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TAK-875 (Fasiglifam) in Combination With Sitagliptin in Adults 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:
NCT01829464
First received: April 9, 2013
Last updated: April 24, 2016
Last verified: April 2016
Results First Received: July 24, 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
Interventions: Drug: Placebo
Drug: TAK-875

  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 49 investigative sites in the United States from 01 April 2013 to 12 March 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with historical diagnosis of type 2 diabetes who were inadequately controlled while on sitagliptin 100 milligram(mg) (with/without metformin) or on Dipeptidyl peptidase-4 inhibitor other than sitagliptin(with/without metformin) therapy enrolled in 1 of 3, placebo; fasiglifam 25 mg once daily (QD); fasiglifam 50 mg QD treatment groups.

Reporting Groups
  Description
Placebo Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 25 mg QD Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 50 mg QD Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.

Participant Flow:   Overall Study
    Placebo   Fasiglifam 25 mg QD   Fasiglifam 50 mg QD
STARTED   30   31   29 
COMPLETED   2   2   3 
NOT COMPLETED   28   29   26 
Adverse Event                1                0                0 
Lost to Follow-up                0                0                1 
Withdrawal by Subject                2                0                0 
Study terminated by sponsor                25                28                25 
Lack of Efficacy                0                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.
Full analysis set (FAS) included all randomized participants who received at least 1 dose of double blind study medication.

Reporting Groups
  Description
Placebo Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 25 mg QD Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 50 mg QD Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Fasiglifam 25 mg QD   Fasiglifam 50 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   31   29   90 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.0  (10.45)   52.4  (11.61)   55.2  (8.57)   54.8  (10.38) 
Age, Customized 
[Units: Participants]
       
Less than (<) 65 years   22   27   24   73 
>= 65 years   8   4   5   17 
Gender, Customized 
[Units: Participants]
       
Female   14   13   16   43 
Male   16   18   13   47 
Race/Ethnicity, Customized 
[Units: Participants]
       
Hispanic or Latino   6   11   5   22 
Not Hispanic or Latino   24   20   24   68 
Race/Ethnicity, Customized 
[Units: Participants]
       
Asian   1   3   1   5 
Black or African American   3   1   2   6 
Native Hawaiian or Other Pacific Islander   1   0   0   1 
White   25   26   26   77 
More than 1 race (multiracial)   0   1   0   1 
Height 
[Units: Centimeter (cm)]
Mean (Standard Deviation)
 168.3  (9.26)   169.0  (10.02)   166.8  (10.76)   168.0  (9.96) 
Body Mass Index 
[Units: Kilogram per square meter (kg/m^2)]
Mean (Standard Deviation)
 34.49  (5.623)   32.12  (5.664)   33.10  (4.315)   33.23  (5.286) 
Region of Enrollment [1] 
[Units: Participants]
 30   31   29   90 
[1] Enrollment in the United States is reported.
Smoking Classification 
[Units: Participants]
       
Never smoked   18   19   22   59 
Current smoker   7   5   1   13 
Ex-smoker   5   7   6   18 
Baseline Glycosylated Hemoglobin (HbA1c) Category 
[Units: Participants]
       
< 8.5 percent (%)   16   16   15   47 
>= 8.5%   14   15   14   43 
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 9.291  (8.039)   8.690  (6.180)   6.406  (4.390)   8.154  (6.444) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in HbA1c at Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Percentage of Participants With HbA1c <7%   [ 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: NCT01829464     History of Changes
Other Study ID Numbers: TAK-875_303
U1111-1124-2270 ( Registry Identifier: UTN (WHO) )
Study First Received: April 9, 2013
Results First Received: July 24, 2015
Last Updated: April 24, 2016
Health Authority: United States: Food and Drug Administration