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    Clinical Trial Results:
    A 12-week Randomized, Controlled Trial to Compare TOUJEO® and TRESIBA® in Terms of Glucose Values in Target Range and Variability During Continuous Glucose Monitoring in Patients With Type 1 Diabetes Mellitus

    Summary
    EudraCT number
    		 2017-002756-91
    Trial protocol
    		 HU   GB   NL  
    Global end of trial date
    16 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Sep 2022
    First version publication date
    29 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LPS14947
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04075513
    WHO universal trial number (UTN)
    		 U1111-1197-8171
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91385
    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 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of insulin glargine 300 units per millilitre (U/ml) in comparison to insulin degludec 100 U/ml on glycemic control and variability in subjects with diabetes mellitus.
    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
    		 Protocol-mandated background therapy was mealtime insulin analog (i.e., rapid insulin analogs [e.g., insulin glulisine, insulin lispro or insulin aspart]). Subjects in both treatment groups continued their short-acting mealtime insulin analogs at least 30 days before the screening visit and continued throughout the study. Dose adjustment was based on a pattern of post-meal self-monitoring of plasma glucose data from the prior 3 days (simple titration) or the carbohydrate content of the meal. Different injection sites were used for the background therapy.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Oct 2019
    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
    Netherlands: 2
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    Hungary: 45
    Country: Number of subjects enrolled
    Brazil: 96
    Country: Number of subjects enrolled
    Turkey: 3
    Country: Number of subjects enrolled
    United States: 160
    Worldwide total number of subjects
    343
    EEA total number of subjects
    76
    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)
    323
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at 40 active sites in 7 countries. 550 subjects were screened between 09 October 2019 and 06 May 2021, of which 343 subjects were enrolled and randomised by interactive response technology (IRT) (1:1 ratio) to receive Toujeo or Tresiba. A total of 207 subjects were screen failure mainly due to not meeting eligibility criteria.

    Pre-assignment
    Screening details
    		 Randomisation was stratified by hemoglobin A1c (HbA1c) at screening (less than [<] 8.0 percent [%]; greater than or equal to [>=] 8.0%). Subjects continued their short-acting mealtime insulin analogue (i.e., rapid insulin analogs) which they had used for at least 30 days before the screening visit and continued the same throughout the study.

    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 U/ml) subcutaneous (SC) injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Toujeo
    Investigational medicinal product code
    HOE901-U300
    Other name
    Insulin glargine
    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 SC injection, once daily in the morning using a pre-filled pen for 12 weeks.

    Arm title
    		 Tresiba
    Arm description
    		 Tresiba (Insulin Degludec, 100 U/ml) SC injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tresiba
    Investigational medicinal product code
    Other name
    Insulin degludec
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Degludec 100 U/ml self-administered SC injection, once daily in the morning using a pre-filled pen for 12 weeks.

    Number of subjects in period 1
    		Toujeo Tresiba
    Started
    172
    171
    Completed
    164
    167
    Not completed
    8
    4
         Lost to follow-up
    4
    2
         Switch to insulin pump
    1
    -
         Withdrawal by subject
    2
    2
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Toujeo
    Reporting group description
    		 Toujeo (Insulin Glargine, 300 U/ml) subcutaneous (SC) injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.

    Reporting group title
    Tresiba
    Reporting group description
    		 Tresiba (Insulin Degludec, 100 U/ml) SC injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.

    Reporting group values
    		 Toujeo Tresiba Total
    Number of subjects
    		 172 171 343
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.9 ( 13.53 ) 42.8 ( 13.05 ) -
    Gender categorical
    Units: Subjects
        Female
    		 86 74 160
        Male
    		 86 97 183

    End points

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    End points reporting groups
    Reporting group title
    Toujeo
    Reporting group description
    		 Toujeo (Insulin Glargine, 300 U/ml) subcutaneous (SC) injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.

    Reporting group title
    Tresiba
    Reporting group description
    		 Tresiba (Insulin Degludec, 100 U/ml) SC injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.

