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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 2 DIABETES MELLITUS PATIENTS

    Summary
    EudraCT number
    		 2014-000881-23
    Trial protocol
    		 SK  
    Global end of trial date
    24 Dec 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Jun 2018
    First version publication date
    02 Jul 2017
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Data for secondary endpoint 'Hypoglycemia Occurrence' includes nocturnal totals and requires update to include all occurrences.

    Trial information

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    Trial identification
    Sponsor protocol code
    MYL-GAI-3002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02227875
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND Number: 105279
    Sponsors
    Sponsor organisation name
    Mylan GmbH
    Sponsor organisation address
    Thurgauerstrasse 40, Zurich, Switzerland, 8050
    Public contact
    Keri L. Vaughan, Director Global Clinical Operations, General Medicine, Mylan, Inc, keri.vaughan@mylan.com
    Scientific contact
    Keri L. Vaughan, Director Global Clinical Operations, General Medicine, Mylan, Inc, keri.vaughan@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
    29 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test whether Mylan’s insulin glargine once daily is non-inferior to Lantus® once daily (both administered in combination with other anti-diabetic drugs) based on the change in HbA1c from baseline to 24 weeks
    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
    16 Jun 2014
    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
    Slovakia: 67
    Country: Number of subjects enrolled
    United States: 453
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    South Africa: 27
    Country: Number of subjects enrolled
    Jordan: 5
    Worldwide total number of subjects
    560
    EEA total number of subjects
    67
    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)
    534
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 · Gender: male or female; · Age: 18-65 years, inclusive; · Body mass index (BMI): 18.5-40.0 kg/m2, inclusive.

    Pre-assignment
    Screening details
    		 Nine hundred fifty-one (951) patients were screened to participate in the study, and 560 patients were randomized to study treatment. Of 560 randomized patients, 228 were insulin-naïve.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MYL IG
    Arm description
    		 Mylan’s insulin glargine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Glargine - new formulation
    Investigational medicinal product code
    MYL-1501D
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL once daily

    Arm title
    		 Lantus
    Arm description
    		 Lantus
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    Lantus®
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL daily

    Number of subjects in period 1
    		MYL IG Lantus
    Started
    277
    283
    Completed
    240
    250
    Not completed
    37
    33
         Consent withdrawn by subject
    12
    13
         Physician decision
    1
    -
         Adverse event, non-fatal
    3
    -
         Other
    1
    3
         Lost to follow-up
    10
    10
         Protocol deviation
    10
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MYL IG
    Reporting group description
    		 Mylan’s insulin glargine

    Reporting group title
    Lantus
    Reporting group description
    		 Lantus

    Reporting group values
    		 MYL IG Lantus Total
    Number of subjects
    		 277 283 560
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 267 267 534
        Adults (65 years)
    		 10 16 26
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55 ( 7.91 ) 55.1 ( 7.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 130 118 248
        Male
    		 147 165 312
    Insulin history
    Units: Subjects
        Yes
    		 165 167 332
        No
    		 112 116 228
    Dosing time
    Units: Subjects
        Morning
    		 68 71 139
        Evening
    		 209 212 421
    Previous exposure to Insulin
    The mean duration of diabetes prior to entry into the study was 11.64 ± 6.57 years, with 332 (59.3%) patients having previously used insulin and 228 (40.7%) having been insulin-naïve. Of the 560 randomized patients, 330 (58.9%) reported previous exposure to insulin, with 230 (41.1%) reported having been insulin-naïve (Table 11 2). This discrepancy in the proportion of patients with prior insulin use was a result of data entry errors during randomization.
    Units: Subjects
        Naive
    		 114 116 230
        Non-naive
    		 163 167 330
    Geographic region
    Units: Subjects
        East Asia
    		 4 4 8
        East Europe
    		 34 33 67
        Middle East and Africa
    		 14 18 32
        North America
    		 225 228 453
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 90.08 ( 16.97 ) 90.65 ( 18.395 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 168.57 ( 9.476 ) 168.95 ( 10.646 ) -
    BMI
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 31.591 ( 4.7907 ) 31.544 ( 4.4357 ) -
    Duration of Diabetes
    Units: years
        arithmetic mean (standard deviation)
    		 11.955 ( 7.0957 ) 11.337 ( 6.0104 ) -
    Baseline fasting plasma blood glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 8.6 ( 2.96 ) 8.6 ( 3.06 ) -
    Baseline HbA1c
    Units: percent
        arithmetic mean (standard deviation)
    		 8.14 ( 1.142 ) 8.13 ( 1.135 ) -

