Introduction and Objective: Once-weekly (QW) insulin aims to reduce treatment burden by lowering injection frequency, potentially enhancing treatment acceptance and adherence. This trial evaluated the efficacy and safety of a novel QW insulin analog GZR4 versus once-daily (QD) insulin degludec (IDeg) in insulin-naïve subjects with T2D inadequately controlled by OADs.Methods: In this open-label, treat-to-target phase 2 trial, 83 eligible subjects with HbA1c between 7.5% and 10.0% were randomized in a 1:1 ratio to receive either GZR4 or IDeg treatment for 16 weeks. The primary endpoint was the change in HbA1c from baseline to week 16. Safety endpoints, including hypoglycemia and TEAE, were evaluated.Results: The LSM HbA1c reduction was comparable between GZR4 and IDeg groups (−1.50% vs. -1.48%, p = 0.902). GZR4 group showed a similar proportion of achieving HbA1c goals and FPG reduction compared to IDeg, but with a half lower weekly insulin dosage at steady state than IDeg (80.6 vs 165.8 U/week, p<0.001). TEAEs were mild and similar between groups, with low and comparable rates of level 2 hypoglycemia. No SAEs were deemed related to GZR4.Conclusion: GZR4 demonstrated comparable efficacy and safety profiles to QD IDeg in subjects with T2D, achieving similar outcomes with a lower insulin dose. GZR4 is promising to be a safe and effective QW 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. W. Chen: None. Z. Gan: None.
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