Original Article
Comparison of efficacy and safety of insulin aspart 30 injection in the treatment of type 2 diabetes mellitus: a multicenter, randomized, open, parallel and phase Ⅲ clinical study
Weimin Wang, Ling Li, Xiuzhen Zhang, Zhongyan Shan, Guixia Wang, Lihui Zhang, Jianhua Ma, Dongmei Li, Jing Yang, Xing Li, Jinkui Yang, Changjiang Wang, Xingwu Ran, Yaoming Xue, Yanlan Yang, Quanmin Li, Hanqing Cai, Zhaoli Yan, Dalong Zhu
Published 2023-01-20
Cite as Chin J Diabetes Mellitus, 2023, 15(1): 32-38. DOI: 10.3760/cma.j.cn115791-20220801-00372
Abstract
ObjectiveTo explore the efficacy and safety of biphasic insulin aspart 30 (Ruisulin®30 and NovoMix®30) in treatment of patients with type 2 diabetes mellitus.
MethodsThis was a multicenter, randomized, open-labeled, parallel, positive drug-controlled phase Ⅲ clinical trial. This trial included the 588 T2DM patients having poor glucose control after using oral hypoglycemic drugs. All patients were treated with Ruisulin®30 or NovoMix®30 for 24 weeks in both groups by a ratio of 3∶1 according to block random method. The decreased value and qualification rates of glycosylated hemoglobin A1c (HbA1c), fasting blood glucose (FPG), 2-hour standard postprandial venous plasma glucose (2hPG), the incidence of hypoglycemic and adverse events, and the positive rate of aspartic islet specific antibody were compared at the end of 24 weeks. The full analysis set and per-protocol dataset were used for the effectiveness index analysis, and the safety set was used for the security index analysis. Analysis of matched samples t-test, t-test, χ2 test and Wilcoxon test were used.
ResultsThe trial included all 588 cases, and 528 of them were completely in accordance with the design plan (395 cases received Ruisulin®30 therapy and 133 cases received NovoMix®30 therapy). There were 583 cases in full analysis set and safety data set (439 cases received Ruisulin®30 therapy and 144 cases received NovoMix®30 therapy), and 515 cases met per-protocol dataset (386 cases received Ruisulin®30 therapy and 129 cases received NovoMix®30 therapy). At the end of 24-week treatment period, HbA1c in Ruisulin®30 group and NovoMix®30 group decreased by (1.73±1.27)% and (1.77±1.40)%, FPG decreased by (2.34±2.69) and (2.68±2.84) mmol/L, and 2hPG decreased by (4.37±4.59) and (4.81±4.43) mmol/L, respectively. There was no statistically significant differences in above parameters between the two groups (all P>0.05). After 24 weeks of treatment, the incidence of hypoglycemic events was 74.3% (326/439) and 68.1% (98/144) in Ruisulin®30 group and NovoMix®30 group, respectively. The incidence of adverse events [ 68.1% (299/439) and 66.7% (96/144), respectively] was similar to the rate of anti-insulin Aspart antibody positivity [51.9% (228/439) and 50.7% (73/144), respectively], and none of the differences were statistically significant (all P>0.05).
ConclusionRuisulin®30 has good safety, and provides similar glycemic control profiles to NovoMix®30, indicating that Ruisulin®30 has clinical application value.
Key words:
Diabetes mellitus, type 2; Insulin aspart 30; Efficacy; Safety
Contributor Information
Weimin Wang
Department of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical Sohool, Nanjing 210008, China
Ling Li
Department of Endocrinology, Shengjing Hospital of China Medical University, Shenyang 110004, China
Xiuzhen Zhang
Department of Endocrinology, Tongji Hospital of Tongji University, Shanghai 200065, China
Zhongyan Shan
Department of Endocrinology, the First Hospital of China Medical University, Shenyang 110001, China
Guixia Wang
Department of Endocrinology, the First Hospital of Jilin University, Changchun 130061, China
Lihui Zhang
Department of Endocrinology, the Second Hospital of Hebei Medical University, Shijiazhuang 050000, China
Jianhua Ma
Department of Endocrinology, Nanjing First Hospital, Nanjing 210012, China
Dongmei Li
Department of Endocrinology, Inner Mongolia Autonomous Region People′s Hospital, Hohhot 737399, China
Jing Yang
Department of Endocrinology, First Hospital of Shanxi Medical University, Taiyuan 030001, China
Xing Li
Department of Endocrinology, Second Hospital of Shanxi Medical University, Taiyuan 030001, China
Jinkui Yang
Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University, Beijing 100005, China
Changjiang Wang
Department of Endocrinology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China
Xingwu Ran
Department of Endocrinology, West China Hospital of Sichuan University, Chengdu 610044, China
Yaoming Xue
Department of Endocrinology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China
Yanlan Yang
Department of Endocrinology, Shanxi Provincial People′s Hospital, Taiyuan 030012, China
Quanmin Li
Department of Endocrinology, Plarocket Force General Hospital, Beijing 100088, China
Hanqing Cai
Department of Endocrinology, the Second Hospital of Jilin University, Changchun 130041, China
Zhaoli Yan
Department of Endocrinology, the Affiliated Hospital of Inner Mongolia Medical University, Hohhot 750306, China
Dalong Zhu
Department of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical Sohool, Nanjing 210008, China
