Effect of Sitagliptin as Add-on Therapy in Elderly Type 2 Diabetes Patients With Inadequate Glycemic Control in Taiwan

Abstract

Background: To evaluate the effectiveness and tolerability of add-on sitagliptin in elderly Taiwanese patients with Type 2 diabetes mellitus who have inadequate glycemic control to existing oral antidiabetic agents (OADs) combination regimens. Methods: Patients were randomized to receive the existing OAD combinations or add-on with sitagliptin (100 mg daily) for 24 weeks. We measured HbA1c, fasting plasma glucose, 2-hours postprandial plasma glucose, body mass index, and recorded the hypoglycemic episodes before and after 24 weeks of adding sitagliptin 100 mg once daily to existing maximal dose of OAD combination therapy for 24 weeks. Results: Compared with the change of 0.0% (95% confidence interval: −0.6% to 0.5%) from a baseline of 10.0% in the controlled arm, HbA1c change from a mean baseline of 9.5% was −1.14%±1.18 after add-on sitagliptin. Confirming significant differences (p<0.0001), sitagliptin was generally well tolerated in all study patients. The between-groups difference in body mass index was not significant after 24 weeks of treatment. Conclusion: In elderly Taiwanese patients with Type 2 diabetes mellitus with inadequate glycemic control from OAD combination, the addition of sitagliptin provided significant HbA1c lowering the efficacy over 24 weeks.