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    Clinical Trial Results:
    6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients with Type 2 Diabetes Mellitus not Adequately Controlled with Non-Insulin Antihyperglycemic Drugs with a 6-month Safety Extension Period

    Summary
    EudraCT number
    		 2012-000146-35
    Trial protocol
    		 DK   SE   FI   EE   CZ   LV   LT   NL   BG   SK  
    Global end of trial date
    26 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2016
    First version publication date
    14 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC12347
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01676220
    WHO universal trial number (UTN)
    		 U1111-1124-5261
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    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
    12 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in subjects with type 2 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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Aug 2012
    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: 7
    Country: Number of subjects enrolled
    Slovakia: 18
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    Bulgaria: 16
    Country: Number of subjects enrolled
    Czech Republic: 7
    Country: Number of subjects enrolled
    Denmark: 27
    Country: Number of subjects enrolled
    Estonia: 4
    Country: Number of subjects enrolled
    Finland: 18
    Country: Number of subjects enrolled
    Hungary: 14
    Country: Number of subjects enrolled
    Latvia: 7
    Country: Number of subjects enrolled
    Lithuania: 20
    Country: Number of subjects enrolled
    Canada: 51
    Country: Number of subjects enrolled
    Romania: 47
    Country: Number of subjects enrolled
    United States: 587
    Country: Number of subjects enrolled
    Japan: 50
    Worldwide total number of subjects
    878
    EEA total number of subjects
    190
    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)
    652
    From 65 to 84 years
    225
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 1396 subjects were screened, of whom 518 subjects were screen failure and 878 subjects were randomized.

    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
    		 HOE901-U300
    Arm description
    		 HOE901-U300 for 12 months in combination with non-insulin antihyperglycemic drug(s).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin glargine- new formulation
    Investigational medicinal product code
    HOE901-U300
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) once daily (evening). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]).

    Arm title
    		 Lantus
    Arm description
    		 Lantus for 12 months in combination with non-insulin antihyperglycemic drug(s).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    HOE901-U100
    Other name
    Lantus
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lantus (HOE901-U100, insulin glargine 100 U/mL) once daily (evening). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

    Number of subjects in period 1
    		HOE901-U300 Lantus
    Started
    439
    439
    Treated
    435
    438
    Modified Intent-To-Treat Population
    432
    430
    Completed
    337
    314
    Not completed
    102
    125
         Received Rescue Therapy
    14
    22
         Adverse Event
    10
    8
         Perceived Lack of Efficacy
    3
    1
         Selection Criterion/Protocol Violation
    9
    9
         No More Need of Insulin
    1
    -
         Non Serious Hypoglycemia
    2
    -
         Randomized But Not Treated
    4
    1
         Protocol Violation
    11
    12
         Personal Reason
    34
    45
         Lost to follow-up
    11
    18
         Site Closure/Site Withdrawal
    1
    4
         Lack of efficacy
    2
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HOE901-U300
    Reporting group description
    		 HOE901-U300 for 12 months in combination with non-insulin antihyperglycemic drug(s).

    Reporting group title
    Lantus
    Reporting group description
    		 Lantus for 12 months in combination with non-insulin antihyperglycemic drug(s).

    Reporting group values
    		 HOE901-U300 Lantus Total
    Number of subjects
    		 439 439 878
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.2 ( 9.9 ) 57.2 ( 10.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 186 185 371
        Male
    		 253 254 507
    Glycated Hemoglobin A1c (HbA1c)
    Units: Subjects
        Less Than (<) 8%
    		 141 142 283
        Greater Than or Equal to (>=) 8%
    		 298 297 595
    Body Mass Index (BMI)
    Units: kilogram per square meter
        arithmetic mean (standard deviation)
    		 32.8 ( 6.9 ) 33.2 ( 6.6 ) -
    Duration of Diabetes
    Number of subjects analyzed for this baseline characteristics = 435 and 436 in HOE901-U300 and Lantus arm, respectively.
    Units: years
        arithmetic mean (standard deviation)
    		 10.11 ( 6.49 ) 9.57 ( 6.22 ) -
    Basal Insulin Daily Dose
    Number of subjects analyzed for this baseline characteristics = 432 and 436 in HOE901-U300 and Lantus arm, respectively.
    Units: units per kilogram (U/kg)
        arithmetic mean (standard deviation)
    		 0.193 ( 0.027 ) 0.193 ( 0.034 ) -

    End points

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    End points reporting groups
    Reporting group title
    HOE901-U300
    Reporting group description
    		 HOE901-U300 for 12 months in combination with non-insulin antihyperglycemic drug(s).

