Takeda Pharmaceutical Company has submitted a new drug application (NDA) to the FDA for alogliptin, a dipeptidyl peptidase-IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes.
DPP-4 inhibitors are a new class of oral agents for the treatment of type 2 diabetes, which slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), according to the Osaka, Japan-based Takeda. The incretins play a role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function, the company said.
The NDA submission was supported by six Phase III clinical trials involving over 2,000 patients conducted in 220 international centers, Takeda reported. The company also said that the safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an additional therapy to other antidiabetic medications including sulfonylureas, metformin, thiazolidinediones (TZDs), and insulin. In the studies, alogliptin was associated with statistically significant reductions in hemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months. Alogliptin was well-tolerated and weight neutral, and there was no increase in hypoglycemia compared to placebo, according to Takeda.