Introduction and Objective: Once-weekly (QW) insulins have emerged as a research focus due to their potential to enhance treatment acceptance and adherence by reducing injection frequency. This trial studied the efficacy and safety of a novel QW insulin analog GZR4 versus once-daily (QD) insulin degludec (IDeg) in basal insulin-treated subjects with T2D inadequately controlled by OADs.Methods: In this open-label, treat-to-target phase 2 trial, 96 eligible subjects with HbA1c from 7.5 to 10.0% were randomized in a 1:1 ratio to receive either GZR4 or IDeg treatment for 16 weeks. The primary endpoint was HbA1c change from baseline to week 16. Safety endpoints, including hypoglycemia and TEAE, were evaluated.Results: The LSM HbA1c reduction was significantly higher in the GZR4 than in the IDeg group (−1.26% vs. −0.87%, p< 0.01). The proportion of subjects achieving HbA1c <7% was higher in GZR4 group. GZR4 group showed a strikingly lower weekly insulin dosage at the steady state than IDeg group ( 88.7 vs. 218.2 U/week, p<0.001). Incidences of TEAEs were similar between the two treatments. GZR4 group showed a slightly higher level 2 hypoglycemia than IDeg group.Conclusion: GZR4 demonstrated superior HbA1c reduction after 16 weeks of treatment in insulin-treated subjects with T2D and is promising to be a safe and effective QW basal insulin in diabetes management.
L. Chen: None. X. Dong: None. H. Wang: None. H. Shu: None. Z. Cheng: None. X. Deng: None. G. Wang: None. J. Zhao: None. C. Hao: None. T. Xie: None. A. He: None. Y. Li: None. H. Wu: None. S. Carter: None. Z. Gan: None. W. Chen: None.
Source link
Leave a Reply