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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 mg and 50 mg Compared with Placebo in Subjects with Type 2 Diabetes

    Summary
    EudraCT number
    		 2011-002741-35
    Trial protocol
    		 SK   HU   BG  
    Global end of trial date
    30 Jul 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    TAK-875_301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01456195
    WHO universal trial number (UTN)
    		 U1111-1124-2154
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    One Takeda Parkway, Deerfield, United States, 60015
    Public contact
    Medical Director, Clinical Science, Takeda , +1 877-825-3327, trialdisclosures@takeda.com
    Scientific contact
    Medical Director, Clinical Science, Takeda , +1 877-825-3327, trialdisclosures@takeda.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
    25 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jun 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 72
    Country: Number of subjects enrolled
    Bulgaria: 24
    Country: Number of subjects enrolled
    Hungary: 23
    Country: Number of subjects enrolled
    Argentina: 30
    Country: Number of subjects enrolled
    Guatemala: 42
    Country: Number of subjects enrolled
    Mexico: 18
    Country: Number of subjects enrolled
    Ukraine: 28
    Country: Number of subjects enrolled
    United States: 184
    Worldwide total number of subjects
    421
    EEA total number of subjects
    119
    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)
    352
    From 65 to 84 years
    69
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 109 investigative sites in United States, Bulgaria, Argentina, Ukraine, Guatemala, Slovakia, Mexico and Hungary from 02 November 2011 to 30 July 2013.

    Pre-assignment
    Screening details
    		 Participants with a diagnosis of Type 2 Diabetes Mellitis were enrolled equally in 1 of 3 treatment groups, once a day placebo, 25 mg fasiglifam or 50 mg fasiglifam.

    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
    		 Investigator, Monitor, Data analyst, Carer, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Fasiglifam placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.

    Arm title
    		 Fasiglifam 25 mg
    Arm description
    		 Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasiglifam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.

    Arm title
    		 Fasiglifam 50 mg
    Arm description
    		 Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasiglifam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Fasiglifam 25 or 50 mg, tablets, orally, once daily for up to 24 weeks.

    Number of subjects in period 1
    		Placebo Fasiglifam 25 mg Fasiglifam 50 mg
    Started
    143
    137
    141
    Completed
    131
    127
    125
    Not completed
    12
    10
    16
         Pretreatment Event/Adverse Event
    1
    4
    -
         Voluntary Withdrawal
    5
    3
    8
         Other Reasons
    3
    -
    -
         Other
    -
    1
    4
         Lost to follow-up
    3
    1
    4
         Lack of efficacy
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.

    Reporting group title
    Fasiglifam 25 mg
    Reporting group description
    		 Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.

    Reporting group title
    Fasiglifam 50 mg
    Reporting group description
    		 Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.

    Reporting group values
    		 Placebo Fasiglifam 25 mg Fasiglifam 50 mg Total
    Number of subjects
    		 143 137 141 421
    Age categorical
    Units: Subjects
        < 65 years
    		 124 114 114 352
        ≥ 65 years
    		 19 23 27 69
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.1 ( 10.61 ) 53.2 ( 11.31 ) 54.2 ( 10.57 ) -
    Gender categorical
    Units: Subjects
        Female
    		 68 65 73 206
        Male
    		 75 72 68 215
    Race/Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 22 25 22 69
        Non-Hispanic or Latino
    		 39 36 41 116
        Not Applicable
    		 82 76 78 236
    Race/Ethnicity
    Units: Subjects
        American Indian or Alaska Native
    		 19 15 16 50
        Asian
    		 5 4 0 9
        Black or African American
    		 8 6 12 26
        White
    		 110 112 113 335
        Multiracial
    		 1 0 0 1
    Region of Enrollment
    Units: Subjects
        Argentina
    		 10 10 10 30
        Bulgaria
    		 8 7 9 24
        Guatemala
    		 15 14 13 42
        Hungary
    		 8 7 8 23
        Mexico
    		 6 5 7 18
        Slovakia
    		 24 24 24 72
        Ukraine
    		 11 9 8 28
        United States
    		 61 61 62 184
    Baseline BMI Group
    Units: Subjects
        < 30 kg/m^2
    		 54 49 56 159
        ≥ 30 kg/m^2
    		 89 88 85 262
    Baseline HbA1c Category
    Units: Subjects
        < 8.5%
    		 102 91 102 295
        ≥ 8.5 %
    		 41 46 39 126
    Smoking Classification
    Units: Subjects
        Never smoked
    		 99 98 97 294
        Current smoker
    		 21 17 23 61
        Ex-smoker
    		 23 22 21 66
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 166.3 ( 10.63 ) 165.3 ( 11.17 ) 166.7 ( 11.11 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 89.66 ( 18.858 ) 89.24 ( 18.541 ) 89.43 ( 18.706 ) -
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 32.33 ( 5.714 ) 32.5 ( 5.256 ) 32.05 ( 5.369 ) -
    Duration of Diabetes
    Units: years
        arithmetic mean (standard deviation)
    		 3.048 ( 3.164 ) 3.29 ( 3.447 ) 3.7 ( 4.56 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.

