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

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 metformin treatment. 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 combined with metformin 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 combined with metformin treatment after 24-week, double-blind treatment. The secondary outcome is to evaluate the efficacy and safety of Supaglutide combined with metformin during the 24-week, double-blinded plus 28-week, open-label treatment period.

Timeline

Start

2021-10-12

Primary completion

2023-06-15

Completion

2023-08-13

Publications

• Jia W, Gao F, Lu J, Cheng Z, Dong X, Shi X, Su X, Li L, Zhang W, Wang Y, Ma J, Li S, Wang H, Cheng L, Mao L, Jiang C, Li Q, Li X, Zheng X, Liu M, Sun J, Peng H, Pan H, Ling H, Jiang C, Song J, Zhang X, Zhang L, Liu Y, Zeng T, Zhao Y, Xu Y, Li Y, Bao Y, Zhou J, Wang Q. Efsubaglutide alfa added to metformin improves glycaemia with beta-cell functional responses in type 2 diabetes: a randomised, double-blind, placebo-controlled, two-stage adaptive phase 2b/3 trial (SUPER 2). Nat Commun. 2026 May 8. doi: 10.1038/s41467-026-72574-7. Online ahead of print.
• Wang Q, Jiang F, Xu Y, Lei Y, Zhang L, Sun X. Exposure-Response Analysis of Efsubaglutide Alfa in Patients with Type 2 Diabetes Treated with Metformin. Clin Pharmacokinet. 2025 Dec;64(12):1799-1809. doi: 10.1007/s40262-025-01569-2. Epub 2025 Sep 24.
• 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