Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes Article Swipe
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
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1001/jamanetworkopen.2024.62185
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1001/jamanetworkopen.2024.62185
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 A 1c (HbA 1c ) 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 HbA 1c 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 HbA 1c 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 patients with T2D (mean [SD] age, 54.3 [10.6] years; 72 male [63.7%]) who were randomized. Among these patients, the mean (SD) HbA 1c level was 8.2% (0.8%); body mass index, 25.5 (3.7), calculated as weight in kilograms divided by height in meters squared; and FPG level, 160.7 (38.3) mg/dL. Baseline disease severity was balanced across treatment groups. The primary end point was achieved with significant dose-dependent reductions in the HbA 1c level in both HTD1801 groups compared with the placebo group. The least-squares mean difference in the HbA 1c level at week 12 was −0.4% (95% CI, −0.79% to −0.03%; P = .04) for the 500-mg group and −0.7% (95% CI, −1.10% to −0.35%; P < .001) for the 1000-mg group compared with the placebo group. HbA 1c level reductions were paralleled with mean (SD) improvements in the FPG level in both the 500-mg group (−13.0 [38.2] mg/dL) and the 1000-mg group (−18.4 [21.8] mg/dL) groups. Reductions were observed in lipids and markers of liver injury in the 1000-mg group. HTD1801 was safe and well tolerated, with 110 patients (97.3%) completing the study. Treatment-emergent adverse events, generally mild, occurred in 59 patients (52.2%) overall. One patient (in the 500-mg group) experienced a serious adverse event of retinal hemorrhage, which was unlikely related to treatment. No patients discontinued due to an adverse event. Conclusions and Relevance In this placebo-controlled randomized clinical trial, treatment with HTD1801 resulted in significant reductions in the HbA 1c 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. Trial Registration ClinicalTrials.gov Identifier: NCT06411275
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1001/jamanetworkopen.2024.62185
- https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2830820/ji_2025_oi_241733_1740068767.56731.pdf
- OA Status
- gold
- Cited By
- 11
- References
- 36
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4408091434
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4408091434Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1001/jamanetworkopen.2024.62185Digital Object Identifier
- Title
-
Berberine Ursodeoxycholate for the Treatment of Type 2 DiabetesWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2025Year of publication
- Publication date
-
2025-03-03Full publication date if available
- Authors
-
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 LiuList of authors in order
- Landing page
-
https://doi.org/10.1001/jamanetworkopen.2024.62185Publisher landing page
- PDF URL
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https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2830820/ji_2025_oi_241733_1740068767.56731.pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
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goldOpen access status per OpenAlex
- OA URL
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https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2830820/ji_2025_oi_241733_1740068767.56731.pdfDirect OA link when available
- Concepts
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Medicine, Glycemic, Type 2 diabetes, Internal medicine, Clinical endpoint, Randomized controlled trial, Placebo, Diabetes mellitus, Physical therapy, Endocrinology, Insulin, Alternative medicine, PathologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
11Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 11Per-year citation counts (last 5 years)
- References (count)
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36Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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