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    Clinical Trial Results:
    AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, PARALLEL-GROUP CLINICAL TRIAL COMPARING THE EFFICACY AND SAFETY OF MYLAN’S INSULIN GLARGINE WITH LANTUS® IN TYPE 1 DIABETES MELLITUS PATIENTS: AN EXTENSION STUDY

    Summary
    EudraCT number
    		 2015-004353-40
    Trial protocol
    		 CZ   SK   LV   HU   EE   DE  
    Global end of trial date
    10 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 May 2018
    First version publication date
    18 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MYL-1501D-3003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02666430
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mylan GmbH
    Sponsor organisation address
    Thurgauerstrasse 40, Zurich, Switzerland, 8050
    Public contact
    David Gillogly, Head of Global CO, Mylan, Inc., +1 724485-6581, David.Gillogly@mylan.com
    Scientific contact
    David Gillogly, Head of Global CO, Mylan, Inc., +1 724485-6581, David.Gillogly@mylan.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
    10 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the equivalence of changes in HbA1C between two treatment sequence groups, when Mylan's insulin glargine and Lantus® are interchanged (Mylan's insulin glargine and Lantus® are administered in combination with mealtime insulin lispro).
    Protection of trial subjects
    All study participants signed an Informed Consent Form prior to study participation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2015
    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: 3
    Country: Number of subjects enrolled
    United States: 67
    Country: Number of subjects enrolled
    Slovakia: 16
    Country: Number of subjects enrolled
    Czech Republic: 12
    Country: Number of subjects enrolled
    Estonia: 6
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Latvia: 10
    Worldwide total number of subjects
    127
    EEA total number of subjects
    57
    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)
    122
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The enrolment period ranged from 18 December 2015 to 10 March 2017. A total of 60 study sites enrolled patients: 32 sites in North America (United States and Canada) and 28 sites in the European Union (EU) (Czech Republic, Estonia, Germany, Hungary, Latvia, and Slovakia).

    Pre-assignment
    Screening details
    		 A total of 129 patients were screened and 127 patients were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mylan Insulin Glargine Sequence
    Arm description
    		 Mylan Insulin Glargine / Lantus® / Mylan Insulin Glargine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mylan Insulin Glargine / Lantus® / Mylan Insulin Glargine
    Investigational medicinal product code
    MYL-1501D / Lantus® / MYL-1501D
    Other name
    Insulin Glargine - New Formulation / Insulin Glargine / Insulin Glargine New Formulation
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Flexible dose

    Arm title
    		 Lantus® Sequence
    Arm description
    		 Lantus® / Lantus® / Lantus®
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lantus® / Lantus® / Lantus®
    Investigational medicinal product code
    Lantus® / Lantus® / Lantus®
    Other name
    Insulin Glargine / Insulin Glargine / Insulin Glargine
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Flexible dose

    Number of subjects in period 1
    		Mylan Insulin Glargine Sequence Lantus® Sequence
    Started
    64
    63
    Completed
    64
    63
    Period 2
    Period 2 title
    Period 1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mylan Insulin Glargine Sequence
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mylan Insulin Glargine
    Investigational medicinal product code
    MYL-1501D
    Other name
    Insulin Glargine New Formulation
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Flexible dose

    Arm title
    		 Lantus® Sequence
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lantus®
    Investigational medicinal product code
    Insulin Glargine
    Other name
    Lantus®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Flexible dose

    Number of subjects in period 2
    		Mylan Insulin Glargine Sequence Lantus® Sequence
    Started
    64
    63
    Completed
    63
    62
    Not completed
    1
    1
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    1
    -
    Period 3
    Period 3 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mylan Insulin Glargine Sequence
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lantus®
    Investigational medicinal product code
    Insulin Glargine
    Other name
    Lantus®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Flexible dose

    Arm title
    		 Lantus® Sequence
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lantus®
    Investigational medicinal product code
    Insulin Glargine
    Other name
    Lantus®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Flexible dose

    Number of subjects in period 3
    		Mylan Insulin Glargine Sequence Lantus® Sequence
    Started
    63
    62
    Completed
    62
    58
    Not completed
    1
    4
         Consent withdrawn by subject
    1
    4
    Period 4
    Period 4 title
    Period 3
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mylan Insulin Glargine Sequence
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mylan Insulin Glargine
    Investigational medicinal product code
    MYL-1501D
    Other name
    Insulin Glargine New Formulation
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Flexible dose

