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    Clinical Trial Results:
    A Twenty Six Week, Randomized, Open-label, 2-Arm, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Toujeo® Compared to Standard of Care Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Uncontrolled Type 2 Diabetes Mellitus, With 6-Month Extension

    Summary
    EudraCT number
    		 2015-001831-18
    Trial protocol
    		 GB   DE   IE   ES   FR   IT  
    Global end of trial date
    16 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2018
    First version publication date
    31 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LPS13931
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02967224
    WHO universal trial number (UTN)
    		 U1111-1170-8104
    Other trial identifiers
    		 Study Name: Reach-Control
    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
    14 Dec 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate non-inferiority of Toujeo versus standard of care basal insulin therapy measured as glycosylated haemoglobin (HbA1c) change from baseline to Month 6.
    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
    		 Subjects received oral anti diabetic drugs (OADs), glucagon-like peptide 1 receptor agonist (GLP1-RA) as background therapy at the discretion of the investigator and consistent with local labeling guidelines for use with insulin.
    Evidence for comparator
    		 Standard of care basal insulin i.e., any commercially available long-acting or intermediate insulins, or any basal insulins (except Toujeo) including biosimilars was used as comparator.
    Actual start date of recruitment
    05 Nov 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
    Brazil: 102
    Country: Number of subjects enrolled
    Italy: 95
    Country: Number of subjects enrolled
    Romania: 87
    Country: Number of subjects enrolled
    Spain: 104
    Country: Number of subjects enrolled
    United Kingdom: 69
    Country: Number of subjects enrolled
    France: 83
    Country: Number of subjects enrolled
    Germany: 161
    Country: Number of subjects enrolled
    Ireland: 2
    Worldwide total number of subjects
    703
    EEA total number of subjects
    601
    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)
    428
    From 65 to 84 years
    272
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 127 active sites in 8 countries. A total of 798 subjects were screened between 05 November 2015 and 6 October 2016, of which 95 were screen failures. Screen failures were mainly due to HbA1c <=7.0% at screening visit.

    Pre-assignment
    Screening details
    		 A total of 703 subjects were randomized, stratified by GLP1-RA use in 6 months prior to randomization (yes, no), sulfonylurea (SU) use at the time of randomization (yes, no), and screening HbA1c category (<9.0%, >=9.0%). Assignment to arms was done centrally using interactive response technology (IRT) in 1:1 ratio (Toujeo: Standard of care).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Toujeo
    Arm description
    		 Toujeo® (Insulin glargine, 300 Units [U]/mL) subcutaneous (SC) injection once daily up to Month 12 on top of non-insulin anti-diabetic treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    HOE901-U300
    Other name
    Toujeo®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin glargine, 300 U/mL (dose range of 1 Unit to 80 Units) was self-administered by deep SC injection at any time of the day according to the local label and titration was performed according to local guidelines and/or the investigator’s discretion.

    Arm title
    		 Standard of Care
    Arm description
    		 "Standard of care" commercially available basal insulin SC injection administered according to local label up to Month 12 on top of non-insulin anti-diabetic treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Basal insulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Long acting or intermediate insulins, or any basal insulins (except Toujeo) including biosimilars with an appropriate pen device was self-administered by deep SC injection according to local label and titration was performed according to local guidelines and/or the investigator’s discretion.

    Number of subjects in period 1
    		Toujeo Standard of Care
    Started
    352
    351
    Treated
    350
    350
    Completed
    334
    336
    Not completed
    18
    15
         Consent withdrawn by subject
    7
    8
         Randomized and not treated
    2
    1
         Adverse event
    1
    -
         Other than specified
    5
    4
         Lost to follow-up
    1
    1
         Protocol deviation
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Toujeo
    Reporting group description
    		 Toujeo® (Insulin glargine, 300 Units [U]/mL) subcutaneous (SC) injection once daily up to Month 12 on top of non-insulin anti-diabetic treatment.

    Reporting group title
    Standard of Care
    Reporting group description
    		 "Standard of care" commercially available basal insulin SC injection administered according to local label up to Month 12 on top of non-insulin anti-diabetic treatment.

