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    Clinical Trial Results:
    A 24-Week, Multicenter, Randomized, Open-Label, Parallel-group Study Comparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-Naive Patients with Type 2 Diabetes Mellitus not Adequately Controlled with Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

    Summary
    EudraCT number
    		 2015-005101-36
    Trial protocol
    		 DK   SE   GR   HU   CZ   SK   FR   GB   SI   BG   HR   IT  
    Global end of trial date
    15 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Aug 2018
    First version publication date
    30 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LPS14584
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02738151
    WHO universal trial number (UTN)
    		 U1111-1177-6327
    Other trial identifiers
    		 STUDY NAME: BRIGHT
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette,, Chilly-Mazarin, France,
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, contact-US@sanofi.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 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of Toujeo to Tresiba in glycated hemoglobin (HbA1c) change from baseline to Week 24.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 Oral Anti diabetic Drugs (OADs), glucagon–like peptide-1 (GLP-1) receptor agonist according to local labelling. Dose remained unchanged during the study unless there was a specific safety issue related to these treatments.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 May 2016
    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
    Israel: 26
    Country: Number of subjects enrolled
    Italy: 43
    Country: Number of subjects enrolled
    Serbia: 31
    Country: Number of subjects enrolled
    Switzerland: 4
    Country: Number of subjects enrolled
    United States: 462
    Country: Number of subjects enrolled
    Romania: 112
    Country: Number of subjects enrolled
    Slovakia: 35
    Country: Number of subjects enrolled
    Sweden: 16
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    Croatia: 10
    Country: Number of subjects enrolled
    Bulgaria: 24
    Country: Number of subjects enrolled
    Czech Republic: 60
    Country: Number of subjects enrolled
    Denmark: 19
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Greece: 21
    Country: Number of subjects enrolled
    Hungary: 32
    Worldwide total number of subjects
    929
    EEA total number of subjects
    406
    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)
    596
    From 65 to 84 years
    329
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 158 study centers across 16 countries. A total of 1376 subjects were screened between 19 May 2016 and 19 February 2017, of whom 447 were screen failures.

    Pre-assignment
    Screening details
    		 A total of 929 subjects were randomized in 1:1 ratio to either Toujeo or Tresiba, stratified by screening glycated hemoglobin A1c (HbA1c) values (<8% or >=8%); and use of sulfonylurea (SU) or meglitinides at screening (’yes’ versus ‘no’).

    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
    		 Toujeo
    Arm description
    		 Toujeo® (Insulin glargine, 300 Unit [U]/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    HOE901-U300
    Other name
    Toujeo
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin glargine, 300 U/ml self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L).

    Arm title
    		 Tresiba
    Arm description
    		 Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin degludec
    Investigational medicinal product code
    Other name
    Tresiba®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin degludec, 100U/ml self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L).

    Number of subjects in period 1
    		Toujeo Tresiba
    Started
    466
    463
    Treated
    462
    462
    Completed
    443
    432
    Not completed
    23
    31
         Randomized but not treated
    4
    1
         Adverse event
    4
    5
         Other than specified
    11
    21
         Poor Compliance to Protocol
    4
    3
         Hypoglycemia
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Toujeo
    Reporting group description
    		 Toujeo® (Insulin glargine, 300 Unit [U]/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.

    Reporting group title
    Tresiba
    Reporting group description
    		 Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.

    Reporting group values
    		 Toujeo Tresiba Total
    Number of subjects
    		 466 463 929
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.6 ± 9.6 60.5 ± 9.8 -
    Gender categorical
    Units: Subjects
        Female
    		 219 211 430
        Male
    		 247 252 499
    Body Mass Index (BMI)
    Units: Kg/m^2
        arithmetic mean (standard deviation)
    		 31.7 ± 4.3 31.3 ± 4.4 -
    Duration of Type 2 Diabetes Mellitus
    Units: years
        arithmetic mean (standard deviation)
    		 10.5 ± 6.1 10.7 ± 6.5 -
    Baseline HbA1c
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    		 8.71 ± 0.83 8.57 ± 0.80 -
    Basal Insulin Daily Dose
    Number of subjects analysed = subjects with available data for specified measure. (461 for both Toujeo and Tresiba arm)
    Units: Units per kilogram (U/kg)
        arithmetic mean (standard deviation)
    		 0.19 ± 0.04 0.12 ± 0.03 -

    End points

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    End points reporting groups
    Reporting group title
    Toujeo
    Reporting group description
    		 Toujeo® (Insulin glargine, 300 Unit [U]/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.