    Primary: Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Decilitre: Non-inferiority Analysis

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    End point title
    		 Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Decilitre: Non-inferiority Analysis
    End point description
    The Continuous Glucose Monitoring (CGM) system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyse glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained using analysis of covariance (ANCOVA) model on data obtained from the multiple imputations during Week 10 to Week 12. Analysis was performed on intent-to-treat (ITT) population which included all randomised subjects (who signed the informed consent form and were allocated to a treatment group before the first investigational medicinal product [IMP] administration and recorded in the IRT database), irrespective of the treatment actually received and were analysed according to the treatment group allocated by randomisation. Here, 'number of subjects analysed' = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    During Week 10 up to Week 12
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    158
    151
    Units: percentage of time
        least squares mean (standard error)
    52.74 ( 0.859 )
    55.09 ( 0.893 )
    Statistical analysis title
    		 Toujeo versus Tresiba
    Statistical analysis description
    Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomisation stratum of screening HbA1c (<8.0%, >=8.0%) and the continuous fixed covariate of Baseline percent time in range value.
    Comparison groups
    Toujeo v Tresiba
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.0067 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Least square mean difference
    Point estimate
    3.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 5.44
    Notes
    [1] - Non-inferiority was based on a relative margin of 10%. Since higher time in range means better outcome, non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference between Toujeo LS mean and 90% of Tresiba LS mean at Week 12 was >0.
    [2] - Threshold of significance at <0.05.

    Secondary: Glucose Total Coefficient of Variation (CV%)

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    End point title
    		 Glucose Total Coefficient of Variation (CV%)
    End point description
    CV% was a measure of spread of variability relative to mean of population. For CGM glucose values, CV% was measure of glycemic variability across 20 days and calculated as ratio of standard deviation of glucose values to mean of glucose values. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomisation stratum of screening HbA1c (<8.0% versus >=8.0%), and the continuous fixed covariate of Baseline value. Analysis was performed on ITT population. Here, 'number of subjects analysed' = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    During Week 10 up to Week 12
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    158
    151
    Units: percentage of mean glucose level
        least squares mean (standard error)
    39.91 ( 0.360 )
    41.22 ( 0.373 )
    Statistical analysis title
    		 Toujeo versus Tresiba
    Statistical analysis description
    A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially only when the previous primary endpoint demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomisation stratum of screening HbA1c (<8.0%, >=8.0%) and the continuous fixed covariate of Baseline percent time in range value.
    Comparison groups
    Toujeo v Tresiba
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.0001 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Least square mean difference
    Point estimate
    -5.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 -4.38
    Notes
    [3] - Non-inferiority was based on a relative margin of 10%. Since lower CV means better outcome, non-inferiority was demonstrated if the upper bound of the two-sided 95% CI of the difference between Toujeo LS mean and 110% of Tresiba LS mean at Week 12 was <0.
    [4] - Threshold of significance at <0.05.

    Secondary: Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Decilitre: Superiority Analysis

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    End point title
    		 Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Decilitre: Superiority Analysis
    End point description
    The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyse glucose levels in real time. Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations during Week 10 to Week 12. Analysis was performed on ITT population. Here, 'number of subjects analysed' = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    During Week 10 up to Week 12
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    158
    151
    Units: percentage of time
        least squares mean (standard error)
    52.74 ( 0.859 )
    55.09 ( 0.893 )
    Statistical analysis title
    		 Toujeo versus Tresiba
    Statistical analysis description
    A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially when the primary endpoint and the secondary endpoint of total CV demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomisation stratum of screening HbA1c (<8.0%, >=8.0%) and the continuous fixed covariate of Baseline percent time in range value.
    Comparison groups
    Toujeo v Tresiba
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.0548 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Least square mean difference
    Point estimate
    -2.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.75
         upper limit
    		 0.05
    Notes
    [5] - Superiority was demonstrated if the lower bound of the two-sided 95% CI of the adjusted difference estimate of Toujeo and Tresiba at Week 12 was > 0.
    [6] - Threshold of significance at <0.05.

