Department of Endocrinology, Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510102, China.
Chin Med J (Engl). 2009 Nov 5;122(21):2540-6.
Glycemic control prevents onset and progression of diabetes-related long-term complications. The objective of this study was to demonstrate that twice daily insulin lispro low mix 25 is noninferior to twice daily human insulin mix 30/70 in achieving glycemic control as measured by hemoglobin A1c (HbA1c), from baseline to endpoint, in patients with type 1 or 2 diabetes.
In this phase IV, crossover, open-label, multicenter study, 117 Chinese patients with diabetes were randomly assigned to one of two treatment sequence groups. One group received 12-week treatment with twice daily human insulin mix 30/70 followed by 12-week treatment with twice daily insulin lispro low mix 25, while the other group received the reverse treatment sequence. HbA1c, baseline-to-endpoint change in HbA1c, proportion of patients achieving target HbA1c <or= 7% and <or= 6.5%, fasting blood glucose, and daily insulin doses were measured for each period. Safety and tolerability were also assessed.
A statistically significant reduction (P <or= 0.0001) of HbA1c was achieved after each treatment (human insulin mix 30/70: mean HbA1c = 7.91% (95%CI: 7.67%, 8.15%); insulin lispro low mix 25: mean HbA1c = 7.96% (95%CI: 7.72%, 8.20%)). The 95%CI (-0.20, 0.10) of the difference between the two treatments satisfied the prespecified noninferiority margin of 0.3% (lower limit of 95% CI > -0.3%). No statistically significant differences between treatments were observed for any of the secondary efficacy measures. The incidence of treatment-emergent adverse events and hypoglycemia between the two treatments and treatment sequence groups was similar. Three serious adverse events were reported (human insulin mix 30/70 group: 2 patients (1.7%, hypoglycemic coma and cardiac failure); insulin lispro low mix 25 group: 1 patient (0.9%, stroke)). All serious adverse events were resolved and no patients died during the study.
The results support noninferiority of twice daily insulin lispro low mix 25 versus twice daily human insulin mix 30/70 in HbA1c control in Chinese patients with type 1 or 2 diabetes.
血糖控制可预防糖尿病相关长期并发症的发生和进展。本研究旨在证明，对于 1 型或 2 型糖尿病患者，与每日两次预混人胰岛素 30/70 相比，每日两次胰岛素赖脯低精蛋白 25 在达到糖化血红蛋白（HbA1c）方面不劣效，从基线到终点。
在这项 4 期、交叉、开放标签、多中心研究中，117 名中国糖尿病患者被随机分配到两个治疗顺序组中的一个。一组接受 12 周每日两次预混人胰岛素 30/70 治疗，然后接受 12 周每日两次胰岛素赖脯低精蛋白 25 治疗，而另一组接受相反的治疗顺序。测量每个时间段的 HbA1c、HbA1c 从基线到终点的变化、达到目标 HbA1c <或=7%和<或=6.5%的患者比例、空腹血糖和每日胰岛素剂量。还评估了安全性和耐受性。
两种治疗均显著降低（P<0.0001）HbA1c（人胰岛素混合 30/70：平均 HbA1c=7.91%（95%CI：7.67%，8.15%）；胰岛素赖脯低精蛋白 25：平均 HbA1c=7.96%（95%CI：7.72%，8.20%））。两种治疗之间差异的 95%CI（-0.20，0.10）满足预设的非劣效性边界 0.3%（下限 95%CI>-0.3%）。两种治疗之间的任何次要疗效测量均无统计学差异。两种治疗和治疗顺序组之间的治疗中出现的不良事件和低血糖的发生率相似。报告了 3 例严重不良事件（人胰岛素混合 30/70 组：2 例（1.7%，低血糖昏迷和心力衰竭）；胰岛素赖脯低精蛋白 25 组：1 例（0.9%，中风））。所有严重不良事件均得到解决，研究期间无患者死亡。
研究结果支持每日两次胰岛素赖脯低精蛋白 25 与每日两次预混人胰岛素 30/70 在糖化血红蛋白控制方面在中国 1 型或 2 型糖尿病患者中的非劣效性。
