Efficacy and safety of glargine insulin injection Uslen versus Lantus in diabetic patients: a multicenter, randomized, open-labeled controlled trial

Objective To evaluate the efficacy and safety of glargine insulin injection (Uslen) in treatment of diabetic patients. Methods A 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. Results All 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 0.05). 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. Conclusion Compared 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