Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical Trial
Authors' conclusion
In this placebo-controlled randomized clinical trial, treatment with HTD1801 resulted in significant reductions in the HbA1c level and improvements in key cardiometabolic and liver parameters. HTD1801 was safe and well tolerated. These findings are being confirmed in ongoing phase 3 studies. The effects demonstrated by HTD1801 support an oral treatment option for T2D and its comorbidities.
Study context
- Population
- Patients with T2D after ≥8 weeks of diet and exercise, hemoglobin A1c (HbA1c) 7.0% to 10.5%, fasting plasma glucose (FPG) <250.5 mg/dL, China; mean age 54.3 years, 63.7% male, mean HbA1c 8.2%110 completed
- Participants
- 113 patients
- Comparison
- HTD1801 500 mg or 1000 mg twice daily vs placebo
- Placebon = 38reference
- 500-mgn = 37
- 1000-mgn = 38
- Primary endpoint
- HbA1c change from baseline
- Follow-up
- Week 12
Methodological detailsphase 2, double-blind, placebo-controlled, randomized 1:1:1
- Phase 2
- Double-blind
- Placebo-controlled
- Randomized 1:1:1
Primary result
As reported in the abstract
Each group vs placeboLeast-squares mean difference, % (95% CI)P value
500-mg
−0.4(−0.79% to −0.03%)
P = 0.041000-mg
−0.7(−1.10% to −0.35%)
P < 0.001Secondary outcomes
Mean, mg/dL
| Outcome | 500-mg | 1000-mg |
|---|---|---|
| FPG change | −13.0 (SD 38.2) | −18.4 (SD 21.8) |
Lipids and liver injury markers
- Reductions observed in lipids and markers of liver injury in the 1000-mg group
Safety
Adverse events
- Treatment-emergent AEs, generally mild, overall
- 59 patients (52.2%)
- Serious AE (retinal hemorrhage, unlikely treatment-related), 500-mg
- 1 patient
- Discontinued due to AE
- 0
Original publication
Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. Published 3 March 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →