Efficacy and Safety of Hebenrun in Patients With Type 2 Diabetes

NCT07768280 | Not Yet Recruiting

• 1 other identifier: JZFYLL20260716175
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Hebenrun; Type 2 diabetes mellitus; Metformin; Functional food; Grain bran; Randomized controlled trial; Blood glucose control

Outcome Measures

Primary Outcomes (1)

• Complete discontinuation rate of oral hypoglycemic drugs

  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%.

  At 48 weeks of follow-up

Secondary Outcomes (16)

• Partial discontinuation rate of metformin at follow-up endpoint

  At 48 weeks of follow-up

• Mean reduction in daily metformin dose (mg/d) from baseline to endpoint

  At 48 weeks of follow-up

• Changes in HbA1c from baseline at each visit

  At 4, 8, 12, 24, 36, 48 weeks

• Changes in fasting plasma glucose (FPG) from baseline at each visit

  At 4, 8, 12, 24, 36, 48 weeks

• Changes in 2-hour postprandial glucose (2hPG) from baseline at each visit

  At 4, 8, 12, 24, 36, 48 weeks

Study Arms (2)

Study Group (Metformin + Hebenrun)

EXPERIMENTAL

On the basis of metformin tablet treatment, Hebenrun is added, taken twice daily (morning and evening, one sachet each time), before meals. Metformin tablets starting dose: 0.5 g/time, twice daily (1000 mg/d), taken before meals; if there is stomach discomfort, take after meals. Treatment course: 48 weeks. Metformin dose adjustment: based on the current metformin dose, if the patient's HbA1c reaches ≤6.5% and the previous two consecutive weekly FBG monitoring is ≤7.0 mmol/L, the daily metformin dose will be reduced by 500 mg/d; under the new dose, if FBG is again ≤7.0 mmol/L for two consecutive weekly monitoring and 2hPG ≤10.0 mmol/L, the daily metformin dose will be reduced by 500 mg/d.

Drug: Metformin; Dietary Supplement: Hebenrun

Control Group (Metformin only)

ACTIVE COMPARATOR

Only metformin tablets are given, 0.5 g/time, twice daily, taken before meals; if there is stomach discomfort, take after meals. No additional Hebenrun is administered. Treatment course: 48 weeks. The same metformin dose adjustment regimen is applied as in the study group.

Drug: Metformin

Interventions

Metformin DRUG

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.

Control Group (Metformin only); Study Group (Metformin + Hebenrun)

Hebenrun DIETARY_SUPPLEMENT

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

Study Group (Metformin + Hebenrun)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age 18-65 years, glycated hemoglobin (HbA1c): 6.5%-8.5%.
• Good patient compliance, cooperation with treatment and follow-up.
• The research has been approved by the hospital ethics committee, and all patients voluntarily participate and sign informed consent.

You may not qualify if:

• Type 1 diabetes, gestational diabetes, and special types of diabetes.
• History of acute diabetic complications (ketoacidosis, hyperosmolar coma, lactic acidosis).
• Major organ diseases (severe heart, liver, kidney dysfunction), malignant tumors, or severe mental disorders.
• Contraindications or allergy history to any component of Hebenrun.
• Psychotropic drug dependence, accompanied by obvious anxiety or depression tendencies.
• Women preparing for pregnancy, during pregnancy, and lactation.
• Expected poor compliance or language communication dysfunction.
• Already enrolled or about to enroll in other clinical studies.
• Withdrawal/Discontinuation Criteria:
• Subjects actively request withdrawal.
• Unable to contact during follow-up.
• Adverse reactions or disease changes making it unsuitable to continue participation.
• The researcher determines that continued participation is detrimental to the subject.
• Unable to follow the prescribed treatment regimen or unable to persist with medication.

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead
• The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine: collaborator

Study Sites (1)

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, 330006, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Li

  The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengfeng Li Li

CONTACT

+8615870693596; 361127933@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)