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    Clinical Trial Results:
    Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog® in Adult Patients With Type 2 Diabetes Mellitus also Using Insulin Glargine

    Summary
    EudraCT number
    2014-002844-42
    Trial protocol
    HU   DE   IT   ES  
    Global end of trial date
    16 Feb 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Mar 2017
    First version publication date
    02 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC13403
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02294474
    WHO universal trial number (UTN)
    U1111-1156-4296
    Other trial identifiers
    Study Name: SORELLA 2
    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
    11 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of SAR342434 versus Humalog in terms of changes in glycated hemoglobin (HbA1c) from baseline to Week 26 in subjects with type 2 diabetes mellitus also using Lantus.
    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
    Insulin Glargine 100 U/ml (Lantus) was used as the mandatory background basal insulin therapy. Doses were adjusted to achieve fasting, pre-breakfast self-measured plasma glucose (SMPG) of 4.4 to 7.2 mmol/l (80 to 130 mg/dL). Non-insulin antihyperglycemic background therapy (except injectable peptides) taken at a stable dose for at least 3 months prior to the screening visit may be continued during the study. Doses were to be kept stable throughout the study unless there was a specific safety issue related to these treatments.
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Jan 2015
    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
    Romania: 40
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Hungary: 45
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Argentina: 37
    Country: Number of subjects enrolled
    Chile: 14
    Country: Number of subjects enrolled
    Colombia: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 17
    Country: Number of subjects enrolled
    Russian Federation: 30
    Country: Number of subjects enrolled
    Turkey: 10
    Country: Number of subjects enrolled
    United States: 242
    Worldwide total number of subjects
    505
    EEA total number of subjects
    154
    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)
    281
    From 65 to 84 years
    222
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 103 centers in 12 countries. A total of 707 subjects were screened between 14 January 2015 and 24 July 2015, of which 202 were screen failures. Screen failures were mainly due to glycated hemoglobin (HbA1c) <6.5% or >10% at screening visit.

    Pre-assignment
    Screening details
    A total of 505 subjects were randomized and treated in the study. Randomization was stratified by HbA1c at the screening visit (<8%, ≥8%) and prior use of Humalog (Yes, No). Assignment to arms was done centrally using interactive voice/web response system in 1:1 ratio (SAR342434: Humalog).

    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
    SAR342434
    Arm description
    SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26.
    Arm type
    Experimental

    Investigational medicinal product name
    SAR342434
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by subcutaneous (SC) injection, immediately (within 5-10 minutes) before meals intake. Dose adjusted to achieve a 2-hour post prandial glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia.

    Arm title
    Humalog
    Arm description
    Humalog before meals intake on top of QD Insulin Glargine, up to Week 26.
    Arm type
    Active comparator

    Investigational medicinal product name
    Humalog
    Investigational medicinal product code
    Other name
    Insulin Lispro
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Humalog 100 U/ml (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meals intake. Dose adjusted to achieve a 2-hour PPG in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia.

    Number of subjects in period 1
    SAR342434 Humalog
    Started
    253
    252
    Completed
    228
    230
    Not completed
    25
    22
         Adverse event
             7
             7
         Lack of efficacy
             2
             1
         Poor compliance to protocol
             4
             2
         Other than specified above
             12
             12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SAR342434
    Reporting group description
    SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26.

    Reporting group title
    Humalog
    Reporting group description
    Humalog before meals intake on top of QD Insulin Glargine, up to Week 26.

    Reporting group values
    SAR342434 Humalog Total
    Number of subjects
    253 252 505
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62.1 ± 9.4 62.8 ± 8.9 -
    Gender categorical
    Units: Subjects
        Female
    117 120 237
        Male
    136 132 268
    Previous meal time insulin
    Units: Subjects
        Humalog/Liprolog
    133 126 259
        NovoLog/NovoRapid
    119 124 243
        Both Humalog/Liprolog and NovoLog/NovoRapid
    1 1 2
        None of the above
    0 1 1
    Randomization Strata of Screening HbA1c
    Units: Subjects
        <8 %
    105 104 209
        ≥8 %
    148 148 296
    Body mass index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    32.3 ± 4.8 32.1 ± 4.8 -
    Duration of type 2 diabetes mellitus (T2DM)
    Units: years
        arithmetic mean (standard deviation)
    16.6 ± 7.93 17.52 ± 8.67 -
    Glycated Haemoglobin (HbA1c %)
    Units: percentage of hemoglobin
        arithmetic mean (standard deviation)
    8 ± 0.86 8.03 ± 0.91 -
    Average Daily Basal Insulin Dose
    Data for average daily basal insulin dose is reported for 476 subjects.
    Units: Units (U)/kg
        arithmetic mean (standard deviation)
    0.477 ± 0.265 0.458 ± 0.239 -
    Average Daily Mealtime Insulin Dose
    Data for average daily mealtime insulin dose is reported for 474 subjects.
    Units: U/kg
        arithmetic mean (standard deviation)
    0.449 ± 0.294 0.433 ± 0.315 -
    Average Daily Total Insulin Dose
    Data for average daily total insulin dose is reported for 472 subjects.
    Units: U/kg
        arithmetic mean (standard deviation)
    0.927 ± 0.47 0.888 ± 0.449 -

    End points

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    End points reporting groups
    Reporting group title
    SAR342434
    Reporting group description
    SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26.

