格列美脲联合胰岛素治疗2型糖尿病的多中心临床研究

目的研究在接受胰岛素治疗的2型糖尿病患者中,联合应用格列美脲治疗的疗效及对胰岛素使用剂量的影响.方法为多中心、开放、自身对照的临床研究.100例胰岛素治疗剂量≥50 U/d(胰岛素单用或与≤2种非胰岛素促泌剂联合应用)的2型糖尿病患者,加用格列美脲治疗12周.结果 12周后,糖化血红蛋白(Hh)A1c由基线时的(8.89±1.77)%降至(7.02±0.86)%,下降了(1.86±1.43)%.以HbA1c≤6.5%和<7.0%为目标值,达标率分别为34%和59%,达标率增加31%和50%.胰岛素的剂量由基线时的66.0 U/d降至50.0 U/d,剂量减少26.67%.患者的全天血糖谱均明显改善.治疗期间,30例患者(30%)发生一般性低血糖68件·次,低血糖发生率为2.95次/(患者·年),无严重低血糖事件.受试者体重及体重指数均无明显变化.结论在胰岛素治疗的基础上联合应用格列美脲可有效降低2型糖尿病患者空腹血糖、餐后血糖水平,有利于患者实现HbA1c达标;同时可显著降低胰岛素用量,提高治疗的安伞性和耐受性.

Efficacy and safety of glimepiride combined with insulin in patients with type 2 diabetes mellitus

Objective To investigate the efficacy and safety of glimepiride combined with insulin in patients with type 2 diabetes mellitus,and their effects on insulin dosage. Methods One hundred of type 2 diabetic patients treated with insulin higher than 50 U/d( insulin alone or in combination with no more than two kinds of non-insulin-secretagogue agents) were enrolled in this multi-center,open-labeled and self-controlled study. Glimepiride was added to patients for 12 weeks. Results HbA1c decreased from ( 8. 89 ± 1.77) % to (7.02 ± 0. 86) % ( decreased ( 1. 86 ± 1.43) % ). About 31 % and 50% patients obtained the target of HbA1c≤6. 5% and HbA1c < 7. 0%. Insulin dose decreased from 66. 0 U/d to 50. 0 U/d ( decreased 26.67% ). The blood glucose profile was also improved significantly. During the study period ,30 patients experienced with minor hypoglycemia for 68 times,and the incidence was 2.95/patients · year; no serious hypoglycemia was reported. Body weight and body weight index did not change. Conclusions Glimepiride combined with insulin is efficient and safe in type 2 diabetic patients, and can decrease insulin dosage, and therefore decrease the therapeutic risks of insulin.