    Arm title
    		 Lantus® Sequence
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lantus®
    Investigational medicinal product code
    Insulin Glargine
    Other name
    Lantus®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Flexible dose

    Number of subjects in period 4
    		Mylan Insulin Glargine Sequence Lantus® Sequence
    Started
    62
    58
    Completed
    61
    58
    Not completed
    1
    0
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mylan Insulin Glargine Sequence
    Reporting group description
    		 Mylan Insulin Glargine / Lantus® / Mylan Insulin Glargine

    Reporting group title
    Lantus® Sequence
    Reporting group description
    		 Lantus® / Lantus® / Lantus®

    Reporting group values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence Total
    Number of subjects
    		 64 63 127
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.8 ( 11.43 ) 43.2 ( 12.69 ) -
    Gender categorical
    Units: Subjects
        Female
    		 23 27 50
        Male
    		 41 36 77
    Race
    Units: Subjects
        Asian
    		 2 0 2
        Black
    		 2 2 4
        Hispanic
    		 1 0 1
        White
    		 59 61 120
    Geographic region
    Units: Subjects
        Europe
    		 30 27 57
        North America
    		 34 36 70
    Dosing time
    Units: Subjects
        Morning
    		 11 12 23
        Evening
    		 53 51 104
    Baseline HIV status
    Units: Subjects
        Negative
    		 64 62 126
        Positive
    		 0 1 1
    Baseline HBsAg
    Units: Subjects
        Negative
    		 64 63 127
    Baseline HCVAb
    Units: Subjects
        Low positive
    		 0 1 1
        Negative
    		 64 62 126
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 80.712 ( 16.5393 ) 82.415 ( 15.2942 ) -
    Height
    Units: centimeter(s)
        arithmetic mean (standard deviation)
    		 173.299 ( 9.9451 ) 174.092 ( 8.5502 ) -
    Body mass index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 26.744 ( 4.1795 ) 27.134 ( 4.4084 ) -
    Duration of diabetes
    Units: years
        arithmetic mean (standard deviation)
    		 21.369 ( 12.8879 ) 20.212 ( 8.9657 ) -
    Baseline fasting plasma blood glucose
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    		 9.82 ( 3.455 ) 9.51 ( 4.099 ) -
    Baseline HbA1c
    Units: percent
        arithmetic mean (standard deviation)
    		 7.64 ( 0.997 ) 7.87 ( 0.913 ) -

    End points

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    End points reporting groups
    Reporting group title
    Mylan Insulin Glargine Sequence
    Reporting group description
    		 Mylan Insulin Glargine / Lantus® / Mylan Insulin Glargine

    Reporting group title
    Lantus® Sequence
    Reporting group description
    		 Lantus® / Lantus® / Lantus®
    Reporting group title
    Mylan Insulin Glargine Sequence
    Reporting group description
    		 -

    Reporting group title
    Lantus® Sequence
    Reporting group description
    		 -
    Reporting group title
    Mylan Insulin Glargine Sequence
    Reporting group description
    		 -

    Reporting group title
    Lantus® Sequence
    Reporting group description
    		 -
    Reporting group title
    Mylan Insulin Glargine Sequence
    Reporting group description
    		 -

    Reporting group title
    Lantus® Sequence
    Reporting group description
    		 -

    Subject analysis set title
    Mylan Insulin Glargine Sequence
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The modified ITT (mITT) population included all randomized patients (including patients who received incorrect treatment sequence, did not complete the trial or did not comply with the protocol, or used prohibited medication) and had at least one baseline (Week 0 visit) HbA1c value and one post-baseline HbA1c value at treatment Period 3 (24 < Week ≤ 36). The mITT was used for primary analysis.

    Subject analysis set title
    Lantus® Sequence
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The modified ITT (mITT) population included all randomized patients (including patients who received incorrect treatment sequence, did not complete the trial or did not comply with the protocol, or used prohibited medication) and had at least one baseline (Week 0 visit) HbA1c value and one post-baseline HbA1c value at treatment Period 3 (24 < Week ≤ 36). The mITT was used for primary analysis.