    End points

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    End points reporting groups
    Reporting group title
    MYL IG
    Reporting group description
    		 Mylan’s insulin glargine

    Reporting group title
    Lantus
    Reporting group description
    		 Lantus

    Subject analysis set title
    Randomized Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Randomized population includes all patients who were enrolled and randomized to study drug. For analyses and displays based on the Randomized population, patients were classified according to their randomized Treatment.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients who received at least one dose of study drug.

    Subject analysis set title
    ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients (including patients who may have received the incorrect treatment, did not complete the study, did not comply with the protocol, or who consumed prohibited medication) who had a Baseline (Randomization visit) and at least 1 post-Baseline primary efficacy value.

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population includes patients who completed the study and had HbA1c measurements in accordance with the protocol, who discontinued, but had at least 12 weeks of HbA1c data and who do not have protocol violations that could impact the primary outcome measure.

    Primary: Change in HbA1c from Baseline to Week 24

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    End point title
    		 Change in HbA1c from Baseline to Week 24
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    274 [1]
    278 [2]
    Units: percentage
        least squares mean (confidence interval 95%)
    -0.6 (-0.779 to -0.414)
    -0.66 (-0.837 to -0.475)
    Notes
    [1] - Intent-To-Treat Population
    [2] - Intent-To-Treat Population
    Statistical analysis title
    		 Mylan's Insulin Glargine versus Lantus
    Comparison groups
    MYL IG v Lantus
    Number of subjects included in analysis
    552
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Mixed-Effect Model for Repeated Measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.098
         upper limit
    		 0.218
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08

    Secondary: Change in HbA1c over Time

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    End point title
    		 Change in HbA1c over Time
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    274 [3]
    278 [4]
    Units: percentage
    arithmetic mean (standard deviation)
        week 12
    -0.57 ( 0.88 )
    -0.59 ( 0.9 )
        week 24
    -0.42 ( 1.038 )
    -0.47 ( 1.061 )
    Notes
    [3] - Intent-To-Treat Population
    [4] - Intent-To-Treat Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in FPG over time

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    End point title
    		 Change from Baseline in FPG over time
    End point description
    End point type
    Secondary
    End point timeframe
    week 12 and 24
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    274 [5]
    278 [6]
    Units: mmol/L
    arithmetic mean (standard deviation)
        week 12
    -0.98 ( 2.829 )
    -1.15 ( 3.077 )
        week 24
    -0.74 ( 3.105 )
    -1.05 ( 3.043 )
    Notes
    [5] - Intent-To-Treat Population
    [6] - Intent-To-Treat Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in 7-point SMBG profile over time

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    End point title
    		 Change from Baseline in 7-point SMBG profile over time
    End point description
    Overall average of SMBG Profile. Number of subjects analyzed indicates the number of subjects in the Intent-to-treat Population.
    End point type
    Secondary
    End point timeframe
    week 12 and week 24
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    274 [7]
    278 [8]
    Units: mmol/L
    arithmetic mean (standard deviation)
        week 12
    -1.133 ( 2.2187 )
    -1.214 ( 2.3124 )
        week 24
    -0.98 ( 2.3947 )
    -1.333 ( 2.4255 )
    Notes
    [7] - Intent-To-Treat Population
    [8] - Intent-To-Treat Population
    No statistical analyses for this end point

    Secondary: Change in basal insulin dose per unit body weight from baseline over time

