Zhang T T, Liu X M, Shi B Y, Wang C J, Mo Z H, Liu Y, Shan Z Y, Yang W Y, Li Q M, Lyu X F, Yang J K, Xue Y M, Zhu D L, Shi Y Q, Huang Q, Zhou Z G, Wang Q, Ji Q H, Li Y B, Gao X, Lu J M, Zhang J Q, Guo X H
Department of Endocrinology, Peking University First Hospital, Beijing 100034, China.
Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin 150001, China.
Zhonghua Nei Ke Za Zhi. 2020 Dec 1;59(12):960-967. doi: 10.3760/cma.j.cn112138-20200423-00417.
To compare the efficacy and safety of Changsulin with Lantus in treating patients with type 2 diabetes mellitus (T2DM). This was a phase Ⅲ, multicenter, randomized, open-label, parallel-group, active-controlled clinical trial. A total of 578 participants with T2DM inadequately controlled on oral hypoglycemic agents were randomized 3∶1 to Changsulin or Lantus treatment for 24 weeks. The efficacy measures included changes in glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2h postprandial plasma glucose (2hPG), 8-point self-monitoring of blood glucose (SMBG) profiles from baseline, and proportions of subjects achieving targets of HbA1c and FPG. The safety outcomes included rates of hypoglycemia, adverse events (AEs) and anti-insulin glargine antibody. After 24 weeks of treatment, mean HbAlc decreased 1.16% and 1.25%, FPG decreased 3.05 mmol/L and 2.90 mmol/L, 2hPG decreased 2.49 mmol/L and 2.38 mmol/L in Changsulin and in Lantus, respectively. No significant differences could be viewed in above parameters between the two groups (all 0.05). There were also no significant differences between Changsulin and Lantus in 8-point SMBG profiles from baseline and proportions of subjects achieving the targets of HbA1c and FPG (all 0.05). The rates of total hypoglycemia (38.00% and 39.01% for Changsulin and Lantus, respectively) and nocturnal hypoglycemia (17.25% and 16.31% for Changsulin and Lantus, respectively) were similar between the two groups (all 0.05). Most of the hypoglycemia events were asymptomatic, and no severe hypoglycemia were found in both groups. No differences were observed in rates of AEs (61.77% vs.52.48%) and anti-insulin glargine antibody (after 24 weeks of treatment, 6.91% vs.3.65%) between the two groups (all 0.05). Changsulin shows similar efficacy and safety profiles compared with Lantus and Changsulin treatment was well tolerated in patients with T2DM.
比较长苏霖与来得时治疗2型糖尿病（T2DM）患者的疗效和安全性。这是一项Ⅲ期、多中心、随机、开放标签、平行组、活性药物对照的临床试验。共有578例口服降糖药控制不佳的T2DM患者按3∶1随机分为长苏霖组或来得时组，治疗24周。疗效指标包括糖化血红蛋白（HbA1c）、空腹血糖（FPG）、餐后2小时血糖（2hPG）较基线的变化、8点自我血糖监测（SMBG）曲线，以及达到HbA1c和FPG目标的受试者比例。安全性指标包括低血糖发生率、不良事件（AE）和抗甘精胰岛素抗体。治疗24周后，长苏霖组和来得时组的平均HbAlc分别下降1.16%和1.25%，FPG分别下降3.05 mmol/L和2.90 mmol/L，2hPG分别下降2.49 mmol/L和2.38 mmol/L。两组上述参数均无显著差异（均P>0.05）。长苏霖组和来得时组在基线8点SMBG曲线以及达到HbA1c和FPG目标的受试者比例方面也无显著差异（均P>0.05）。两组的总低血糖发生率（长苏霖组和来得时组分别为38.00%和39.01%）和夜间低血糖发生率（长苏霖组和来得时组分别为17.25%和16.31%）相似（均P>0.05）。大多数低血糖事件无症状，两组均未发现严重低血糖。两组的不良事件发生率（61.77%对52.48%）和抗甘精胰岛素抗体（治疗24周后，6.91%对3.65%）无差异（均P>0.05）。与来得时相比，长苏霖显示出相似的疗效和安全性，T2DM患者对长苏霖治疗耐受性良好。