    Subject analysis set title
    Mylan Insulin Glargine Sequence
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intent-to-Treat (ITT) population included all randomized patients (including patients who received incorrect treatment sequence, did not complete the trial or did not comply with the protocol, or used prohibited medication) and had baseline (Week 0 visit) and at least one post-baseline visit. The patients in the ITT population were analyzed according to the planned treatment sequence.

    Subject analysis set title
    Lantus® Sequence
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intent-to-Treat (ITT) population included all randomized patients (including patients who received incorrect treatment sequence, did not complete the trial or did not comply with the protocol, or used prohibited medication) and had baseline (Week 0 visit) and at least one post-baseline visit. The patients in the ITT population were analyzed according to the planned treatment sequence.

    Subject analysis set title
    Mylan Insulin Glargine Sequence
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population included patients who were randomized and took at least 1 dose of the study drug. The safety analysis was conducted according to the treatment that a patient actually received.

    Subject analysis set title
    Lantus® Sequence
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population included patients who were randomized and took at least 1 dose of the study drug. The safety analysis was conducted according to the treatment that a patient actually received.

    Primary: Change in HbA1C from Baseline

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    End point title
    		 Change in HbA1C from Baseline
    End point description
    End point type
    Primary
    End point timeframe
    Week 36
    End point values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Number of subjects analysed
    61 [1]
    57 [2]
    Units: percent
        least squares mean (standard error)
    -0.05 ( 0.032 )
    -0.06 ( 0.034 )
    Notes
    [1] - modified Intent-to-Treat population
    [2] - modified Intent-to-Treat population
    Statistical analysis title
    		 Analysis of Covariance (ANCOVA)
    Statistical analysis description
    An ANCOVA was performed on the primary outcome variable. The model included region and sequence group as fixed effect and baseline value as covariate using the mITT population. A 95% CI for the difference between the two treatment sequence groups for mean change from baseline HbA1c at endpoint was produced using the ANCOVA method.
    Comparison groups
    Lantus® Sequence v Mylan Insulin Glargine Sequence
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.085
         upper limit
    		 0.101
    Notes
    [3] - The pre-defined equivalence margins are +/- 0.4. The 95% confidence interval of treatment-sequence difference is (-0.085, 0.101) and is within the pre-defined margins. Therefore, equivalence of Mylan's insulin glargine sequence to Lantus® sequence was established.

    Secondary: Change from Baseline in Fasting Plasma Glucose

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    End point title
    		 Change from Baseline in Fasting Plasma Glucose
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Number of subjects analysed
    64 [4]
    63 [5]
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    -0.56 ( 3.458 )
    0.10 ( 4.521 )
    Notes
    [4] - Intent-to-Treat-population
    [5] - Intent-to-Treat-population
    No statistical analyses for this end point

    Secondary: Overall Average of SMBG Change from Baseline

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    End point title
    		 Overall Average of SMBG Change from Baseline
    End point description
    SMBG = self-monitored blood glucose
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Number of subjects analysed
    64 [6]
    63 [7]
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    -0.144 ( 1.2569 )
    -0.426 ( 1.1243 )
    Notes
    [6] - Intent-to-Treat-population
    [7] - Intent-to-Treat-population
    No statistical analyses for this end point

    Secondary: Change from Baseline Total Daily Insulin Dose

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    End point title
    		 Change from Baseline Total Daily Insulin Dose
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Number of subjects analysed
    64 [8]
    63 [9]
    Units: Units per kilogram
        arithmetic mean (standard deviation)
    0.0016 ( 0.09239 )
    0.0023 ( 0.07712 )
    Notes
    [8] - Intent-to-Treat population
    [9] - Intent-to-Treat population
    No statistical analyses for this end point

    Secondary: Local and Systemic Allergic Reactions

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    End point title
    		 Local and Systemic Allergic Reactions
    End point description
    End point type
    Secondary
    End point timeframe
    40 weeks
    End point values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Number of subjects analysed
    64 [10]
    63 [11]
    Units: patients
        Local
    1
    1
        Systemic
    1
    0
    Notes
    [10] - Safety Population
    [11] - Safety Population
    No statistical analyses for this end point

    Secondary: Hypoglycemic Rate

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    End point title
    		 Hypoglycemic Rate
    End point description
    Change from Baseline
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Number of subjects analysed
    64 [12]
    63 [13]
    Units: Episodes/30 Days
        arithmetic mean (standard deviation)
    0.627 ( 2.7180 )
    0.410 ( 4.0911 )
    Notes
    [12] - Safety Population
    [13] - Safety Population
    No statistical analyses for this end point