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    End point title
    		 Change in basal insulin dose per unit body weight from baseline over time
    End point description
    End point type
    Secondary
    End point timeframe
    week 12 and 24
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    274 [9]
    278 [10]
    Units: U/Kg
    arithmetic mean (standard deviation)
        week 12
    0.1062 ( 0.1198 )
    0.1065 ( 0.13013 )
        week 24
    0.1244 ( 0.13864 )
    0.122 ( 0.14184 )
    Notes
    [9] - Intent-To-Treat Population
    [10] - Intent-To-Treat Population
    No statistical analyses for this end point

    Secondary: Proportion of Patients with HbA1c <7%

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    End point title
    		 Proportion of Patients with HbA1c <7%
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    274 [11]
    278 [12]
    Units: count
    63
    68
    Notes
    [11] - Intent-To-Treat Population
    [12] - Intent-To-Treat Population
    No statistical analyses for this end point

    Secondary: Rate of hypoglycemic events per 30 days over time

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    End point title
    		 Rate of hypoglycemic events per 30 days over time
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12 and 24
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    276 [13]
    282 [14]
    Units: Episodes/30 Days
    arithmetic mean (standard deviation)
        week 12
    0.341 ( 1.8963 )
    0.24 ( 2.0551 )
        week 24
    -0.057 ( 0.919 )
    -0.102 ( 1.6791 )
    Notes
    [13] - Safety Population
    [14] - Safety Population
    No statistical analyses for this end point

    Secondary: Hypoglycemia occurrence

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    End point title
    		 Hypoglycemia occurrence
    End point description
    Overall hypoglycemic incidence during treatment period
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    276
    282
    Units: number
        Any Hypoglycemic Event
    130
    136
        Severe Hypoglycemia
    0
    1
        Documented Symptomatic Hypoglycemia
    75
    76
        Asymptomatic Hypoglycemia
    85
    92
        Probable Symptomatic Hypoglycemia
    7
    4
        Relative Hypoglycemia
    20
    11
        Unknown
    29
    25
    No statistical analyses for this end point

    Secondary: Occurrence of local and systemic reactions

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    End point title
    		 Occurrence of local and systemic reactions
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    276 [15]
    282 [16]
    Units: patients
        Local
    2
    1
        Systemic
    2
    1
    Notes
    [15] - Safety Population
    [16] - Safety Population
    No statistical analyses for this end point

    Secondary: Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay over time

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    End point title
    		 Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay over time
    End point description
    Comparison of change from Baseline in Immunogenicity
    End point type
    Secondary
    End point timeframe
    Week 12 and week 24
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    276 [17]
    282 [18]
    Units: %SB
    arithmetic mean (standard deviation)
        week 12
    1.9238 ( 12.54369 )
    0.6585 ( 8.05473 )
        week 24
    1.7802 ( 9.64745 )
    0.7838 ( 8.15086 )
    Notes
    [17] - Safety Population
    [18] - Safety Population
    No statistical analyses for this end point

    Secondary: Change in Total Insulin Antibody Percent Binding for Lantus Assay over time

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    End point title
    		 Change in Total Insulin Antibody Percent Binding for Lantus Assay over time
    End point description
    Comparison of change from Baseline in Immunogenicity
    End point type
    Secondary
    End point timeframe
    week 12 and week 24
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    276 [19]
    282 [20]
    Units: %SB
    arithmetic mean (standard deviation)
        week 12
    1.787 ( 11.67578 )
    0.6462 ( 7.56375 )
        week 24
    1.6866 ( 9.57132 )
    0.8212 ( 8.1084 )
    Notes
    [19] - Safety Population
    [20] - Safety Population
    No statistical analyses for this end point

    Secondary: Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay over time

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    End point title
    		 Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay over time
    End point description
    Comparison of change from Baseline in Immunogenicity
    End point type
    Secondary
    End point timeframe
    week 12 and week 24
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    276 [21]
    282 [22]
    Units: %SB
    arithmetic mean (standard deviation)
        week 12
    1.7488 ( 11.68129 )
    0.5116 ( 7.25175 )
        week 24
    1.6301 ( 9.11098 )
    0.7524 ( 7.93317 )
    Notes
    [21] - Safety Population
    [22] - Safety Population
    No statistical analyses for this end point

