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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 50mg Compared With Placebo as an Add-On to Glimepiride in Subjects With Type 2 Diabetes

    Summary
    EudraCT number
    		 2013-000007-17
    Trial protocol
    		 SK   HU   BG   PL  
    Global end of trial date
    11 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Mar 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TAK-875_309
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01829477
    WHO universal trial number (UTN)
    		 U1111-1138-8680
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    61 Aldwych, London, United Kingdom, WC2B 4AE
    Public contact
    Program Manager, Takeda Development Centre Europe Ltd., 0044 0203116 8000, clinicaloperations@tgrd.com
    Scientific contact
    Program Manager, Takeda Development Centre Europe Ltd., 0044 0203116 8000, clinicaloperations@tgrd.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
    08 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of TAK-875 compared to placebo on glycemic control as assessed by glycosylated hemoglobin (HbA1c) change from baseline over a 24-week treatment period when used as an add-on to glimepiride in addition to diet and exercise.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Apr 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
    Slovakia: 11
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    United States: 17
    Country: Number of subjects enrolled
    Canada: 1
    Worldwide total number of subjects
    33
    EEA total number of subjects
    15
    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)
    22
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects took part in the study at 18 investigative sites in the United States, Slovakia, Bulgaria, Hungary, and Canada from 19 April 2013 to 11 February 2014.

    Pre-assignment
    Screening details
    		 Subjects with a historical diagnosis of type 2 diabetes mellitus (T2DM), inadequately controlled when treated with only diet, exercise and a sulfonlyurea for at least 12 weeks prior to screening, were enrolled in 1 of 2 treatment groups: placebo; fasiglifam 50 milligram (mg).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
    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
    Fasiglifam placebo-matching tablet, orally, once daily for up to 24 weeks.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.

    Arm title
    		 Fasiglifam 50 mg
    Arm description
    		 Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasiglifam
    Investigational medicinal product code
    TAK-875
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Fasiglifam 50 mg, tablet, orally, once daily for up to 24 weeks.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.

    Number of subjects in period 1
    		Placebo Fasiglifam 50 mg
    Started
    17
    16
    Completed
    1
    1
    Not completed
    16
    15
         Consent withdrawn by subject
    1
    -
         'Study Terminated by Sponsor '
    15
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.

    Reporting group title
    Fasiglifam 50 mg
    Reporting group description
    		 Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.

    Reporting group values
    		 Placebo Fasiglifam 50 mg Total
    Number of subjects
    		 17 16 33
    Age categorical
    Units: Subjects
        18-64 years
    		 10 12 22
        65-84 years
    		 7 4 11
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.8 ± 11.82 58.5 ± 9.7 -
    Gender categorical
    Units: Subjects
        Female
    		 7 6 13
        Male
    		 10 10 20
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    		 3 1 4
        White
    		 14 15 29
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 6 5 11
        Not Hispanic or Latino
    		 5 2 7
        Not Applicable
    		 6 9 15
    Baseline Glycosylated Hemoglobin (HbA1c) Category
    Units: Subjects
        Less Than (<) 8.5 Percent (%)
    		 10 11 21
        Greater Than or Equal to (>=) 8.5%
    		 7 5 12

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.

    Reporting group title
    Fasiglifam 50 mg
    Reporting group description
    		 Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.

    Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

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    End point title
    		 Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [1]
    End point description
    The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline. In accordance with the Statistical Analysis Plan (SAP), due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.
    End point type
    Primary
    End point timeframe
    Baseline and 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: In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.
    End point values
    		 Placebo Fasiglifam 50 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: percentage of glycosylated hemoglobin
        least squares mean (standard error)
    ±
    ±
    Notes
    [2] - Limited enrollment at the time of study termination.
    [3] - Limited enrollment at the time of study termination.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HbA1c <7 % at Week 24

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    End point title
    		 Percentage of Subjects With HbA1c <7 % at Week 24
    End point description
    In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Fasiglifam 50 mg
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [4] - Limited enrollment at the time of study termination.
    [5] - Limited enrollment at the time of study termination.
    No statistical analyses for this end point

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

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
    End point description
    The change between the fasting plasma glucose value collected at week 24 or final visit relative to baseline. In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo Fasiglifam 50 mg
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: millimole per liter (mmol/L)
        least squares mean (standard error)
    ±
    ±
    Notes
    [6] - Limited enrollment at the time of study termination.
    [7] - Limited enrollment at the time of study termination.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug.
    Adverse event reporting additional description
    At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.

    Reporting group title
    Fasiglifam 50 mg
    Reporting group description
    		 Fasiglifam 50 mg, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.

    Serious adverse events
    		 Placebo Fasiglifam 50 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Fasiglifam 50 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 17 (29.41%)
    3 / 16 (18.75%)
    Investigations
    Electrocardiogram (ECG) abnormal
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Cardiac disorders
    Myocardial ischemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Eye disorders
    Episcleritis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Nasal polyps
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperuricemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0

    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? Yes
    Date
    Interruption
    Restart date
    26 Dec 2013
    Due to specific liver-related safety signals that emerged in the phase 3 program, Takeda concluded that based on all available information, the benefits of treating subjects with fasiglifam do not outweigh the potential risks, thus Takeda decided voluntarily to terminate all development activities for fasiglifam based on liver safety concerns.
    -

    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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