Efficacy and Safety of Hebenrun in Patients With Type 2 Diabetes

NCT07768280 · tracked via the Priya Life Science China tracker

Sponsor

Jiangxi University of Traditional Chinese Medicine

Phase

Not applicable

Started

2026-09

Last updated

2026-08-17

Condition(s) studied

Type 2 Diabetes Mellitus

Investigational drug(s) / intervention(s)

Metformin →Hebenrun

Metformin: Metformin tablet, 0.5 g, twice daily, taken before meals; dose may be adjusted ±500 mg/d based on glycemic control; treatment duration: 48 weeks.

Hebenrun: Hebenrun, a functional food based on natural grain bran, taken as one sachet twice daily (morning and evening) before meals, for 48 weeks.

Study summary

This study aims to evaluate the efficacy and safety of Hebenrun (a functional food based on natural grain bran) combined with metformin in patients with type 2 diabetes mellitus (T2DM). The study hypothesis is that Hebenrun combined with metformin will achieve a higher complete discontinuation rate of oral hypoglycemic drugs compared to metformin alone. A total of 110 T2DM patients will be randomly assigned (1:1) to the study group (metformin + Hebenrun) or the control group (metformin alone) and followed for 48 weeks. The primary outcome is the complete discontinuation rate of oral hypoglycemic drugs at the end of follow-up.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: 1. Meets the Western medicine diagnostic criteria for type 2 diabetes (T2DM), referring to the Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition). If typical diabetes symptoms are present (such as polydipsia, polyuria, polyphagia, unexplained weight loss), meeting any one of the following can confirm the diagnosis: fasting blood glucose (FBG) ≥7.0 mmol/L; random blood glucose ≥11.1 mmol/L; oral glucose tolerance test (OGTT) 2-hour blood glucose ≥11.1 mmol/L; glycated hemoglobin (HbA1c) ≥6.5%. If typical diabetes symptoms are lacking, two of the above blood glucose indicators at the same time point or at two different time points (excluding random blood glucose) need to reach or exceed the diagnostic cut-off point to diagnose diabetes. 2. Age 18-65 years, glycated hemoglobin (HbA1c): 6.5%-8.5%. 3. Good patient compliance, cooperation with treatment and follow-up. 4. The research has been approved by the hospital ethics committee, and all patients voluntarily participate and sign informed consent. Exclusion Criteria: 1. Type 1 diabetes, gestational diabetes, and special types of diabetes. 2. History of acute diabetic complications (ketoacidosis, hyperosmolar coma, lactic acidosis). 3. Major organ diseases (severe heart, liver, kidney dysfunction), malignant tumors, or severe mental disorders. 4. Contraindications or allergy history to any component of Hebenrun. 5. Psychotropic drug dependence, accompanied by obvious anxiety or depression tendencies. 6. Women preparing for pregnancy, during pregnancy, and lactation. 7. Expected poor compliance or language communication dysfunction. 8. Already enrolled or about to enroll in other clinical studies. Withdrawal/Discontinuation Criteria: 1. Subjects actively request withdrawal. 2. Unable to contact during follow-up. 3. Adverse reactions or disease changes making it unsuitable to continue participation. 4. The researcher determines that continued participation is detrimental to the subject. 5. Unable to follow the prescribed treatment regimen or unable to persist with medication.

Primary outcome measure(s)

Complete discontinuation rate of oral hypoglycemic drugs — At 48 weeks of follow-up
Complete discontinuation is defined as: (1) Complete discontinuation of all hypoglycemic drugs (insulin, metformin, GLP-1, SGLT-2, sulfonylureas, etc. all stopped; not including simple antihypertensive or lipid-regulating drugs); (2) Discontinuation sustained for ≥3 months, with glycated hemoglobin (HbA1c) ≤6.5% and fasting blood glucose (FBG) ≤7.0 mmol/L. The complete discontinuation rate = (number of patients meeting the complete discontinuation criteria at the end of follow-up) / (total enrolled diabetic patients in the group) × 100%.

Trial sites (1)

Facility	City	Region	Status
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine	Nanchang	Jiangxi

On this site

📄 Glucophage (metformin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07768280 on ClinicalTrials.gov ↗ ← All trials in China