Abstract
INTRODUCTION: Some type 2 diabetes (T2DM) patients treated with premixed insulin alone or in combination with oral glucose-lowering agents (without sulfonylureas) cannot reach the required glucose targets. Clinical studies have demonstrated that diabetes patients treated with sulfonylureas achieve stable glycemic control, with a low hypoglycemic rate. The aim of our study was to evaluate the efficacy and safety of therapy with the combination of premixed insulin and sulfonylureas. METHODS: A total of 120 patients with T2DM who were unable to achieve glycemic control on premixed human insulin were randomized into four groups, namely, a control group (premixed human insulin only) and three groups receiving combination therapy with premixed human insulin and one of the following sulfonylureas: gliclazide sustained release tablets [Diamicron], glipizide extended release tablets [Glucotrol XL], and glimepiride medium-to-long-acting tablets [Amaryl], with 30 patients in each group. Hemoglobin A1c, blood glucose, and adverse events were assessed at baseline and at the end of the 12-week treatment period. RESULTS: After treatment for 12 weeks, HbA1c, fasting glucose, and 2-h postprandial glucose levels in the four groups were significantly decreased when compared with baseline (P < 0.05). However, there was no difference between the four groups at the end of the study. In the control group, the daily insulin dose had been significantly increased at the end of the follow-up when compared with baseline (P < 0.05), while there were no significant changes in premixed insulin dose in the three combination therapy groups. There were no significant differences in adverse events among the four groups. CONCLUSION: Insulin combined with sulfonylureas could improve glycemic control without increasing daily insulin dose and adverse events. Based on our results, we consider the combination of premixed insulin and sulfonylureas to be effective and safe for the treatment of T2DM. TRIAL REGISTRATION: This trial was registered as ChiCTR-TRC-14004751. Trial Registration Date: 5 June 2014.