    Secondary: Hypoglycemic incidence

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    End point title
    		 Hypoglycemic incidence
    End point description
    Overall incidence
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Number of subjects analysed
    64 [14]
    63 [15]
    Units: events
    58
    57
    Notes
    [14] - Safety Population
    [15] - Safety Population
    No statistical analyses for this end point

    Secondary: Total Insulin Antibodies - Mylan Insulin Glargine Assay

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    End point title
    		 Total Insulin Antibodies - Mylan Insulin Glargine Assay
    End point description
    Change from Baseline
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Number of subjects analysed
    64 [16]
    63 [17]
    Units: percent binding
        arithmetic mean (standard deviation)
    -2.098 ( 5.3826 )
    -2.474 ( 5.2505 )
    Notes
    [16] - Safety Population
    [17] - Safety Population
    No statistical analyses for this end point

    Secondary: Total Insulin Antibodies - Lantus® Assay

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    End point title
    		 Total Insulin Antibodies - Lantus® Assay
    End point description
    Change from Baseline
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Number of subjects analysed
    64 [18]
    63 [19]
    Units: percent binding
        arithmetic mean (standard deviation)
    -1.288 ( 4.9617 )
    -2.351 ( 5.3774 )
    Notes
    [18] - Safety Population
    [19] - Safety Population
    No statistical analyses for this end point

    Secondary: Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay

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    End point title
    		 Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay
    End point description
    Change from Baseline
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Number of subjects analysed
    64 [20]
    63 [21]
    Units: percent binding
        arithmetic mean (standard deviation)
    -2.051 ( 5.3697 )
    -2.252 ( 5.1904 )
    Notes
    [20] - Safety Population
    [21] - Safety Population
    No statistical analyses for this end point

    Secondary: Cross-Reactive Insulin Antibody - Lantus® Assay

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    End point title
    		 Cross-Reactive Insulin Antibody - Lantus® Assay
    End point description
    Change from Baseline
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Number of subjects analysed
    64 [22]
    63 [23]
    Units: percent binding
        arithmetic mean (standard deviation)
    -1.232 ( 4.8965 )
    -2.192 ( 5.1741 )
    Notes
    [22] - Safety Population
    [23] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    40 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Mylan Insulin Glargine Sequence
    Reporting group description
    		 Mylan Insulin Glargine / Lantus® / Mylan Insulin Glargine

    Reporting group title
    Lantus® Sequence
    Reporting group description
    		 Lantus® / Lantus® / Lantus®

    Serious adverse events
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 64 (3.13%)
    5 / 63 (7.94%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         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
    Injury
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Ketoacidosis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Mylan Insulin Glargine Sequence Lantus® Sequence
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 64 (64.06%)
    42 / 63 (66.67%)
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 63 (3.17%)
         occurrences all number
    2
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    3 / 64 (4.69%)
    1 / 63 (1.59%)
         occurrences all number
    4
    1
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    1 / 64 (1.56%)
    4 / 63 (6.35%)
         occurrences all number
    1
    4
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 63 (1.59%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 63 (3.17%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Stress
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 63 (3.17%)
         occurrences all number
    1
    2
    Gastroenteritis viral
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 63 (3.17%)
         occurrences all number
    2
    2
    Herpes zoster
         subjects affected / exposed
    0 / 64 (0.00%)
    3 / 63 (4.76%)
         occurrences all number
    0
    3
    Influenza
         subjects affected / exposed
    3 / 64 (4.69%)
    2 / 63 (3.17%)
         occurrences all number
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    3 / 64 (4.69%)
    4 / 63 (6.35%)
         occurrences all number
    3
    8
    Sinusitis
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 63 (1.59%)
         occurrences all number
    3
    1
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 64 (10.94%)
    5 / 63 (7.94%)
         occurrences all number
    8
    7

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 May 2016
    Clarifications made regarding wording of primary and secondary objective of immunogenicity, estimated number of patients, collection period for adverse events, collection of medical history and prior and concomitant medications and dilated ophthalmoscopy/retinal photography testing. Modifications were also made to throughout the data analysis/statistical methods section, and minor editorial and formatting corrections were made throughout the protocol.

    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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