Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 2 Randomized, Placebo-Controlled, Double-Blind Parallel-Group, Multicenter Study to Evaluate the Glycemic Effects and Safety of Fasiglifam 25 mg Twice Daily and 50 mg Once Daily on Glycemic Control in Subjects with Type 2 Diabetes

    Summary
    EudraCT number
    		 2013-000886-35
    Trial protocol
    		 SK  
    Global end of trial date
    31 Jan 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

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TAK-875_203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01982253
    WHO universal trial number (UTN)
    		 U1111-1146-1263
    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
    28 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of fasiglifam 25 mg BID and fasiglifam 50 mg QD on glycemic control over a 12-week treatment period in subjects with type 2 diabetes mellitus (T2DM) who are inadequately controlled on diet and exercise alone.
    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
    21 Oct 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
    United States: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    0
    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)
    9
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects took part in the study at 5 investigative sites in the United States from 21 October 2013 to 31 January 2014.

    Pre-assignment
    Screening details
    		 Subjects with a historical diagnosis of T2DM and inadequate glycemic control on diet and exercise alone were enrolled in 1 of 3 treatment groups, placebo, fasiglifam 25 milligram (mg) twice daily (BID) and fasiglifam 50 mg once daily (QD).

    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 tablets, orally, twice daily for up to Day 47.
    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 tablets, orally, twice daily for up to Day 47.

    Arm title
    		 Fasiglifam 25 mg BID
    Arm description
    		 Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
    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, twice daily for up to Day 47.

    Arm title
    		 Fasiglifam 50 mg QD
    Arm description
    		 Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
    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 50 mg tablet, orally, once daily for up to Day 47.

    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 Day 47.

    Number of subjects in period 1
    		Placebo Fasiglifam 25 mg BID Fasiglifam 50 mg QD
    Started
    2
    4
    4
    Completed
    0
    0
    0
    Not completed
    2
    4
    4
         Consent withdrawn by subject
    1
    -
    -
         Study terminated by sponsor
    1
    4
    4

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.

    Reporting group title
    Fasiglifam 25 mg BID
    Reporting group description
    		 Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.

    Reporting group title
    Fasiglifam 50 mg QD
    Reporting group description
    		 Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.

    Reporting group values
    		 Placebo Fasiglifam 25 mg BID Fasiglifam 50 mg QD Total
    Number of subjects
    		 2 4 4 10
    Age categorical
    Units: Subjects
        18 to 64 years
    		 1 4 4 9
        65 to 84 years
    		 1 0 0 1
    Gender categorical
    Units: Subjects
        Female
    		 1 3 2 6
        Male
    		 1 1 2 4
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    		 1 0 1 2
        White
    		 1 4 3 8
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 1 3 1 5
        Not Hispanic or Latino
    		 1 1 3 5
    Glycosylated Haemoglobin (HbA1c)
    Units: Subjects
        Less than (<) 8.5 percent (%)
    		 2 2 3 7
        Greater than or equal to (≥) 8.5 percent (%)
    		 0 2 1 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.

    Reporting group title
    Fasiglifam 25 mg BID
    Reporting group description
    		 Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.

    Reporting group title
    Fasiglifam 50 mg QD
    Reporting group description
    		 Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.

    Primary: Change From Baseline in HbA1c at Week 12

    		 Close Top of page
    End point title
    		 Change From Baseline in HbA1c at Week 12 [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 12 or final visit 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 12
    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 25 mg BID Fasiglifam 50 mg QD
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    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. 
    [4] - 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 12

    		 Close Top of page
    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
    End point description
    The change between the FPG value collected at week 12 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 12
    End point values
    		 Placebo Fasiglifam 25 mg BID Fasiglifam 50 mg QD
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: millimole per liter (mmol/L)
        least squares mean (standard error)
    ±
    ±
    ±
    Notes
    [5] - Limited enrollment at the time of study termination. 
    [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

    		 Close Top of page
    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-blind 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 subject 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 tablets, orally, twice daily for up to Day 47.

    Reporting group title
    Fasiglifam 25 mg BID
    Reporting group description
    		 Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.

    Reporting group title
    Fasiglifam 50 mg QD
    Reporting group description
    		 Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.

    Serious adverse events
    		 Placebo Fasiglifam 25 mg BID Fasiglifam 50 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Fasiglifam 25 mg BID Fasiglifam 50 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 4 (25.00%)
    2 / 4 (50.00%)
    General disorders and administration site conditions
    Abdominal distension
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal hernia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Skin fissures
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed Apr 24 18:53:13 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA