Takeda Pharmaceutical Co says it has initiated a late-stage programme for TAK-875, an investigational therapy for type 2 diabetes.
The drug is a selective agonist of GPR40, one of the G-protein-coupled receptors that are expressed in pancreatic islet cells. Takeda noted that TAK-875 is the first treatment in this class to reach late-stage studies.
GPR40 agonists have a mechanism of action for type 2 diabetes different from that of sulfonylureas, such as Sanofi's Amaryl (glimepiride). They work by selectively improving glucose-dependent insulin secretion with a potential for reduced risk of hypoglycaemia.
Phase III trials got underway in Japan last month and the first late-stage study in the US/Europe programme will enrol 450 patients with type 2 diabetes who are not adequately controlled on diet and exercise, at 140 sites. The latter's study's primary endpoint will be the change in HbA1c at week 24; results are expected by 2014.
In July, Takeda resubmitted two New Drug Applications to regulators in the USA for its investigational type 2 diabetes therapy alogliptin, a selective dipeptidyl peptidase IV inhibitor (DPP-4) inhibitor, and the fixed-dose combination of the latter and the Japanese drugmaker's Actos (pioglitazone).