TAK-875 is a selective agonist of GPR40, one of the GPCRs that are expressed in pancreatic islet cells.
The Phase 2 trial is a randomized double-blind placebo- and active (glimepiride) comparator-controlled multicenter study, intended to evaluate once-daily treatment with five different doses of TAK-875 (6.25 mg, 25 mg, 50 mg, 100 mg, and 200 mg) and glimepiride (2 mg -4 mg), over 12 weeks.
The study showed that at doses ranging from 6.25 to 200 mg a day, the drug has met its primary endpoint of significantly lowering HbA1c (blood glucose) levels.
The primary objective of the study is the change from baseline in HbA1c levels at week 12, while the secondary endpoints included fasting blood glucose, area under the curve (AUC) for glucose and insulin during an oral glucose tolerance test (OGTT), and body weight.
Takeda Development therapeutic area head Thomas Strack said because of its observed ability to potently stimulate insulin secretion and improve glycemic control with less or no hypoglycemia, these data further support TAK-875 as a potential therapy for the treatment of type 2 diabetes.
TAK-875 is the first GPR40 agonist to reach late-stage Phase 3 clinical development, the company said.