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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of one dose of imeglimin versus placebo after 18 weeks of treatment in subjects with type 2 diabetes mellitus

    Summary
    EudraCT number
    		 2013-001539-35
    Trial protocol
    		 HU   LV  
    Global end of trial date
    23 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2021
    First version publication date
    27 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PXL008-009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    POXEL SA
    Sponsor organisation address
    259/261 avenue Jean Jaurès, LYON, France, 69007
    Public contact
    Pascale Fouqueray, POXEL S.A., +33 437372010, pascale.fouqueray@poxelpharma.com
    Scientific contact
    Pascale Fouqueray, POXEL S.A., +33 437372010, pascale.fouqueray@poxelpharma.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
    24 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of imeglimin versus placebo on glucose tolerance during a 3-hour Oral Glucose Tolerance Test (OGTT) after 18 weeks of treatment in type 2 diabetic subjects.
    Protection of trial subjects
    Subjects provided their written consent to participate in the study after having been informed about the nature and purpose of the study, participation/termination conditions, and risks and benefits of treatment. The subject information sheet in the local language and prepared in accordance with the ICH GCP guidance was provided by the sponsor for the purpose of obtaining informed consent. The subject’s written informed consent to participate in the study must have been given before any study-related activities were carried out. Whenever important new information became available that was relevant to the subject’s consent, the written subject information sheet and any other written information provided to subjects were revised by the Sponsor and submitted again to the IEC/IRB for review and favourable opinion. The agreed, revised information was forwarded to each subject in the study. The Investigator explained the changes to the previous version and the subject was asked to sign the new version. Subjects were free to discontinue the study at any time without giving their reasons. To overcome the risk to expose T2DM subjects to inappropriate glycaemic levels, some proactive measures were implemented. First, the upper level of HbA1c inclusion criteria at randomisation was limited to 9.5% to avoid highly uncontrolled subjects entering the study. Second, fasting plasma glucose [FPG] was closely monitored throughout the study by the subject (glucometer) and by the Investigator at each visit and whenever necessary. Thresholds were defined following the Food and Drug Administration (FDA) guidance to withdraw subjects whose glycaemic parameters continued to deteriorate during the study period so that rescue therapy could be initiated.
    Background therapy
    		 No background therapy was allowed during the study.
    Evidence for comparator
    		 This mechanistic study was designed to evaluate the efficacy of imeglimin on both fasting and postprandial glycaemic control compared to placebo after 18 weeks of treatment duration, and their respective participation in decreasing HbA1c.
    Actual start date of recruitment
    12 Aug 2013
    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
    Hungary: 26
    Country: Number of subjects enrolled
    Latvia: 19
    Country: Number of subjects enrolled
    Romania: 14
    Worldwide total number of subjects
    59
    EEA total number of subjects
    59
    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)
    50
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Among the 13 sites initiated, this study was conducted at 9 recruiting centres in 3 countries (4 centres in Hungary, 2 centres in Latvia, and 3 centres in Romania). Four sites were inactive (1 centre in Hungary and 3 in Romania). First subject screened: 12Aug2013 - Last subject randomized: 11Jun2014

    Pre-assignment
    Screening details
    		 Subjects were screened within 3 weeks, followed by a 4-week single blind placebo wash-out period.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Imeglimin 1500 mg twice daily
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imeglimin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3×500 mg tablet of imeglimin twice daily for 18 weeks

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 tablets of placebo twice daily for 18 weeks

    Number of subjects in period 1
    		Imeglimin 1500 mg twice daily Placebo
    Started
    30
    29
    Completed
    25
    18
    Not completed
    5
    11
         Consent withdrawn by subject
    4
    -
         Adverse event, non-fatal
    -
    1
         Lack of efficacy
    1
    9
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Imeglimin 1500 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Imeglimin 1500 mg twice daily Placebo Total
    Number of subjects
    		 30 29 59
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.4 ( 8.0 ) 54.3 ( 8.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 13 31
        Male
    		 12 16 28
    BMI
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 32.83 ( 4.95 ) 32.91 ( 4.26 ) -
    HbA1c
    Units: percent
        arithmetic mean (standard deviation)
    		 8.12 ( 0.56 ) 8.14 ( 0.61 ) -
    Fasting Plasma Glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 11.33 ( 2.53 ) 10.25 ( 1.92 ) -

