Takeda Initiates TAK-875 Phase 3 Trial

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.

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. The findings from the study are expected by 2014.

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 fastin