Long-term Efficacy and Safety of HMS5552 add-on to Metformin in T2DM Subjects

Phase 3 Completed 767 enrolled Hua Medicine Limited Covance · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study evaluates the efficacy and safety and population PK of HMS5552 add-on to Metformin in adult type 2 diabetic subjects. There will be 2 groups in the first 24 weeks, one group will receive HMS5552 plus Metformin, while the other group will receive placebo plus Metformin; after 24 weeks, all subjects will receive HMS5552 plus Metformin for 28 weeks.

Timeline

Start: 2017-10-15
Primary completion: 2021-02-28
Completion: 2021-02-28

Outcome

Met primary endpoint

paper estimated treatment difference, -0.66%; 95% CI: -0.79, -0.53; P < 0.0001). PMID 35551292 ↗

release “In addition, 24-week topline results were announced recently: The phase III metformin combination clinical trial met the primary efficacy endpoint.” huamedicine.com ↗

release “DAWN study include: Significant and long-lasting efficacy: ● The HbA1c reduction was 1.02% from baseline” huamedicine.com ↗

Publications

Yang W, Zhu D, Gan S, Dong X, Su J, Li W, Jiang H, Zhao W, Yao M, Song W, Lu Y, Zhang X, Li H, Wang G, Qiu W, Yuan G, Ma J, Li W, Li Z, Wang X, Zeng J, Yang Z, Liu J, Liang Y, Lu S, Zhang H, Liu H, Liu P, Fan K, Jiang X, Li Y, Su Q, Ning T, Tan H, An Z, Jiang Z, Liu L, Zhou Z, Zhang Q, Li X, Shan Z, Xue Y, Mao H, Shi L, Ye S, Zhang X, Sun J, Li P, Yang T, Li F, Lin J, Zhang Z, Zhao Y, Li R, Guo X, Yao Q, Lu W, Qu S, Li H, Tan L, Wang W, Yao Y, Chen D, Li Y, Gao J, Hu W, Fei X, Wu T, Dong S, Jin W, Li C, Zhao D, Feng B, Zhao Y, Zhang Y, Li X, Chen L. Dorzagliatin add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial. Nat Med. 2022 May;28(5):974-981. doi: 10.1038/s41591-022-01803-5. Epub 2022 May 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dorzagliatin	Small molecule	75 mg	Oral