    Reporting group title
    Lantus
    Reporting group description
    		 Lantus for 12 months in combination with non-insulin antihyperglycemic drug(s).

    Primary: Change in HbA1c From Baseline to Month 6 Endpoint

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    End point title
    		 Change in HbA1c From Baseline to Month 6 Endpoint
    End point description
    Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. Modified Intent-to-Treat (mITT) population:randomized subjects who received at least 1 dose, had baseline and at least 1 post-baseline data of any efficacy variable, irrespective of compliance. Number of subjects analyzed=subjects included in mITT population with baseline and at least 1 post-baseline HbA1c data (Week 12 and/or Month 6).
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    402
    394
    Units: percentage of hemoglobin
        least squares mean (standard error)
    -1.42 ( 0.047 )
    -1.46 ( 0.048 )
    Statistical analysis title
    		 HOE901-U300 vs. Lantus
    Statistical analysis description
    Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (<8.0, >=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.
    Comparison groups
    HOE901-U300 v Lantus
    Number of subjects included in analysis
    796
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.174
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.067
    Notes
    [1] - Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially: 1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is <0.4%. 2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is <0.

    Secondary: Percentage of Subjects With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6

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    End point title
    		 Percentage of Subjects With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6
    End point description
    Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the subject was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively. Modified intent-to-treat population.
    End point type
    Secondary
    End point timeframe
    Week 9 Up to Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    432
    430
    Units: percentage of subjects
        number (not applicable)
    15.5
    17.4
    Statistical analysis title
    		 HOE901-U300 vs. Lantus
    Statistical analysis description
    A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method stratified by randomization strata of screening HbA1c (<8.0, >=8.0%), randomization strata of geographical region (Non-Japan; Japan).
    Comparison groups
    HOE901-U300 v Lantus
    Number of subjects included in analysis
    862
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4536
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.2

    Secondary: Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint

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    End point title
    		 Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
    End point description
    Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. mITT population. Number of subjects analyzed = subjects included in the mITT population with baseline and at least one pre-injection SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6)
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    207
    222
    Units: mmol/L
        least squares mean (standard error)
    -2.16 ( 0.162 )
    -2.33 ( 0.156 )
    Statistical analysis title
    		 HOE901-U300 vs. Lantus
    Statistical analysis description
    Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (<8.0, >=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline preinjection SMPG value and baseline preinjection SMPG value-by-visit interaction as continuous fixed covariates.
    Comparison groups
    HOE901-U300 v Lantus
    Number of subjects included in analysis
    429
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.275
         upper limit
    		 0.605
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.224

    Secondary: Variability of Preinjection SMPG at Month 6 Endpoint

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    End point title
    		 Variability of Preinjection SMPG at Month 6 Endpoint
    End point description
    Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. mITT population. Number of subjects analyzed = subjects included in the mITT Population with at least one pre-injection SMPG variability assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    422
    418
    Units: percentage of mean
        least squares mean (standard error)
    18.7 ( 0.502 )
    18.33 ( 0.521 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HbA1c <7% at Month 6

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    End point title
    		 Percentage of Subjects With HbA1c <7% at Month 6
    End point description
    Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. mITT Population. Subjects without any available Month 6 HbA1C assessment were considered as failures (non-responders).
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    432
    430
    Units: percentage of subjects
        number (not applicable)
    43.1
    42.1
    No statistical analyses for this end point

    Secondary: Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint

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    End point title
    		 Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
    End point description
    Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. mITT Population. Number of subjects analyzed = subjects included in the mITT population with baseline and at least one post-baseline FPG assessment (Week 12 and/or Month 6).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    398
    387
    Units: mmol/L
        least squares mean (standard error)
    -3.41 ( 0.103 )
    -3.8 ( 0.105 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With FPG <5.6 mmol/L (100 mg/dL) at Month 6

