Diabetes Mellitus, Type 2Phase 2NCT07920640
Fuling Yunhua Granules and Dihuang Baoyuan Granules in Adults With Type 2 Diabetes and Poor Glycemic Control Despite Lifestyle Intervention
A Phase 2 study testing Fuling Yunhua Granules and Dihuang Baoyuan Granules in people with Diabetes Mellitus, Type 2, run by Beijing Supreme Life Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This trial tests whether Fuling Yunhua Granules and Dihuang Baoyuan Granules, alone or in sequence, lower blood sugar in adults with type 2 diabetes whose blood sugar remains high despite diet and exercise. It will also assess their safety. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Fuling Yunhua Granules and Dihuang Baoyuan Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2026to 15 Mar 2028
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years (inclusive), male or female;
- Body weight ≥50 kg for men and ≥45 kg for women at both screening and baseline; body mass index (BMI) between 23.0 and 35.0 kg/m2 (inclusive) at both visits;
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months according to the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Diabetes;
- Maintained diet control and exercise therapy for 3 months prior to screening, and did not receive any systemic treatment for diabetes during this period (no prior use of hypoglycemic agents, or prior use of hypoglycemic agents but no use within 3 months before screening);
- Glycated hemoglobin (HbA1c) ≥7.5% and <11.0% at screening (local laboratory); HbA1c ≥7.0% and <11.0% at baseline (central laboratory);
- Fasting plasma glucose (FPG) <13.9 mmol/L at both screening and baseline;
- Traditional Chinese Medicine (TCM) syndrome differentiation consistent with spleen Yin deficiency, Yin deficiency with internal heat accompanied by spleen dampness and stomach heat, and phlegm-fluid retention pattern;
- Able to understand the procedures and methods of this study, willing to strictly abide by the clinical research protocol to complete this study, maintain the same diet and exercise habits throughout the trial, and voluntarily sign the informed consent form (ICF).
Who cannot join
- History of allergic reaction to any component of the study drugs, or history of significant allergic or hypersensitivity reaction to concomitant medications specified in this trial;
- Non-type 2 diabetes mellitus: type 1 diabetes, gestational diabetes, or special types of diabetes (such as diabetes due to pancreatic injury, Cushing syndrome, or acromegaly);
- History of acute diabetic complications within 6 months before screening (diabetic ketoacidosis, hyperosmolar hyperglycemic state, or lactic acidosis), requiring treatment as diagnosed by the investigator;
- Personal or family history of medullary thyroid C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or localized multiple endocrine neoplasia [MEN] type 2A or 2B syndrome);
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, or pancreatic injury, or other high-risk factors for pancreatitis deemed unsuitable for this trial by the investigator;
- History of organ transplantation, or severe autoimmune diseases in the past or present (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, and vasculitis);
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- Diagnosed with malignant tumors within 5 years before screening (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix), or currently under evaluation for potential malignancy;
- Thyroid dysfunction that cannot be controlled with stable drug dosage at screening;
- Any disease that may cause hemolysis or red blood cell instability affecting HbA1c measurement at screening (such as hemolytic anemia or thalassemia);
- Severe trauma or severe acute infection that may affect glycemic control within 3 months before screening;
- Severe cardiovascular disease within 6 months before screening, such as heart failure (New York Heart Association [NYHA] grade III-IV), myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention, sustained and clinically significant arrhythmia (such as second- or third-degree atrioventricular block, or QTcF interval prolongation [≥450 ms in males and ≥470 ms in females]), acute coronary syndrome, transient ischemic attack, hemorrhagic stroke, or ischemic stroke, deemed unsuitable for this trial by the investigator;
- Diseases that may significantly affect drug absorption, distribution, metabolism and excretion within 6 months before screening: inflammatory bowel disease, peptic ulcer, history of gastrointestinal or rectal bleeding, history of major gastrointestinal surgery (such as gastrectomy, gastrointestinal anastomosis, or intestinal resection), etc.;
- History of major surgery (intrathoracic, intracranial, abdominal, etc.) within 6 months before screening, or planned surgery during the study that may affect study completion or compliance;
- Severe hypoglycemic event (Grade 3 or above) or recurrent unexplained hypoglycemic events (at least 3 episodes per month with blood glucose <3.9 mmol/L or symptomatic hypoglycemia) within 6 months before randomization;
- Use of drugs that may affect glucose metabolism within 2 months before screening, including growth hormone therapy, and long-term or intermittent systemic glucocorticoids (intravenous or oral administration for >2 consecutive weeks or repeated courses, excluding inhaled or topical use), etc.;
