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    Clinical Trial Results:
    A Multi-Center, Open-Label, Single-Arm, Multiple Dose Study With HOE901-U300 to Assess the Ease of Use And Safety of a New U300 Pen Injector in Insulin-Naive Patients With T2DM

    Summary
    EudraCT number
    2014-001253-16
    Trial protocol
    DE  
    Global end of trial date
    20 Nov 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    15 May 2016
    First version publication date
    15 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PDY14065
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02227212
    WHO universal trial number (UTN)
    U1111-1155-7309
    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
    05 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the ease of use of the U300 pen injector in pen-naive and insulin-naive type 2 diabetes mellitus (T2DM) subjects in a 4-week once-daily dosing regimen with HOE901-U300.
    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 continued their background anti-hyperglycemic treatment during the study except sulfonylureas, glinides and other anti-hyperglycemic agents not approved in combination with Insulin.
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Aug 2014
    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
    Germany: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    17
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 7 centres in Germany. A total of 51 subjects were screened between 22 August 2014 and 30 September 2014.

    Pre-assignment
    Screening details
    Of 51 screened subjects, 43 subjects were enrolled and 40 were treated.

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

    Arms
    Arm title
    HOE901-U300
    Arm description
    HOE901-U300 for 4 weeks using U300 pen injector.
    Arm type
    Experimental

    Investigational medicinal product name
    Insulin Glargine U300
    Investigational medicinal product code
    HOE901-U300
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    HOE901-U300 (Insulin Glargine 300 U/ml) was self-administered once daily in evening. Subjects were individually up-titrated weekly from dose 0.2 U/kg seeking a fasting self-monitored plasma glucose (SMPG) in the range of 80 to 100 mg/dL/day (4.4 to 5.6 mmol/L). The injection time was fixed at the baseline visit and was maintained for the duration of the study with +/-1 hour window.

    Number of subjects in period 1
    HOE901-U300
    Started
    40
    Completed
    40

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HOE901-U300
    Reporting group description
    HOE901-U300 for 4 weeks using U300 pen injector.

    Reporting group values
    HOE901-U300 Total
    Number of subjects
    40 40
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    66.2 ± 9.8 -
    Gender categorical
    Units: Subjects
        Female
    21 21
        Male
    19 19

    End points

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    End points reporting groups
    Reporting group title
    HOE901-U300
    Reporting group description
    HOE901-U300 for 4 weeks using U300 pen injector.

    Primary: Percentage of Subjects with an Excellent/Good Responses on Ease of Use/Ease of Learning Questionnaires

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    End point title
    Percentage of Subjects with an Excellent/Good Responses on Ease of Use/Ease of Learning Questionnaires [1]
    End point description
    The questionnaire consists of 8 questions to assess ease of use and 4 questions to assess ease of learning, ease of use in general, overall assessment of the pen, and does the subject recommend the pen. The responses for the first 11 questions were assessed on a 5-point Likert scale ranging from 1 (excellent) to 5 (very poor) about how easy it was to learn and use the pen device. The response of last question (Subject’s recommendation of U300 pen injector) was evaluated in the form of ‘Yes’ or ‘No’ and % of subjects answering “yes“ were reported . Analysis was performed on safety population, which included all enrolled subjects exposed to at least one dose of investigational medicinal product (IMP).
    End point type
    Primary
    End point timeframe
    Baseline, Week 4
    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: Data were descriptive in nature, hence statistical analysis could not be provided.
    End point values
    HOE901-U300
    Number of subjects analysed
    40
    Units: Percentage of subjects
    number (not applicable)
        Ease of selecting the dose (Baseline)
    92.3
        Ease of selecting the dose (Week 4)
    95
        Ease of correcting a misdialed dose (Baseline)
    97.4
        Ease of correcting a misdialed dose (Week 4)
    97.5
        Ease of reading the insulin dose (Baseline)
    84.6
        Ease of reading the insulin dose (Week 4)
    92.5
        Ease of feeling/hearing dialing clicks (Baseline)
    76.9
        Ease of feeling/hearing dialing clicks (Week 4)
    85
        Force/effort needed to inject insulin (Baseline)
    89.7
        Force/effort needed to inject insulin (Week 4)
    95
        Smoothness/gentleness of injection (Baseline)
    89.7
        Smoothness/gentleness of injection (Week 4)
    92.5
        Ease of knowing injection if complete (Baseline)
    74.4
        Ease of knowing injection if complete (Week 4)
    85
        Ease of reading remaining insulin (Baseline)
    59
        Ease of reading remaining insulin (Week 4)
    90
        Ease of learning (Baseline)
    89.7
        Ease of learning (Week 4)
    95
        General ease of use (Baseline)
    92.3
        General ease of use (Week 4)
    97.5
        Overall assessment (Baseline)
    89.7
        Overall assessment (Week 4)
    95
        Would you recommend U300 pen injector (Baseline)
    100
        Would you recommend U300 pen injector (Week 4)
    97.5
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total Treatment Satisfaction Score using Diabetes Treatment Satisfaction Questionnaire status (DTSQs)

