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Received:September 23, 2022 Published Online:March 20, 2023
Received:September 23, 2022 Published Online:March 20, 2023
中文摘要: 目的 比较甘精胰岛素注射液（HS004）和来得时?治疗糖尿病的有效性和安全性。方法 本研究为多中心、随机、开放、平行组、阳性药平行对照的Ⅲ期临床研究，研究共筛选2017年10月至2019年9月35家中心的914例受试者，最终610例随机分配于HS004组和来得时组，治疗24周。比较两组治疗前后糖化血红蛋白（HbA1c）、空腹血糖（FPG）、餐后2 h静脉血糖（2hPG）、体重、胰岛素每日用量、胰岛素u/kg用量、不良事件的发生率和甘精胰岛素特异性抗体阳性率。结果 治疗24周后，全部人群HS004组与来得时组的HbA1c的降幅（0.84% vs0.96%）、2型糖尿病（T2DM）受试者中两组的降幅（0.92% vs1.02%）以及治疗12周时T2DM受试者两组HbA1c的降幅（0.92% vs1.05%）差异均无统计学意义（P＞0.05）。〖ＪＰ＋１〗T2DM受试者治疗24周后，HS004组与来得时组HbA1c≤6.5%的受试者的比例分别为12.82%和8.20%，HbA1c＜7.0%的受试者的比例分别为27.47%和26.17%；两组FPG较基线的平均降幅分别为1.709 mmol/L、1.950 mmol/L，2hPG的平均降幅分别为2.908 mmol/L、3.005 mmol/L；两组体重较基线变化的均值分别为0.79 kg和0.97 kg；两组胰岛素每日用量均值分别为13.95 u、13.02 u；两组胰岛素u/kg用量均值分别为0.20 u/kg、0.19 u/kg，上述指标两组间差异均无统计学意义（P＞0.05）。对于其中的T2DM受试者，与来得时组相比，HS004组中低血糖事件的发生率降低了0.7%，组间差异无统计学意义（P＞0.05）；T2DM受试者，HS004组和来得时组基线抗药物抗体（ADA）阳性率差异无统计学意义（5.80% vs 9.30%，P＞0.05）；治疗期间末次访视，两组ADA阳性率差异无统计学意义（12.59% vs 14.34%，P＞0.05）。结论 甘精胰岛素注射液（HS004）治疗糖尿病的有效性和安全性与来得时?相当，并具有良好的耐受性。
Abstract:Objective To compare the efficacy and safety of insulin glargine injection (HS004) and Lantus? in treating patients with diabetes mellitus. Methods This was a phase Ⅲ, multicenter, randomized, open-label, parallel-group, active-controlled clinical trial. A total of 914 participants with diabetes from 35 hospitals,610 subjects of them were randomly assigned to HS004 group and Lantus? group for 24 weeks. The efficacy measures included changes in glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2 h postprandial plasma glucose (2hPG), body weight from baseline, daily dosage of insulin, dosage of insulin u/kg. The safety outcomes included rates of hypoglycemia, adverse events and anti-insulin glargine antibody. Results After 24 weeks of treatment, there was no significant differences in the change of HbA1c of total subjects in HS004 group and Lantus? group (0.84% vs 0.96%, P＞0.05), so were the change of HbA1c of T2DM subjects at 24 weeks (0.92% vs 1.02%, P＞0.05) and 12 weeks (0.92% vs 1.05%, P＞0.05). After 24 weeks of treatment in T2DM subjects, the proportions of HbA1c≤6.5% were 12.82% in HS004 group and 8.20% in Lantus? group, and the proportions of HbA1c＜7.0% were 27.47% and 26.17%, respectively. FPG decreased by 1.709 mmol/L and 1.950 mmol/L from baseline in the two groups, respectively, and 2 hPG decreased by 2.908 mmol/L and 3.005 mmol/L, respectively. The mean body weight changes from baseline in the two groups were 0.79 kg and 0.97 kg, respectively. The daily dosage of insulin in the two groups was 13.95 u and 13.02 u, respectively. The dosages of insulin u/kg were 0.20 u/kg in HS004 group and 0.19 u/kg in Lantus? group, respectively. In T2DM subjects, the incidence of hypoglycemia reduced by 0.7% in HS004 group compared with Lantus? group, but there was no significant difference between them (P＞0.05). In T2DM subjects, there was no significant difference in anti-drug antibody (ADA) positive rate at baseline (5.80% vs 9.30%, P＞0.05) between the two groups, and no significant difference in the ADA positive rate at the last visit during treatment (12.59% vs 14.34%, P＞0.05). Conclusion Insulin glargine injection (HS004) shows similar efficacy and safety profiles compared with Lantus? in treating patients with diabetes mellitus, and insulin glargine injection (HS004) treatment was well tolerated in patients.
keywords: Diabetes Insulin glargine Glycated hemoglobin Fasting blood glucose Insulin dosage Anti-drug antibody Efficacy Safety
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