Takeda Pharmaceutical and its wholly-owned subsidiaries have initiated the Phase 3 clinical trial of its TAK-875, an investigational therapy for type 2 diabetes.
TAK-875 is the first GPR40 agonist to reach late stage (Phase 3) clinical development, the company said.
The double-blind randomised 24-week safety and efficacy Phase 3 study will enroll approximately 450 patients with type 2 diabetes who are not adequately controlled on diet and exercise.
The study's primary endpoint will be the change in HbA1c at week 24 while other endpoints will include assessment of a clinically meaningful response based on reaching HbA1c targets, changes in fasting plasma glucose (FPG) and two-hour postprandial plasma glucose (PPG).
Earlier studies have suggested that TAK-875 demonstrated glucose-lowering effects in patients with type 2 diabetes by enhancing glucose-dependent insulin secretion.
Takeda Global Research & Development Center clinical science vice president Thomas Strack said 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.
''TAK-875 is being developed globally, with Phase 3 trials already underway in Japan," Strack said.
The findings from the study are expected by 2014.