Original Article
Comparison of efficacy and safety of insulin aspart injection Rishulin and NovoRapid for treatment of diabetes: a multicenter, randomized, open-labeled, controlled trial
Jia Weiping, Bao Yuqian, Miao Heng, Tu Ping, Liu Yu, Yang Tao, Wang Wenbo, Shi Bingyin, Liu Ming, Hua Wenjin, Hou Ningning, Zhang Qiu, Hu Ling, Pang Shuguang, Liu Jingdong, Wang Guixia
Published 2021-12-01
Cite as Chin J Intern Med, 2021, 60(12): 1148-1156. DOI: 10.3760/cma.j.cn112138-20210127-00075
Abstract
ObjectiveTo compare the efficacy and safety of Tonghua Dongbao′s insulin aspart injection (Rishulin) and NovoRapid (Novo Nordisk) in the treatment of diabetes.
MethodsA 26-week, randomized, open-label, parallel-group, positive control drug and non-inferiority trial was conducted in 23 centers in China. A total of 563 diabetes with poor blood glucose control treated with insulin for at least 3 months before were included. The subjects were randomized(stratified block random method) into those receiving Rishulin or NovoRapid at a ratio of 3∶1. Both groups were combined with basal insulin (Lantus). The primary endpoint was the change in glycosylated hemoglobin (HbA1c) from baseline to the end of 24 weeks of treatment.
ResultsFor full analysis set, after 24 weeks of treatment, HbA1c level of Ruishulin group decreased from (8.66±1.28)% to (7.77±1.09)% (P<0.001), and that of NovoRapid group decreased from (8.47±1.28) % to (7.65±0.97) % (P<0.001). Treatment difference in HbA1c (NovoRapid group-Ruishulin group) was -0.061% (95%CI -0.320-0.199). HbA1c<7.0% target reacing rates were 24.26% and 21.21% (P=0.456), and HbA1c<6.5% target reacing rates were 9.65% and 6.82% (P=0.310) in Ruishulin group and NovoRapid group, repectively. The standard 2 hours postprandial blood glucose (2hPG) in Ruishulin group decreased from (16.23±5.22) mmol/L to (12.65±4.57) mmol/L (P<0.001), and 2hPG in NovoRapid group decreased from (16.13±5.37) mmol/L to (11.91)±4.21) mmol/L (P<0.001). The fingertips blood glucose at 7-point of both groups exhibited varying degrees of reduction compared with those at baseline, repectively. Positive ratios of specific antibodies were 31.68% in Ruishulin group and 36.36% in NovoRapid group (P=0.320). Ratios of negative to positive were 7.43% and 10.61% (P=0.360), and ratios of positive to negative were 10.40% and 7.58% (P=0.360) in Ruishulin group and NovoRapid group, respectively. The incidence of hypoglycemia was 60.05% and 55.40% (P=0.371), and the incidence of adverse events was 76.60% and 77.70% (P=0.818) in Ruishulin group and NovoRapid group, respectively.
ConclusionsRishulin is not inferior to NovoRapid, and has shown good efficacy and safety. It can be an ideal choice for clinicians in patients with poor blood glucose control with insulin.
Key words:
Diabetes mellitus; Insulin aspart; Efficacy; Safety
Contributor Information
Jia Weiping
Department of Endocrinology, Shanghai Jiaotong University Affiliated Sixth People′s Hospital, Shanghai 200233, China
Bao Yuqian
Department of Endocrinology, Shanghai Jiaotong University Affiliated Sixth People′s Hospital, Shanghai 200233, China
Miao Heng
Department of Endocrinology, Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, China
Tu Ping
Department of Endocrinology, Nanchang Third Hospital, Nanchang 330009, China
Liu Yu
Department of Endocrinology, Second Hospital of Jilin University, Changchun 130041, China
Yang Tao
Department of Endocrinology, Jiangsu Province People′s Hospital, Nanjing 210029, China
Wang Wenbo
Department of Endocrinology, Shougang Hospital of Peking University, Beijing 100144, China
Shi Bingyin
Department of Endocrinology, First Affiliated Hospital of Xi′an Jiaotong University, Xi′an 710061, China
Liu Ming
Department of Endocrinology, General Hospital of Tianjin Medical University,Tianjin 300020,China
Hua Wenjin
Department of Endocrinology, Wuxi Third People′s Hospital, Wuxi 214043, China
Hou Ningning
Department of Endocrinology, Affiliated Hospital of Weifang Medical College, Weifang, Shandong 261033, China
Zhang Qiu
Department of Endocrinology, First Affiliated Hospital of Anhui Medical University, Hefei 230022, China
Hu Ling
Department of Endocrinology, Nanchang First Hospital, Nanchang 330008, China
Pang Shuguang
Department of Endocrinology, Ji′nan Central Hospital, Ji′nan 250013, China
Liu Jingdong
Department of Endocrinology, Jiangxi Province People′s Hospital, Nanchang 330006, China
Wang Guixia
Department of Endocrinology, First Hospital of Jilin University, Changchun 130021, China