    Reporting group values
    		 Toujeo Standard of Care Total
    Number of subjects
    		 352 351 703
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.4 ( 9.9 ) 61.4 ( 10.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 147 152 299
        Male
    		 205 199 404
    Body Mass Index (BMI)
    Data for BMI was reported for a total of 699 subjects (Toujeo: 349 and Standard of Care: 350).
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 31.15 ( 6.06 ) 31.13 ( 5.76 ) -
    Duration of Type 2 Diabetes Mellitus
    Units: years
        arithmetic mean (standard deviation)
    		 11.16 ( 7.37 ) 10.88 ( 7.10 ) -
    Baseline HbA1c
    Units: percentage of HbA1c
        arithmetic mean (standard deviation)
    		 8.99 ( 1.40 ) 9.08 ( 1.49 ) -
    Basal Insulin Daily Dose
    Data for daily basal insulin dose (U/kg) was reported for a total of 699 subjects (Toujeo: 350 and Standard of Care: 349).
    Units: U/kg
        arithmetic mean (standard deviation)
    		 0.176 ( 0.073 ) 0.173 ( 0.065 ) -

    End points

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    End points reporting groups
    Reporting group title
    Toujeo
    Reporting group description
    		 Toujeo® (Insulin glargine, 300 Units [U]/mL) subcutaneous (SC) injection once daily up to Month 12 on top of non-insulin anti-diabetic treatment.

    Reporting group title
    Standard of Care
    Reporting group description
    		 "Standard of care" commercially available basal insulin SC injection administered according to local label up to Month 12 on top of non-insulin anti-diabetic treatment.

    Primary: Change From Baseline in HbA1c to Month 6

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    End point title
    		 Change From Baseline in HbA1c to Month 6
    End point description
    Change in HbA1c was calculated by subtracting baseline value from Month 6 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 randomized period (defined as the time from randomization up to Day 180) regardless of study drug discontinuation or intensification. Analysis was performed on Intent-to-treat (ITT) population which included all randomized subjects who received at least 1 dose of IMP, regardless of whether treatment was actually being received & analysed as per allocated treatment group. Number of subjects analysed=subjects with at least 1 baseline & 1 post-baseline HbA1c assessment during the 6 month randomized period.
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    End point values
    		 Toujeo Standard of Care
    Number of subjects analysed
    342
    339
    Units: percentage of HbA1c
        least squares mean (standard error)
    -1.38 ( 0.059 )
    -1.50 ( 0.059 )
    Statistical analysis title
    		 Toujeo vs. Standard of Care
    Statistical analysis description
    A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using a MMRM approach with fixed categorical effects of treatment arm, visit, treatment-by-visit interaction, multi-country organization (MCO), randomization strata of SU use (yes/no), randomization strata of GLP-1 receptor agonist use (yes/no), as well as continuous fixed covariates of baseline HbA1c and baseline HbA1c value-by-visit interaction.
    Comparison groups
    Toujeo v Standard of Care
    Number of subjects included in analysis
    681
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.0145 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square (LS) Mean difference
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.046
         upper limit
    		 0.281
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.083
    Notes
    [1] - Non-inferiority of Toujeo vs. Standard of Care was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was <0.3%.
    [2] - Threshold for significance at 0.025 level.
    Statistical analysis title
    		 Toujeo vs. Standard of Care
    Comparison groups
    Toujeo v Standard of Care
    Number of subjects included in analysis
    681
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.1585
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.046
         upper limit
    		 0.281
    Variability estimate
    Standard deviation
    Dispersion value
    0.083
    Notes
    [3] - Superiority of Toujeo over ‘standard of care’ was demonstrated if the upper bound of the two-sided 95% CI for the difference between groups was <0 (zero).

