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    Clinical Trial Results:
    Phase IV Study to Evaluate the Safety and Efficacy of the Treatment of Hyperglycemia with Gla-300 in Basal-Bolus Regimen in Hospitalised Type 2 Diabetes Mellitus (T2D) Patients Poorly Controlled with Basal Insulin and/or Non-Insulin Treatments and Therapy Intensification at Discharge with Basal Insulin

    Summary
    EudraCT number
    2015-004715-20
    Trial protocol
    ES  
    Global end of trial date
    17 Jul 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Aug 2019
    First version publication date
    01 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLARGL07710
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    STUDY NAME: COBALTA
    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
    01 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of therapy intensification on discharge with basal insulin in hospitalized type 2 diabetes subjects poorly controlled with basal insulin and/or non-insulin antidiabetic agents (glycated hemoglobin [HbA1c] >= 8.0% on admission) measured by the decrease in HbA1c at 6 months post-discharge.
    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
    During hospitalization, the treatment regimen consisted of a basal-bolus-correction (BBC) insulin therapy. The initial total daily insulin dose was calculated according to the site protocol and distributed 50% as bolus insulin and 50% as basal insulin (Gla-300). Both insulins were titrated according to a pre-defined titration algorithm. Non-insulin antidiabetic drugs (NIADs) were retired during hospitalization and re-established at hospital discharge according to clinical criteria.
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Jun 2016
    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: 112
    Worldwide total number of subjects
    112
    EEA total number of subjects
    112
    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)
    27
    From 65 to 84 years
    71
    85 years and over
    14

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 15 sites in Spain. A total of 115 subjects were screened between 10 June 2016 and 20 December 2017, of which 3 subjects were screening failure. Screen failures were mainly due to exclusion criteria met.

    Pre-assignment
    Screening details
    A total of 112 subjects were included in the study.

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

    Arms
    Arm title
    Insulin glargine 300 U/mL
    Arm description
    Subjects received Insulin glargine 300 U/mL once daily for around 26 weeks (maximum 2 weeks hospitalization and 6 months follow-up).
    Arm type
    Experimental

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    HOE901
    Other name
    Toujeo®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    HOE901-U300 was administered by subcutaneous injection once daily in the evening using a pre-filled pen. The dose was self-titrated every 3-4 days to achieve fasting blood glucose levels in the target range of 90-140mg/dL.

    Number of subjects in period 1
    Insulin glargine 300 U/mL
    Started
    112
    Completed
    93
    Not completed
    19
         Exclusion criteria
    1
         Protocol deviation
    1
         Death
    6
         Posterior diagnose of cancer
    1
         Revocation of informed consent
    2
         Adverse event
    2
         Discontinuation of study treatment
    1
         Not allowed concomitant medication
    1
         Lost to follow-up
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    Subjects received Insulin glargine 300 U/mL once daily for around 26 weeks (maximum 2 weeks hospitalization and 6 months follow-up).

    Reporting group values
    Overall Study Total
    Number of subjects
    112 112
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    72.3 ± 10.8 -
    Gender categorical
    Units: Subjects
        Female
    44 44
        Male
    68 68
    Body Weight
    Units: kilogram (kg)
        arithmetic mean (standard deviation)
    80.1 ± 16.6 -
    Body Mass Index
    Units: kilogram per square meter (kg/m^2)
        arithmetic mean (standard deviation)
    30.1 ± 5.9 -
    Hemoglobin A1C (HbA1C)
    Units: percentage of hemoglobin
        arithmetic mean (standard deviation)
    8.9 ± 0.7 -
    Fasting Blood Glucose
    Units: milligrams per deciliter (mg/dL)
        arithmetic mean (standard deviation)
    205.4 ± 83.9 -

    End points

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    End points reporting groups
    Reporting group title
    Insulin glargine 300 U/mL
    Reporting group description
    Subjects received Insulin glargine 300 U/mL once daily for around 26 weeks (maximum 2 weeks hospitalization and 6 months follow-up).

