Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

Summary

The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin.

Timeline

Start

2023-11-13

Primary completion

2024-12-12

Completion

2025-07-30

Outcome

Met primary endpoint

paper The adjusted least-squares mean difference between groups for the change in HbA1c from baseline to week 24 was -0.5 (95% CI, -0.7 to -0.4; P<0.0001). PMID 42251702 ↗

Publications

• Ji L, Cheng Z, Ma J, Liu D, Zhang X, Dong X, Lin Y, Yang M, Gan S, Cai H, Wang X, Liu Y, Shi X, Liu K, MacConell L, Yu M, Liu L. HTD1801 in Combination with Metformin for Type 2 Diabetes. NEJM Evid. 2026 Jul;5(7):EVIDoa2500317. doi: 10.1056/EVIDoa2500317. Epub 2026 Jun 7.

Drugs

Indications