Type 2 Diabetes MellitusNCT07768280
Efficacy and Safety of Hebenrun in Patients With Type 2 Diabetes
A study testing Metformin and Hebenrun in people with Type 2 Diabetes Mellitus, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Metformin and Hebenrun
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, 330006
Zhengfeng Li Li, +8615870693596, 361127933@qq.com
About this study
Official title: Evaluation of the Efficacy and Safety of Hebenrun in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Metformin, Hebenrun
- Keywords
- Hebenrun, Type 2 diabetes mellitus, Metformin, Functional food, Grain bran, Randomized controlled trial, Blood glucose control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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.
HebenrunDietary 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 | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: At 48 weeks of follow-up
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 4, 8, 12, 24, 36, 48 weeks
Number of hypoglycemic medication types used
Measured: Through 48 weeks of follow-up
Proportion of participants achieving glycemic targets at follow-up endpoint
Measured: Through 48 weeks of follow-up
Time to metformin discontinuation
Measured: Through 48 weeks of follow-up
Change in HOMA-IR from baseline at each visit timepoint
Measured: Through 48 weeks of follow-up
Change in uric acid from baseline at each visit time point.
Measured: Through 48 weeks of follow-up
Change in total cholesterol from baseline at each visit time point.
Measured: Through 48 weeks of follow-up
Change in triglycerides from baseline at each visit time point.
Measured: Through 48 weeks of follow-up
Change in HDL-C (high-density lipoprotein cholesterol) from baseline at each visit time point.
Measured: Through 48 weeks of follow-up
Change in LDL-C (low-density lipoprotein cholesterol) from baseline at each visit time point.
Measured: Through 48 weeks of follow-up
Change in body mass index (BMI) from baseline at each visit time point.
Measured: Through 48 weeks of follow-up
Change in waist-to-hip ratio from baseline at each visit time point.
Measured: Through 48 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Xu Zhou, Jiangxi University of Traditional Chinese Medicine
- Investigators
- Li, Principal investigator, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768280
- Sponsor's protocol ID
- JZFYLL20260716175
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Hebenrun in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07768280
- Acronym / sponsor ID
- JZFYLL20260716175
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Hebenrun, Type 2 diabetes mellitus, Metformin, Functional food, Grain bran, Randomized controlled trial, Blood glucose control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group (Metformin + Hebenrun) | Experimental | Drug: Metformin, Dietary Supplement: HebenrunOn 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. |
| Control Group (Metformin only) | Active comparator | Drug: MetforminOnly 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin tablet, 0.5 g, twice daily, taken before meals; dose may be adjusted ±500 mg/d based on glycemic control; treatment duration: 48 weeks. | Drug | Control Group (Metformin only), Study Group (Metformin + Hebenrun) |
| HebenrunHebenrun, a functional food based on natural grain bran, taken as one sachet twice daily (morning and evening) before meals, for 48 weeks. | Dietary supplement | Study Group (Metformin + Hebenrun) |
Primary outcome
Complete discontinuation rate of oral hypoglycemic drugs
Time frame: 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%.
16 secondary outcomes
Partial discontinuation rate of metformin at follow-up endpoint
Time frame: At 48 weeks of follow-up
Mean reduction in daily metformin dose (mg/d) from baseline to endpoint
Time frame: At 48 weeks of follow-up
Changes in HbA1c from baseline at each visit
Time frame: At 4, 8, 12, 24, 36, 48 weeks
Changes in fasting plasma glucose (FPG) from baseline at each visit
Time frame: At 4, 8, 12, 24, 36, 48 weeks
Changes in 2-hour postprandial glucose (2hPG) from baseline at each visit
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li principal investigator
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin and Hebenrun in people with Type 2 Diabetes Mellitus, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhengfeng Li Li (+8615870693596, 361127933@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete discontinuation rate of oral hypoglycemic drugs (time frame: At 48 weeks of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.