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Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01456195
First received: October 18, 2011
Last updated: March 4, 2016
Last verified: March 2016
Results First Received: April 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Placebo
Drug: Fasiglifam

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
Fasiglifam 25 mg Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 50 mg Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.

Participant Flow:   Overall Study
    Placebo   Fasiglifam 25 mg   Fasiglifam 50 mg
STARTED   143   137   141 
COMPLETED   132   127   127 
NOT COMPLETED   11   10   14 
Pretreatment Event/Adverse Event                1                4                1 
Lost to Follow-up                3                1                3 
Voluntary Withdrawal                5                3                7 
Lack of Efficacy                0                1                0 
Other Reasons                2                1                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
Fasiglifam 25 mg Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 50 mg Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Fasiglifam 25 mg   Fasiglifam 50 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 143   137   141   421 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.1  (10.61)   53.2  (11.31)   54.2  (10.57)   53.5  (10.82) 
Age, Customized 
[Units: Participants]
       
< 65 years   124   114   114   352 
≥ 65 years   19   23   27   69 
Gender 
[Units: Participants]
       
Female   68   65   73   206 
Male   75   72   68   215 
Race/Ethnicity, Customized 
[Units: Participants]
       
Hispanic or Latino   22   25   22   69 
Non-Hispanic or Latino   39   36   41   116 
Not Applicable   82   76   78   236 
Race/Ethnicity, Customized 
[Units: Participants]
       
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: Participants]
       
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 
Height 
[Units: Cm]
Mean (Standard Deviation)
 166.3  (10.63)   165.3  (11.17)   166.7  (11.11)   166.1  (10.96) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 89.66  (18.858)   89.24  (18.541)   89.43  (18.706)   89.45  (18.660) 
Baseline Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 32.33  (5.714)   32.50  (5.256)   32.05  (5.369)   32.29  (5.443) 
Baseline BMI Group 
[Units: Participants]
       
< 30 kg/m^2   54   49   56   159 
≥ 30 kg/m^2   89   88   85   262 
Baseline HbA1c Category 
[Units: Participants]
       
< 8.5%   102   91   102   295 
≥ 8.5 %   41   46   39   126 
Smoking Classification 
[Units: Participants]
       
Never smoked   99   98   97   294 
Current smoker   21   17   23   61 
Ex-smoker   23   22   21   66 
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 3.048  (3.164)   3.290  (3.447)   3.700  (4.560)   3.345  (3.773) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Incidence of HbA1c <7%   [ Time Frame: Week 24 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose   [ Time Frame: Baseline and Week 24 ]

4.  Secondary:   Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT)   [ Time Frame: Baseline and Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director, Clinical Science
Organization: Takeda
phone: +1-877-825-3327
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01456195     History of Changes
Other Study ID Numbers: TAK-875_301
2011-002741-35 ( EudraCT Number )
U1111-1124-2154 ( Registry Identifier: WHO )
Study First Received: October 18, 2011
Results First Received: April 8, 2015
Last Updated: March 4, 2016
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Mexico: National Institute of Public Health, Health Secretariat
Guatemala: Ministry of Public Health and Social Assistance
Ukraine: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Slovakia: State Institute for Drug Control
Hungary: National Institute of Pharmacy