Long-term efficacy and safety of sitagliptin in the treatment of Japanese Type 2 diabetes (ASSET-K1) to a target of HbA_1c<7%

Abstract

Background: Few studies have investigated the factors related to improvement and maintenance of glycemic control with sitagliptin in Type 2 diabetes (T2D) patients. Aim: To identify factors contributing to reaching and maintaining glycated hemoglobin (HbA_1c) <7% with sitagliptin in Japanese T2D patients. Subjects and methods: This study included 1327 patients who were: taking sitagliptin as monotherapy; switched to sitagliptin; or taking sitagliptin in combination therapy. At baseline and 1, 3, 6, and 12 months after starting sitagliptin, weight, body mass index (BMI), HbA_1c, fasting plasma glucose (FPG), and post-prandial plasma glucose (PPG) were measured. The subjects were divided into a group that achieved HbA_1c<7% at 12 months, a poor control group(HbA_1c≥8% at 12 months), and a discontinued group. Multiple regression analysis was performed to identify factors contributing to long-term control and maintenance with sitagliptin treatment. Results: HbA_1c decreased significantly from 8.0% at baseline to 7.3%, but weight was unchanged. FPG and PPG improved significantly. The HbA_1c<7% group had a significantly higher age and a significantly lower BMI at baseline than the HbA_1c≥8% group and the discontinued group. On multivariate regression analysis, baseline HbA_1c, baseline BMI, and Δbody weight after 12 months were significantly related to HbA_1c reduction. The most common adverse event was hypoglycemia, and the most common adverse event responsible for discontinuation was constipation. Conclusions: HbA_1c<7.0% was achieved in 31 % of T2D patients who had poor control with conventional treatment. Weight management is important for maintaining good long-term control with sitagliptin.