A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients(SUPER-1)

Summary

This is a study to evaluate the efficacy and safety of Supaglutide injection in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention. This trial includes dosage determination (Phase IIb) and efficacy confirmation stage(Phase III). The primary outcome of the phase IIb period is to preliminarily evaluate the efficacy and safety of Supaglutide and to provide the recommended dosage for the Phase 3 period after 12-week treatment. The primary outcome of the Phase III period is to evaluate the efficacy and safety of Supaglutide after 24-week, double-blind treatment. The secondary outcome is to evaluate the efficacy and safety of Supaglutide after 24-week, double-blinded plus 28-week, open-label treatment period.

Timeline

Start

2021-08-03

Primary completion

2023-06-20

Completion

2023-08-16

Outcome

Met primary endpoint

paper The estimated treatment difference vs placebo was -13.71 mmol/mol (-1.26%) (95% CI -17.39, -10.06) for the 1 mg dose PMID 41272211 ↗

Publications

• Zhu D, Ma J, Wang W, Shi B, Dong X, Bian F, Li Q, Wang Y, Jiang C, Wang X, Wang K, Ling H, Shi X, Cheng Z, Yuan G, Li L, Su X, Lu Y, Song W, Zhang Y, Hu W, Zhang X, Wang H, Liu Y, Li J, Zhang L, Liu Y, Sun X, Wang X, Zhang K, Zhao Y, Zhang L, Pan T, Li P, Li S, Zhou H, Jiang C, Zheng X, Ni L, Feng B, Li F, Piao L, Jin H, Liu Y, Cao H, Li Y, Cai H, Mao H, Liang Y, Guo J, Wang Y, Li Y, Xu N, Zhang J, Zhang Q, Pang W, Yu J, Xu Y, Zhou Y, Li Y, Wang Q. Efficacy and safety of efsubaglutide alfa in individuals with type 2 diabetes (SUPER1): a randomised, double-blind, placebo-controlled, Phase IIb/III trial. Diabetologia. 2026 Jun;69(6):1494-1507. doi: 10.1007/s00125-025-06593-2. Epub 2025 Nov 21.
• Wang Q, Jiang F, Xu Y, Lei Y, Zhang L, Sun X. Exposure-Response Analysis of Efsubaglutide Alfa in Patients with Type 2 Diabetes Mellitus. Clin Pharmacokinet. 2025 Dec;64(12):1785-1797. doi: 10.1007/s40262-025-01570-9. Epub 2025 Oct 17.
• Lou YR, Xu YL, Xiong Y, Deng C, Wang Q. Population Pharmacokinetics of Efsubaglutide Alfa in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2025 Apr;64(4):533-552. doi: 10.1007/s40262-025-01475-7. Epub 2025 Feb 17.

Drugs

Indications