    Reporting group title
    Tresiba
    Reporting group description
    		 Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.

    Primary: Change From Baseline in HbA1c to Week 24

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    End point title
    		 Change From Baseline in HbA1c to Week 24
    End point description
    Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 24-week on-treatment period. Analysis was performed on Intent-to-treat (ITT) population which included all randomized subjects who received at least 1 dose of IMP, regardless of whether treatment was actually being received & analysed as per allocated treatment group. Overall number of subjects analysed=subjects with at least 1 baseline & 1 post-baseline HbA1c assessment during 24 week on-treatment period.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    430
    425
    Units: percentage of HbA1c
    least squares mean (standard error)
        Week 24
    -1.64 ± 0.037
    -1.59 ± 0.037
    Statistical analysis title
    		 Toujeo vs Tresiba
    Statistical analysis description
    A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit, and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates.
    Comparison groups
    Toujeo v Tresiba
    Number of subjects included in analysis
    855
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.0001 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square (LS) Mean difference
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.152
         upper limit
    		 0.051
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.052
    Notes
    [1] - Non-inferiority of Toujeo vs Tresiba was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was <0.3%.
    [2] - Threshold for significance at 0.025 level.
    Statistical analysis title
    		 Toujeo vs. Tresiba
    Comparison groups
    Toujeo v Tresiba
    Number of subjects included in analysis
    855
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.3302
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.152
         upper limit
    		 0.051
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.052
    Notes
    [3] - Superiority of Toujeo over Tresiba was demonstrated if the upper bound of the two-sided 95% CI for the difference in the mean change in HbA1c from baseline to Week 24 between Toujeo over Tresiba on ITT population was <0 (zero).

    Secondary: Change From Baseline in HbA1c to Week 12

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    End point title
    		 Change From Baseline in HbA1c to Week 12
    End point description
    Change in HbA1c was calculated by subtracting baseline value from Week 12 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM. Analysis was performed on ITT population. Here, overall number of subjects analysed = subjects with at least one baseline and one post-baseline HbA1c assessment during the 12 week on-treatment period.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    448
    445
    Units: percentage of HbA1c
    least squares mean (standard error)
        Week 12
    -1.37 ± 0.036
    -1.39 ± 0.036
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24
    End point description
    Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 value. Adjusted LS means were obtained from MMRM including post baseline values during the 24-week on-treatment period. Analysis was performed on ITT population. Here, n = subjects with at least one baseline and one post baseline FPG values at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: mmol/L
    least squares mean (standard error)
        Week 12 (n=442, 441)
    -3.64 ± 0.099
    -3.89 ± 0.100
        Week 24 (n=417, 408)
    -3.52 ± 0.109
    -3.95 ± 0.110
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24

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    End point title
    		 Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24
    End point description
    Fasting SMPG was measured by the subject before breakfast and before the administration of the glucose-lowering agents once a day during the study. Adjusted LS means were obtained from MMRM including post baseline values during the 24 week on-treatment period. Analysis was performed on ITT population. Here, n = subjects with at least one baseline and one post baseline fasting SMPG values at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: mmol/L
    least squares mean (standard error)
        Week 12 (n=430, 431)
    -3.26 ± 0.067
    -3.25 ± 0.067
        Week 24 (n=421, 416)
    -3.23 ± 0.067
    -3.29 ± 0.068
    No statistical analyses for this end point

    Secondary: Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point

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    End point title
    		 Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point
    End point description
    8-point SMPG profiles were measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Analysis was performed on ITT population. Here, n = subjects with at least one baseline and one post baseline SMPG values at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: mmol/L
    arithmetic mean (standard deviation)
        Week 12: 03:00 at night (n=342, 334)
    -2.77 ± 3.16
    -2.28 ± 3.49
        Week 12: Pre-breakfast (n=378, 371)
    -3.42 ± 2.79
    -3.00 ± 2.63
        Week 12: 2 hours after breakfast (n=365, 351)
    -3.20 ± 4.02
    -3.23 ± 3.92
        Week 12: Pre-lunch (n=365, 358)
    -2.64 ± 3.90
    -2.50 ± 3.65
        Week 12: 2 hours after lunch (n=365, 367)
    -2.51 ± 4.15
    -1.99 ± 3.94
        Week 12: Pre-dinner (n=366, 363)
    -2.04 ± 3.63
    -1.93 ± 3.74
        Week 12: 2 hours after dinner (n=355, 352)
    -2.32 ± 4.20
    -1.76 ± 3.87
        Week 12: Bedtime (n=344, 331)
    -2.44 ± 4.07
    -2.08 ± 3.95
        Week 24: 03:00 at night (n=331, 305)
    -2.65 ± 3.43
    -2.43 ± 3.51
        Week 24: Pre-breakfast (n=363, 341)
    -3.37 ± 2.81
    -3.03 ± 2.85
        Week 24: 2 hours after breakfast (n=346, 326)
    -3.30 ± 3.68
    -3.50 ± 4.00
        Week 24: Pre-lunch (n=350, 331)
    -2.81 ± 3.67
    -2.29 ± 3.93
        Week 24: 2 hours after lunch (n=350, 338)
    -2.74 ± 3.73
    -1.93 ± 3.91
        Week 24: Pre-dinner (n=350, 333)
    -1.87 ± 3.78
    -1.86 ± 4.01
        Week 24: 2 hours after dinner (n=338, 326)
    -2.28 ± 4.19
    -2.07 ± 4.00
        Week 24: Bedtime (n=315, 286)
    -2.52 ± 3.87
    -2.09 ± 3.96
    No statistical analyses for this end point

