004047-20
    Trial protocol
    		 PL   SK  
    Global end of trial date
    27 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2021
    First version publication date
    01 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN1250-4419
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03687827
    WHO universal trial number (UTN)
    		 U1111-1203-0580
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, +1 866 8677178, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, +1 866 8677178, 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
    04 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Percentage of time spent in glycaemic target range 70-180 milligrams per deciliter (mg/dL) (3.9–10.0 (millimoles per litre) mmol/L) both inclusive, using flash glucose monitoring (FGM).
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, adopted by the 18th World Medical Association (WMA) General Assembly, Helsinki, Finland, June 1964, and subsequent amendments and International Council for Harmonisation (ICH) Good Clinical Practice (GCP) European Medicines Agency (EMA)/Committee for Medicinal Products for Human Use CHMP)/ICH/135/1995), including archiving of essential documents and the European Union Clinical Trial Directive (CTD)2001/20/EC.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    02 Oct 2018
    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
    Canada: 80
    Country: Number of subjects enrolled
    Poland: 66
    Country: Number of subjects enrolled
    Slovakia: 58
    Country: Number of subjects enrolled
    United States: 253
    Country: Number of subjects enrolled
    South Africa: 41
    Worldwide total number of subjects
    498
    EEA total number of subjects
    124
    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)
    257
    From 65 to 84 years
    236
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted in 5 countries as follows: Canada: 10 sites, Poland: 5 sites, Slovakia: 10 sites, South Africa: 7 sites, United States of America: 34 sites

    Pre-assignment
    Screening details
    		 This was a cross-over trial. The trial included a 2-week run-in period (which was after the screening visit) for eligibility assessment in regard to adherence to FGM requirements. The subjects were randomised into one of two treatment sequences.

    Period 1
    Period 1 title
    Treatment Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A: Insulin degludec then Insulin glargine
    Arm description
    		 Subjects were to receive a subcutaneous (s.c.) injection of Insulin degludec 100 Units per milliliter (U/mL) once daily (in treatment period 1), followed by a s.c. injection of Insulin glargine 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin degludec
    Investigational medicinal product code
    Other name
    Tresiba®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive a subcutaneous (s.c.) injection of Insulin degludec 100U/mL once daily (in treatment period 1 and 2), for 36 weeks with or without oral anti-diabetic drugs using flash glucose monitoring.

    Arm title
    		 Sequence B: Insulin glargine then Insulin degludec
    Arm description
    		 Subjects were to receive a subcutaneous (s.c.) injection of Insulin glargine 100U/mL once daily (in treatment period 1), followed by a s.c. injection of Insulin degludec 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    Other name
    Lantus®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive a subcutaneous (s.c.) injection of Insulin glargine 100U/mL once daily (in treatment period 1 and 2), for 36 weeks with or without oral anti-diabetic drugs using flash glucose monitoring.

    Number of subjects in period 1
    		Sequence A: Insulin degludec then Insulin glargine Sequence B: Insulin glargine then Insulin degludec
    Started
    249
    249
    Completed
    235
    241
    Not completed
    14
    8
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    7
    3
         Physician decision
    5
    2
         Lost to follow-up
    2
    2
    Period 2
    Period 2 title
    Treatment Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A: Insulin degludec then Insulin glargine
    Arm description
    		 Subjects were to receive a subcutaneous (s.c.) injection of Insulin degludec 100U/mL once daily (in treatment period 1), followed by a s.c. injection of Insulin glargine 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin degludec
    Investigational medicinal product code
    Other name
    Tresiba®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive a subcutaneous (s.c.) injection of Insulin degludec 100U/mL once daily (in treatment period 1 and 2), for 36 weeks with or without oral anti-diabetic drugs using flash glucose monitoring.

    Arm title
    		 Sequence B: Insulin glargine then Insulin degludec
    Arm description
    		 Subjects were to receive a subcutaneous (s.c.) injection of Insulin glargine 100U/mL once daily (in treatment period 1), followed by a s.c. injection of Insulin degludec 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    Other name
    Lantus®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive a subcutaneous (s.c.) injection of Insulin glargine 100U/mL once daily (in treatment period 1 and 2), for 36 weeks with or without oral anti-diabetic drugs using flash glucose monitoring.

    Number of subjects in period 2
    		Sequence A: Insulin degludec then Insulin glargine Sequence B: Insulin glargine then Insulin degludec
    Started
    235
    241
    Completed
    230
    238
    Not completed
    5
    3
         Consent withdrawn by subject
    1
    2
         Physician decision
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period 1
    Reporting group description
    		 Subjects were to receive either a subcutaneous (s.c.) injection of Insulin degludec 100U/mL once daily or a s.c. injection of Insulin glargine 100U/mL once daily (during treatment period 1 followed by treatment period 2); with or without oral anti-diabetic drugs using flash glucose monitoring.

