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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  
Number of Participants  
[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