Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes

作者：Linong Ji, Jianhua Ma, Yujin Ma, Zhifeng Cheng, Shenglian Gan, Guoyue Yuan, Dexue Liu, Sheli Li, Yu Liu, Xia Xue, Jie Bai, Kun Wang, Hanqing Cai, Shu Li, Kui Liu, Meng Yu, Liping Liu · 发表于：JAMA Network Open · 年份：2025 · DOI：10.1001/jamanetworkopen.2024.62185 · 被引用次数：32 · 研究领域：Berberine and alkaloids research、Ginseng Biological Effects and Applications、Dietary Effects on Health

Importance: Few of the available therapies for type 2 diabetes (T2D) comprehensively address disease burden beyond glycemic control. Examining whether berberine ursodeoxycholate (HTD1801), a first-in-class gut-liver anti-inflammatory metabolic modulator, has the potential to treat the core aspects of metabolic disease is important. Objective: To assess the safety and efficacy of HTD1801 in patients with T2D that is inadequately controlled with diet and exercise. Design, Setting, and Participants: This phase 2 double-blind, placebo-controlled, 12-week randomized clinical trial, conducted in China between March 2022 and January 2023, included patients with T2D who underwent 8 or more weeks of diet and exercise, had a hemoglobin A1c (HbA1c) level of 7.0% to 10.5%, and had a fasting plasma glucose (FPG) level less than 250.5 mg/dL. Interventions: Patients were randomized 1:1:1 to placebo (n = 38), HTD1801 500 mg twice daily (n = 37), and HTD1801 1000 mg twice daily (n = 38). Main Outcomes and Measures: The primary end point was the HbA1c level change from baseline to week 12. Secondary end points included glycemic, hepatic, and cardiometabolic parameters. The primary end point was analyzed using a mixed-effects model for repeated measures, with the HbA1c level change from baseline as the dependent variable. Treatment group, measurement time point, and interaction between treatment group and measurement time point were independent variables. Results: The study included 113 patient...