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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: October 15, 2015
Last verified: October 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 
Overall Participants Analyzed 
[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) 
[1] For this outcome measure, number of participants evaluable were 1598 and 1597 for each arm, respectively.
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) 
[1] For this outcome measure, number of participants evaluable were 1598 and 1597 for each arm, respectively.
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 [1] 
[Units: Years]
Mean (Standard Deviation)
 13.583  (8.409)   13.333  (8.321)   13.458  (8.365) 
[1] For this outcome measure, number of participants evaluable were 1602 and 1602 for each arm, respectively.
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 


  Outcome Measures
  Show All Outcome Measures

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



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01609582     History of Changes
Other Study ID Numbers: TAK-875_306
2011-001732-37 ( EudraCT Number )
U1111-1129-7824 ( Registry Identifier: WHO )
TAK-875_306CTIL ( Registry Identifier: Israel MOH )
DOH-27-0313-4117 ( Registry Identifier: SANCTR )
12/SC/0504 ( Registry Identifier: NRES )
NMRR-12-433-12087 ( Registry Identifier: NMRR (Malaysia) )
PHRR130916-000119 ( Registry Identifier: PHRR (Philippines) )
1015031332 ( Registry Identifier: TCTIN )
Study First Received: May 29, 2012
Results First Received: July 24, 2015
Last Updated: October 15, 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