Takeda Pharmaceutical Company Limited (Takeda) has reviewed the development strategy for the Marketing Authorization Applications (MAAs) for its investigational compounds, alogliptin and alogliptin/ACTOS (generic name: pioglitazone HCl), in Europe, and accordingly, has initiated an additional long-term clinical study for alogliptin.
The additional two-year study is to evaluate the efficacy and safety of alogliptin compared to glipizide when used in combination with metformin in targeted number of almost 2,500 subjects with type-2 diabetes, whose blood sugar level is inadequately controlled with metformin.
With the results of this additional study, Takeda expects that the MAA submissions will be made with a more robust data set necessary to ensure its approval, and as a result, the target timing of MAAs is revised from the original plan of mid-2009 to 2012.
Alogliptin, which was discovered by Takeda's wholly owned US subsidiary, Takeda San Diego, Inc is a dipeptidyl peptidase IV (DPP-4) inhibitor for the treatment of type-2 diabetes. By providing complementary mechanisms of action, alogliptin/ACTOS targets the core defects of type-2 diabetes - insulin resistance (when the body does not efficiently use the insulin it produces) and insulin deficiency (when the body does not produce enough insulin).