    Reporting group title
    Humalog
    Reporting group description
    Humalog before meals intake on top of QD Insulin Glargine, up to Week 26.

    Primary: Change in HbA1c From Baseline to Week 26

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    End point title
    Change in HbA1c From Baseline to Week 26
    End point description
    Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 6-month period and adequate contrasts at Week 26. Analysis was performed on intent-to-treat (ITT) population that included all randomized subjects, irrespective of compliance with the study protocol and procedures. Here, number of subjects analyzed = subjects with at least one post-baseline HbA1c assessment during the 6-month study period.
    End point type
    Primary
    End point timeframe
    Baseline, Week 26
    End point values
    SAR342434 Humalog
    Number of subjects analysed
    239
    246
    Units: percentage of HbA1c
        least squares mean (standard error)
    -0.92 ± 0.051
    -0.85 ± 0.051
    Statistical analysis title
    SAR342434 vs. Humalog
    Statistical analysis description
    Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit (Week 12, Week 26) and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-subject errors.
    Comparison groups
    SAR342434 v Humalog
    Number of subjects included in analysis
    485
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Least square (LS) mean difference
    Point estimate
    -0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.215
         upper limit
    0.067
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.072
    Notes
    [1] - Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 & Humalog was <0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure: if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested and demonstrated if lower bound of 2-sided 95% CI of difference between SAR342434 & Humalog >-03%.

    Secondary: Percentage of Subjects with HbA1c <7.0% and ≤6.5% at Week 26

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    End point title
    Percentage of Subjects with HbA1c <7.0% and ≤6.5% at Week 26
    End point description
    Subjects who had no available assessment for HbA1c at Week 26 were considered as non-responders. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    SAR342434 Humalog
    Number of subjects analysed
    253
    252
    Units: percentage of subject
    number (not applicable)
        HbA1c <7.0%
    42.3
    40.5
        HbA1c ≤6.5%
    27.3
    24.2
    No statistical analyses for this end point

    Secondary: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

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    End point title
    Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
    End point description
    Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the 6-month period and adequate contrasts at Week 26. Analysis was performed on ITT population. Here, number of subjects analyzed = subjects with at least one post-baseline FPG assessment during the 6-months study period.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    SAR342434 Humalog
    Number of subjects analysed
    228
    235
    Units: mmol/L
        least squares mean (standard error)
    -0.62 ± 0.176
    -0.67 ± 0.176
    No statistical analyses for this end point

    Secondary: Change in Mean 24-Hour Plasma Glucose Concentration from Baseline to Week 26

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    End point title
    Change in Mean 24-Hour Plasma Glucose Concentration from Baseline to Week 26
    End point description
    The mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. 7-point SMPGs were performed at least two times in a week before baseline, before visit Week 12 and before visit Week 26. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during 6-month period and adequate contrasts at Week 26. Analysis was performed on ITT population. Here, number of subjects analyzed=subjects with at least one post-baseline mean 24-hour plasma glucose concentration assessment during 6-month study period.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    SAR342434 Humalog
    Number of subjects analysed
    201
    210
    Units: mmol/L
        least squares mean (standard error)
    -1 ± 0.137
    -0.91 ± 0.133
    No statistical analyses for this end point

    Secondary: Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26

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    End point title
    Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26
    End point description
    Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the 6-month period and adequate contrasts at Week 26. Analysis was performed on ITT population. Here, 'n' signifies number of subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    SAR342434 Humalog
    Number of subjects analysed
    253
    252
    Units: mmol/L
    least squares mean (standard error)
        At breakfast (n=194, 204)
    -0.72 ± 0.236
    -0.23 ± 0.228
        At lunch (n=195, 200)
    0.06 ± 0.255
    0.11 ± 0.25
        At dinner (n=190, 193)
    0.11 ± 0.264
    -0.1 ± 0.264
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)

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    End point title
    Percentage of Subjects with Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)
    End point description
    Percentage of subjects with at least one treatment emergent hypoglycemia reported at any time of the day were reported. Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (<3.0 mmol/L) were also analyzed. Analysis was performed on safety population that included all subjects randomized and exposed to at least 1 dose of investigational medicinal product (IMP) (SAR342434 or Humalog), regardless of the amount of treatment administered.
    End point type
    Secondary
    End point timeframe
    First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)
    End point values
    SAR342434 Humalog
    Number of subjects analysed
    253
    252
    Units: percentage of subjects
    number (not applicable)
        Any hypoglycemia
    68.4
    74.6
        Severe hypoglycemia
    2.4
    1.6
        Documented Symptomatic Hypoglycemia (≤3.9mmol/L)
    60.1
    66.3
        Documented Symptomatic Hypoglycemia (<3.0mmol/L)
    28.9
    27.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Hypersensitivity Reactions and Injection Site Reactions