    Secondary: Glucose Within-day CV% and Between-day CV%

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    End point title
    		 Glucose Within-day CV% and Between-day CV%
    End point description
    CV% was a measure of spread of variability relative to mean of population. For CGM glucose values, CV% was measure of glycemic variability across 20 days and calculated within day and between days as ratio of standard deviation of glucose values to mean of glucose values. LS mean and SE were obtained from ANCOVA model including fixed categorical effects of treatment groups (TOUJEO, TRESIBA), randomisation stratum of screening HbA1c (<8.0% versus >=8.0%), and as well as, the continuous fixed covariate of Baseline value. Analysis was performed on ITT population. Here, 'number of subjects analysed' = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    During Week 10 up to Week 12
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    158
    151
    Units: percentage of mean glucose level
    least squares mean (standard error)
        Within-day CV%
    33.48 ( 0.342 )
    34.37 ( 0.351 )
        Between-day CV%
    17.23 ( 0.404 )
    18.08 ( 0.415 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12

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    End point title
    		 Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12
    End point description
    Change in HbA1c at Week 12 was analysed using an ANCOVA model including the fixed categorical effects of treatment groups (Toujeo, Tresiba), and the continuous fixed covariate of Baseline HbA1c value. Analysis was performed on ITT population. Here, 'number of subjects analysed' = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    154
    153
    Units: percentage of HbA1c
        least squares mean (standard error)
    -0.75 ( 0.058 )
    -0.92 ( 0.057 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
    End point description
    Change in FPG was analysed using an ANCOVA model including the fixed categorical effects of treatment groups (Toujeo, Tresiba) and the randomisation stratum of HbA1c at screening (<8.0%, >=8.0%) and the continuous fixed covariate of Baseline FPG value. Analysis was performed on ITT population. Here, 'number of subjects analysed' = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    154
    151
    Units: milligrams per decilitre
        least squares mean (standard error)
    -16.05 ( 5.455 )
    -34.55 ( 5.523 )
    No statistical analyses for this end point

    Secondary: Percentage of Time With Glucose Level <70 Milligrams Per Decilitre (All Time and During the Night)

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    End point title
    		 Percentage of Time With Glucose Level <70 Milligrams Per Decilitre (All Time and During the Night)
    End point description
    The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyse glucose levels in real time. "All time" represent the time between 00.00 hour to 23.59 hours and "night" represent the time between 00.00 hour to 05.59 hours. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomisation stratum of screening HbA1c (<8.0% versus >=8.0%), and the continuous fixed covariate of Baseline value. Analysis was performed on ITT population. Here, 'number of subjects analysed' = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    During Week 10 up to Week 12
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    158
    151
    Units: percentage of time
    least squares mean (standard error)
        All time
    5.55 ( 0.353 )
    6.49 ( 0.362 )
        Night
    6.32 ( 0.511 )
    6.26 ( 0.524 )
    No statistical analyses for this end point

    Secondary: Mean Hours Per Day With Glucose Level <70 Milligrams Per Decilitre (All Time and During the Night)

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    End point title
    		 Mean Hours Per Day With Glucose Level <70 Milligrams Per Decilitre (All Time and During the Night)
    End point description
    "All time" represent the time between 00.00 hour to 23.59 hours and "night" represent the time between 00.00 hour to 05.59 hours. Mean hours per day with glucose level <70 milligrams per decilitre during “all time” and only “during night” for the duration of Week 10 to Week 12 is reported in this endpoint. Analysis was performed on ITT population. Here, 'number of subjects analysed' = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    During Week 10 up to Week 12
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    158
    151
    Units: hours per day
    least squares mean (standard error)
        All time
    1.33 ( 0.085 )
    1.56 ( 0.087 )
        Night
    0.38 ( 0.031 )
    0.38 ( 0.031 )
    No statistical analyses for this end point

