Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease
Recruiting at574 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Takeda
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
SM
Sr. Medical Director Clinical Science
Principal Investigator
Takeda
Eligibility Criteria
Inclusion Criteria
In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements, including scheduled clinic appointments.
The patient or, when applicable, the patient's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Has a diagnosis of type 2 diabetes mellitus.
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Treatment Details
Interventions
- TAK-875 (Antidiabetic Agent)
- TAK-875 Placebo (Drug)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TAK-875 50 mgExperimental Treatment1 Intervention
TAK-875 50 mg tablets, orally, once daily for up to 6 years.
Group II: PlaceboPlacebo Group1 Intervention
TAK-875 placebo-matching tablets, orally, once daily for up to 6 years.
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Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Trials
1,255
Recruited
4,219,000+
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier