Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiaries, Takeda Global Research & Development Center, Inc. ("TGRD U.S."), and Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe"), announced today the initiation of the Company's Phase 3 clinical trial program for TAK-875, an investigational therapy for type 2 diabetes. The program will be conducted across the United States (U.S.), Latin America, and Europe. TAK-875 is the first GPR40 agonist to reach late stage (Phase 3) clinical development.
Completed studies of TAK-875, discovered by Takeda, have suggested glucose-lowering effects in patients with type 2 diabetes by enhancing glucose-dependent insulin secretion.
"Takeda is committed to enhancing the clinical investigation of TAK-875 in order to accelerate the development of a potential new type 2 diabetes treatment option for patients and healthcare professionals," said Thomas Strack, M.D., vice president, clinical science, Takeda Global Research & Development Center, Inc., U.S. "An outcome of our robust focus on diabetes over many years, TAK-875 was discovered by Takeda based on our GPCR research and is the first GPR40 agonist to reach late stage (Phase 3) clinical development. TAK-875 is being developed globally, with Phase 3 trials already underway in Japan."
The first Phase 3 trial in the U.S./Europe program, a double-blind, randomized, 24-week safety and efficacy study, will enroll approximately 450 patients with type 2 diabetes who are not adequately controlled on diet and exercise, at approximately 140 sites in the U.S., Latin America, and Europe. The study's primary endpoint will be the change in HbA1c at week 24 while other endpoints will include the assessment of a clinically meaningful response based on reaching HbA1c targets, changes in fasting plasma glucose (FPG) and two-hour postprandial plasma glucose (PPG). Results are expected by 2014.
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