insulin aspart in Chinese patients with type 2 diabetes inadequately controlled on basal or premixed insulin: A multicenter, randomized, open-label, phase 3 study.

2025-11-21
Journal of diabetes investigation 17(1)
- Leili Gao
- Zhifeng Cheng
- Guoqing Ma
- Xiaojun Cai
- Xiaoyun Wang
- Yibing Lu
- Ziling Li
- Wei Li
- Shuping Zhao
- Xuefeng Li
- Chengwei Song
- Yunming Gao
- Jianlin Geng
- Haiyan Cao
- Jingfang Sun
- Linong Ji

PubMed: 41269878
DOI: 10.1111/jdi.70175

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 367
Population: Chinese patients with type 2 diabetes mellitus (T2DM) who were inadequately controlled on once- or twice-daily (BID) premixed or basal insulin ± oral antidiabetic drugs (OADs)
Methods: multicenter, randomized, open-label, parallel-group, active-controlled, phase 3 study, 367 participants randomized 1:1 to receive BID injections of HS-IDegAsp or NN-IDegAsp for 24 weeks
Blinding: Open-label
Duration: 24 weeks
Funding: Unclear

Large Human Trial

Aims

To compare the efficacy and safety of insulin degludec/insulin aspart biosimilar B01711 (HS-IDegAsp) with originator insulin degludec/insulin aspart-Ryzodeg (NN-IDegAsp) in Chinese patients with type 2 diabetes mellitus (T2DM) who were inadequately controlled on once- or twice-daily (BID) premixed or basal insulin ± oral antidiabetic drugs (OADs).

Materials and methods

In this multicenter, randomized, open-label, parallel-group, active-controlled, phase 3 study, 367 participants with T2DM were randomized 1:1 to receive BID injections of HS-IDegAsp (n = 183) or NN-IDegAsp (n = 184) for 24 weeks. Insulins were administered subcutaneously with breakfast and the main evening meal at the same titration target. The primary endpoint was the change from baseline in glycated hemoglobin (HbA_1c) to week 24.

Results

At Week 24, the least squares (LS) mean change in HbA_1c from baseline was -1.12% (95% CI -1.24 to -1.01) and -1.23% (95% CI -1.34 to -1.11) with HS-IDegAsp and NN-IDegAsp, respectively. The LS mean difference (HS-IDegAsp minus NN-IDegAsp) at Week 24 was 0.10% (95% CI -0.06 to 0.27), demonstrating that HS-IDegAsp was non-inferior to NN-IDegAsp. There was no statistically significant difference (P > 0.05) in fasting plasma glucose or proportion of patients achieving HbA_1c < 7.0% at Week 24 between both groups. Safety and immunogenicity were similar between both groups.

Conclusions

HS-IDegAsp demonstrated comparable efficacy and safety to NN-IDegAsp during the 24-week treatment period in Chinese patients with inadequately controlled T2DM previously treated on once- or twice-daily premixed or basal insulin, with or without OADs.