    Secondary: Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point

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    End point title
    		 Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point
    End point description
    4-point SMPG profiles were measured at the following 4 points: prebreakfast, prelunch, predinner and bedtime. Analysis was performed on ITT population. Here, n = subjects with at least one baseline and one post baseline SMPG values at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: mmol/L
    arithmetic mean (standard deviation)
        Week 12: Pre-breakfast (n=380, 374)
    -3.41 ± 2.75
    -2.97 ± 2.62
        Week 12: Pre-lunch (n=369, 362)
    -2.63 ± 3.88
    -2.44 ± 3.65
        Week 12: Pre-dinner (n=371, 370)
    -2.03 ± 3.64
    -1.92 ± 3.76
        Week 12: Bedtime (n=346, 336)
    -2.41 ± 4.10
    -2.11 ± 3.96
        Week 24: Pre-breakfast (n=363, 341)
    -3.38 ± 2.81
    -2.99 ± 2.81
        Week 24: Pre-lunch (n=351, 332)
    -2.81 ± 3.67
    -2.26 ± 3.92
        Week 24: Pre-dinner (n=353, 335)
    -1.88 ± 3.79
    -1.86 ± 4.01
        Week 24: Bedtime (n=314, 289)
    -2.51 ± 3.87
    -2.10 ± 4.00
    No statistical analyses for this end point

    Secondary: Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24

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    End point title
    		 Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24
    End point description
    The 8-point SMPG profile was measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Adjusted LS means were obtained from MMRM. Analysis was performed on ITT population. Here, n = subjects with at least one baseline and one post-baseline 24-hour average SMPG values at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: mmol/L
    least squares mean (standard error)
        Week 12 (n= 379,375)
    -2.57 ± 0.092
    -2.50 ± 0.093
        Week 24 (n=363, 345)
    -2.62 ± 0.094
    -2.53 ± 0.096
    No statistical analyses for this end point

    Secondary: Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24

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    End point title
    		 Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24
    End point description
    Adjusted LS means were obtained from MMRM. Variability was assessed by the mean of coefficient of variation calculated over at least 3 SMPG measured during the 7 days preceding the given visit. Analysis was performed on ITT population. Here, n = subjects with at least one baseline and one post baseline Fasting SMPG values at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: percentage of mean variability
    least squares mean (standard error)
        Week 12 (n=430, 431)
    2.38 ± 0.418
    2.62 ± 0.416
        Week 24 (n=421, 416)
    1.49 ± 0.391
    1.97 ± 0.390
    No statistical analyses for this end point

    Secondary: Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24

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    End point title
    		 Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24
    End point description
    Adjusted LS means were obtained from MMRM. Data was presented in form of percentage of SMPG profile. Analysis was performed on ITT population. Here, n = subjects with at least one baseline and one post-baseline 24-hour average SMPG values at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: percentage of mean variability
    least squares mean (standard error)
        Week 12 (n=379,375)
    4.08 ± 0.562
    4.73 ± 0.561
        Week 24 (n=363, 345)
    3.70 ± 0.588
    3.95 ± 0.599
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24

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    End point title
    		 Percentage of Subjects Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24
    End point description
    Only the post-baseline HbA1c measurements before rescue and during the 12 week and 24-week on-treatment period were considered in the analysis. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Week 12, and Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: percentage of subjects
    number (not applicable)
        Subjects who reached the target <7% at Week 12
    34.63
    36.15
        Subjects who reached target <=6.5% at Week 12
    11.47
    14.29
        Subjects who reached the target <7% at Week 24
    48.70
    44.59
        Subjects who reached target <=6.5% at Week 24
    21.21
    19.70
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event