    Secondary: Change From Baseline in HbA1c to Month 12

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    End point title
    		 Change From Baseline in HbA1c to Month 12
    End point description
    Change in HbA1c was calculated by subtracting baseline value from Month 12 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measurements. Analysis was performed on ITT population. Here, number of subjects analysed = subjects with at least one baseline and one post-baseline HbA1c assessment during the 12 month randomized period (defined as the time from randomization up to Day 360).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 Toujeo Standard of Care
    Number of subjects analysed
    330
    333
    Units: percentage of HbA1c
        least squares mean (standard error)
    -1.39 ( 0.057 )
    -1.46 ( 0.056 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved a Target HbA1c of < 7% at Month 6 and Month 12

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    End point title
    		 Percentage of Subjects Who Achieved a Target HbA1c of < 7% at Month 6 and Month 12
    End point description
    Measurements at Month 6 and Month 12 were considered in the analysis. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Month 6 and Month 12
    End point values
    		 Toujeo Standard of Care
    Number of subjects analysed
    352
    351
    Units: percentage of subjects
    number (not applicable)
        At Month 6
    29.0
    30.5
        At Month 12
    24.1
    29.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved a Target HbA1c of <7% Without Severe and/or Symptomatic Documented Hypoglycaemia (Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and <54 mg/dL [<3.0 mmol/L]) at Month 6 and Month 12

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    End point title
    		 Percentage of Subjects Who Achieved a Target HbA1c of <7% Without Severe and/or Symptomatic Documented Hypoglycaemia (Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and <54 mg/dL [<3.0 mmol/L]) at Month 6 and Month 12
    End point description
    Severe hypoglycaemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L) or <54 mg/dL (3.0 mmol/L). Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Month 6 and Month 12
    End point values
    		 Toujeo Standard of Care
    Number of subjects analysed
    352
    351
    Units: percentage of subjects
    number (not applicable)
        At (<=70 mg/dL [3.9 mmol/L]): Month 6
    21.0
    24.2
        At (<54 mg/dL [3.0 mmol/L]): Month 6
    25.9
    27.4
        At (<=70 mg/dL [3.9 mmol/L]): Month 12
    16.2
    22.8
        At (<54 mg/dL [3.0 mmol/L]): Month 12
    21
    26.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Remained on Assigned Basal Insulin Therapy Without Intensification at Month 6 and Month 12

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    End point title
    		 Percentage of Subjects Who Remained on Assigned Basal Insulin Therapy Without Intensification at Month 6 and Month 12
    End point description
    Intensification was defined by: addition of an OAD or GLP-1 RA, addition of a rapid acting insulin, increase in dose of any of their background anti-diabetes medications. Remaining on assigned therapy was defined by - subjects who neither permanently withdraw nor switch from Toujeo to “standard of care” basal insulin or from “standard of care” basal insulin to Toujeo. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Month 6 and Month 12
    End point values
    		 Toujeo Standard of Care
    Number of subjects analysed
    352
    351
    Units: percentage of subjects
    number (not applicable)
        At Month 6
    82.1
    80.1
        At Month 12
    73.6
    72.1
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6 and Month 12

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6 and Month 12
    End point description
    Change in FPG was calculated by subtracting baseline value from Month 6 and Month 12 value. Adjusted least squares means and standard errors were obtained from a MMRM approach including all post-baseline FPG data available during the 12 month randomized period. Analysis was run on subjects with at least one baseline and one post-baseline FPG assessment during the 12 month randomized period (defined as the time from randomization up to Day 360) . Analysis was performed on ITT population. Here 'n' signifies subjects with at least one baseline and one post baseline FPG values at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6 and Month 12
    End point values
    		 Toujeo Standard of Care
    Number of subjects analysed
    352
    351
    Units: mmol/L
    least squares mean (standard error)
        Change At Month 6 (n = 328, 330)
    -2.92 ( 0.134 )
    -3.22 ( 0.134 )
        Change At Month 12 (n = 320, 325)
    -3.32 ( 0.136 )
    -3.27 ( 0.135 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With At Least One Hypoglycaemic Event (Severe and/or Confirmed Hypoglycaemia [<=70 mg/dL and < 54 mg/dL]) During 12 Month On–Treatment Period

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    End point title
    		 Percentage of Subjects With At Least One Hypoglycaemic Event (Severe and/or Confirmed Hypoglycaemia [<=70 mg/dL and < 54 mg/dL]) During 12 Month On–Treatment Period
    End point description
    Severe hypoglycaemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycaemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Assessment was done during 12-month on-treatment period i.e. time from the first study drug intake up to 1 day after last injection of study drug. Analysis was performed on safety population defined as all randomized subjects who received at least one dose of Toujeo or “standard of care” basal insulin, regardless of the study drug administered.
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 12
    End point values
    		 Toujeo Standard of Care
    Number of subjects analysed
    350
    350
    Units: percentage of subjects
    number (not applicable)
        At <=70 mg/dL
    30.6
    28.3
        At <54 mg/dL
    10.0
    9.1
    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 the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Treatment-emergent AEs were AEs that developed or worsened or became serious during the 12-month on-treatment period i.e. time from the first study drug intake up to 1 day after last injection of study drug. Treatment-emergent AEs leading to death were analysed. Analysis was performed on safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Toujeo
    Reporting group description
    		 Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12 on top of non-insulin anti-diabetic treatment.

