Alogliptin as add-on to metformin and pioglitazone improves glycemic control, beta-cell function
December - 2 - 2011
As type 2 diabetes (T2DM) progresses, not only one but two or more therapies are required to control glycemia. A randomized, double-blind, active-controlled, parallel-group study investigated the efficacy and safety of the novel DPP IV inhibitor alogliptin as add-on to ongoing therapies with oral antidiabetic drugs (OADs). T2DM patients whose glycemia was inadequately controlled by first-line OADs were randomized to either two OADs (metformin + uptitrated pioglitazone 45 mg; n=399) or triple OAD therapy (metformin + pioglitazone 30 mg + add-on alogliptin 25 mg; n=404). Primary endpoint was reductions in glycated hemoglobin (HbA1c) from baseline to 26 and 52 weeks. Secondary endpoints included proportion of patients achieving glycemic targets, changes in fasting plasma glucose (FPG), hypoglycemia incidence and beta-cell function. After 52 weeks, the 3-OAD therapy group showed better glycemic control, with significantly larger HbA1c reductions than in the 2-OAD therapy group (-0.70 vs. -0.29%). Glycemic target of 7% HbA1c or less was achieved by more patients in the triple OAD group (33.2%) than in the 2-OAD group (21.3%). The triple OAD treatment was also superior in terms of improvements in FPG and beta-cell function. The results showed that addition of alogliptin to standard OAD therapy improves glycemic control, FPG, beta-cell function, without increased safety risks (Bosi, E. et al. Diabetes Obes Metab 2011, 13(12): 1088).