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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® Both in Combination With Oral Antihyperglycemic Drug(s) in Subjects With Type 2 Diabetes Mellitus With a 6 Month Safety Extension Period

    Summary
    EudraCT number
    		 2010-023770-39
    Trial protocol
    		 DE   PT   ES   HU   FI  
    Global end of trial date
    22 Nov 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC11629
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01499095
    WHO universal trial number (UTN)
    		 U1111-1118-6943
    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
    10 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult 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
    14 Dec 2011
    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
    Spain: 30
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    France: 28
    Country: Number of subjects enrolled
    Germany: 24
    Country: Number of subjects enrolled
    Hungary: 34
    Country: Number of subjects enrolled
    Mexico: 61
    Country: Number of subjects enrolled
    Russian Federation: 91
    Country: Number of subjects enrolled
    South Africa: 12
    Country: Number of subjects enrolled
    Chile: 61
    Country: Number of subjects enrolled
    Canada: 47
    Country: Number of subjects enrolled
    Romania: 100
    Country: Number of subjects enrolled
    United States: 322
    Worldwide total number of subjects
    811
    EEA total number of subjects
    217
    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)
    621
    From 65 to 84 years
    190
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 1250 subjects were screened, of whom 439 subjects were screen failure and 811 subject were randomized.

    Pre-assignment
    Screening details
    		 Following the main 6 month treatment period, eligible subject previously using HOE901-U300 were randomized (1:1) in a substudy and continued with fixed-dosing (every 24 hours) or started a adaptable-dosing (at intervals of 24 +/- 3 hours) regimen for 3 Months (Month 6 to 9).

    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 oral antidiabetic 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]). After 6 months subjects were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.

    Arm title
    		 Lantus
    Arm description
    		 Lantus (HOE901-U100) for 12 months in combination with oral antidiabetic drug(s).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    HOE901-U100
    Other name
    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
    404
    407
    Treated
    403
    406
    Participated in Substudy
    89 [1]
    0 [2]
    Modified Intent-to-Treat Population
    403
    405
    Completed
    315
    314
    Not completed
    89
    93
         Lack of Efficacy
    2
    1
         Received Rescue Therapy
    32
    40
         Adverse Event
    12
    7
         Perceived Lack of Efficacy
    1
    1
         Lost to Follow-up
    6
    4
         Diverse Reasons
    22
    25
         Insulin Dropped Below Authorized Dose
    -
    5
         Protocol Violation
    6
    7
         Randomized But Not Treated
    1
    1
         Hypoglycemia
    3
    1
         Change in Injection Schedule
    2
    -
         Diagnosed With Type 1 Diabetes Mellitus
    2
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 89 subjects participated in the substudy (45 subjects received adaptable dosing regimen and 44 subjects received fixed dosing regimen.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subject participated in the substudy from Lantus arm as participation in substudy was allowed only to those subjects who received HOE901-U300.

    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 oral antidiabetic drug(s).

    Reporting group title
    Lantus
    Reporting group description
    		 Lantus (HOE901-U100) for 12 months in combination with oral antidiabetic drug(s).

    Reporting group values
    		 HOE901-U300 Lantus Total
    Number of subjects
    		 404 407 811
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.9 ( 9.1 ) 58.5 ( 9.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 217 222 439
        Male
    		 187 185 372
    Glycated Hemoglobin A1c (HbA1c)
    Units: Subjects
        Less Than (<) 8%
    		 144 146 290
        Greater Than or Equal to (>=) 8%
    		 260 261 521
    Body Mass Index (BMI)
    Units: kilogram per square meter
        arithmetic mean (standard deviation)
    		 34.8 ( 6.6 ) 34.8 ( 6.1 ) -
    Duration of Diabetes
    Number of subjects analyzed for this baseline characteristics = 403 and 407 in HOE901-­U300 and Lantus arm, respectively.
    Units: years
        median (full range (min-max))
    		 11.6 (1 to 54) 11.7 (1 to 51) -
    Basal Insulin Daily Dose
    Number of subjects analyzed for this baseline characteristics = 378 and 382 in HOE901-U300 and Lantus arm, respectively.
    Units: units per kilogram
        arithmetic mean (standard deviation)
    		 0.66 ( 0.221 ) 0.681 ( 0.253 ) -

    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 oral antidiabetic drug(s).

    Reporting group title
    Lantus
    Reporting group description
    		 Lantus (HOE901-U100) for 12 months in combination with oral antidiabetic drug(s).

    Subject analysis set title
    HOE901-U300: Adaptable Dosing Intervals
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    HOE901-U300 SC injection once daily for 6 months in combination with oral antidiabetic drug(s). From Month 6 to Month 9 subjects received HOE901-U300 once daily at intervals of 24 +/- 3 hours.