    Secondary: Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay over time

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    End point title
    		 Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay over time
    End point description
    Comparison of change from Baseline in Immunogenicity
    End point type
    Secondary
    End point timeframe
    Week 12 and week 24
    End point values
    		 MYL IG Lantus
    Number of subjects analysed
    276 [23]
    282 [24]
    Units: %SB
    arithmetic mean (standard deviation)
        week 12
    1.5994 ( 10.64782 )
    0.5014 ( 6.72058 )
        week 24
    1.5648 ( 9.04243 )
    0.8361 ( 7.96308 )
    Notes
    [23] - Safety Population
    [24] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    MYL IG
    Reporting group description
    		 Mylan’s insulin glargine

    Reporting group title
    Lantus
    Reporting group description
    		 Lantus

    Serious adverse events
    		 MYL IG Lantus
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 276 (2.90%)
    9 / 282 (3.19%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Helicobacter test positive
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Endometrial adenocarcinoma
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye haemorrhage
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 282 (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
    Asthma
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 276 (0.00%)
    2 / 282 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 282 (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 / 276 (0.36%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraspinal abscess
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 282 (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
    Dehydration
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperosmolar hyperglycaemic state
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 282 (0.35%)
         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: 1%
    Non-serious adverse events
    		 MYL IG Lantus
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    177 / 276 (64.13%)
    164 / 282 (58.16%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 276 (2.17%)
    2 / 282 (0.71%)
         occurrences all number
    6
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 276 (1.45%)
    2 / 282 (0.71%)
         occurrences all number
    4
    2
    Injection site pain
         subjects affected / exposed
    3 / 276 (1.09%)
    2 / 282 (0.71%)
         occurrences all number
    4
    3
    Oedema peripheral
         subjects affected / exposed
    2 / 276 (0.72%)
    6 / 282 (2.13%)
         occurrences all number
    2
    6
    Immune system disorders
    Seasonal allergy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 276 (0.36%)
    4 / 282 (1.42%)
         occurrences all number
    1
    4
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 276 (1.81%)
    5 / 282 (1.77%)
         occurrences all number
    5
    5
    Cough
         subjects affected / exposed
    4 / 276 (1.45%)
    10 / 282 (3.55%)
         occurrences all number
    4
    10
    Respiratory tract congestion
         subjects affected / exposed
    3 / 276 (1.09%)
    0 / 282 (0.00%)
         occurrences all number
    3
    0
    Investigations
    Lipase increased
         subjects affected / exposed
    4 / 276 (1.45%)
    1 / 282 (0.35%)
         occurrences all number
    4
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 276 (0.36%)
    4 / 282 (1.42%)
         occurrences all number
    1
    4
    Laceration
         subjects affected / exposed
    0 / 276 (0.00%)
    4 / 282 (1.42%)
         occurrences all number
    0
    4
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 276 (2.90%)
    10 / 282 (3.55%)
         occurrences all number
    9
    11
    Tremor
         subjects affected / exposed
    6 / 276 (2.17%)
    1 / 282 (0.35%)
         occurrences all number
    9
    3
    Dizziness
         subjects affected / exposed
    4 / 276 (1.45%)
    7 / 282 (2.48%)
         occurrences all number
    4
    8
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 276 (2.17%)
    4 / 282 (1.42%)
         occurrences all number
    6
    4
    Vomiting
         subjects affected / exposed
    5 / 276 (1.81%)
    5 / 282 (1.77%)
         occurrences all number
    5
    5
    Diarrhoea
         subjects affected / exposed
    4 / 276 (1.45%)
    5 / 282 (1.77%)
         occurrences all number
    4
    10
    Abdominal pain
         subjects affected / exposed
    4 / 276 (1.45%)
    1 / 282 (0.35%)
         occurrences all number
    4
    1
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 276 (1.09%)
    0 / 282 (0.00%)
         occurrences all number
    5
    0
    Dyspepsia
         subjects affected / exposed
    3 / 276 (1.09%)
    0 / 282 (0.00%)
         occurrences all number
    3
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 276 (0.36%)
    3 / 282 (1.06%)
         occurrences all number
    1
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 276 (0.72%)
    3 / 282 (1.06%)
         occurrences all number
    3
    3
    Pruritus
         subjects affected / exposed
    1 / 276 (0.36%)
    3 / 282 (1.06%)
         occurrences all number
    1
    3
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    3 / 276 (1.09%)
    0 / 282 (0.00%)
         occurrences all number
    3
    0
    Dysuria
         subjects affected / exposed
    0 / 276 (0.00%)
    3 / 282 (1.06%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 276 (2.54%)
    6 / 282 (2.13%)
         occurrences all number
    7
    6
    Pain in extremity
         subjects affected / exposed
    5 / 276 (1.81%)
    4 / 282 (1.42%)
         occurrences all number
    5
    4
    Arthralgia
         subjects affected / exposed
    4 / 276 (1.45%)
    5 / 282 (1.77%)
         occurrences all number
    4
    7
    Musculoskeletal pain
         subjects affected / exposed
    2 / 276 (0.72%)
    5 / 282 (1.77%)
         occurrences all number
    2
    5
    Infections and infestations
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    17 / 276 (6.16%)
    15 / 282 (5.32%)
         occurrences all number
    19
    15
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    12 / 276 (4.35%)
    8 / 282 (2.84%)
         occurrences all number
    13
    8
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 276 (3.62%)
    13 / 282 (4.61%)
         occurrences all number
    11
    14
    Sinusitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 276 (2.90%)
    4 / 282 (1.42%)
         occurrences all number
    9
    5
    Influenza
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 276 (2.17%)
    3 / 282 (1.06%)
         occurrences all number
    7
    3
    Bronchitis
         subjects affected / exposed
    4 / 276 (1.45%)
    6 / 282 (2.13%)
         occurrences all number
    4
    6
    Gastroenteritis
         subjects affected / exposed
    5 / 276 (1.81%)
    1 / 282 (0.35%)
         occurrences all number
    5
    1
    Pharyngitis
         subjects affected / exposed
    3 / 276 (1.09%)
    1 / 282 (0.35%)
         occurrences all number
    3
    1
    Pneumonia
         subjects affected / exposed
    3 / 276 (1.09%)
    0 / 282 (0.00%)
         occurrences all number
    3
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    3 / 276 (1.09%)
    0 / 282 (0.00%)
         occurrences all number
    3
    0
    Metabolism and nutrition disorders
    Hypoglycemia
         subjects affected / exposed
    75 / 276 (27.17%)
    66 / 282 (23.40%)
         occurrences all number
    330
    282

