Efficacy and Safety of alogliptin administered to 219 type 2 diabetic patients for 12 months

Objectives: This retrospective study was undertaken to clarify the efficacy and safety of alogliptin. The characteristics of the patients in whom alogliptin exerts its HbA1c-lowering effect fully were also explored. Methods: Alogliptin was administered as initial, additive, or exchange medication to 219 type 2 diabetic patients. The primary efficacy endpoint was the change in HbA1c at 12 months after the start of alogliptin treatment. Results: Administration of alogliptin significantly decreased HbA1c (7.79±0.96% at baseline→7.24±0.85 at 3 months→7.18±0.89% at 6 months→7.20±0.98% at 9 months→7.23±0.94% at 12 months at all time points : P<0.0001 vs. baseline). There was no significant difference in ΔHbA1c (=HbA1c at 12 months-HbA1c at baseline) between patients who took other oral hypoglycemic agents (OHA) concomitantly and those who took alogliptin as the only OHA. There was no significant difference in ΔHbA1c with respect to the kind of oral hypoglycemic agents used concomitantly, either. Multiple logistic regression analysis indicated that factors that contributed to ΔHbA1c were baseline HbA1c and initial/additive rather than exchange administration of alogliptin. ΔHbA1c was significantly, negatively correlated with baseline HbA1c value. There were no changes in clinical parameters thought to be adverse events. Conclusions: Administration of alogliptin provided a significant and clinically relevant reduction in HbA1c. High baseline HbA1c value may predict a large effect of alogliptin.