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    Clinical Trial Results:
    An interventional, Open-Label, Single-Arm, Multicenter, 24 Weeks Phase 4 Study Assessing the Efficacy and Safety of Toujeo in Patients with Type 2 Diabetes Inadequately Controlled with Basal Insulin

    Summary
    EudraCT number
    2015-002416-33
    Trial protocol
    FR  
    Global end of trial date
    24 Jul 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Aug 2018
    First version publication date
    03 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLARGL07667
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02967237
    WHO universal trial number (UTN)
    U1111-1176-6203
    Sponsors
    Sponsor organisation name
    Sanofi Aventis France
    Sponsor organisation address
    82, avenue Raspail, Gentilly Cedex, France, 94255
    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
    27 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the effect of HOE901-U300 in subjects with type 2 diabetes inadequately controlled by their basal insulin and eligible for a change of basal insulin, according to the investigator’s judgement, in terms of improvement of glycated hemoglobin (HbA1c).
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Jan 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
    France: 140
    Worldwide total number of subjects
    140
    EEA total number of subjects
    140
    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)
    79
    From 65 to 84 years
    60
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted in France. A total of 194 subjects were screened between 04 January 2016 and 29 December 2016, of which 54 subjects were screen failures. Screen failures were mainly due to inclusion criteria not met. A total of 140 subjects were included.

    Pre-assignment
    Screening details
    Among 140 subjects, 3 subjects did not receive any dose of investigational medicinal product (IMP) and 137 subjects were included in the safety population.

    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: HOE901-U300
    Arm description
    Subjects received HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 24 weeks. The dose was adjusted every 3-4 days to achieve fasting self-measured plasma glucose (SMPG) in the target range of 80-130 mg/dL, as recommended by the American diabetes association/ European association for the Study of Diabetes (ADA/EASD).
    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 at approximately the same time every day (i.e., without exceeding ± 3 hours compared to the usual time).

    Number of subjects in period 1
    Insulin glargine: HOE901-U300
    Started
    140
    Treated (Safety population)
    137
    Completed
    129
    Not completed
    11
         Protocol deviation
             1
         Included but not treated
             3
         Adverse event
             5
         Consent withdrawn by subject
             2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    Subjects received HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 24 weeks. The dose was adjusted every 3-4 days to achieve fasting self-measured plasma glucose (SMPG) in the target range of 80-130 mg/dL, as recommended by the American diabetes association/ European association for the study of Diabetes (ADA/EASD).

    Reporting group values
    Overall Study Total
    Number of subjects
    140 140
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    79 79
        From 65-84 years
    60 60
        85 years and over
    1 1
    Gender categorical
    Units: Subjects
        Female
    50 50
        Male
    90 90

    End points

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    End points reporting groups
    Reporting group title
    Insulin glargine: HOE901-U300
    Reporting group description
    Subjects received HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 24 weeks. The dose was adjusted every 3-4 days to achieve fasting self-measured plasma glucose (SMPG) in the target range of 80-130 mg/dL, as recommended by the American diabetes association/ European association for the Study of Diabetes (ADA/EASD).

    Primary: Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 24

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    End point title
    Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 24 [1]
    End point description
    Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Analysis was performed on modified intention-to-treat population (mITT) population that included all subjects in the study who received at least one dose of IMP and were assessable for the primary endpoint. Here, "subjects analysed" = subjects with available data for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    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: The study consisted of single-arm hence, no comparative analysis was performed. The 95% CI is given adjusted by baseline value.
    End point values
    Insulin glargine: HOE901-U300
    Number of subjects analysed
    132
    Units: HbA1c (%)
        least squares mean (confidence interval 95%)
    -0.64 (-0.81 to -0.46)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reaching Fasting Self-monitored Plasma Glucose (SMPG) Target Range of 90-130 mg/dL at Week 12 and Week 24

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    End point title
    Percentage of Subjects Reaching Fasting Self-monitored Plasma Glucose (SMPG) Target Range of 90-130 mg/dL at Week 12 and Week 24
    End point description
    Fasting SMPG values at Week 24 time-point was calculated by the mean of the last 3 readings in the week prior to the specified week visit. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    Insulin glargine: HOE901-U300
    Number of subjects analysed
    136
    Units: percentage of subjects
    number (not applicable)
        At Week 12
    35.0
        At Week 24
    38.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HbA1c <7.0%, <7.5% and <8% at Week 24

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    End point title
    Percentage of Subjects with HbA1c <7.0%, <7.5% and <8% at Week 24
    End point description
    Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Insulin glargine: HOE901-U300
    Number of subjects analysed
    136
    Units: percentage of subjects
    number (not applicable)
        HbA1c <7.0%
    11.4
        HbA1c <7.5%
    29.5
        HbA1c <8.0%
    50.8
    No statistical analyses for this end point

    Secondary: Change From Baseline in HbA1c Across HbA1c Subgroups Categories (=<8%, >8 to 9%, and >9%) at Week 12 and Week 24

