Efficacy and safety of domestic exenatide injection in treating type 2 diabetes: A multicenter, randomized, controlled, and non-inferiority trial
10.3760/cma.j.issn.1000-6699.2017.04.006
- VernacularTitle:国产艾塞那肽注射液治疗2型糖尿病的疗效和安全性:一项多中心随机对照非劣效性研究
- Author:
Qing TIAN
;
Tianpei HONG
;
Lixin GUO
;
Quanmin LI
;
Liyong ZHONG
;
Jinkui YANG
;
Jing YANG
;
Yongyi GAO
;
Wenhua XIAO
;
Jin YANG
- Keywords:
Diabetes mellitus;
type 2;
Exenatide;
Non-inferiority trial
- From:
Chinese Journal of Endocrinology and Metabolism
2017;33(4):301-306
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the efficacy and safety of domestic exenatide injection versus imported exenatide injection in type 2 diabetic patients with inadequate glycemic control on monotherapy or combination therapy of metformin and insulin secretagogues. Methods A multicenter, randomized, parallel-controlled, and non-inferiority trial was carried out. A total of 240 subjects were randomized at a 1:1 ratio to add domestic exenatide injection (trial group) or imported exenatide injection (control group) on the background therapies. The primary endpoint of efficacy was HbA1C change from baseline to week 16. The secondary endpoints of efficacy were the proportion of HbA1C<7.0%, and the changes in fasting plasma glucose (FPG), 2 h plasma glucose after standard meal (2hPG), 7-point self monitoring of blood glucose (7P-SMBG), and body weight from baseline to week 16. Results Among subjects of per-protocol sets, adjusted mean HbA1C reduction was -1.07% in the trial group versus -1.06% in the control group after 16 weeks of treatment. The lower boundary of the two-sided 95% confidence intervals of the mean HbA1C reduction difference between the trial and control groups was -0.29%, which was more than -0.35%, suggesting that the predefined statistical criterion for non-inferiority was achieved. The proportions of subjects achieving HbA1C<7.0% at the end of the 16-week treatment were 56.19% and 54.08% in the trial and control groups, respectively (P>0.05). The changes in FPG, 2hPG, 7P-SMBG and body weight from baseline to week 16 were comparable between the two groups (all P>0.05). Moreover, the incidences of hypoglycemia and adverse events were similar between the two groups (both P>0.05). Conclusion In type 2 diabetic patients inadequately controlled by monotherapy or combination therapy of metformin and insulin secretagogues, the efficacy of cotreatment with domestic exenatide injection is not inferior to that of imported product ones, with a similar safety profile.
