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.
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData”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.
