Summary
Berberine has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Type 2 Diabetes. ClinicalTrials.gov lists 8 registered trials linking Berberine to Type 2 Diabetes: 1 is currently recruiting; 3 are active or not yet recruiting; 4 have completed. The most advanced is Phase 3 (NCT06353347). It plans or enrolled 551 participants. Registration activity spans 2008 to 2026. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2019 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Type 2 Diabetes Mellitus ranks 767 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: 1.6-1.7% at 7 years on standard care (population-level cohorts UK and US).
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 61.0 (trials 26.0, literature 30.0, tier 5, approved bonus 0.0) |
| Registered trials | 8 total: 1 recruiting, 3 active / not yet recruiting, 4 completed, 0 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 1 systematic review) |
| Agent type | Supplement (Nutraceutical) |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Potential dietary and lifestyle interventions for decreasing insulin resistance · Halma MTJ, Syed M, Marik PE · 2023 |
| Data sources | OSMF Chronic Disease Review |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT06353347 | Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin 2023 | completed | Phase 3 | 551 |
| NCT06350890 | Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes 2023 | completed | Phase 3 | 408 |
| NCT06415773 | Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin 2024 | completed | Phase 3 | 367 |
| NCT00633282 | Role of Pioglitazone and Berberine in Treatment of Non-Alcoholic Fatty Liver Disease 2008 | completed | Phase 2 | 184 |
| NCT06911983 | Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes 2025 | not yet recruiting | Not applicable | 60 |
| NCT07606872 | Validation of the Snouda Metabolic Score for Phenotyping and Guiding Reversal in Type 2 Diabetes 2026 | not yet recruiting | Not applicable | 150 |
| NCT06496893 | A Study to Assess Effect of Glucocil® on Metabolic Health in Individuals With Prediabetes and Type 2 Diabetes Mellitus. 2024 | not yet recruiting | Not applicable | 100 |
| NCT06979440 | Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated With Depression 2024 | recruiting | Not applicable | 40 |
Published literature
- Cochrane review Gegen Qinlian decoction ameliorates insulin resistance in type 2 diabetes: A systematic review and meta-analysis of RCTs with mechanistic insights into SIRT1/AMPK pathway activationLiao Y, Yang L, Tang S et al. · Journal of ethnopharmacology · 2026 · PMID 41297722
- Meta-analysis Probiotics, synbiotics and berberine in Type 2 diabetes mellitus: A systematic review, meta-analysis, and molecular dynamics simulation studyShadin M, Bhuia MS, Alfaifi M et al. · PloS one · 2026 · PMID 42213651
- Clinical trial publication Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical TrialJi L, Ma J, Ma Y et al. · JAMA network open · 2025 · PMID 40029660
- Clinical trial publication The efficacy and safety of berberine in combination with cinnamon supplementation in patients with type 2 diabetes: a randomized clinical trialMansour A, Sajjadi-Jazi SM, Gerami H et al. · European journal of nutrition · 2025 · PMID 39998703
- Clinical trial publication The Pharmacokinetic Interaction Between Metformin and the Natural Product Goldenseal Is Metformin Dose-Dependent: A Three-Arm Crossover Study in Adults With Type 2 DiabetesNguyen JT, Arian CM, Tanna RS et al. · Clinical and translational science · 2025 · PMID 39943692
- Cochrane review Clinical Efficacy of Curcumin, Resveratrol, Silymarin, and Berberine on Cardio-Metabolic Risk Factors Among Patients With Type 2 Diabetes Mellitus: A Systemic Review and Bayesian Network Meta-AnalysisMiao R, Zhang B, Zhou D et al. · Phytotherapy research : PTR · 2025 · PMID 40439602
- Cochrane review Berberine and health outcomes: an overview of systematic reviewsShi L, Wang W, Jing C et al. · BMC complementary medicine and therapies · 2025 · PMID 40269802
- Systematic review The Effect of Berberine Supplementation on Glycemic Control and Inflammatory Biomarkers in Metabolic Disorders: An Umbrella Meta-analysis of Randomized Controlled TrialsNazari A, Ghotbabadi ZR, Kazemi KS et al. · Clinical therapeutics · 2024 · PMID 38016844
- Clinical trial publication Efficacy and safety of HIMABERB® Berberine on glycemic control in patients with prediabetes: double-blind, placebo-controlled, and randomized pilot trialPanigrahi A, Mohanty S · BMC endocrine disorders · 2023 · PMID 37679692
- Clinical trial publication Combined berberine and probiotic treatment as an effective regimen for improving postprandial hyperlipidemia in type 2 diabetes patients: a double blinded placebo controlled randomized studyWang S, Ren H, Zhong H et al. · Gut microbes · 2022 · PMID 34923903
- Cochrane review The Effect of Berberine on Metabolic Profiles in Type 2 Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled TrialsGuo J, Chen H, Zhang X et al. · Oxidative medicine and cellular longevity · 2021 · PMID 34956436
- Cochrane review Efficacy and safety of berberine in the treatment of type 2 diabetes with insulin resistance: Protocol for a systematic reviewWang Y, Yan A, Li S et al. · Medicine · 2019 · PMID 31464934
- Meta-analysis Effects of berberine on blood glucose in patients with type 2 diabetes mellitus: a systematic literature review and a meta-analysisLiang Y, Xu X, Yin M et al. · Endocrine journal · 2019 · PMID 30393248
Mechanism and notes
Recorded mechanism or class: Potential dietary and lifestyle interventions for decreasing insulin resistance · Halma MTJ, Syed M, Marik PE · 2023.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Berberine approved for Type 2 Diabetes?
Berberine has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Type 2 Diabetes. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Berberine in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Berberine to Type 2 Diabetes: 1 is currently recruiting; 3 are active or not yet recruiting; 4 have completed. The most advanced is Phase 3 (NCT06353347). It plans or enrolled 551 participants. Registration activity spans 2008 to 2026.
What does the evidence show for Berberine in Type 2 Diabetes?
Berberine has both completed registered trials and synthesis-level publications linked to Type 2 Diabetes. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.