An interventional study of Metformin and Hebenrun in Type 2 Diabetes Mellitus, sponsored by Jiangxi University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Jiangxi University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease characterized by insulin resistance and insufficient insulin secretion, and has become a major global public health problem. According to the International Diabetes Federation (IDF), the number of T2DM patients aged 20-79 reached 537 million in 2021, accounting for 10.5% of the global population. Long-term hyperglycemia can lead to multi-system damage, inducing cardiovascular disease, stroke, blindness, renal failure, and foot ulcers, causing disability and shortening life expectancy, and bringing huge socioeconomic burden.
Conventional interventions for T2DM include oral hypoglycemic agents, insulin, and incretin-based hypoglycemic drugs, but overall blood glucose control in the population is not optimistic. According to the Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition), the awareness rate, treatment rate, and control rate of diabetes have improved slowly. Even with combined oral medications and insulin therapy, half of patients still fail to achieve the target glycated hemoglobin level, and the risk of long-term microvascular and macrovascular complications is significantly increased. The hypoglycemic capacity of existing drugs is limited, and multi-drug combinations significantly increase the risk of adverse reactions (such as hypoglycemia and gastrointestinal symptoms). Insufficient compliance (especially with insulin injections) is also a bottleneck in blood glucose management. Therefore, finding effective, safe, and highly compliant food substitution therapies is of great significance.
Hebenrun is a functional food formulated primarily with natural grain bran as the main ingredient. Preliminary pre-experiments have found that it has hypoglycemic effects. When used in combination with Western medicine, fasting blood glucose, postprandial blood glucose, and glycated hemoglobin can all be reduced, and after gradually reducing the Western medicine dosage, blood glucose can still be maintained at normal or near-normal levels. This study aims to evaluate the efficacy and safety of Hebenrun on blood glucose control in T2DM patients through standardized clinical observation, providing evidence-based support for its rational application.
This is a single-center, randomized, parallel-group, open-label superiority controlled trial. Eligible T2DM patients will be randomly assigned (1:1) to the study group (metformin tablets + Hebenrun) or the control group (metformin tablets). Both groups will use the same metformin tablet dose adjustment regimen, with a total enrollment of 110 patients (55 per group). Follow-up time points are 0 weeks (baseline), week 4, week 8, week 12, week 24, week 36, and week 48. This trial protocol is written in accordance with the SPIRIT clinical trial protocol reporting standards.
Exclusion Criteria:
Withdrawal/Discontinuation Criteria:
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
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
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, a functional food based on natural grain bran, taken as one sachet twice daily (morning and evening) before meals, for 48 weeks.
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%.
Time frame: At 48 weeks of follow-up
Partial discontinuation rate of metformin at follow-up endpoint
Partial discontinuation is defined as: (1) Compared with baseline metformin 1000 mg/day, the metformin dose at follow-up endpoint is less than 1000 mg/day, without addition of other hypoglycemic drugs (insulin, GLP-1, SGLT-2, sulfonylureas, etc., not including simple antihypertensive or lipid-regulating drugs); (2) Dose reduction sustained for ≥3 months, with glycated hemoglobin (HbA1c) ≤6.5% and fasting blood glucose (FBG) ≤7.0 mmol/L.
Time frame: At 48 weeks of follow-up
Mean reduction in daily metformin dose (mg/d) from baseline to endpoint
Mean reduction in daily metformin dose at the end of follow-up compared to baseline dose.
Time frame: At 48 weeks of follow-up
Changes in HbA1c from baseline at each visit
Difference in glycated hemoglobin (HbA1c) at each visit time point relative to baseline.
Time frame: At 4, 8, 12, 24, 36, 48 weeks
Changes in fasting plasma glucose (FPG) from baseline at each visit
Difference in fasting plasma glucose (FPG) at each visit time point relative to baseline.
Time frame: At 4, 8, 12, 24, 36, 48 weeks
Changes in 2-hour postprandial glucose (2hPG) from baseline at each visit
Difference in 2-hour postprandial glucose (2hPG) at each visit time point relative to baseline.
Time frame: At 4, 8, 12, 24, 36, 48 weeks
Number of hypoglycemic medication types used
Time frame: Through 48 weeks of follow-up
Proportion of participants achieving glycemic targets at follow-up endpoint
Time frame: Through 48 weeks of follow-up
Time to metformin discontinuation
Time frame: Through 48 weeks of follow-up
Change in HOMA-IR from baseline at each visit timepoint
Time frame: Through 48 weeks of follow-up
Change in uric acid from baseline at each visit time point.
Time frame: Through 48 weeks of follow-up
Change in total cholesterol from baseline at each visit time point.
Time frame: Through 48 weeks of follow-up
Change in triglycerides from baseline at each visit time point.
Time frame: Through 48 weeks of follow-up
Change in HDL-C (high-density lipoprotein cholesterol) from baseline at each visit time point.
Time frame: Through 48 weeks of follow-up
Change in LDL-C (low-density lipoprotein cholesterol) from baseline at each visit time point.
Time frame: Through 48 weeks of follow-up
Change in body mass index (BMI) from baseline at each visit time point.
Time frame: Through 48 weeks of follow-up
Change in waist-to-hip ratio from baseline at each visit time point.
Time frame: Through 48 weeks of follow-up
Plan to share: No — Due to privacy protection and regulatory requirements, individual participant data will not be shared outside the research group. Study results will be published in peer-reviewed journals and presented at scientific conferences.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jiangxi University of Traditional Chinese Medicine