    Primary: Change From Discharge in Glycated Hemoglobin (HbA1c) to Month 6

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    End point title
    Change From Discharge in Glycated Hemoglobin (HbA1c) to Month 6 [1]
    End point description
    Change in HbA1c was calculated by subtracting discharge value from Month 6 value. Analysis was performed on intent-to-treat (ITT) population that included all subjects who received at least one dose of Gla-300 study insulin and had a primary or secondary measure of effectiveness evaluation both at baseline and in at least one follow-up visit.
    End point type
    Primary
    End point timeframe
    Discharge, Month 6 (post discharge)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint contains single arm, no statistical analysis is provided.
    End point values
    Insulin glargine 300 U/mL
    Number of subjects analysed
    94
    Units: percentage of HbA1c
        arithmetic mean (standard deviation)
    1.6 ± 1.1
    No statistical analyses for this end point

    Secondary: Mean Change From Hospital Admission in 7-Point Capillary Glycaemia to Hospital Discharge

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    End point title
    Mean Change From Hospital Admission in 7-Point Capillary Glycaemia to Hospital Discharge
    End point description
    7-Point Capillary blood glucose were measured at the following 7 time points at baseline (hospital admission) and hospital discharge: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, at bedtime. 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 (hospital admission), discharge
    End point values
    Insulin glargine 300 U/mL
    Number of subjects analysed
    94
    Units: mg/dL
    arithmetic mean (standard deviation)
        Glycaemia before breakfast (n= 87)
    25.1 ± 66.6
        Glycaemia 2 hours after breakfast (n=61)
    44.0 ± 87.3
        Food glucose before lunch (n=90)
    43.6 ± 70.6
        Glycaemia 2 hours after lunch (n= 68)
    63.0 ± 85.4
        Glycaemia before dinner (n= 91)
    53.8 ± 83.4
        Glycaemia 2 hours after dinner (n= 66)
    43.4 ± 81.1
        Glycaemia at bedtime (n= 76)
    47.9 ± 78.5
    No statistical analyses for this end point

    Secondary: Mean Change From Hospital Admission in Fasting Plasma Glucose (FPG) to Discharge, Month 3 and Month 6

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    End point title
    Mean Change From Hospital Admission in Fasting Plasma Glucose (FPG) to Discharge, Month 3 and Month 6
    End point description
    Mean Change in FPG was calculated by subtracting baseline (hospital admission) value from hospital discharge value, Month 3 value and Month 6 value. Analysis was performed on ITT population. Here, ‘n’ signifies number of subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline (hospital admission), discharge, Month 3, Month 6 (post discharge)
    End point values
    Insulin glargine 300 U/mL
    Number of subjects analysed
    94
    Units: mg/dL
    arithmetic mean (standard deviation)
        Discharge (n= 94)
    51.5 ± 90.9
        Month 3 (n=92)
    68.2 ± 96.0
        Month 6 (n=93)
    77.6 ± 86.4
    No statistical analyses for this end point

    Secondary: Diabetes Treatment Satisfaction Questionnaire (DTSQ) Mean Score at Month 6

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    End point title
    Diabetes Treatment Satisfaction Questionnaire (DTSQ) Mean Score at Month 6
    End point description
    The DTSQs is a validated questionnaire to assess subject’s satisfaction with their diabetes treatment. Total DTSQ score consists of the sum of 6 items (Q1 and Q4 - Q8), each rated on a 7-point scale (from 0 to 6). Total DTSQ score ranged from 0 (very dissatisfied) to 36 (very satisfied); higher score = more satisfaction. Analysis was performed on ITT population. Here, subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Month 6 (post discharge)
    End point values
    Insulin glargine 300 U/mL
    Number of subjects analysed
    91
    Units: score on a scale
        arithmetic mean (standard deviation)
    31.0 ± 4.5
    No statistical analyses for this end point

