Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical Trial.

ABSTRACT:

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

SUBMITTER: Ji L 

PROVIDER: S-EPMC11877176 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature