Comprehensive Efficacy of the Dipeptidyl Peptidase 4 Inhibitor Alogliptin in Practical Clinical Settings: A Prospective Multi-Center Interventional Observational Study.

BACKGROUND: This study aimed to verify the safety and efficacy, including glycemic control, of the selective dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes. METHODS: This study used a multi-center, open-label, prospective observational design. Type 2 diabetes patients who were undergoing dietary therapy and/or exercise therapy alone without sufficient glycemic control (hemoglobin A1c (HbA1c) ≥ 6.5% and < 10%) were administered alogliptin (25 mg/day). The long-term effects (6 and 12 months) on blood glucose, blood pressure, heart rate, body weight and lipids were assessed. RESULTS: A final 50 patients were included with a high prevalence of hypertension (77%) and dyslipidemia (72%), and a mean duration of diabetes of 4.5 years. Pre-treatment HbA1c was 7.5% and was significantly decreased at 6 and 12 months (6M: 6.4%, 12M: 6.2%; P < 0.02 vs. 0M, respectively). Body weight, blood pressure and low-density lipoprotein cholesterol were significantly decreased by 6 months and maintained at 12 months. Triglycerides showed a significant decrease at 12 months. No significant differences were observed in HbA1c decrease for different grade of age, duration of diabetes, body mass index and renal function. The degree of decrease in HbA1c was most strongly correlated with pre-treatment HbA1c. Adverse events were noted in three patients, with no serious outcomes. CONCLUSION: The blood glucose-lowering effect and safety of alogliptin were demonstrated regardless of baseline HbA1c, although its effect appeared stronger with higher pre-treatment HbA1c values. Additionally, alogliptin appears useful for managing atherosclerotic risk factors such as body weight and blood pressure.