    Subject analysis set title
    HOE901-U300: Fixed Dosing Intervals
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    HOE901-U300 SC injection once daily for 12 months in combination with of oral antidiabetic drug(s). From Month 6 up to Month 9 subjects received HOE901-U300 once daily every 24 hours.

    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 measurements performed before initiation of rescue therapy were considered in the analysis. Modified Intent-to-Treat population: all randomized subjects who received at least (>=)1 dose, had baseline and >=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of subjects analyzed = subjects with baseline and Week 6 HbA1c assessment. Missing data imputed using last observation carried forward.
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    386
    392
    Units: percentage of hemoglobin
        least squares mean (standard error)
    -0.57 ( 0.094 )
    -0.56 ( 0.093 )
    Statistical analysis title
    		 HOE901-U300 vs Lantus
    Statistical analysis description
    Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (<8.0 and >=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.
    Comparison groups
    HOE901-U300 v Lantus
    Number of subjects included in analysis
    778
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Least Squares (LS) Mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.139
         upper limit
    		 0.119
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.066
    Notes
    [1] - Stepwise closed testing approach was to assess non-inferiority and superiority sequentially: 1. Non­inferiority 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 non­inferiority 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 Endpoint

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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 Endpoint
    End point description
    Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the subjects 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 mmol/L (70 milligram per deciliter [mg/dL]). Only measurements performed before initiation of rescue therapy were considered in the analysis. 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
    403
    405
    Units: percentage of subjects
        number (not applicable)
    21.6
    27.9
    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 with treatment as a factor and stratified on strata of screening HbA1c (<8.0 and >=8.0%).
    Comparison groups
    HOE901-U300 v Lantus
    Number of subjects included in analysis
    808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.038
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 0.99

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

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    End point title
    		 Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
    End point description
    Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis. mITT population. Missing data imputed using last observation carried forward. Number of subjects analyzed = subjects with baseline and Month 6 preinjection SMPG assessment.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    353
    350
    Units: mmol/L
        least squares mean (standard error)
    -0.56 ( 0.278 )
    -0.51 ( 0.275 )
    Statistical analysis title
    		 HOE901-U300 vs Lantus
    Statistical analysis description
    Change in pre­injection SMPG was analysed using an ANCOVA model with treatment, strata of screening HbA1c (<8.0 and >=8.0%), and country as fixed effects and using the pre­injection SMPG baseline value as a covariate. A test for superiority of HOE901-­U300 over Lantus was to be performed one­sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycaemia was significant.
    Comparison groups
    Lantus v HOE901-U300
    Number of subjects included in analysis
    703
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8279
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.438
         upper limit
    		 0.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.201

    Secondary: Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint

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    End point title
    		 Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
    End point description
    Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient 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 measurements performed before initiation of rescue therapy were considered in the analysis. mITT population. Missing data imputed using last observation carried forward. Number of subjects analyzed = subjects with baseline and Month 6 preinjection SMPG assessment.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    353
    350
    Units: percentage of mean
        least squares mean (standard error)
    -2.34 ( 1.425 )
    -0.53 ( 1.408 )
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With HbA1c <7% at Month 6 Endpoint
    End point description
    Only measurements performed before initiation of rescue therapy were considered in the analysis. mITT Population. Number of subjects analyzed = subjects with Month 6 HbA1c assessment. Missing data imputed using last observation carried forward.
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    386
    392
    Units: percentage of subjects
        number (not applicable)
    30.6
    30.4
    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 measurements performed before initiation of rescue therapy were considered in the analysis. mITT Population. Number of subjects analyzed = subject with baseline and Month 6 FPG assessment. Missing data imputed using last observation carried forward.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    375
    379
    Units: mmol/L
        least squares mean (standard error)
    -1.03 ( 0.242 )
    -1.21 ( 0.241 )
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
    End point description
    Only measurements performed before initiation of rescue therapy were considered in the analysis. mITT Population. Number of subjects analyzed = subjects with Month 6 FPG assessment. Missing data imputed using last observation carried forward.
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    384
    390
    Units: percentage of subjects
        number (not applicable)
    29.4
    33.6
    No statistical analyses for this end point

