Efficacy and safety of Changsulin ? compared with Lantus ? in type 2 diabetes: a phase Ⅲ multicenter, randomized, open-label, parallel, controlled clinical trial
10.3760/cma.j.cn112138-20200423-00417
- VernacularTitle:长舒霖 ?和来得时 ?治疗2型糖尿病的有效性和安全性比较：多中心、随机、开放、平行、Ⅲ期临床研究
- Author:
Tingting ZHANG
1
;
Xiaomin LIU
;
Bingyin SHI
;
Changjiang WANG
;
Zhaohui MO
;
Yu LIU
;
Zhongyan SHAN
;
Wenying YANG
;
Quanmin LI
;
Xiaofeng LYU
;
Jinkui YANG
;
Yaoming XUE
;
Dalong ZHU
;
Yongquan SHI
;
Qin HUANG
;
Zhiguang ZHOU
;
Qing WANG
;
Qiuhe JI
;
Yanbing LI
;
Xin GAO
;
Juming LU
;
Junqing ZHANG
;
Xiaohui GUO
Author Information
1. 北京大学第一医院内分泌科 100034
- From:
Chinese Journal of Internal Medicine
2020;59(12):960-967
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the efficacy and safety of Changsulin ? with Lantus ? in treating patients with type 2 diabetes mellitus (T2DM). Methods: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. Results: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 P>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 P>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 P>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 P>0.05). Conclusions:Changsulin ? shows similar efficacy and safety profiles compared with Lantus ? and Changsulin ? treatment was well tolerated in patients with T2DM.
