Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease
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ClinicalTrials.gov Identifier: NCT01609582 |
Recruitment Status
:
Terminated
(Due to potential concerns about liver safety (See Detailed Description))
First Posted
: June 1, 2012
Results First Posted
: August 21, 2015
Last Update Posted
: October 19, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | May 29, 2012 | |||
First Posted Date ICMJE | June 1, 2012 | |||
Results First Submitted Date | July 24, 2015 | |||
Results First Posted Date | August 21, 2015 | |||
Last Update Posted Date | October 19, 2015 | |||
Study Start Date ICMJE | June 2012 | |||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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) ] The time from randomization to the first occurrences of any event in the primary MACE composite was evaluated using Kaplan-Meier analysis. The primary MACE composite comprised cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).
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Original Primary Outcome Measures ICMJE |
Time to the first occurrence of any component of the primary major adverse cardiovascular event (MACE) composite [ Time Frame: 6 years. ] The time to the first occurrence of any component of the primary MACE composite, including:
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Change History | Complete list of historical versions of study NCT01609582 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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) ] The time from randomization to the first occurrences of any event in the secondary MACE composite was evaluated using Kaplan-Meier analysis. The secondary MACE composite comprised CV death, nonfatal MI, and nonfatal stroke.
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Original Secondary Outcome Measures ICMJE |
The time to first occurrence of any component of the secondary major adverse cardiovascular event MACE composite [ Time Frame: 6 years. ] The time to first occurrence of any component of the secondary MACE composite, including:
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease | |||
Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects With Type 2 Diabetes and With Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events | |||
Brief Summary | The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite events exists following long term treatment with TAK-875 compared with placebo. | |||
Detailed Description | The drug being tested in this study is called TAK-875. TAK-875 is being tested to treat people who have diabetes. This study will look at the number of cardiovascular events (for example, heart attacks) of people who take TAK-875 in comparison to placebo in addition to standard care. The study will enroll approximately 5000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
All participants will be asked to take one tablet at the same time each day throughout the study. All participants will be asked to record any time they have low blood sugar symptoms in a diary. This multi-centre trial will be conducted worldwide, in approximately 700 sites. The overall time to participate in this study is 6 years. Participants will make up to approximately 24 visits to the clinic, with telephone visits conducted on an alternate 6 month schedule starting from Month 27. Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks. For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
3207 | |||
Original Estimated Enrollment ICMJE |
5000 | |||
Actual Study Completion Date | May 2014 | |||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Estonia, France, Germany, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Taiwan, Thailand, Ukraine, United Kingdom, United States | |||
Removed Location Countries | Guatemala | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01609582 | |||
Other Study ID Numbers ICMJE | 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 ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Takeda | |||
Study Sponsor ICMJE | Takeda | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Takeda | |||
Verification Date | October 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |