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
| Autor: | Jun, Yao, Xiaohui, Guo, Li, Sun, Ping, Han, Xiaofeng, Lv, Xiuzhen, Zhang, Zhaohui, Mo, Wenying, Yang, Lihui, Zhang, Zhanjian, Wang, Lvyun, Zhu, Quanmin, Li, Tao, Yang, Wenbo, Wang, Yaoming, Xue, Yongquan, Shi, Juming, Lu, Yongde, Peng, Fan, Zhang, Dewen, Yan, Damei, Wang, Xuefeng, Yu |
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| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | Current Medical Research and Opinion. 38:1797-1806 |
| ISSN: | 1473-4877 0300-7995 2000-3129 |
| Popis: | This phase 3 confirmatory diabetes mellitus treatment study compared the safety and efficacy of Rapilin and NovoRapid insulin asparts in combination with metformin.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 HbA1c7.0% and ≤6.5%.590 patients with type 2 diabetes mellitus were randomized to Rapilin (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.ChiCTR20003129041. |
| Databáze: | OpenAIRE |
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