Investigational herbal product lowers HbA1c in T2DM patients

Berberine ursodeoxycholate (HTD1801), a first-in-class orally administered gut-liver anti-inflammatory metabolic modulator, offers a novel therapeutic option for T2DM, addressing multiple metabolic and hepatic parameters.

Study details: This randomized clinical trial assessed the efficacy and safety of HTD1801 in 113 patients with T2DM. The mean baseline HbA1c was 8.2%, BMI was 25.5, and FPG was 160.7 mg/dL. Participants were randomized to receive either HTD1801 500-mg twice daily (n=37), 1,000-mg twice daily (n=38), or placebo (n=38) for 12 weeks. The primary endpoint was the change in HbA1c levels, with secondary endpoints evaluating glycemic, hepatic, and cardiometabolic parameters.

Results: At week 12, the 500-mg and 1,000-mg doses of HTD1801 significantly reduced HbA1c levels by -0.4% (95% confidence interval [CI] -0.79% to -0.03%, P=0.04) and -0.7% (95% CI -1.10% to -0.35%, P<0.001), respectively, compared with placebo. A higher percentage of participants in the 1,000-mg group achieved HbA1c levels <7% (55.9% vs. 15.2%) and <6.5% (29.4% vs. 6.1%) compared with placebo, with notable reductions in fasting plasma glucose in both the 500-mg and 1000-mg groups (-13.0 mg/dL and -18.4 mg/dL, respectively).

Source:

Ji L, et al. (2025, March 3). JAMA Netw Open. Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/40029660/