    Secondary: Change in Body Weight From Discharge to Month 6

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    End point title
    Change in Body Weight From Discharge to Month 6
    End point description
    Change in body weight was calculated by subtracting discharge value from Month 6 value. Analysis was performed on safety population that consisted of all included all subjects who received at least one dose of the Gla-300 study insulin. Here, subjects analysed signifies number of subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Discharge, Month 6 (post discharge)
    End point values
    Insulin glargine 300 U/mL
    Number of subjects analysed
    86
    Units: kilogram (Kg)
        arithmetic mean (standard deviation)
    0.0 ± 6.2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Confirmed or Severe Hypoglycemia During Hospitalisation and at Month 6 After Discharge

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    End point title
    Number of Subjects With Confirmed or Severe Hypoglycemia During Hospitalisation and at Month 6 After Discharge
    End point description
    Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Analysis was performed on safety population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    From Baseline to discharge, Month 6 (post discharge)
    End point values
    Insulin glargine 300 U/mL
    Number of subjects analysed
    112
    Units: subjects
    number (not applicable)
        During hospitalization (n=112)
    28
        Month 6 (n=93)
    55
    No statistical analyses for this end point

    Secondary: Number of Re-hospitalisations or Emergency Visits at Month 6 After Discharge

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    End point title
    Number of Re-hospitalisations or Emergency Visits at Month 6 After Discharge
    End point description
    Analysis was performed on safety population. Here, subjects analysed signifies number of subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Month 6 (post discharge)
    End point values
    Insulin glargine 300 U/mL
    Number of subjects analysed
    45
    Units: number of visits
    number (not applicable)
        Re-hospitalization
    46
        Emergency visits
    64
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (Month 6) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs and deaths are treatment-emergent AEs that developed/worsened and deaths that occurred during the time from first study drug intake up to Month 6. Analysis was performed on safety population.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Insulin glargine 300 U/mL
    Reporting group description
    Subjects received Insulin glargine 300 U/mL once daily for 24 weeks. The dose was self-titrated every 3-4 days to achieve fasting self-measured plasma glucose (SMPG) in the target range of 80-110 mg/dL.

    Serious adverse events
    Insulin glargine 300 U/mL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 112 (33.04%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    Vascular disorders
    Peripheral Ischaemia
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pulmonary Embolism
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Varicose Ulceration
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder Neoplasm
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Colon Cancer
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung Neoplasm
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Injury, poisoning and procedural complications
    Intervertebral Discitis
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Angina Pectoris
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    4 / 112 (3.57%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Cardiac Failure Acute
         subjects affected / exposed
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac Failure Chronic
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac Tamponade
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiogenic Shock
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Left Ventricular Failure
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Myocardial Ischaemia
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Plasma Cell Myeloma
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Bronchitis
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    7 / 112 (6.25%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Pulmonary Mass
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonsillar Hypertrophy
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Brain Stem Stroke
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhagic Stroke
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoxic-Ischaemic Encephalopathy
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lacunar Infarction
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis Ischaemic
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enteritis Infectious
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Chronic Kidney Disease
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Infection Fungal
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic Ulcer
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin Ulcer
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral Discitis
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pelvic Fracture
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Klebsiella Sepsis
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Stoma Site Infection
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Insulin glargine 300 U/mL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 112 (28.57%)
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    9 / 112 (8.04%)
         occurrences all number
    10
    Renal and urinary disorders
    Urinary Tract Infection
         subjects affected / exposed
    14 / 112 (12.50%)
         occurrences all number
    18
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    11 / 112 (9.82%)
         occurrences all number
    16
    Vitamin D Deficiency
         subjects affected / exposed
    6 / 112 (5.36%)
         occurrences all number
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jan 2016
    Following changes were made: Change in exclusion criteria: Following criteria added: - Subjects that required intensification with rapid-acting insulin at discharge. - Pregnant, lactating women or fertile women not using contraceptive methods during study. - Subjects unable or unwilling to sign informed consent.
    04 Oct 2016
    - Change in inclusion criteria: -Minimum expected hospitalization length moved from 7 to 5 days. - Criteria removed: Maximum age of 75 years. - Change in exclusion criteria:- Criteria added: subjects who were unable to titrate or manage correctly the insulin treatment due to their medical condition. - Non-allowed treatments: -Corticosteroid treatment limitations were clarified: Oral or parenteral corticosteroids were not allowed.

    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
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
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