The efficacy and safety of recombinant human insulin injection in the treatment of diabetic patients: a multicenter, randomized, controlled and open-labled clinical trial / 中华内科杂志

ABSTRACT

Objective A multicenter, randomized, controlled and open-labled clinical trial was performed to compare the efficacy and safety of recombinant human insulin injection ( Yousilin R) and treated with Yousilin R versus Novolin R for 12 weeks respectively. Results Compared with baseline,the levels of glycosylated hemoglobin A1c ( HbA1c ) at the end of 12 weeks treatment decreased from 10. 77% to 7. 72% ( P ＜0. 05 ) in Yousilin R group and from 10. 33% to 7. 62% ( P ＜0. 05 ) in Novolin R group,2-hour postprandial plasma glucose ( 2hPG ) decreased from 15.49 mmol/L to 9. 72 mmol/L ( P ＜ 0. 05 ) in Yousilin R group and from 15.33 mmol/L to 10. 07 mmol/L( P ＜ 0. 05 ) in Novolin R group, and fasting plasma glucose (FPG) decreased from 10. 90 mmol/L to 7. 31 mmol/L( P ＜0. 05 ) in Yousilin R group and from 10. 22 mmol/L to 7.21 mmol/L (P ＜0. 05) in Novolin R group. The changes of HbA1c, 2hPG and FPG from baseline to endpoint in Yousilin R group was similar to those in Novolin R group ( P ＞ 0. 05 ).Furthermore, hypoglycemic events(26. 42% vs 30. 48% ), other adverse events( 13.21%vs 16. 19% ) ,and serious adverse events( 1.89%vs 1.90% )were comparable between Yousilin R and Novolin R groups(P ＞0. 05 ). Conclusions Yousilin R has similar efficacy, safety and compliance profiles to Novolin R group in the treatment of diabetic patients.