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Comparison of TAK-875 to Placebo as an Add-on to Glimepiride in Patients With Type 2 Diabetes

This study has been terminated.
(Due to potential concerns about liver safety (See Detailed Description))
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01829477
First received: April 9, 2013
Last updated: April 24, 2016
Last verified: April 2016
Results First Received: July 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: TAK-875
Drug: TAK-875 Placebo
Drug: Glimepiride

  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 18 investigative sites in the United States, Slovakia, Bulgaria, Hungary, and Canada from 19 April 2013 to 11 February 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a historical diagnosis of type 2 diabetes mellitus (T2DM), inadequately controlled when treated with only diet, exercise and a sulfonylurea for at least 12 weeks prior to screening, were enrolled in 1 of 2 treatment groups: placebo; fasiglifam 50 milligram (mg).

Reporting Groups
  Description
Placebo Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
Fasiglifam 50 mg Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.

Participant Flow:   Overall Study
    Placebo     Fasiglifam 50 mg  
STARTED     17     16  
COMPLETED     1     1  
NOT COMPLETED     16     15  
Study Terminated by Sponsor                 15                 15  
Withdrawal by Subject                 1                 0  



  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.
Analysis population included all randomized participants.

Reporting Groups
  Description
Placebo Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
Fasiglifam 50 mg Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Fasiglifam 50 mg     Total  
Number of Participants  
[units: participants]
  17     16     33  
Age, Customized  
[units: Participants]
     
18 to 64 years     10     12     22  
65 to 84 years     7     4     11  
Gender  
[units: participants]
     
Female     7     6     13  
Male     10     10     20  
Race/Ethnicity, Customized  
[units: participants]
     
Black or African American     3     1     4  
White     14     15     29  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     6     5     11  
Not Hispanic or Latino     5     2     7  
Not Applicable     6     9     15  
Baseline Glycosylated Hemoglobin (HbA1c) Category  
[units: participants]
     
Less Than (<) 8.5 Percent (%)     10     11     21  
Greater Than or Equal to (>=) 8.5%     7     5     12  



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

2.  Secondary:   Percentage of Participants With HbA1c <7 % at Week 24.   [ Time Frame: Week 24 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24   [ 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
Organization: Takeda
phone: +1-877-825-3327
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01829477     History of Changes
Other Study ID Numbers: TAK-875_309
2013-000007-17 ( EudraCT Number )
U1111-1138-8680 ( Registry Identifier: WHO )
164539 ( Registry Identifier: HC-CTD )
Study First Received: April 9, 2013
Results First Received: July 22, 2015
Last Updated: April 24, 2016
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Canada: Health Canada
Slovakia: State Institute for Drug Control