    Reporting group title
    Fasiglifam 25 mg
    Reporting group description
    		 Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.

    Reporting group title
    Fasiglifam 50 mg
    Reporting group description
    		 Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.

    Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c)

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    End point title
    		 Change From Baseline in Glycosylated Hemoglobin (HbA1c)
    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. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo Fasiglifam 25 mg Fasiglifam 50 mg
    Number of subjects analysed
    101
    119
    116
    Units: percent
        least squares mean (standard error)
    -0.17 ( 0.09 )
    -0.65 ( 0.087 )
    -0.93 ( 0.087 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Fasiglifam 25 mg
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 -0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.122
    Notes
    [1] - MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Fasiglifam 50 mg
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 -0.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.122
    Notes
    [2] - MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.

    Secondary: Incidence of HbA1c <7%

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    End point title
    		 Incidence of HbA1c <7%
    End point description
    The incidence (percentage of participants with) HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of less than seven percent for target glycemic control at Week 24.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Fasiglifam 25 mg Fasiglifam 50 mg
    Number of subjects analysed
    137
    136
    139
    Units: percentage of participants
        number (not applicable)
    24.1
    36
    50.4
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Fasiglifam 25 mg
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01 [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 3.79
    Notes
    [3] - P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Fasiglifam 50 mg
    Number of subjects included in analysis
    276
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.48
         upper limit
    		 7.82
    Notes
    [4] - P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.

    Secondary: Change From Baseline in Fasting Plasma Glucose

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose
    End point description
    The change between the fasting plasma glucose value collected at Week 24 relative to Baseline measured in milligrams per deciliter (mg/dL). A MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo Fasiglifam 25 mg Fasiglifam 50 mg
    Number of subjects analysed
    101
    116
    116
    Units: mg/dL
        least squares mean (standard error)
    1.4 ( 3.45 )
    -12.3 ( 3.29 )
    -20.9 ( 3.26 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Fasiglifam 25 mg
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003 [5]
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -13.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.7
         upper limit
    		 -4.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.59
    Notes
    [5] - Mixed Model Repeated Measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Fasiglifam 50 mg
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -22.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.4
         upper limit
    		 -13.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.6
    Notes
    [6] - MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.

    Secondary: Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT)

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    End point title
    		 Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT)
    End point description
    The change between the value of glucose after a meal, measured by the meal tolerance test collected at Week 24 relative to Baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal measured in millimoles per liter (mmol/L). An Analysis of Covariance (ANCOVA) model with treatment and country as fixed factors and Baseline value as covariate was used for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo Fasiglifam 25 mg Fasiglifam 50 mg
    Number of subjects analysed
    18
    20
    18
    Units: mmol/L
        least squares mean (standard error)
    -0.6 ( 12.47 )
    -29.4 ( 11.82 )
    -30.6 ( 12.5 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Fasiglifam 25 mg
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1 [7]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -28.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -63.2
         upper limit
    		 5.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    17.17
    Notes
    [7] - ANCOVA model with treatment and country as fixed factors and baseline value as covariate.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Fasiglifam 50 mg
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.096 [8]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -65.5
         upper limit
    		 5.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    17.7
    Notes
    [8] - ANCOVA model with treatment and country as fixed factors and baseline value as covariate.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Randomization to 30 days past last dose (up to 219 days)
    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
    16.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.

    Reporting group title
    Fasiglifam 25 mg
    Reporting group description
    		 Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.

    Reporting group title
    Fasiglifam 50 mg
    Reporting group description
    		 Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.

    Serious adverse events
    		 Placebo Fasiglifam 25 mg Fasiglifam 50 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 143 (2.10%)
    3 / 137 (2.19%)
    3 / 141 (2.13%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 137 (0.00%)
    1 / 141 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    0 / 143 (0.00%)
    1 / 137 (0.73%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 137 (0.00%)
    1 / 141 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 143 (0.00%)
    1 / 137 (0.73%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 143 (0.70%)
    0 / 137 (0.00%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 143 (0.00%)
    0 / 137 (0.00%)
    1 / 141 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 143 (0.70%)
    0 / 137 (0.00%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 143 (0.70%)
    0 / 137 (0.00%)
    1 / 141 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 143 (0.00%)
    1 / 137 (0.73%)
    0 / 141 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Fasiglifam 25 mg Fasiglifam 50 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 143 (6.29%)
    6 / 137 (4.38%)
    7 / 141 (4.96%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 143 (6.29%)
    6 / 137 (4.38%)
    7 / 141 (4.96%)
         occurrences all number
    10
    6
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Sep 2011
    Amendment 1: 13 Sept 2011: -Meal Tolerance Test (MTT) was optional for participants. - The blood volume for the MTT and the total blood volume for the study were updated. - Text was added to indicate that abnormal LFT results would be recorded on the LFT increases page of the eCRF.. - The exclusion period for investigational medications other than antidiabetic medications was changed.
    08 May 2012
    Amendment 2: 08 May 2012: The primary purpose amendment 2 was to update inclusion and exclusion criteria, excluded medications, statistical analysis section, and safety information including contraceptive language, removal of partner pregnancy, and special interest adverse events.

    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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