ADA: TAK-875 a Novel Agent in the Treatment of Type 2 Diabetes

Takeda Pharmaceuticals recently completed a Phase 2 study with its novel anti-diabetic agent TAK-875, which could help lead to more individualized patient care and diabetes management….

TAK-875 is a selective agonist of GPR40, a G-protein coupled receptor in the islet cells of the pancreas. The activation of GPR40 improves glucose-dependent insulin secretion from the beta cells with minimal hypoglycemia and an improved HbA1c. TAK-875 is thought to produce less hypoglycemia compared to other insulin secretagogues like sulfonylureas or incretin hormones.  

Recently, the results from a Phase 2 randomized, double-blind, placebo- and active comparator-controlled, parallel-group, multicenter study evaluating the efficacy, safety, and tolerability of five doses of TAK-875 delivered promising results in favor of the novel agent. When compared to placebo, all doses of TAK-875 produced a statistically significant drop in HbA1c. When compared to the active-control, glimepiride, the 50 mg dose of TAK-875 produced the same reductions in HbA1c at 12 weeks. With a TAK-875 dose of greater than or equal to 25 mg, approximately 33-48% of the patients had an HbA1c less than 7% at week 12, and these results were similar to those of glimepiride. Hypoglycemia incidence was approximately equal between TAK-875 and placebo (2.3 vs. 3.3%), and was significantly lower compared to glimepiride (16.1%). Treatment-emergent events were higher with glimepiride, but in general there was minor discontinuation in any arm of the study that was attributed to adverse events.  

TAK-875, with its novel mechanism of action, could lead to a breakthrough in management of type 2 diabetes, pending the results of its Phase 3 studies and market approval. With the development of novel agents, anti-diabetic therapy options are becoming more individualized and are no longer ‘one size fits all’.  

From: ADA 71^st Scientific Sessions: Abstract 0134-LBOR. Presented June 28, 2011.