Chen Ying-Hua, Li Hui-Zhi, Tang Zhao-Sheng, Xu Lei, Wang Hua, Feng Bo
Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China.
Diabetes Ther. 2019 Apr;10(2):463-471. doi: 10.1007/s13300-019-0564-z. Epub 2019 Jan 18.
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.
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.
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.
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.
This trial was registered as ChiCTR-TRC-14004751. Trial Registration Date: 5 June 2014.
一些仅接受预混胰岛素治疗或联合口服降糖药（不含磺脲类药物）治疗的2型糖尿病（T2DM）患者无法达到所需的血糖目标。临床研究表明，接受磺脲类药物治疗的糖尿病患者能实现稳定的血糖控制，且低血糖发生率较低。我们研究的目的是评估预混胰岛素与磺脲类药物联合治疗的疗效和安全性。
总共120例使用预混人胰岛素无法实现血糖控制的T2DM患者被随机分为四组，即对照组（仅使用预混人胰岛素）和三组接受预混人胰岛素与下列磺脲类药物之一联合治疗的组：格列齐特缓释片[达美康]、格列吡嗪控释片[美吡达]和格列美脲中长效片[亚莫利]，每组30例患者。在基线和12周治疗期结束时评估糖化血红蛋白、血糖和不良事件。
治疗12周后，与基线相比，四组的糖化血红蛋白、空腹血糖和餐后2小时血糖水平均显著降低（P < 0.05）。然而，研究结束时四组之间没有差异。在对照组中，随访结束时每日胰岛素剂量与基线相比显著增加（P < 0.05），而在三组联合治疗组中预混胰岛素剂量没有显著变化。四组之间不良事件没有显著差异。
胰岛素联合磺脲类药物可改善血糖控制，而不增加每日胰岛素剂量和不良事件。基于我们的结果，我们认为预混胰岛素与磺脲类药物联合治疗T2DM是有效且安全的。
本试验注册为ChiCTR-TRC-14004751。试验注册日期：2014年6月5日。