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

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    End point title
    		 Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
    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 measurements performed before initiation of rescue therapy were considered in the analysis. mITT population. Only subjects from the mITT population with a value at baseline and at the specified timepoint were analyzed (represented by n=X, X in the category titles). Missing data imputed using last observation carried forward.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    403
    405
    Units: mmol/L
    least squares mean (standard error)
        03:00 at Night (n= 338, 328)
    -0.56 ( 0.323 )
    -0.9 ( 0.321 )
        Pre-breakfast (n= 347, 338)
    -1.31 ( 0.221 )
    -1.81 ( 0.219 )
        2 hours after breakfast (n= 341, 328)
    -1.41 ( 0.331 )
    -1.82 ( 0.329 )
        Pre-lunch (n= 344, 332)
    -0.64 ( 0.3 )
    -1.12 ( 0.298 )
        2 hours after lunch (n= 339, 328)
    -1.02 ( 0.342 )
    -1.04 ( 0.34 )
        Pre-dinner (n=347, 336)
    -0.94 ( 0.327 )
    -0.69 ( 0.324 )
        2 hours after dinner (n= 338, 327)
    -0.69 ( 0.359 )
    -1 ( 0.357 )
        Bedtime (n= 325, 303)
    -0.99 ( 0.345 )
    -1 ( 0.343 )
    No statistical analyses for this end point

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

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    End point title
    		 Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
    End point description
    Only measurements performed before initiation of rescue therapy were considered in the analysis. mITT Population. Number of subjects analyzed = subjects with Baseline and Month 6 basal insulin dose assessment. Missing data imputed using last observation carried forward.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    402
    403
    Units: U/kg
        least squares mean (standard error)
    0.28 ( 0.021 )
    0.17 ( 0.021 )
    No statistical analyses for this end point

    Secondary: Change in 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 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 4­8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only measurements performed before initiation of rescue therapy were considered in the analysis. mITT Population. Number of subjects analyzed = subjects with Baseline and Month 6 DTSQ assessment. Missing data imputed using last observation carried forward.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    346
    359
    Units: units on a scale
        least squares mean (standard error)
    3.05 ( 0.448 )
    3.61 ( 0.44 )
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With Hypoglycemia (All and Nocturnal) Events From Baseline 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 Month 12
    End point values
    		 HOE901-U300 Lantus
    Number of subjects analysed
    403
    406
    Units: percentage of subjects
    number (not applicable)
        Any Hypoglycemia Event: All Hypoglycemia
    79.9
    83
        Severe Hypoglycemia: All Hypoglycemia
    1.7
    1.5
        Documented Symptomatic: All Hypoglycemia
    58.8
    63.3
        Asymptomatic: All Hypoglycemia
    58.6
    64
        Probable Symptomatic: All Hypoglycemia
    2.7
    3.4
        Relative: All Hypoglycemia
    7.9
    12.8
        Severe and/or Confirmed: All Hypoglycemia
    78.4
    82
        Any Hypoglycemia Event: Nocturnal Hypoglycemia
    39.7
    46.1
        Severe Hypoglycemia: Nocturnal Hypoglycemia
    0.2
    0.5
        Documented Symptomatic: Nocturnal Hypoglycemia
    29.5
    34.2
        Asymptomatic: Nocturnal Hypoglycemia
    14.4
    22.2
        Probable Symptomatic: Nocturnal Hypoglycemia
    1.2
    1
        Relative: Nocturnal Hypoglycemia
    2.2
    6.4
        Severe and/or Confirmed: Nocturnal Hypoglycemia
    37.5
    44.6
    No statistical analyses for this end point

    Other pre-specified: Change in HbA1c From Month 6 to Month 9

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    End point title
    		 Change in HbA1c From Month 6 to Month 9
    End point description
    Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of subjects randomized to HOE901-U300 and treated for 6 months. Only measurements performed before initiation of rescue therapy were considered in the analysis. mITT substudy population. Number of subjects analyzed = subjects with Month 6 and Month 9 HbA1c assessment. Analysis was planned to be performed for subjects who were receiving HOE901-U300 (Adaptable dosing intervals or Fixed dosing intervals). Missing data imputed using last observation carried forward.
    End point type
    Other pre-specified
    End point timeframe
    Month 6 up to Month 9
    End point values
    		 HOE901-U300: Adaptable Dosing Intervals HOE901-U300: Fixed Dosing Intervals
    Number of subjects analysed
    40
    37
    Units: percentage of hemoglobin
        least squares mean (standard error)
    -0.12 ( 0.151 )
    -0.25 ( 0.162 )
    Statistical analysis title
    		 HOE901-U300: Adaptable vs Fixed Dosing
    Statistical analysis description
    Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline (Month 6) HbA1c value as a covariate.
    Comparison groups
    HOE901-U300: Adaptable Dosing Intervals v HOE901-U300: Fixed Dosing Intervals
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Least squares mean difference
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.152
         upper limit
    		 0.415
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.142

    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
    16.1
    Reporting groups
    Reporting group title
    HOE901-U300
    Reporting group description
    		 HOE901-U300 for 12 months in combination with oral antidiabetic drug(s).