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    End point title
    Change from Baseline in Total Treatment Satisfaction Score using Diabetes Treatment Satisfaction Questionnaire status (DTSQs)
    End point description
    DTSQs is a validated questionnaire designed to measure total diabetes treatment satisfaction and perceived frequency of hyper and hypoglycemia. It consists of 8 questions which are answered on a 7-point Likert scale with responses ranging from 0 (very dissatisfied) to 6 (very satisfied). A total treatment satisfaction score range between 0 and 36 was calculated as the sum of the following single items: Item 1 (current treatment), Item 4 (convenience), Item 5 (flexibility), Item 6 (understanding), Item 7 (recommend), and Item 8 (continue). Analysis was performed on safety population. Number of subjects analysed = subjects with DTSQs assessment at specified time-points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    HOE901-U300
    Number of subjects analysed
    39
    Units: score on a scale
        arithmetic mean (standard deviation)
    1.13 ± 6.79
    No statistical analyses for this end point

    Secondary: Change in Fasting Plasma Glucose (FPG) from Baseline to Week 4

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    End point title
    Change in Fasting Plasma Glucose (FPG) from Baseline to Week 4
    End point description
    Subjects were self-monitored their FPG as usually done in the standard care after initiating an insulin treatment in insulin-naïve subjects. Analysis was performed on safety population. Number of subjects analysed = subjects with FPG assessment at specified time-points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    HOE901-U300
    Number of subjects analysed
    38
    Units: mmol/L
        arithmetic mean (standard deviation)
    -2.34 ± 2.54
    No statistical analyses for this end point

    Secondary: Number of subjects with Product Technical Complaints (PTC)

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    End point title
    Number of subjects with Product Technical Complaints (PTC)
    End point description
    The incidences PTC with the new U300 pen injector were assessed using PTC forms. Any malfunction of the U300 pen injector whether or not associated with an AE, must had been reported to the monitoring team on a PTC form. Analysis was performed on safety population.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 4
    End point values
    HOE901-U300
    Number of subjects analysed
    40
    Units: Subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Daily Insulin Dose to Week 4

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    End point title
    Change from Baseline in Daily Insulin Dose to Week 4
    End point description
    Analysis was performed on safety population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    HOE901-U300
    Number of subjects analysed
    39
    Units: U/kg
        arithmetic mean (standard deviation)
    0.15 ± 0.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Hypoglycemia Events

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    End point title
    Percentage of Subjects with Hypoglycemia Events
    End point description
    Hypoglycemia events included: Severe (required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) ; Documented symptomatic (typical symptoms of hypoglycemia were accompanied by plasma glucose =<3.9 mmol/L) ; Asymptomatic (not accompanied by typical symptoms of hypoglycemia but with plasma glucose =<3.9 mmol/L) ; Probable symptomatic (symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by plasma glucose = <3.9 mmol/L) ; And Relative (subjects reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but with plasma glucose >3.9 mmol/L). Analysis was performed on safety population.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 4
    End point values
    HOE901-U300
    Number of subjects analysed
    40
    Units: Percentage of subjects
    number (not applicable)
        Any hypoglycemia event
    17.5
        Asymptomatic hypoglycemia
    7.5
        Documented hypoglycemia
    10
        Probable hypoglycemia
    0
        Relative hypoglycemia
    2.5
        Severe Hypoglycemia
    0
    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 6) 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 during the ‘on treatment period’ (the time from the first IMP administration until 2 days after the last dose of IMP).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    HOE901-U300
    Reporting group description
    HOE901-U300 for 4 weeks using U300 pen injector.

    Serious adverse events
    HOE901-U300
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    HOE901-U300
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 40 (27.50%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma Of Liver
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Cardiac disorders
    Mitral Valve Incompetence
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Immune system disorders
    Allergy To Arthropod Sting
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    General disorders and administration site conditions
    Injection Site Haematoma
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Peripheral Swelling
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Injection Site Pain
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Urinary Tract Infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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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