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    End point title
    		 Percentage of Subjects With FPG <5.6 mmol/L (100 mg/dL) at Month 6
    End point description
    Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. mITT Population. Subjects without any available FPG assessment at Month 6 were considered as failures (non-responders).
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    432
    430
    Units: percentage of subjects
        number (not applicable)
    26.2
    29.5
    No statistical analyses for this end point

    Secondary: Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6

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    End point title
    		 Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6
    End point description
    Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. mITT Population. Only subjects from the mITT population with a value at baseline and at specified timepoint were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    432
    430
    Units: mmol/L
    arithmetic mean (standard deviation)
        03:00 at Night Plasma Glucose (n=281,277)
    -2.63 ( 3.24 )
    -3.01 ( 3.75 )
        Pre-Breakfast Plasma Glucose (n=292,286)
    -3.28 ( 2.72 )
    -3.72 ( 2.96 )
        2 Hours After Breakfast Plasma Glucose (n=278,278)
    -3.69 ( 3.65 )
    -4.08 ( 4.03 )
        Pre-Lunch Plasma Glucose (n=289,281)
    -2.58 ( 3.39 )
    -3.39 ( 3.76 )
        2 Hours After Lunch Plasma Glucose (n=280,269)
    -2.19 ( 3.88 )
    -3.13 ( 3.77 )
        Pre-Dinner Plasma Glucose (n=291,285)
    -2.57 ( 3.49 )
    -2.43 ( 3.79 )
        2 Hours After Dinner Plasma Glucose (n=282,269)
    -2.36 ( 3.89 )
    -2.33 ( 4.03 )
        Bedtime Plasma Glucose (n=249,249)
    -2.19 ( 3.75 )
    -2.26 ( 3.66 )
    No statistical analyses for this end point

    Secondary: Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint

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    End point title
    		 Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint
    End point description
    Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. mITT Population. Number of subjects analyzed = subjects included in the mITT population with baseline and at least one post-baseline 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    381
    393
    Units: mmol/L
        least squares mean (standard error)
    -2.72 ( 0.088 )
    -2.9 ( 0.089 )
    No statistical analyses for this end point

    Secondary: Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint

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    End point title
    		 Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint
    End point description
    Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. mITT Population. Number of subjects analyzed = subjects included in the mITT population with baseline and at least one post-baseline variability of 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    381
    393
    Units: percentage of mean
        least squares mean (standard error)
    1.53 ( 0.643 )
    1.41 ( 0.647 )
    No statistical analyses for this end point

    Secondary: Change in Daily Basal Insulin Dose From Baseline to Month 6

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    End point title
    		 Change in Daily Basal Insulin Dose From Baseline to Month 6
    End point description
    Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. mITT Population. Number of subjects analyzed = subjects included in the mITT population with Baseline and Month 6 basal insulin dose assessment.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    362
    340
    Units: U/kg
        arithmetic mean (standard deviation)
    0.43 ( 0.29 )
    0.34 ( 0.24 )
    No statistical analyses for this end point

    Secondary: Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint

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    End point title
    		 Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
    End point description
    DTSQ is a validated measure to assess how satisfied subjects with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. mITT Population. Number of subjects analyzed = subjects included in the mITT population with Baseline and at least one post-baseline DTSQ assessment (Week 12 and/or Month 6).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    371
    367
    Units: units on a scale
        least squares mean (standard error)
    4.89 ( 0.246 )
    5.12 ( 0.251 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12