    End points

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    End points reporting groups
    Reporting group title
    Imeglimin 1500 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change in glucose AUC during the 3-hour OGTT from baseline to Week 18 versus placebo

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    End point title
    		 Change in glucose AUC during the 3-hour OGTT from baseline to Week 18 versus placebo
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 18 (End of Treatment)
    End point values
    		 Imeglimin 1500 mg twice daily Placebo
    Number of subjects analysed
    29
    28
    Units: mmol/L·min
        arithmetic mean (standard deviation)
    -800.1 ( 620.0 )
    -257.3 ( 586.2 )
    Statistical analysis title
    		 Imeglimin 1500 mg bid versus Placebo
    Statistical analysis description
    Change from baseline to Week 18 in glucose AUC during the OGTT was assessed with an analysis of covariance (ANCOVA) model, with country and treatment effect fitted as factors and baseline AUC glucose fitted as a covariate. This analysis was performed on the ITT population using LOCF.
    Comparison groups
    Imeglimin 1500 mg twice daily v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -429.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -678
         upper limit
    		 181.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    123.7

    Secondary: Change in HbA1c from baseline to Week 18 versus placebo

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    End point title
    		 Change in HbA1c from baseline to Week 18 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 18 (End of Treatment)
    End point values
    		 Imeglimin 1500 mg twice daily Placebo
    Number of subjects analysed
    29
    28
    Units: percent
        arithmetic mean (standard deviation)
    -0.44 ( 0.76 )
    0.16 ( 1.00 )
    Statistical analysis title
    		 Imeglimin 1500 mg bid versus Placebo
    Statistical analysis description
    Change from baseline to Week 18 was to be assessed with an ANCOVA model with country and treatment effect fitted as factors and baseline HbA1c fitted as a covariate. The analysis was performed on the ITT population using LOCF (when applicable).
    Comparison groups
    Imeglimin 1500 mg twice daily v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.11
         upper limit
    		 -0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.24

    Secondary: Change in Predose FPG from baseline to Week 18 versus placebo

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    End point title
    		 Change in Predose FPG from baseline to Week 18 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 18 (End of Treatment)
    End point values
    		 Imeglimin 1500 mg twice daily Placebo
    Number of subjects analysed
    29
    28
    Units: mmol/L
        arithmetic mean (standard deviation)
    -1.77 ( 2.42 )
    -0.41 ( 1.91 )
    Statistical analysis title
    		 Imeglimin 1500 mg bid versus Placebo
    Statistical analysis description
    Change from baseline to Week 18 was to be assessed with an ANCOVA model with country and treatment effect fitted as factors and baseline predose FPG as a covariate. The analysis was performed on the ITT population using LOCF (when applicable).
    Comparison groups
    Imeglimin 1500 mg twice daily v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.092
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.97
         upper limit
    		 0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.53

    Secondary: Change in Postdose FPG from baseline to Week 18 versus placebo

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    End point title
    		 Change in Postdose FPG from baseline to Week 18 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 18 (End of Treatment)
    End point values
    		 Imeglimin 1500 mg twice daily Placebo
    Number of subjects analysed
    29
    28
    Units: mmol/L
        arithmetic mean (standard deviation)
    -2.26 ( 2.60 )
    -0.53 ( 1.71 )
    Statistical analysis title
    		 Imeglimin 1500 mg bid versus Placebo
    Statistical analysis description
    Change from baseline to Week 18 was to be assessed with an ANCOVA model with country and treatment effect fitted as factors and baseline Postdose FPG fitted as a covariate. The analysis was performed on the ITT population using LOCF (when applicable).
    Comparison groups
    Imeglimin 1500 mg twice daily v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.25
         upper limit
    		 -0.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.52

    Secondary: Change in Rate sensitivity from baseline to Week 18 versus placebo

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    End point title
    		 Change in Rate sensitivity from baseline to Week 18 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 18 (End of Treatment)
    End point values
    		 Imeglimin 1500 mg twice daily Placebo
    Number of subjects analysed
    29
    28
    Units: pmol.m^-2.mM^-1
        arithmetic mean (standard deviation)
    223.20 ( 385.75 )
    39.20 ( 273.54 )
    Statistical analysis title
    		 Imeglimin 1500 mg bid versus Placebo
    Comparison groups
    Imeglimin 1500 mg twice daily v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.051
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    183.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.17
         upper limit
    		 367.67
    Variability estimate
    Standard error of the mean
    Dispersion value
    91.86

    Secondary: Change in insulinogenic index from baseline to Week 18 versus placebo

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    End point title
    		 Change in insulinogenic index from baseline to Week 18 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 18 (End of Treatment)
    End point values
    		 Imeglimin 1500 mg twice daily Placebo
    Number of subjects analysed
    29
    28
    Units: not applicable
        arithmetic mean (standard deviation)
    2.57 ( 2.40 )
    0.69 ( 2.89 )
    Statistical analysis title
    		 Imeglimin 1500 mg bid versus Placebo
    Comparison groups
    Imeglimin 1500 mg twice daily v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 3.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.77

    Secondary: Change in glucose sensitivity from baseline to Week 18 versus placebo

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    End point title
    		 Change in glucose sensitivity from baseline to Week 18 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 18 (End of Treatment)
    End point values
    		 Imeglimin 1500 mg twice daily Placebo
    Number of subjects analysed
    29
    28
    Units: pmol.min^-1.m^-2.mM^-1
        arithmetic mean (standard deviation)
    14.98 ( 18.50 )
    0.96 ( 13.22 )
    Statistical analysis title
    		 Imeglimin 1500 mg bid versus Placebo
    Comparison groups
    Imeglimin 1500 mg twice daily v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.2
         upper limit
    		 20.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.01

    Secondary: Change in Stumvoll index from baseline to Week 18 versus placebo

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    End point title
    		 Change in Stumvoll index from baseline to Week 18 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 18 (End of Treatment)
    End point values
    		 Imeglimin 1500 mg twice daily Placebo
    Number of subjects analysed
    29
    28
    Units: No unit
        arithmetic mean (standard deviation)
    0.0188 ( 0.0139 )
    0.0056 ( 0.0150 )
    Statistical analysis title
    		 Imeglimin 1500 mg bid versus Placebo
    Comparison groups
    Imeglimin 1500 mg twice daily v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0133
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.0058
         upper limit
    		 0.0208
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0037

    Secondary: Change in incremental AUC 0-180 C-Peptide / incremental AUC 0-180 Glucose from baseline to Week 18 versus placebo

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    End point title
    		 Change in incremental AUC 0-180 C-Peptide / incremental AUC 0-180 Glucose from baseline to Week 18 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 18
    End point values
    		 Imeglimin 1500 mg twice daily Placebo
    Number of subjects analysed
    29
    28
    Units: No unit
        arithmetic mean (standard deviation)
    0.119 ( 0.132 )
    0.028 ( 0.058 )
    Statistical analysis title
    		 Imeglimin 1500 mg bid versus Placebo
    Comparison groups
    Imeglimin 1500 mg twice daily v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.091
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.033
         upper limit
    		 0.149
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.029

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Informed Consent Form signature up to to the end of the follow-up period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Imeglimin 1500 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Imeglimin 1500 mg twice daily Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Meigs' syndrome
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Imeglimin 1500 mg twice daily Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 30 (20.00%)
    14 / 29 (48.28%)
    Cardiac disorders
    Left ventricular hypertrophy
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Diabetic neuropathy
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    5 / 30 (16.67%)
    12 / 29 (41.38%)
         occurrences all number
    7
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Dec 2013
    The purpose of this amendment was: - To change 1 study procedure (OGTT at 6 weeks became optional). - To change 1 inclusion criteria (broaden HbA1c eligible lower range, without affecting subject’s safety and efficacy assessment). - To clarify the CGM procedure. - To correct inconsistencies in the protocol. - To include administrative changes.
    29 Apr 2014
    The purpose of this amendment was: - To include administrative change concerning the laboratory assigned for bioanalysis. - To extend the study period due to recruitment being slower than expected. - To update the title and contact details of the Sponsor’s Medical Responsible Person.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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