    Reporting group values
    		 Treatment Period 1 Total
    Number of subjects
    		 498 498
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 257 257
        From 65-84 years
    		 236 236
        85 years and over
    		 5 5
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.8 ± 9.8 -
    Gender Categorical
    Units: Subjects
        Female
    		 259 259
        Male
    		 239 239

    End points

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    End points reporting groups
    Reporting group title
    Sequence A: Insulin degludec then Insulin glargine
    Reporting group description
    		 Subjects were to receive a subcutaneous (s.c.) injection of Insulin degludec 100 Units per milliliter (U/mL) once daily (in treatment period 1), followed by a s.c. injection of Insulin glargine 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

    Reporting group title
    Sequence B: Insulin glargine then Insulin degludec
    Reporting group description
    		 Subjects were to receive a subcutaneous (s.c.) injection of Insulin glargine 100U/mL once daily (in treatment period 1), followed by a s.c. injection of Insulin degludec 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
    Reporting group title
    Sequence A: Insulin degludec then Insulin glargine
    Reporting group description
    		 Subjects were to receive a subcutaneous (s.c.) injection of Insulin degludec 100U/mL once daily (in treatment period 1), followed by a s.c. injection of Insulin glargine 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

    Reporting group title
    Sequence B: Insulin glargine then Insulin degludec
    Reporting group description
    		 Subjects were to receive a subcutaneous (s.c.) injection of Insulin glargine 100U/mL once daily (in treatment period 1), followed by a s.c. injection of Insulin degludec 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

    Subject analysis set title
    Insulin degludec 100U/mL
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

    Subject analysis set title
    Insulin glargine 100U/mL
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

    Primary: Percentage of time spent in glycaemic target range 70-180 mg/dL (3.9–10.0 mmol/L) both inclusive, using Flash Glucose Monitoring.

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    End point title
    		 Percentage of time spent in glycaemic target range 70-180 mg/dL (3.9–10.0 mmol/L) both inclusive, using Flash Glucose Monitoring.
    End point description
    The percentage of time spent in glycaemic target range was calculated as the number of recorded measurements in glycaemic target range (70-180 mg/dL (3.9-10.0 mmol/L), both inclusive) divided by the total number of recorded measurements. The endpoint is based on data recorded by FGM system. It was required that at least 70% of the planned FGM measurements during weeks 16-17 and weeks 34-35 were available for endpoint data to be included in the analysis.
    End point type
    Primary
    End point timeframe
    During the 2-week maintenance periods (week 16-17 in treatment period-1 and week 34-35 in treatment period-2).
    End point values
    		 Insulin degludec 100U/mL Insulin glargine 100U/mL
    Number of subjects analysed
    448
    448
    Units: Percentage of time
        least squares mean (standard error)
    72.11 ± 0.74
    70.68 ± 0.74
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    Due to cross-over design of the study, the following “number of subjects included in analysis” is being erroneously displayed as 896. The actual “number of subjects included in analysis” is 448.
    Comparison groups
    Insulin degludec 100U/mL v Insulin glargine 100U/mL
    Number of subjects included in analysis
    896
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0321
    Method
    		 t-test, 2-sided
    Parameter type
    		 Estimated treatment difference
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 2.74
    Notes
    [1] - Superiority is confirmed if non-inferiority is confirmed and the lower limit of the two-sided 95% confidence interval is entirely above zero
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    Due to cross-over design of the study, the following “number of subjects included in analysis” is being erroneously displayed as 896. The actual “number of subjects included in analysis” is 448.
    Comparison groups
    Insulin degludec 100U/mL v Insulin glargine 100U/mL
    Number of subjects included in analysis
    896
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Estimated treatment difference
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 2.74
    Notes
    [2] - A non-inferiority margin of -0.83% has been applied, corresponding to 0.2 hours/24 hours

    Secondary: Time spent in tight glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, using Flash Glucose Monitoring

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    End point title
    		 Time spent in tight glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, using Flash Glucose Monitoring
    End point description
    The percentage of time spent in tight glycaemic target range 70-140 mg/dL (3.9–7.8 mmol/L) both inclusive, during the 2-week maintenance periods using FGM (visit 9-21 (week 16-17) and visit 37-39 (week 34-35))
    End point type
    Secondary
    End point timeframe
    During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2)
    End point values
    		 Insulin degludec 100U/mL Insulin glargine 100U/mL
    Number of subjects analysed
    448
    448
    Units: Percentage of Time
        least squares mean (standard error)
    52.97 ± 0.82
    51.45 ± 0.82
    No statistical analyses for this end point