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jul 2014
    - Planned number of insulin-naïve patients changed to 224 - Inclusion criterion for insulin-naïve patients added: 7.5 to 10.5 %HbA1c - Recommended starting dose for insulin-naïve patients added - Retinal photography added - Clarification on recording Insulin dose added - Titration committee added - Clarification added regarding recording of device-related safety - Immunogenicity sampling added at visit 2 and visit 4 - Measurement and analysis of cross-reacting antibody added - Treatment compliance criteria modified - Clarification of analysis of insulin-naïve group added - Clarifications and minor editorial corrections
    30 Jul 2015
    • Planned number of insulin-naïve patients changed to 224 • Inclusion criterion for insulin-naïve patients added: 7.5 to 10.5% HbA1c • Recommended starting dose for insulin-naïve patients added • Clarification added regarding recording of device-related safety • Immunogenicity sampling added at visit 2 and visit 4 • Add other additional study related items
    23 Dec 2015
    - Text that refers to the extension study has been removed. - Clarification made that patients will go back to their prescribed medication after the treatment period. - The brief summary of the extension study has been removed from the Study Design section. - The addendum containing the extension study protocol has been removed. Logistical issues prevented the establishment in time of systems required to conduct the study. Hence the sponsor decided to halt the extension study, to maintain good clinical practice and a sound scientific approach. This step was not prompted by any known or suspected safety concerns.

    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
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