Original Article
Efficacy and safety of glargine insulin injection Uslen versus Lantus in diabetic patients: a multicenter, randomized, open-labeled controlled trial
Yunhui Liu, Liqiong Hou, Tieyun Zhao, Haoming Tian, Xiaofeng Lyu, Jinkui Yang, Ling Li, Lyuyun Zhu, Lihui Zhang, Changjiang Wang, Shandong Ye, Zhiguang Zhou, Zhaohui Mo, Xiaoyue Wang, Zhongyuan Wen, Yaoming Xue, Hailin Pan, Xiaodong Yan, Mian Xu, Ganxiong Liang, Jianhua Ma, Guangyao Song, Ying Zhang
Published 2014-06-27
Cite as Chin J Diabetes Mellitus, 2014, 06(6): 377-381. DOI: 10.3760/cma.j.issn.1674-5809.2014.06.006
Abstract
ObjectiveTo evaluate the efficacy and safety of glargine insulin injection (Uslen) in treatment of diabetic patients.
MethodsA multicenter, randomized, open-labeled and positive control clinical trial included the patients with type 1 or type 2 diabetes mellitus having poor glucose control after using oral antidiabetic drug or short-acting insulin. All patients were treated with Uslen or Lantus for 16 weeks in two groups by a ratio of 1∶1. The decreased value and qualification rates of glycated hemoglobin A1c(HbA1c) and fasting blood glucose (FBG), the incidence of hypoglycemic and the adverse events were compared pretreatment at the end of 16 weeks' treatment.
ResultsAll of 664 cases were randomized into two groups and received therapy (1∶1). But 623 cases were in complete conformity to design plan, 313 cases received Uslen therapy and 310 cases received Lantus therapy. There were no different in age, sex, nation, height and weight between two groups. At the end of 16 weeks' treatment, according to the per-protocol analysis (PPS), the decreased values of HbA1c separately (9.2±1.5)% vs (7.7±1.2)% and (9.3±1.5) vs (7.7±1.1)%, FBG separately (10.2±2.1 vs 7.2±2.0) mmol/L and (10.3±2.3 vs 7.4±2.3) mmol/L were all proved significantly in both Uslen group and Lantus group (all P<0.001). But the changes of HbA1c(1.5% vs 1.6%, F=0.766, P=0.382) and FBG(3.0 vs 2.9 mmol/L, F=0.280, P=0.597)from baseline to endpoint were similar between the treatment groups (P>0.05). There were no significant difference in the two groups on the qualification rates of HbA1c(26.2%(82/313)vs 21.3%(66/310), P=0.155) and FBG(29.1%(91/313) vs 28.4%(88/310), P>0.05). There were no significant difference separately 22.7% (75/330) and 22.0% (74/333) on hypoglycemia incidences, and the other adverse events incidences were similar separately 0.3% (1/330 vs 1/333, P>0.05) in two groups.
ConclusionCompared with Lantus, the glargine insulin injection of Uslen has similar effect on lowering blood sugar and good security, which has better clinical value.
Key words:
Diabetes mellitus; Insulin, glargine; Efficacy; Safety
Contributor Information
Yunhui Liu
Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu 610041, China
Liqiong Hou
Tieyun Zhao
Haoming Tian
Xiaofeng Lyu
Jinkui Yang
Ling Li
Lyuyun Zhu
Lihui Zhang
Changjiang Wang
Shandong Ye
Zhiguang Zhou
Zhaohui Mo
Xiaoyue Wang
Zhongyuan Wen
Yaoming Xue
Hailin Pan
Xiaodong Yan
Mian Xu
Ganxiong Liang
Jianhua Ma
Guangyao Song
Ying Zhang
