Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease

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:
NCT01609582
First received: May 29, 2012
Last updated: July 24, 2015
Last verified: July 2015
Results First Received: July 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes
Cardiovascular Disease
Interventions: Drug: TAK-875
Drug: TAK-875 Placebo

  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 469 investigative sites in 31 countries; 192 sites in North America, 175 in the Europe, Middle East, and Africa (EMEA) region (including Russia, Ukraine, Israel, and South Africa), 65 in the Asia Pacific region, and 37 in Latin/South America from 01 June 2012 to 05 May 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) and clinically-evident cardiovascular (CV) disease or multiple risk factors for CV events who were inadequately controlled while receiving the standard of care were enrolled in 1 of 2 treatment groups: placebo; fasiglifam 50 milligram (mg).

Reporting Groups
  Description
Placebo Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
Fasiglifam 50 mg Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.

Participant Flow:   Overall Study
    Placebo     Fasiglifam 50 mg  
STARTED     1603     1604  
Treated     1603     1601  
COMPLETED     0     0  
NOT COMPLETED     1603     1604  
Adverse Event                 20                 18  
Lost to Follow-up                 10                 10  
Withdrawal by Subject                 21                 15  
Study Terminated by Sponsor                 1543                 1548  
Other                 9                 10  
Randomized, but not treated                 0                 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.
The randomized set included all randomized participants.

Reporting Groups
  Description
Placebo Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
Fasiglifam 50 mg Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
Total Total of all reporting groups

Baseline Measures
    Placebo     Fasiglifam 50 mg     Total  
Number of Participants  
[units: participants]
  1603     1604     3207  
Age  
[units: years]
Mean (Standard Deviation)
  63.9  (9.03)     63.4  (9.20)     63.7  (9.12)  
Age, Customized  
[units: participants]
     
Less than (<) 65 years     794     851     1645  
Greater than or equal to (>=) 65 years     809     753     1562  
Gender  
[units: participants]
     
Female     543     563     1106  
Male     1060     1041     2101  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     150     119     269  
Not Hispanic or Latino     446     477     923  
Unknown or Not Reported     1007     1008     2015  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     47     41     88  
Asian     199     205     404  
Native Hawaiian or Other Pacific Islander     6     7     13  
Black or African American     79     95     174  
White     1265     1246     2511  
Multiracial/More than 1 race     7     10     17  
Height [1]
[units: centimeter (cm)]
Mean (Standard Deviation)
  168.1  (9.84)     167.6  (10.54)     167.8  (10.20)  
Weight  
[units: kilogram (kg)]
Mean (Standard Deviation)
  91.14  (19.832)     91.40  (21.319)     91.27  (20.586)  
Body Mass Index (BMI) [1]
[units: kilogram per square meter (kg/m^2)]
Mean (Standard Deviation)
  32.14  (6.107)     32.45  (7.497)     32.30  (6.838)  
Glycosylated Hemoglobin (HbA1c) Category  
[units: participants]
     
<8.5 percent (%)     988     936     1924  
>=8.5%     615     668     1283  
Smoking Classification  
[units: participants]
     
Never smoked     667     668     1335  
Current smoker     330     328     658  
Ex-smoker     606     608     1214  
Duration of Diabetes [2]
[units: years]
Mean (Standard Deviation)
  13.583  (8.409)     13.333  (8.321)     13.458  (8.365)  
Region of Enrollment  
[units: participants]
     
Argentina     121     121     242  
Australia     34     35     69  
Bulgaria     21     22     43  
Canada     104     107     211  
Croatia     16     17     33  
Czech Republic     56     56     112  
Estonia     13     11     24  
France     3     4     7  
Germany     30     30     60  
Hong Kong     29     29     58  
Hungary     74     72     146  
Israel     25     26     51  
Italy     3     3     6  
Korea, Republic of     29     27     56  
Latvia     11     11     22  
Lithuania     15     15     30  
Malaysia     30     31     61  
Mexico     26     26     52  
New Zealand     20     20     40  
Peru     18     17     35  
Philippines     25     24     49  
Poland     118     118     236  
Romania     5     4     9  
Russian Federation     25     23     48  
Slovakia     31     31     62  
South Africa     10     10     20  
Taiwan, Province of China     31     31     62  
Thailand     29     32     61  
Ukraine     76     76     152  
United Kingdom     16     16     32  
United States     559     559     1118  
[1] For this outcome measure, number of participants evaluable were 1598 and 1597 for each arm, respectively.
[2] For this outcome measure, number of participants evaluable were 1602 and 1602 for each arm, respectively.



  Outcome Measures
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1.  Primary:   Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite   [ Time Frame: Baseline up to end of study (up to Day 588) ]

2.  Secondary:   Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite   [ Time Frame: Baseline up to end of study (up to Day 588) ]


  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


No publications provided


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01609582     History of Changes
Other Study ID Numbers: TAK-875_306, 2011-001732-37, U1111-1129-7824, TAK-875_306CTIL, DOH-27-0313-4117, 12/SC/0504, NMRR-12-433-12087, PHRR130916-000119
Study First Received: May 29, 2012
Results First Received: July 24, 2015
Last Updated: July 24, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Bulgaria: Ministry of Health
Canada: Health Canada
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Ethics Committee
Hungary: National Institute of Pharmacy
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Malaysia: Ministry of Health
Mexico: Ministry of Health
New Zealand: Medsafe
Peru: Ministry of Health
Philippines: Department of Health
Poland: Ministry of Health
Romania: State Institute for Drug Control
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Taiwan: Department of Health
Thailand: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: National Health Service
United States: Food and Drug Administration