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    End point title
    		 Percentage of Subjects Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event
    End point description
    Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed by plasma glucose =<3.9 mmol/L (=<70 mg/dL). Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Week 12, and Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: percentage of subjects
    number (not applicable)
        Week 12: Subjects who reached the target <7%
    16.45
    13.64
        Week 12: Subjects who reached target <=6.5%
    4.11
    4.55
        Week 24: Subjects who reached the target <7%
    13.42
    12.99
        Week 24: Subjects who reached target <=6.5%
    5.84
    5.19
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia

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    End point title
    		 Percentage of Subjects With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia
    End point description
    Percentage of subjects With Sulphonylurea or Meglitinide dose reduction/ discontinuation due to Hypoglycemia during 24 Week treatment period were reported. Only subjects with Sulphonylurea or meglitinides at Screening as per actual strata were taken into account in this analysis. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: percentage of subjects
        number (not applicable)
    4.98
    4.76
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Requiring a Rescue Therapy During 24 Weeks Treatment Period

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    End point title
    		 Percentage of Subjects Requiring a Rescue Therapy During 24 Weeks Treatment Period
    End point description
    Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. Threshold values at Week 12: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: percentage of subjects
        number (not applicable)
    1.30
    1.30
    No statistical analyses for this end point

    Secondary: Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24

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    End point title
    		 Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24
    End point description
    Only the insulin dose measurements performed before initiation of rescue therapy and during the on-treatment period were considered in the analysis. Analysis was performed on Safety Population which included all randomized subjects who did actually receive at least one dose of IMP, regardless of the amount of treatment administered.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: Units per kilogram (U/kg)
    arithmetic mean (standard deviation)
        Week 12 (n=450, 445)
    0.289 ± 0.200
    0.255 ± 0.195
        Week 24 (n=436, 425)
    0.357 ± 0.253
    0.309 ± 0.241
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period

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    End point title
    		 Percentage of Subjects With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period
    End point description
    Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks (24W)). Percentage of subjects with at least one hypoglycemia (hypo) event at any time of the day were reported. Analysis was performed on Safety Population.
    End point type
    Secondary
    End point timeframe
    Day 1-Week 12, Week 13-Week 24, and 24 Week Period
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: percentage of subjects
    number (not applicable)
        Any hypo Day1-Week 12
    53.0
    58.4
        Any hypo Week13-14
    57.2
    57.4
        Any hypo 24 week period
    70.1
    71.2
        Severe and/or confirmed hypo (=<70mg/dL) D1–W12
    47.4
    54.3
        Severe and/or confirmed hypo (=<70mg/dL) W13-14
    54.1
    55.8
        Severe and/or confirmed hypo(=<70mg/dL) 24W period
    66.5
    69.0
        Severe and/or confirmed hypo (< 54mg/dL) D1–W12
    7.8
    11.7
        Severe and/or confirmed hypo( <54 mg/dL) W13-14
    9.8
    11.2
        Severe and/or confirmed hypo (<54mg/dL) 24W period
    14.7
    18.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period

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    End point title
    		 Percentage of Subjects With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period
    End point description
    Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycaemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks). Safety population included all randomized subjects who did actually receive at least one dose of IMP, regardless of the amount of treatment administered.
    End point type
    Secondary
    End point timeframe
    Day 1-Week 12, Week 13-Week 24, and 24 Week Period
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: percentage of subjects
    number (not applicable)
        Any hypo D1-W12
    18.4
    21.0
        Any hypo W13-14
    22.7
    21.2
        Any hypo 24W period
    31.2
    30.3
        Severe and/or confirmed hypo (=<70mg/dL) D1-W12
    15.2
    18.8
        Severe and/or confirmed hypo (=<70mg/dL) W13-14
    21.4
    21.0
        Severe and/or confirmed hypo(=<70mg/dL) 24W Period
    28.6
    28.8
        Severe and/or confirmed hypo (< 54mg/dL) D1-W12
    2.8
    3.5
        Severe and/or confirmed hypo (< 54mg/dL) W13-14
    4.5
    3.8
        Severe and/or confirmed hypo(< 54mg/dL) 24W Period
    6.1
    6.1
    No statistical analyses for this end point

    Secondary: Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Subject Year During Study Period