    Reporting group title
    Lantus
    Reporting group description
    		 Lantus (HOE901-U100) for 12 months in combination with oral antidiabetic drug(s).

    Serious adverse events
    		 HOE901-U300 Lantus
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 403 (7.44%)
    30 / 406 (7.39%)
         number of deaths (all causes)
    3
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive Lobular Breast Carcinoma
         subjects affected / exposed
    2 / 403 (0.50%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic Syndrome
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Adenocarcinoma Stage Iv
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Papillary Thyroid Cancer
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue Neoplasm Malignant Stage Unspecified
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Angiopathy
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         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
    Contusion
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroparesis Postoperative
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haematoma
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Complication
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    2 / 403 (0.50%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Angina Pectoris
         subjects affected / exposed
    0 / 403 (0.00%)
    2 / 406 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Disorder
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    1 / 403 (0.25%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular Disorder
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    2 / 403 (0.50%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nodal Rhythm
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrospinal Fluid Leakage
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (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 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    0 / 403 (0.00%)
    3 / 406 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis Acute
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Polyp
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin Ulcer
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (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
    Calculus Urinary
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         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
    Back Pain
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Degeneration
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         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
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Sinusitis
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Echinococciasis
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Bites
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised Infection
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 403 (0.00%)
    2 / 406 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Chronic
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Superinfection
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculous Pleurisy
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    2 / 403 (0.50%)
    3 / 406 (0.74%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    1 / 403 (0.25%)
    0 / 406 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 403 (0.25%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 406 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 HOE901-U300 Lantus
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    106 / 403 (26.30%)
    96 / 406 (23.65%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    27 / 403 (6.70%)
    20 / 406 (4.93%)
         occurrences all number
    45
    26
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    25 / 403 (6.20%)
    23 / 406 (5.67%)
         occurrences all number
    31
    26
    Nasopharyngitis
         subjects affected / exposed
    49 / 403 (12.16%)
    31 / 406 (7.64%)
         occurrences all number
    63
    37
    Upper Respiratory Tract Infection
         subjects affected / exposed
    23 / 403 (5.71%)
    35 / 406 (8.62%)
         occurrences all number
    25
    45

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Dec 2011
    - Change of the definition of "nocturnal hypoglycemia" for the analysis of the first main secondary endpoint in order to exclude self-reported non-severe hypoglycemia episodes that were not confirmed by plasma glucose data. - Replacement of the e-diary by a paper diary. - Clarification to "Secondary objectives" - "treatment satisfaction" was assessed and not "quality of life". - Minor corrections in study Flowchart. - Update in the exclusion criterion - criterion of half-live of the prior investigational product added. - Harmonize the visit periods across the protocol. - Update of the definition of the safety endpoint of the local tolerability. Explicit instruction that phone visits were to be conducted by the Investigator or qualified designee. However, the Investigator had to be consulted always when an adverse event was suspected.
    11 Jul 2012
    - Change to the definition of "nocturnal hypoglycemia" for the analysis of the first main secondary endpoint by applying a tighter time window for nocturnal hypoglycemia. - Change to visits number by addition of 2 phone visits during the 6-month safety extension period. - Reduction of the number of mandatory 4-point profiles required to be done by the subjects. - Change to the scope of data recorded into the electronic case report form upon phone call visits. - Change to the reasons justifying prolongation of the screening period of one additional week. - Change to the reasons justifying re-screening. - Change to the requirements concerning return of unused study drug at on-site visits where study drug dispensation was scheduled, clarification on drug accountability and compliance. - Clarification of inconsistency in instructions for subject's position during blood pressure and heart rate measurements. - Explanation that for calculation of the study drug starting dose, median value of last 3 fasting SMPG prior to the baseline visit were also be taken into account. - Clarification to safety endpoints. - Addition of symptomatic overdose with non-study drug to adverse event of special interest with immediate notification. - Change to the timelines for reporting of serious adverse events by the Investigator.
    02 Aug 2012
    Protocol for a 3-month administration sub study to compare the efficacy and safety of HOE901-U300 injected once daily every 24 hours and HOE901-U300 injected once daily at intervals of 24±3 hours in subjects randomized and treated with HOE901-U300 during the 6-month on-treatment period (starting at baseline and ending Month 6).
    21 Mar 2013
    Addition of an independent review of all hypoglycemia events reported by the Investigator as severe and/or reported as serious adverse events by a Severe Hypoglycemia Review Board blinded to treatment arm.
    25 Apr 2013
    Change to study periods - a 4-week follow-up period was added in order to gain data about the switch from HOE901-U300 to a marketed basal insulin.

    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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