Comparative efficacy and safety of two insulin aspart formulations (Rapilin and NovoRapid) when combined with metformin, for patients with diabetes mellitus: a multicenter, randomized, open-label, controlled clinical trial

作者：Yao, Jun; Guo, Xiaohui^*; Sun, Li; Han, Ping; Lv, Xiaofeng; Zhang, Xiuzhen; Mo, Zhaohui; Yang, Wenying; Zhang, Lihui; Wang, Zhanjian; Zhu, Lvyun; Li, Quanmin; Yang, Tao; Wang, Wenbo; Xue, Yaoming; Shi, Yongquan; Lu, Juming; Peng, Yongde; Zhang, Fan; Yan, Dewen; Wang, Damei; Yu, Xuefeng

来源：Current Medical Research and Opinion, 2022, 38(11): 1797-1806.

DOI：10.1080/03007995.2022.2100652

• Clinical trial
• diabetes mellitus
• efficacy
• insulin aspart
• NovoRapid
• Rapilin

Objective This phase 3 confirmatory diabetes mellitus treatment study compared the safety and efficacy of Rapilin and NovoRapid insulin asparts in combination with metformin. Methods This 24-week, open-label, randomized, active-controlled, noninferiority phase 3 confirmatory study conducted across centers in China aimed to enroll patients with type 2 diabetes mellitus and blood sugar glucose inadequately controlled by oral antidiabetic drugs. Randomized patients received subcutaneous mealtime Rapilin or NovoRapid (3:1) injections, with metformin. The primary objectives were to demonstrate noninferiority (margin of 0.4%) in HbA1c change from baseline and compare safety profiles of Rapilin versus NovoRapid after 24 weeks. Secondary outcomes included 2-h postprandial plasma glucose (PPG), fasting plasma glucose (FPG), and patients achieving HbA1c Results 590 patients with type 2 diabetes mellitus were randomized to Rapilin (n = 441) and NovoRapid (n = 149) groups. After 24 weeks, the mean HbA1c change from baseline was -2.20% (Rapilin) and -2.32% (NovoRapid); the estimated treatment difference based on least-square means was 0.04% (95% CI: -0.17, 0.26), meeting the noninferiority criteria for Rapilin versus NovoRapid. Comparable improvements were reported for mean 2-hour PPG (6.14 and 6.29 mmol/L), FPG (2.02 and 1.70 mmol/L), and patients with HbA1c <7.0% (52.6% and 51.0%) and <= 6.5% (34.2% and 30.9%), in the Rapilin and NovoRapid groups, respectively, with no significant safety or immunogenicity outcome differences. Conclusions Rapilin demonstrated non-inferior glycemic control, and matching safety and immunogenicity to NovoRapid in patients with type 2 diabetes mellitus also receiving metformin over 24 weeks.

• 单位
  河北医科大学; 5; 华中科技大学; 同济大学; 中国医科大学; 深圳市第二人民医院; 北京大学; 南方医科大学