Tier 2 — strong

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

Ji L, Ma J, Ma Y, Cheng Z, Gan S, Yuan G, Liu D, Li S, Liu Y, Xue X, Bai J, Wang K, Cai H, Li S, Liu K, Yu M, Liu L
JAMA network open 2025 8(3):e2462185

Bibliography

PubMed
PMID 40029660
PubMed Central
PMC11877176
DOI
10.1001/jamanetworkopen.2024.62185
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Sponsored by Shenzhen HighTide Biopharmaceutical, which participated in design, conduct, analysis planning and publication work.
Competing interests
Disclosures include HighTide stock options and other pharmaceutical-industry fees or research relationships.

Study snapshot

DesignDouble-blind placebo-controlled phase II randomized trial
ModelHuman participants; see population
Sample113 adults with diabetes; three arms
InterventionHTD1801 500 or 1000 mg twice/day versus placebo
Duration12 weeks
EndpointsGlycemic, lipid or liver measures; Dose response; Safety and tolerability

What the study showed, in plain terms

This phase II study found dose-related HbA1c improvement with berberine ursodeoxycholate.

Key findings

  • Reported placebo-adjusted HbA1c differences were about -0.4 and -0.7 percentage points at the two doses.

What this study can and cannot tell us

Short-term surrogate outcomes and a distinct investigational salt; not a trial of a branded berberine supplement.

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Citation network

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Editorial review

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology