First-in-class diabetes drug goes to phase III trials

Thu, 20 Oct 2011
The drug giant Takeda Pharmaceutical Co has announced that its first-in-class type 2 diabetes investigational therapy TAK-875 is to begin phase III trials. The Japanese company stated that it has launched a late-stage programme for the drug, which it hopes will lead to becoming commercially available for treating type 2 diabetes.

The phase III trials of TAK-875 started in Japan in September, while the first of the late-stage studies in the programme in Europe and the US will involve around 450 patients suffering from type 2 diabetes that is not well managed through either diet or exercise.

The drug therapy, a selective agonist of GPR40, which is one of the G-protein-coupled receptors expressed in pancreatic islet cells, is the first treatment in this class that has managed to reach such late-stage studies.

GPR40 agonists, work differently for type 2 diabetes as compared to sulfonylureas, including Amaryl (also known as glimepiride), which was developed by Sanofi. They operate by selectively helping the improvement of glucose-dependent insulin secretion in the body, and they also have the potential for lowering the risk of hypoglycaemia.

With a main endpoint of a change in the HbA1c measurement by week 24, the findings from the trials are due by 2014.

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