多中心、随机、开放、对照研究比较甘舒霖30R和诺和灵30R治疗糖尿病的有效性和安全性

目的比较两种预混型人胰岛素制剂(甘舒霖30R与诺和灵30R)治疗2型糖尿病的有效性和安全性。方法由中国9家医院参加的多中心、随机、开放、对照临床研究,甘舒霖30R组人选2型糖尿病200例,诺和灵30R组100例,治疗12周。结果(1)治疗12周甘舒霖30R组和诺和灵30R组的HbA1c分别下降了1.08%和1.01%,2h餐后血糖分别下降了3.79和3.05mmol/L,空腹血糖分别下降2.0和2.2 mmol/L,治疗前后有明显变化(均P<0.05),但两组间比较差异无统计学意义(P>0.05)。(2)低血糖事件分别为22%和14%,大部分为轻度。胰岛素抗体阳性率在两组间无差别。结论甘舒霖30R是一种治疗糖尿病的有效安全的胰岛素剂型。

Comparison of efficacy and safety of Gansulin 30R and Novolin 30R in the treatment of type 2 diabetic patients: a multicenter randomized open controlled clinical trial

Objective To compare the efficacy and safety of Cansulin 30R and Novolin 30R in therapy of type 2 diabetes mellitus (DM). Methods A multicenter, randomized, and controlled clinical trial of Gansulin 30R and Novolin 30R was performed in 9 centers in China. Two hundred patients with type 2 DM received Gansulin 30R therapy and 100 patients received Novolin 30R for 12 weeks. Results (1) At the end of 12-week treatment, significant improvements in HbAlc, 2 h postprandial plasma glucose (2hPG) and fasting plasma glucose (FPG) levels were shown in both groups, HbAlc decreased 1.08% and 1.01% , 2hPG decreased 3.79 and 3.05 mmol/L and FPG decreased 2.0 and 2. 2 mmol/L, in Gansulin 30R group and in Novolin 30R group respectively (all P<0.05). No difference existed between two groups (P<0.05). (2) Hypoglycemia incidences were 22% and 14% in Gansulin 30R and Novolin 30R respectively, most events were mild. The titers of anti-insulin antibodies were not obviously different between two groups. Conclusion Gansulin 30R is an effective and safe regimen in treating diabetes.