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    End point title
    Percentage of Subjects with Hypersensitivity Reactions and Injection Site Reactions
    End point description
    Analysis was performed on safety population that included all subjects randomized and exposed to at least 1 dose of IMP (SAR342434 or Humalog), regardless of the amount of treatment administered.
    End point type
    Secondary
    End point timeframe
    First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)
    End point values
    SAR342434 Humalog
    Number of subjects analysed
    253
    252
    Units: percentage of subjects
    number (not applicable)
        Any hypersensitivity reactions
    4
    3.6
        Any injection site reactions
    0.4
    1.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-emergent Anti-insulin Antibodies (AIAs)

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    End point title
    Percentage of Subjects with Treatment-emergent Anti-insulin Antibodies (AIAs)
    End point description
    Subjects with treatment-emergent AIA (incidence) were reported (as subjects with treatment-boosted or treatment-induced AIAs). Subjects with treatment-induced AIAs were subjects who developed AIA following IMP administration (subjects with at least one positive AIA sample at any time during on-treatment period, in those subjects without pre-existing AIA or with missing baseline sample). Subjects with treatment-boosted AIAs were subjects with pre-existing AIAs that were boosted significant higher titer following IMP administration (subjects with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those subjects with pre-existing AIA). Analysis was performed on anti-insulin antibody population that included all subjects from the safety population with at least one AIA sample available for analysis during the 6-months on-treatment period.
    End point type
    Secondary
    End point timeframe
    First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)
    End point values
    SAR342434 Humalog
    Number of subjects analysed
    245
    248
    Units: percentage of subjects
        number (not applicable)
    18.8
    14.5
    No statistical analyses for this end point

    Other pre-specified: Change in Daily Insulin Dose from Baseline to Week 26

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    End point title
    Change in Daily Insulin Dose from Baseline to Week 26
    End point description
    Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 value. Analysis was performed on safety population. Here, 'n' signifies number of subjects with available data for specified category.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 26
    End point values
    SAR342434 Humalog
    Number of subjects analysed
    253
    252
    Units: U/kg
    arithmetic mean (standard deviation)
        Basal insulin (n=196, 218)
    0.082 ± 0.133
    0.071 ± 0.122
        Mealtime insulin (n=197, 218)
    0.087 ± 0.209
    0.08 ± 0.248
        Total insulin (n=196, 216)
    0.172 ± 0.296
    0.151 ± 0.297
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported adverse events are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the ‘on treatment period’ (time from first injection of IMP up to 1 day after the last injection of IMP).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    SAR342434
    Reporting group description
    SAR342434 before meals intake on top of QD Insulin Glargine, up to Week 26.

    Reporting group title
    Humalog
    Reporting group description
    Humalog before meals intake on top of QD Insulin Glargine, up to Week 26.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events with a frequency ≥5% were recorded during the study.
    Serious adverse events
    SAR342434 Humalog
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 253 (5.53%)
    27 / 252 (10.71%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma Of Colon
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic Carcinoma Of The Bladder
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatic Carcinoma
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    0 / 253 (0.00%)
    3 / 252 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 253 (0.00%)
    2 / 252 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle Branch Block Left
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure Chronic
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 253 (0.40%)
    2 / 252 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiopulmonary Failure
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary Artery Disease
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Bradycardia
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         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
    Pulmonary Embolism
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carpal Tunnel Syndrome
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 252 (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
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gliosis
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 252 (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
    2 / 253 (0.79%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous Haemorrhage
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo Positional
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis Erosive
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Perforation
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    2 / 253 (0.79%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stone
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         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
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Spinal Stenosis
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic Ketoacidosis
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 253 (0.00%)
    2 / 252 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 253 (0.79%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 252 (0.40%)
         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
    SAR342434 Humalog
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 252 (0.00%)

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Oct 2015
    Clarified the following points: -appropriateness of measurements referring to efficacy and safety endpoints; -procedures of notification in case of changes of the pre-defined injection area; -criteria for permanent discontinuation due to subject’s request; -procedures and consequences of subject withdrawal from the study; -addition of pregnancy, symptomatic overdose and alanine transaminase (ALT) value increase as adverse events of special interests (AESIs) to be reported to health authorities; -Definition of hypoglycemia: asymptomatic and relative hypoglycemia have been added; -Procedures of notification of ALT increases respect to baselines values.

    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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