TAK-875 is a selective agonist of GPR40, one of the G-protein-coupled receptors that are expressed in pancreatic islet cells.
The first double-blind, randomized, 24-week Phase 3 trial in the US/Europe program will enroll nearly 450 patients with type 2 diabetes to test the efficacy of the drug candidate.
The primary endpoint of the trial will be the change in HbA1c at week 24 while other endpoints will include evaluation of a clinical response based on reaching HbA1c targets, changes in fasting plasma glucose (FPG) and two-hour postprandial plasma glucose (PPG).
The company is likely to announce the results by 2014.