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    End point title
    Change From Baseline in HbA1c Across HbA1c Subgroups Categories (=<8%, >8 to 9%, and >9%) at Week 12 and Week 24
    End point description
    Change in HbA1c was calculated by subtracting baseline value from Week 12 and Week 24 time point value for each subgroup category at baseline. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    Insulin glargine: HOE901-U300
    Number of subjects analysed
    136
    Units: HbA1c (%)
    arithmetic mean (standard deviation)
        Change in HbA1c for <=8% level at Week 12 (n=43)
    -0.22 ± 0.57
        Change in HbA1c for <=8% level at Week 24 (n=41)
    -0.19 ± 0.66
        Change in HbA1c for 8%-9% level at Week 12 (n=57)
    -0.45 ± 0.71
        Change in HbA1c for 8%-9% level at Week 24 (n=56)
    -0.56 ± 1.01
        Change in HbA1c for >9% level at Week 12 (n=36)
    -0.95 ± 0.89
        Change in HbA1c for >9% level at Week 24 (n=35)
    -1.35 ± 0.97
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and Week 24

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    End point title
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and Week 24
    End point description
    Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 time point value. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    Insulin glargine: HOE901-U300
    Number of subjects analysed
    136
    Units: mg/dL
    arithmetic mean (standard deviation)
        Change at Week 12
    -21.0 ± 58.9
        Change at Week 24
    -24.9 ± 61.5
    No statistical analyses for this end point

    Secondary: Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24

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    End point title
    Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24
    End point description
    The DTSQs is a validated questionnaire to assess subject’s satisfaction with their diabetes treatment. It consisted of 8 questions (Q1- Q8), each item is rated on a 7-point scale ranged from 0 to 6 (0 [never] to 6 [most of the time]). Treatment satisfaction score consists of the sum of 6 items (Q1 and Q4 - Q8). Total DTSQ score ranged from 0 (very dissatisfied) to 36 (very satisfied); higher score = more satisfaction. Q2 and Q3 are related to blood glucose and rated separately from the satisfaction-related items. Question 2 gives an indication on the perception of frequency of hyperglycemias and question 3 gives an indication on the perception of frequency of hypoglycaemia. Each question was rated on a 7-point scale ranges from 0 (never) to 6 (most of the time), where higher score indicates higher recurrence. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Insulin glargine: HOE901-U300
    Number of subjects analysed
    136
    Units: units on a scale
    arithmetic mean (standard deviation)
        Perception of frequency of hyperglycemia
    -1.4 ± 2.3
        Perception of frequency of hypoglycemia
    0.2 ± 2.2
        Treatment Satisfaction
    4.3 ± 9.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With At Least One Hypoglycemia Event (Any Hypoglycemia, Symptomatic Documented Hypoglycemia, Severe Hypoglycemia) During On-Treatment Period

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    End point title
    Percentage of Subjects With At Least One Hypoglycemia Event (Any Hypoglycemia, Symptomatic Documented Hypoglycemia, Severe Hypoglycemia) During On-Treatment Period
    End point description
    Categories of hypoglycaemia event were based on ADA classification. Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which subjects didn’t need assistance to treat the hypoglycemia but had at least one symptom (tremor, perspiration, dizziness, hunger sensation, headaches, weakness, irritability, palpitations, loss of consciousness, convulsions, other) with measured plasma glucose concentration of <=70 mg/dL. Percentage of subjects with symptomatic documented, severe and any hypoglycaemia (severe or symptomatic) were reported. On-treatment period was defined as the time from first dose of IMP up to 24 weeks of treatment period. Analysis was performed on safety population that consisted of all included subjects in the study and who had received at least one treatment dose.
    End point type
    Secondary
    End point timeframe
    First dose of study drug up to 24 weeks
    End point values
    Insulin glargine: HOE901-U300
    Number of subjects analysed
    137
    Units: percentage of subjects
    number (not applicable)
        Any hypoglycemia
    45.99
        Severe hypoglycemia
    2.19
        Documented symptomatic hypoglycemia
    31.39
    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 (Week 24) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (from the first dose IMP up to 24 weeks of treatment period). 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
    Insulin glargine: HOE901-U300
    Reporting group description
    Subjects received HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 24 weeks. The dose was adjusted every 3-4 days to achieve fasting SMPG in the target range of 80-130 mg/dL, as recommended by the ADA/EASD.

    Serious adverse events
    Insulin glargine: HOE901-U300
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 137 (9.49%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 137 (0.73%)
         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)
    Nasal Cavity Cancer
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocardial Infarction
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal Failure
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal Injury
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis Acute
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    4 / 137 (2.92%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 137 (0.73%)
         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: HOE901-U300
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 137 (12.41%)
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    9 / 137 (6.57%)
         occurrences all number
    10
    Nasopharyngitis
         subjects affected / exposed
    8 / 137 (5.84%)
         occurrences all number
    8

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jun 2016
    Following amendment were made: Selection criteria was modified and updated as: - subjects treated or not treated with oral antidiabetic agents (including metformin, sulfonylureas, glinides, DPP-4 inhibitors, SGLT2 inhibitors…) in the 8 weeks prior to the screening visit. Inclusion criteria was modified and updated as: - Mean of the last 3 fasting plasma glucose values measured in the week prior to the inclusion visit of >130 mg/dl or at least 2 fasting plasma glucose values in the week prior to the inclusion visit >130 mg/dl. - “The last 3 measurements” was replaced by “these measurements” and text was updated as: these measurements before the V1 will allow to evaluate the corresponding inclusion criterion.

    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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