Takeda Pharmaceutical announced results from data presented by Takeda Global Research & Development Center, Inc. that evaluated the safety, tolerability and hemoglobin A1c (HbA1c) lowering activity for TAK-875, an investigational compound for the treatment of type 2 diabetes.
TAK-875 is the first GPR40 agonist to reach clinical development and completed studies have demonstrated glucose-lowering effects in patients with type 2 diabetes by stimulating glucose-dependent insulin secretion.
Agonists of GPR40, one of the G-protein-coupled receptors expressed in pancreatic islet cells, have a novel mechanism of action for type 2 diabetes. They work by selectively improving glucose-dependent insulin secretion with a low risk of inducing hypoglycemia, which is different from the mechanisms of sulfonylurea or incretin hormones.
The data were presented from a Phase 2 randomized, double-blind, placebo- and active (glimepiride) comparator-controlled, parallel-group, multicenter study, which was conducted to evaluate the efficacy, safety and tolerability of once-daily treatment with five different doses of TAK-875 over 12 weeks. The primary efficacy endpoint was the change from baseline in HbA1c levels at week 12.
Study results found that all doses of TAK-875 showed significantly greater HbA1c reductions at week 12 versus placebo, and the magnitude of decrease in HbA1c produced by TAK-875 ?50 mg was comparable to glimepiride at week 12. Compared to placebo, approximately twice as many subjects treated with TAK-875 ?25 mg achieved HbA1c less than seven percent at week 12, similar to glimepiride. The incidence of hypoglycemia was significantly lower for all doses of TAK-875 (2.3%) compared to glimepiride (16.1 percent) and similar to placebo (3.3% ). Treatment-emergent adverse events ranged from 43.5% to 61.3% and were highest with glimepiride. There was minimal discontinuation due to adverse events (1.6-3.3 percent) among all active treatment groups.
Release Date: June 28, 2011
Source: Takeda Pharmaceutical
Filed Under: Drug Discovery