Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin 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:
NCT01834274
First received: April 12, 2013
Last updated: August 26, 2015
Last verified: August 2015
Results First Received: March 27, 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: Fasiglifam (TAK-875)
Drug: Fasiglifam (TAK-875) Placebo
Drug: Sitagliptin
Drug: Sitagliptin Placebo
Drug: Metformin

  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 25 sites in the United States and 1 site in Canada from 18 May 2013 (first patient to sign informed consent) to 05 March 2014.

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 2 treatment groups, once a day fasiglifam 50 mg or Sitagliptin 100 mg in combination with metformin.

Reporting Groups
  Description
Fasiglifam 50 mg Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
Sitagliptin 100 mg Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.

Participant Flow:   Overall Study
    Fasiglifam 50 mg     Sitagliptin 100 mg  
STARTED     50     46  
COMPLETED     3     5  
NOT COMPLETED     47     41  
Study Termination                 41                 38  
Withdrawal by Subject                 1                 1  
Lost to Follow-up                 3                 1  
Unknown                 2                 1  



  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.
All randomized participants.

Reporting Groups
  Description
Fasiglifam 50 mg Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
Sitagliptin 100 mg Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Fasiglifam 50 mg     Sitagliptin 100 mg     Total  
Number of Participants  
[units: participants]
  50     46     96  
Age  
[units: Years]
Mean (Standard Deviation)
  57.6  (7.14)     55.1  (9.07)     56.4  (8.17)  
Age, Customized  
[units: participants]
     
< 65 years     41     41     82  
≥ 65 years     9     5     14  
Gender  
[units: Participants]
     
Female     24     20     44  
Male     26     26     52  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     2     1     3  
Black or African American     6     6     12  
Native Hawaiian or Other Pacific Islander     0     1     1  
White     42     37     79  
Multiracial     0     1     1  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     34     31     65  
Non-Hispanic or Latino     15     15     30  
Not Available     1     0     1  
Region of Enrollment  
[units: participants]
     
Canada     1     0     1  
United States     49     46     95  
Height  
[units: cm]
Mean (Standard Deviation)
  168.7  (11.45)     169.9  (10.79)     169.3  (11.10)  
Weight  
[units: kg]
Mean (Standard Deviation)
  87.50  (18.769)     96.09  (19.295)     91.62  (19.408)  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean (Standard Deviation)
  30.77  (6.112)     33.13  (4.787)     31.90  (5.614)  
Baseline BMI Category  
[units: participants]
     
< 30 kg/m^2     31     11     42  
≥ 30 kg/m^2     19     35     54  
Baseline Glycosylated Hemoglobin (HbA)1c Category  
[units: participants]
     
< 9%     27     28     55  
≥ 9 %     23     18     41  
Duration of Diabetes  
[units: years]
Mean (Standard Deviation)
  10.075  (6.530)     8.877  (5.942)     9.501  (6.252)  
Smoking Classification  
[units: participants]
     
Never smoked     38     29     67  
Current smoker     7     9     16  
Ex-smoker     5     8     13  



  Outcome Measures
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1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c)   [ 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)   [ 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: trialdisclosures@takeda.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01834274     History of Changes
Other Study ID Numbers: TAK-875_310
2013-000542-19 ( EudraCT Number )
U1111-1139-0467 ( Registry Identifier: WHO UTN )
DOH-27-0913-4426 ( Registry Identifier: SANCTR (South Africa) )
NMRR-13-518-16346 ( Registry Identifier: NMRR (Malaysia) )
PHRR140127-000165 ( Registry Identifier: PHRR (Philippines) )
Study First Received: April 12, 2013
Results First Received: March 27, 2015
Last Updated: August 26, 2015
Health Authority: United States: Food and Drug Administration
Argentina: National Administration of Drugs, Foods and Medical Devices (ANMAT)
Peru: General Directorate of Medicines, Supplies and Drugs (DIGEMID)
South Africa: Medicines Control Council
Canada: Health Canada
Croatia: Agency for Medicinal Products and Medical Devices
Hungary: Hungary: National Institute for Quality- and Organizational Development in Healthcare and Medicines
Russia: Federal Service on Surveillance in Healthcare
Ukraine: Ministry of Health
Malaysia: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal
Philippines: Bureau of Food and Drugs (BFAD)
Thailand: Bureau of Drug Control