Abstract: Objective To observe the efficacy and safety of sitagliptin combined with high-dose insulin on type 2 diabetes mellitus. Methods Sixty patients with type 2 diabetes who needed high-dose insulin(greater than 60 U/d) treatment, diagnosed during Sep. 2012 to Sep. 2013 in our hospital, were divided into insulin combined with sitagliptin group(insulin>60 U/d and sitagliptin 100 mg 1 time/d) and insulin group (insulin>60 U/d ), with 30 patients in each group. After 3-month treatment, the levels of blood glucose, serum lipid and other indicators were compared between the two groups. Results After 3-month treatment, fasting blood glucose(FBG), 2-hour postprandial glucose (2hPG), glycosylated hemoglobin(HbA1c) decreased significantly (all P<0.05) in both group. The insulin dosage, body mass index (BMI) increased significantly (P<0.05) after treatment in insulin group, while the insulin dosage, BMI and triglyceride(TG)reduced significantly (P<0.05) after treatment in insulin combined with sitagliptin group. Compared with insulin group, the patients in insulin combined with sitagliptin group showed lower insulin dosage[(70.32±6.56) vs (59.26±5.03)U], TG[(2.64±1.32) vs (2.21±0.92) mmol/L] and BMI (27.24±2.36 vs 26.25±1.92)(all P<0.01). One patient(3.30%)in insulin combined with sitagliptin group and 8 patients (26.70%) in insulin group occurred hypoglycemia. Conclusion Sitagliptin(100 mg, 1 time/d) combined with high-dose(>60 U/d)insulin in the therapy of patients with type 2 diabetes mellitus is beneficial for controlling the indicators, such as blood glucose, serum lipid, BMI as well as reducing the dosage of insulin and occurrence of hypoglycemia.

Key words: Type 2 diabetes mellitus, High-dose insulin, Low blood glucose, Sitagliptin