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NCT04698330
Effects of Berberine Plus Inulin on Diabetes Care in Patients With Latent Autoimmune Diabetes in Adults: A Randomized Controlled Trial
Phase 4 trial testing Berberine in Type 1 Diabetes Mellitus in 240 participants. Not yet recruiting.
1 December 2025
Quick facts
| Lead sponsor | Second Xiangya Hospital of Central South University |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 1 May 2022 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Berberine — full drug profile →
- Inulin — full drug profile →
- Berberine placebo tablets — full drug profile →
- Inulin placebo tablets — full drug profile →
Conditions studied
- Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →
- Autoimmune Diabetes — all drugs for Autoimmune Diabetes →
Sponsor
Second Xiangya Hospital of Central South University
Who can join
Adults 18 to 70, any sex, with Type 1 Diabetes Mellitus or Autoimmune Diabetes. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in HbA1c
Time frame: 1 year after start of trial
The primary outcome measure is the change in mean HbA1c level, reflecting the blood glucose management status of the patients.
Sponsor's own description
The primary purpose of this study is to evaluate the effects of oral berberine (BBR) and inulin combined with insulin therapy on diabetes care in patients with LADA.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effects of Berberine Plus Inulin on Diabetes Care in Patients With Latent Autoimmune Diabetes in Adults: Protocol for a Randomized Controlled Trial.
Zhang R, Xiao Y, Yan J, Yang W, et al · · 2022 · cited 4× · PMID 35784546 · DOI 10.3389/fendo.2022.876657 -
Phytochemicals as modulators of dendritic cell functions: implications for tolerogenic cell-based therapy.
Fekete T, Pázmándi K. · · 2025 · PMID 41306974 · DOI 10.3389/fimmu.2025.1653803
Verify or expand the search:
- PubMed search for NCT04698330
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Berberine
Trials testing the same drug.
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- NCT07480018 — Berberine Supplementation, Sprint Interval Training, and Immune Function Study · NA · recruiting
- NCT06911983 — Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabete · NA · not yet recruiting
- NCT05720299 — A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects. · NA · completed
- NCT06514274 — Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Era · Phase 4 · completed
Other recruiting trials for Type 1 Diabetes Mellitus
Currently open trials in the same condition.
- NCT07142252 — Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus · Phase 2 · recruiting
- NCT07296276 — Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM · NA · recruiting
- NCT07409701 — Gamification Intervertion in Children With Type 1 Diabetes · NA · recruiting
- NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
- NCT07434154 — Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults · recruiting
Other Second Xiangya Hospital of Central South University trials
Trials by the same sponsor.
- NCT07278947 — ACT-based Parenting Program for Caregivers of Children With Hearing Loss Post-cochlear: A Pilot Randomised Controlled Tr · NA · not yet recruiting
- NCT07460336 — Effects of Cofrogliptin on Beta-Cell Function in LADA Patients · NA · not yet recruiting
- NCT06951646 — ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immuno · Phase 2 · recruiting
- NCT07343154 — Multimodal Brain Function in Migraine Patients With Patent Foramen Ovale · not yet recruiting
- NCT07338487 — A Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Canc · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04698330 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Xiangya Hospital of Central South University
- Last refreshed: 8 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04698330.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing