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    Clinical Trial Results:
    A Phase 2, 4 Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Peripheral Neuropathy

    Summary
    EudraCT number
    		 2012-002320-33
    Trial protocol
    		 GB   DE   CZ  
    Global end of trial date
    23 Jul 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    12 Mar 2016
    First version publication date
    24 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • New data added to full data set
    Public contact name changed to Amol Pendse (Amol.Pendse@glenmarkpharma.com)

    Trial information

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    Trial identification
    Sponsor protocol code
    GRC 17536-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Glenmark Pharmaceuticals S.A
    Sponsor organisation address
    Chemin de la Combeta, 5, Ch-2300 , La Chaux-de-fonds, Switzerland,
    Public contact
    Amol Pendse, Glenmark Pharmaceuticals S.A, +91 2267720000, Amol.Pendse@glenmarkpharma.com
    Scientific contact
    Dr. Monika Tandon, Glenmark Pharmaceuticals S.A, +91 2267720000, Monika.Tandon@glenmarkpharma.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
    04 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of GRC 17536 in the treatment of pain associated with diabetic peripheral neuropathy
    Protection of trial subjects
    In the interests of subject safety and acceptable standards of medical care the Investigator was permitted to prescribe treatment(s) at his/her discretion. All treatments taken by the subjects during the study were recorded in the subjects’ CRF (medication, dose, treatment duration and indication).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Dec 2012
    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
    Czech Republic: 18
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    India: 114
    Worldwide total number of subjects
    138
    EEA total number of subjects
    24
    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)
    126
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of first patient enrollment: 20 Dec 2012 Date of last patient completed: 23 Jul 2014 Countries: Czech Republic, Germany, India

    Pre-assignment
    Screening details
    		 Screening period:2-week screening and washout period, Patients with painful diabetic peripheral neuropathy

    Period 1
    Period 1 title
    GRC 17536 Vs Placebo (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GRC 17536 250 mg
    Arm description
    		 GRC 17536 250 mg administered BID orally for 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GRC 17536 250 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    GRC 17536 250 mg administered orally, BID, for 28 days.

    Arm title
    		 Placebo
    Arm description
    		 Placebo to match investigational product, administered BID orally for 28 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered BID orally for 28 days.

    Number of subjects in period 1
    		GRC 17536 250 mg Placebo
    Started
    72
    66
    Completed
    64
    61
    Not completed
    8
    5
         Physician decision
    2
    -
         Adverse event, non-fatal
    1
    -
         Protocol deviation
    1
    -
         Subject withdrawal
    4
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GRC 17536 250 mg
    Reporting group description
    		 GRC 17536 250 mg administered BID orally for 28 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to match investigational product, administered BID orally for 28 days.

    Reporting group values
    		 GRC 17536 250 mg Placebo Total
    Number of subjects
    		 72 66 138
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        Adults (18-75 years)
    		 72 66 138
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.07 ( 8.57 ) 56.11 ( 8.53 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 23 42
        Male
    		 53 43 96
    Subject analysis sets

    Subject analysis set title
    GRC 17536 250 mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    1. Intent-to-Treat (ITT) population was defined as all randomized subjects with non-missing API score at baseline, who received at least 1 dose of randomized study medication, and had an API score from at least 1 post-baseline visit (inclusive of 4 days of data). 2. Exploratory analysis was performed in the non-denervation group with moderate to severe pain [ITT population excluding subjects with a baseline mean 24-hour API score <5 based on NRS and excluding subjects with cold detection threshold (CDT) <18°C and/or warm detection threshold (WDT) >49°C]

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    1. Intent-to-Treat (ITT) population was defined as all randomized subjects with non-missing API score at baseline, who received at least 1 dose of randomized study medication, and had an API score from at least 1 post-baseline visit (inclusive of 4 days of data). 2. Exploratory analysis was performed in the non-denervation group with moderate to severe pain [ITT population excluding subjects with a baseline mean 24-hour API score <5 based on NRS and excluding subjects with cold detection threshold (CDT) <18°C and/or warm detection threshold (WDT) >49°C]

    Subject analysis sets values
    		 GRC 17536 250 mg Placebo
    Number of subjects
    70
    66
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
        Adults (18-75 years)
    70
    66
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.03 ( 9.46 )
    57.29 ( 7.5 )
    Gender categorical
    Units: Subjects
        Female
    19
    23
        Male
    51
    43

    End points

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    End points reporting groups
    Reporting group title
    GRC 17536 250 mg
    Reporting group description
    		 GRC 17536 250 mg administered BID orally for 28 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to match investigational product, administered BID orally for 28 days.

    Subject analysis set title
    GRC 17536 250 mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    1. Intent-to-Treat (ITT) population was defined as all randomized subjects with non-missing API score at baseline, who received at least 1 dose of randomized study medication, and had an API score from at least 1 post-baseline visit (inclusive of 4 days of data). 2. Exploratory analysis was performed in the non-denervation group with moderate to severe pain [ITT population excluding subjects with a baseline mean 24-hour API score <5 based on NRS and excluding subjects with cold detection threshold (CDT) <18°C and/or warm detection threshold (WDT) >49°C]

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    1. Intent-to-Treat (ITT) population was defined as all randomized subjects with non-missing API score at baseline, who received at least 1 dose of randomized study medication, and had an API score from at least 1 post-baseline visit (inclusive of 4 days of data). 2. Exploratory analysis was performed in the non-denervation group with moderate to severe pain [ITT population excluding subjects with a baseline mean 24-hour API score <5 based on NRS and excluding subjects with cold detection threshold (CDT) <18°C and/or warm detection threshold (WDT) >49°C]

    Primary: Change from baseline to end of treatment (week 4) in the mean 24-hour average pain intensity (API) score

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    End point title
    		 Change from baseline to end of treatment (week 4) in the mean 24-hour average pain intensity (API) score
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    		 GRC 17536 250 mg Placebo
    Number of subjects analysed
    70
    66
    Units: number
        least squares mean (confidence interval 95%)
    -1.94 (-2.32 to -1.56)
    -1.68 (-2.07 to -1.29)
    Statistical analysis title
    		 Statistical Analysis of Primary Efficacy Endpoint
    Comparison groups
    Placebo v GRC 17536 250 mg
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.81
         upper limit
    		 0.28
    Notes
    [1] - ANCOVA

    Other pre-specified: Exploratory Analysis – Change from baseline to end of treatment (week 4) in the mean 24-hour average pain intensity (API) score (in non-denervation group with moderate to severe pain)

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    End point title
    		 Exploratory Analysis – Change from baseline to end of treatment (week 4) in the mean 24-hour average pain intensity (API) score (in non-denervation group with moderate to severe pain)
    End point description
    Change from baseline to end of treatment (week 4) in the mean 24-hour average pain intensity (API) score in the non-denervation group with moderate to severe pain (ITT population excluding subjects with a baseline mean 24-hour API score <5 based on NRS and excluding subjects with CDT <18°C and/or WDT >49°C)
    End point type
    Other pre-specified
    End point timeframe
    Week 4
    End point values
    		 GRC 17536 250 mg Placebo
    Number of subjects analysed
    30
    35
    Units: Number
        least squares mean (confidence interval 95%)
    -2.48 (-3.01 to -1.95)
    -1.52 (-2 to -1.04)
    Statistical analysis title
    		 Exploratory Analysis
    Comparison groups
    GRC 17536 250 mg v Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.009
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.68
         upper limit
    		 -0.24

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    9 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered BID orally for 28 days.

    Reporting group title
    GRC 17536 250 mg
    Reporting group description
    		 GRC 17536 250 mg administered BID orally for 28 days.

    Serious adverse events
    		 Placebo GRC 17536 250 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo GRC 17536 250 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 66 (37.88%)
    23 / 72 (31.94%)
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Local swelling
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 72 (2.78%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 72 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Throat irritation
         subjects affected / exposed
    3 / 66 (4.55%)
    1 / 72 (1.39%)
         occurrences all number
    3
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 72 (1.39%)
         occurrences all number
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 72 (1.39%)
         occurrences all number
    1
    1
    Blood creatine phosphokinase abnormal
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 66 (4.55%)
    1 / 72 (1.39%)
         occurrences all number
    3
    1
    Blood potassium increased
         subjects affected / exposed
    2 / 66 (3.03%)
    2 / 72 (2.78%)
         occurrences all number
    2
    2
    Blood sodium decreased
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Urine analysis abnormal
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 72 (1.39%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    1 / 66 (1.52%)
    2 / 72 (2.78%)
         occurrences all number
    1
    2
    Headache
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Hypogeusia
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Leukocytosis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Neutrophilia
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Dry eye
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 72 (1.39%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 72 (2.78%)
         occurrences all number
    0
    2
    Dyspepsia
         subjects affected / exposed
    3 / 66 (4.55%)
    2 / 72 (2.78%)
         occurrences all number
    3
    2
    Dysphagia
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Gastric ulcer
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Hyperchlorhydria
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 72 (1.39%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Skin hypopigmentation
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Diabetic nephropathy
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Glycosuria
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Proteinuria
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 72 (0.00%)
         occurrences all number
    2
    0
    Renal impairment
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 72 (1.39%)
         occurrences all number
    1
    1
    Pain in extremity
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Dyslipidaemia
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    2 / 66 (3.03%)
    2 / 72 (2.78%)
         occurrences all number
    2
    2
    Hypoglycaemia
         subjects affected / exposed
    3 / 66 (4.55%)
    0 / 72 (0.00%)
         occurrences all number
    3
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    Impaired fasting glucose
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Oct 2012
    Following change was made in the Protocol Version 3.0 (Germany only), 25 Oct 2012: -ALT/AST based treatment stopping rule.
    22 Feb 2013
    Following changes were made in the Protocol Version 5.0 (Germany only), 22 Feb 2013: - Corrected QT (QTc) interval of >430 msec in males or >450 msec in females according to the method described by Pfeufer et al. - Change in the baseline 24-hour average daily pain intensity score at study entry from ≥5 and < 9 to ≥4 and < 9.
    26 Feb 2013
    Following changes were made in the Protocol Version 4.0, 26 Feb 2013: - Corrected QT (QTc) interval of >430 msec in males or >450 msec in females according to the method described by Pfeufer et al. - Change in the baseline 24-hour average daily pain intensity score at study entry from ≥5 and < 9 to ≥4 and < 9.
    01 Mar 2013
    Following changes were made in the Protocol Version 4.0 (India only), 01 Mar 2013: - Corrected QT (QTc) interval of >430 msec in males or >450 msec in females according to the method described by Pfeufer et al. - Change in the baseline 24-hour average daily pain intensity score at study entry from ≥5 and < 9 to ≥4 and < 9.

    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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