    Secondary: Time spent in nocturnal glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, in the nocturnal period (00:01 am - 05:59 am both inclusive) using Flash Glucose Monitoring

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    End point title
    		 Time spent in nocturnal glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, in the nocturnal period (00:01 am - 05:59 am both inclusive) using Flash Glucose Monitoring
    End point description
    Percentage of time spent in nocturnal glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, in the nocturnal period (00:01 am – 05:59 am both inclusive) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)).
    End point type
    Secondary
    End point timeframe
    During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
    End point values
    		 Insulin degludec 100U/mL Insulin glargine 100U/mL
    Number of subjects analysed
    448
    448
    Units: Percentage of Time
        least squares mean (standard error)
    15.15 ± 0.26
    14.91 ± 0.26
    No statistical analyses for this end point

    Secondary: Level of glycated haemoglobin (HbA1c) - Percentage

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    End point title
    		 Level of glycated haemoglobin (HbA1c) - Percentage
    End point description
    Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).
    End point type
    Secondary
    End point timeframe
    After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
    End point values
    		 Insulin degludec 100U/mL Insulin glargine 100U/mL
    Number of subjects analysed
    448
    448
    Units: Percentage of glycated haemoglobin
        least squares mean (standard error)
    7.10 ± 0.04
    7.16 ± 0.04
    No statistical analyses for this end point

    Secondary: Level of glycated haemoglobin (HbA1c) - mmol/mol

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    End point title
    		 Level of glycated haemoglobin (HbA1c) - mmol/mol
    End point description
    Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).
    End point type
    Secondary
    End point timeframe
    After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
    End point values
    		 Insulin degludec 100U/mL Insulin glargine 100U/mL
    Number of subjects analysed
    448
    448
    Units: millimoles per mole (mmol/mol)
        least squares mean (standard error)
    54.10 ± 0.42
    54.78 ± 0.42
    No statistical analyses for this end point

    Secondary: Mean glucose levels using flash glucose monitoring (FGM) - mmol/L

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    End point title
    		 Mean glucose levels using flash glucose monitoring (FGM) - mmol/L
    End point description
    Mean glucose levels (mmol/L) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)).
    End point type
    Secondary
    End point timeframe
    During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
    End point values
    		 Insulin degludec 100U/mL Insulin glargine 100U/mL
    Number of subjects analysed
    448
    448
    Units: mmol/L
        least squares mean (standard error)
    7.57 ± 0.08
    7.61 ± 0.08
    No statistical analyses for this end point

    Secondary: Mean glucose levels using flash glucose monitoring (FGM) - mg/dL

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    End point title
    		 Mean glucose levels using flash glucose monitoring (FGM) - mg/dL
    End point description
    Mean glucose levels (mmol/L) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)).
    End point type
    Secondary
    End point timeframe
    During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
    End point values
    		 Insulin degludec 100U/mL Insulin glargine 100U/mL
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: mg/dL
        least squares mean (standard error)
    ±
    ±
    Notes
    [3] - Mean glucose levels (mg/dL) are not reported in the clinical trial report. Hence not reported here.
    [4] - Mean glucose levels (mg/dL) are not reported in the clinical trial report. Hence not reported here.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
    Adverse event reporting additional description
    Safety Analysis Set was defined as all subjects that were randomized and treated with at least one dose of trial drug after randomization
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Insulin Glargine 100U/mL
    Reporting group description
    		 Participants were to receive a subcutaneous (s.c.) injection of Insulin glargine 100U/mL once daily (in treatment period 1), followed by a s.c. injection of Insulin degludec 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

    Reporting group title
    Insulin Degludec 100U/mL
    Reporting group description
    		 Participants were to receive a subcutaneous (s.c.) injection of Insulin degludec 100U/mL once daily (in treatment period 1), followed by a s.c. injection of Insulin glargine 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No values to display for non-serious AE with 5% threshold
    Serious adverse events
    		 Insulin Glargine 100U/mL Insulin Degludec 100U/mL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 484 (4.75%)
    26 / 490 (5.31%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Coronary arterial stent insertion
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast mass
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Scan myocardial perfusion abnormal
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arteriovenous malformation
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 484 (0.21%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 484 (0.21%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic unconsciousness
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intercostal neuralgia
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diabetic gastroparesis
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 484 (0.00%)
    2 / 490 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 484 (0.21%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (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
    Bronchitis
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 484 (0.41%)
    3 / 490 (0.61%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 484 (0.00%)
    1 / 490 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 484 (0.21%)
    0 / 490 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    		 Insulin Glargine 100U/mL Insulin Degludec 100U/mL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 484 (0.00%)
    0 / 490 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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