    Reporting group title
    Standard of Care
    Reporting group description
    		 "Standard of care" commercially available basal insulin SC injection administered according to local label up to Month 12 on top of non-insulin anti-diabetic treatment.

    Serious adverse events
    		 Toujeo Standard of Care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    43 / 350 (12.29%)
    41 / 350 (11.71%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer Recurrent
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive Lobular Breast Carcinoma
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Neoplasm Malignant
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases To Central Nervous System
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Lung
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic Gastric Cancer
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Germ Cell Teratoma
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Carcinoma Stage Iv
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary Cystadenoma Lymphomatosum
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic Stenosis
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Occlusive Disease
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity Necrosis
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 350 (0.29%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         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
    Face Oedema
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection Site Reaction
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 350 (0.29%)
    2 / 350 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast Fibrosis
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         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
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alveolitis Allergic
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 350 (0.57%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Confusional State
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Injury, poisoning and procedural complications
    Abdominal Injury
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Injury
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 350 (0.29%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional Hernia
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (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
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic Fracture
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    1 / 350 (0.29%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    0 / 350 (0.00%)
    2 / 350 (0.57%)
         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
    2 / 350 (0.57%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (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 / 350 (0.29%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic Shock
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    1 / 350 (0.29%)
    2 / 350 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Stenosis
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Ischaemia
         subjects affected / exposed
    2 / 350 (0.57%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Embolic Stroke
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypoglycaemic Unconsciousness
         subjects affected / exposed
    1 / 350 (0.29%)
    2 / 350 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-Ischaemic Encephalopathy
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         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 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (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 / 350 (0.29%)
    2 / 350 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Of Malignant Disease
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal Fistula
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Fistula
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated Inguinal Hernia
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stone
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice Cholestatic
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic Foot
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Ulcer
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    1 / 350 (0.29%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Kidney Disease
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis Noninfective
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Nephropathy
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iga Nephropathy
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic Syndrome
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Polyp
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         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 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Stiffness
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (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
    4 / 350 (1.14%)
    5 / 350 (1.43%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal Abscess
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         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 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Bacteraemia
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Pyelonephritis
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Exacerbation Of Chronic Obstructive Airways Disease
         subjects affected / exposed
    0 / 350 (0.00%)
    2 / 350 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Discitis
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (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
    3 / 350 (0.86%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Infection
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth Abscess
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Toujeo Standard of Care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 350 (8.29%)
    20 / 350 (5.71%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    29 / 350 (8.29%)
    20 / 350 (5.71%)
         occurrences all number
    32
    22

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2015
    Following changes were made: - Added exclusion criterion for subjects with hypersensitivity to Toujeo or excipients - added a sensitivity analysis for the primary endpoint on per-protocol population instead of the 6-month completer population - clarified the definition of the per-protocol population and the 6-month completer population - added the α-glucosidase inhibitor class to the list of oral agents as part of inclusion criterion - removed the value “self-monitored plasma glucose (SMPG) <=70 mg/dL” in order to collect probable symptomatic and relative hypoglycaemia - clarified the responsibilities of reporting adverse events by the Investigators or third party - extended the period between last subject last visit and database lock - added decision tree for neutropenia - clarified the origin of the hypoglycaemic control subscale - clarified that the standard of care basal insulin could be provided by the site or dispensing pharmacy, - removed the term “country” as an effect in statistical models in order to prevent convergence issues - clarified that laboratory testing could be performed during the entire screening period - clarified contraceptive methods for subjects in the United Kingdom - clarified adverse event reporting instructions for alanine aminotransferase (ALT) increase - clarified the definition of procedure and consequence for subjects who withdrew from the study.

    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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