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    End point title
    		 Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Subject Year During Study Period
    End point description
    Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Analysis was performed on Safety population.
    End point type
    Secondary
    End point timeframe
    Day 1-Week 12, Week 13-Week 24, and 24 Week Period
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: Events per subject year
    number (not applicable)
        Any hypo D1-W12
    8.93
    11.31
        Any hypo W13-14
    11.28
    11.60
        Any hypo 24W period
    10.09
    11.45
        Severe and/or confirmed hypo (=<70mg/dL) D1-W12
    8.08
    10.47
        Severe and/or confirmed hypo (=<70mg/dL) W13-14
    10.64
    11.21
        Severe and/or confirmed hypo (≤70mg/dL) 24W period
    9.34
    10.83
        Severe and/or confirmed hypo (< 54mg/dL) D1-W12
    0.49
    0.86
        Severe and/or confirmed hypo( <54 mg/dL) W13-14
    0.73
    0.91
        Severe and/or confirmed hypo (<54mg/dL) 24W period
    0.61
    0.88
    No statistical analyses for this end point

    Secondary: Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per subject Year During Study Period

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    End point title
    		 Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per subject Year During Study Period
    End point description
    Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). Analysis was performed on Safety Population.
    End point type
    Secondary
    End point timeframe
    Day 1-Week 12, Week 13-Week 24, and 24 Week Period
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: Events per Subject year
    number (not applicable)
        Any hypo D1-W12
    1.65
    2.36
        Any hypo W13-14
    2.32
    2.39
        Any hypo 24W period
    1.98
    2.38
        Severe and/or confirmed hypo (=<70mg/dL) D1-W12
    1.42
    2.20
        Severe and/or confirmed hypo (=<70mg/dL) W13-14
    2.24
    2.33
        Severe and/or confirmed hypo (=<70mg/dL)24W Period
    1.83
    2.26
        Severe and/or confirmed hypo(< 54mg/dL) D1-W12
    0.16
    0.19
        Severe and/or confirmed hypo(< 54mg/dL) W13-14
    0.33
    0.26
        Severe and/or confirmed hypo(< 54mg/dL) 24W Period
    0.24
    0.22
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24

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    End point title
    		 Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24
    End point description
    The DTSQs is a validated questionnaire to assess subject’s satisfaction with their diabetes treatment. It consists of 8 items that are answered on a Likert scale from 0 to 6. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment). Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM. Analysis was performed on ITT population. Here, n = subjects with at least one baseline and one post-baseline DTSQ status (DTSQs) total score.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    462
    462
    Units: score on a scale
    least squares mean (standard error)
        Week 12 (n= 438, 436)
    5.08 ± 0.246
    5.32 ± 0.245
        Week 24 (n= 419, 416)
    5.77 ± 0.257
    5.44 ± 0.256
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AEs) were collected from signature of the informed consent form until 7 days after last treatment administration (maximum exposure: 24 Weeks).
    Adverse event reporting additional description
    Reported AEs and death were treatment-emergent AEs that is AEs that developed/worsened during the ‘on-treatment period’ (On-treatment period was defined as time from the first injection of open-label IMP upto 7days after the last injection of open-label IMP, regardless of introduction of rescue therapy). Analysis was performed on safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Toujeo
    Reporting group description
    		 Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.

    Reporting group title
    Tresiba
    Reporting group description
    		 Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.

    Serious adverse events
    		 Toujeo Tresiba
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 462 (4.55%)
    20 / 462 (4.33%)
         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)
    Acoustic Neuroma
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma Of Colon
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Carcinoid Tumour Pulmonary
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Carcinoma Metastatic
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic Stenosis
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose Ulceration
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 462 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         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
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial Lung Disease
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol Abuse
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Use Disorder
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         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
    Meniscus Injury
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 462 (0.00%)
    3 / 462 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Insufficiency
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         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
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carpal Tunnel Syndrome
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    0 / 462 (0.00%)
    3 / 462 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal Neuralgia
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (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 Haemorrhage
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (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
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Fissure
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (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
    Nephrolithiasis
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         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
    Osteoarthritis
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         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
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Pyelonephritis
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 462 (0.22%)
    2 / 462 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 462 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 462 (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 / 462 (0.22%)
    0 / 462 (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
    1 / 462 (0.22%)
    0 / 462 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Toujeo Tresiba
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 462 (12.12%)
    58 / 462 (12.55%)
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    24 / 462 (5.19%)
    19 / 462 (4.11%)
         occurrences all number
    25
    20
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    38 / 462 (8.23%)
    40 / 462 (8.66%)
         occurrences all number
    49
    45

    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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