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    End point title
    		 Percentage of Subjects With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12
    End point description
    Hypoglycaemia included: Severe (required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic (typical symptoms of hypoglycaemia were accompanied by plasma glucose =<3.9 mmol/L); Asymptomatic (not accompanied by typical symptoms of hypoglycaemia but with plasma glucose =<3.9 mmol/L); Probable symptomatic (symptoms of hypoglycaemia were not accompanied by a plasma glucose determination, but was presumably caused by plasma glucose =<3.9 mmol/L); and Relative (subject reported any of the typical symptoms of hypoglycaemia, and interpreted the symptoms as indicative of hypoglycaemia, but with plasma glucose >3.9 mmol/L). Safety population: all subjects randomized and treated, regardless of amount of treatment administered. In event of subjects having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    435
    438
    Units: percentage of subjects
    number (not applicable)
        Any Hypoglycemia Event: All Hypoglycemia
    58.9
    63.2
        Severe Hypoglycemia: All Hypoglycemia
    1.4
    2.1
        Documented Symptomatic: All Hypoglycemia
    39.1
    44.1
        Asymptomatic: All Hypoglycemia
    41.6
    46.8
        Probable Symptomatic: All Hypoglycemia
    3.2
    3
        Relative: All Hypoglycemia
    10.6
    11.6
        Severe and/or Confirmed: All Hypoglycemia
    56.3
    61.2
        Any Hypoglycemia Event: Nocturnal Hypoglycemia
    27.6
    30.1
        Severe Hypoglycemia: Nocturnal Hypoglycemia
    0
    0.7
        Documented Symptomatic: Nocturnal Hypoglycemia
    18.6
    20.8
        Asymptomatic: Nocturnal Hypoglycemia
    13.3
    16
        Probable Symptomatic: Nocturnal Hypoglycemia
    0.7
    0
        Relative: Nocturnal Hypoglycemia
    4.4
    3.2
        Severe and/or Confirmed: Nocturnal Hypoglycemia
    25.3
    29.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug.
    Adverse event reporting additional description
    Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened and death that occurred during on-treatment period (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Lantus
    Reporting group description
    		 Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).

    Reporting group title
    HOE901-U300
    Reporting group description
    		 HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).

    Serious adverse events
    		 Lantus HOE901-U300
    Total subjects affected by serious adverse events
         subjects affected / exposed
    39 / 438 (8.90%)
    35 / 435 (8.05%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    1 / 438 (0.23%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose Vein
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Medical Device Removal
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (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 / 438 (0.00%)
    2 / 435 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Menorrhagia
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         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
    2 / 438 (0.46%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial Lung Disease
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep Apnoea Syndrome
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Bilirubin Increased
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         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
    Fall
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         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
    2 / 438 (0.46%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    2 / 438 (0.46%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    1 / 438 (0.23%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis Coronary Artery
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial Fibrillation
         subjects affected / exposed
    1 / 438 (0.23%)
    2 / 435 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 438 (0.23%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    0 / 438 (0.00%)
    2 / 435 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    1 / 438 (0.23%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid Artery Aneurysm
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Artery Embolism
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Infarction
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic Unconsciousness
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 438 (0.23%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Detachment
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Hernia
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    3 / 438 (0.68%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Ischaemic
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum Intestinal
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer Haemorrhage
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    2 / 438 (0.46%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 438 (0.00%)
    2 / 435 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 438 (0.23%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrocalcinosis Pyrophosphate
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank Pain
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    2 / 438 (0.46%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain In Extremity
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         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 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot Infection
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 438 (0.00%)
    2 / 435 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Abscess
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Mycosis
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 435 (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
    		 Lantus HOE901-U300
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    107 / 438 (24.43%)
    115 / 435 (26.44%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    22 / 438 (5.02%)
    36 / 435 (8.28%)
         occurrences all number
    28
    48
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    47 / 438 (10.73%)
    41 / 435 (9.43%)
         occurrences all number
    59
    48
    Sinusitis
         subjects affected / exposed
    23 / 438 (5.25%)
    11 / 435 (2.53%)
         occurrences all number
    30
    13
    Upper Respiratory Tract Infection
         subjects affected / exposed
    34 / 438 (7.76%)
    45 / 435 (10.34%)
         occurrences all number
    44
    60

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Aug 2013
    - Review of severe hypoglycemia classification by an external Review Board. - Procedures when the titration extends beyond the originally planned 8 to 12 weeks post-randomization. - Clarification of definition of an injection area and an injection site within that area. - Clarification of timing of investigational medicinal product (IMP) injection. - Clarification of the screening period. - Clarification of serious adverse event (SAE) and adverse event of special interest (AESI) reporting. - Clarification of uses and documentation of SMPG. - Change to the scope of data recorded into the electronic case report form (e-CRF) upon phone call visits.

    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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