    Secondary: Percentage of Time With Glucose Level >180 Milligrams Per Decilitre

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    End point title
    		 Percentage of Time With Glucose Level >180 Milligrams Per Decilitre
    End point description
    The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyse glucose levels in real time. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomisation stratum of screening HbA1c (<8.0% versus >=8.0%), and the continuous fixed covariate of Baseline value. Analysis was performed on ITT population. Here, 'number of subjects analysed' = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    During Week 10 up to Week 12
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    158
    151
    Units: percentage of time
        least squares mean (standard error)
    41.52 ( 0.975 )
    38.31 ( 1.002 )
    No statistical analyses for this end point

    Secondary: Mean Hours Per Day With Glucose Level >180 Milligrams Per Decilitre

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    End point title
    		 Mean Hours Per Day With Glucose Level >180 Milligrams Per Decilitre
    End point description
    Mean hours per day with glucose level >180 milligrams per decilitre for the duration of Week 10 to Week 12 is reported in this endpoint. Analysis was performed on ITT population. Here, 'number of subjects analysed' = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    During Week 10 up to Week 12
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    158
    151
    Units: hours per day
        least squares mean (standard error)
    9.96 ( 0.234 )
    9.19 ( 0.240 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With at Least One Hypoglycemic Event During the On-treatment Period

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    End point title
    		 Number of Subjects With at Least One Hypoglycemic Event During the On-treatment 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, because the subject was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <3.9 millimoles per litre (mmol/L) (<70 milligrams per decilitre). On-treatment period was defined as the time from the first injection of IMP (included) up to 2 days after the last injection of IMP. Analysis was performed on safety population that included all randomised subjects who had received at least one dose or part of a dose of IMP and were analysed according to the treatment actually received.
    End point type
    Secondary
    End point timeframe
    From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days)
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    172
    171
    Units: subjects
        Any hypoglycemia
    165
    166
        Severe hypoglycemia
    8
    10
        Documented symptomatic hypoglycemia
    136
    134
    No statistical analyses for this end point

    Secondary: Number of Hypoglycemic Events Per Subject Year During the On-treatment Period

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    End point title
    		 Number of Hypoglycemic Events Per Subject Year During the On-treatment Period
    End point description
    Number of hypoglycemia events (any, severe and documented) per subject-year of exposure were reported. Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the subject was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <3.9 mmol/L (<70 milligrams per decilitre). On-treatment period was defined as the time from the first injection of IMP (included) up to 2 days after the last injection of IMP. Total subject years = The sum of the duration of exposure for all subject, expressed in subject years. Analysis was performed on safety population.
    End point type
    Secondary
    End point timeframe
    From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days)
    End point values
    		 Toujeo Tresiba
    Number of subjects analysed
    172
    171
    Units: events per subject-year
    number (not applicable)
        Any hypoglycemia
    109.4
    114.9
        Severe hypoglycemia
    0.2
    0.3
        Documented symptomatic hypoglycemia
    67.1
    66.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days)
    Adverse event reporting additional description
    Reported AEs were TEAEs that developed/worsened or became serious during on-treatment period (defined as the time from the first injection of IMP to the last injection of IMP + 2 days). Analysis was performed on safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Toujeo
    Reporting group description
    		 Toujeo (Insulin Glargine, 300 U/ml) SC injection, before meals once daily in the morning for 12 weeks on top of rapid acting insulin analog.

    Reporting group title
    Tresiba
    Reporting group description
    		 Tresiba (Insulin Degludec, 100 U/ml) SC injection, before meals once daily in the morning for 12 weeks on top of rapid acting insulin analog.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events were reported at the frequency threshold of 5%.
    Serious adverse events
    		 Toujeo Tresiba
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 172 (4.07%)
    8 / 171 (4.68%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hypoglycaemic Seizure
         subjects affected / exposed
    2 / 172 (1.16%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic Unconsciousness
         subjects affected / exposed
    4 / 172 (2.33%)
    2 / 171 (1.17%)
         occurrences causally related to treatment / all
    1 / 4
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic Intolerance
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic Ketoacidosis
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 171 (0.58%)
         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 / 172 (0.00%)
    4 / 171 (2.34%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
         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
    0 / 172 (0.00%)
    0 / 171 (0.00%)

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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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