- Use of any immunosuppressant within 6 months before screening, or use of any drug that the investigator judges may affect trial results;
- Medical or non-medical weight management within 3 months before screening, including unapproved weight management drugs or products, or weight change ≥5% within 3 months before screening (based on participant self-report), or weight change ≥5% (gain or loss) between randomization and screening;
- Any laboratory test meets any of the following criteria at screening:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN) ×2.5, or total bilirubin (TBIL) > ULN ×1.5; Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 calculated using the CKD-EPI formula; Fasting triglycerides (TG) >5.7 mmol/L; Fasting C-peptide <0.8 ng/mL (or 0.26 nmol/L); Hemoglobin <100 g/L;
- Hepatitis B surface antigen (HBsAg) positive at screening (if HBsAg positive, HBV DNA testing is required), or hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, or Treponema pallidum antibody positive;
- Blood pressure poorly controlled at screening and baseline (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg);
- Blood donation or massive blood loss (>400 mL) within 3 months before screening;
- Participated in any interventional drug clinical trial within 3 months before screening (except screening failures without treatment);
- Pregnant or lactating women, or men or women of childbearing potential who plan to become pregnant during the study or are unwilling to take medically recognized contraceptive measures;
- Known or suspected alcohol dependence (defined as >14 units of alcohol per week; 1 unit equals 357 mL beer with 5% alcohol content, 45 mL spirits with 40% alcohol content, or 147 mL wine with 12% alcohol content) or drug abuse at screening;
- Severe psychiatric disorder or language barrier that prevents adequate understanding and cooperation;
- Participants who the investigator believes have any other factors that are inappropriate for participating in this study.
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
Peking University People's Hospital
Beijing
Linong Ji, Doctor, +86-10-88324100, jiln@bjmu.edu.cn
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Adult Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control Despite Diet and Exercise Intervention
This trial tests whether Fuling Yunhua Granules and Dihuang Baoyuan Granules, alone or in sequence, lower blood sugar in adults with type 2 diabetes whose blood sugar remains high despite diet and exercise. It will also assess their safety.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. About 150 participants aged 18-70 will be randomly assigned to one of six groups: Fuling Yunhua monotherapy, Dihuang Baoyuan monotherapy, sequential low-dose, sequential high-dose, low-dose placebo, or high-dose placebo. Neither participants nor researchers will know who gets which treatment.
The trial includes a 4-week run-in period (diet and exercise only), 24 weeks of daily treatment, and a 12-week follow-up after stopping treatment. Participants whose blood sugar stays healthy may continue follow-up for up to 52 weeks after stopping treatment.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Fuling Yunhua Granules, Dihuang Baoyuan Granules, Fuling Yunhua Granules Matched Placebo, Dihuang Baoyuan Granules Matched Placebo
- 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.
Fuling Yunhua GranulesDrug
Traditional Chinese herbal medicine granules, 12 g per bag, taken orally before meals.
Dihuang Baoyuan GranulesDrug
Traditional Chinese herbal medicine granules, 18 g per bag, taken orally before meals.
Fuling Yunhua Granules Matched PlaceboDrug
Matched placebo for Fuling Yunhua Granules; identical in appearance (shape, color and packaging), odor and taste, but containing no active herbal components. Granules, 12 g per bag, taken orally before meals.
Dihuang Baoyuan Granules Matched PlaceboDrug
Matched placebo for Dihuang Baoyuan Granules; identical in appearance (shape, color and packaging), odor and taste, but containing no active herbal components. Granules, 18 g per bag, taken orally before meals.
| Study group | Role | What they receive |
|---|---|---|
| Fuling Yunhua Granules Monotherapy Group | Experimental | Fuling Yunhua Granules, one bag taken orally three times daily before breakfast, lunch and dinner, for 24 weeks. Receives: Drug: Fuling Yunhua Granules |
| Dihuang Baoyuan Granules Monotherapy Group | Experimental | Dihuang Baoyuan Granules, one bag taken orally three times daily before breakfast, lunch and dinner, for 24 weeks. Receives: Drug: Dihuang Baoyuan Granules |
| Sequential Treatment Low-Dose Group | Experimental | Participants receive Dihuang Baoyuan Granules and Fuling Yunhua Granules alternately every 4 weeks for 24 weeks: Dihuang Baoyuan Granules in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules in weeks 5-8, 13-16 and 21-24. One bag is taken orally twice daily, before breakfast and dinner. Receives: Drug: Fuling Yunhua Granules; Drug: Dihuang Baoyuan Granules |
| Sequential Treatment High-Dose Group | Experimental | Participants receive Dihuang Baoyuan Granules and Fuling Yunhua Granules alternately every 4 weeks for 24 weeks: Dihuang Baoyuan Granules in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules in weeks 5-8, 13-16 and 21-24. One bag is taken orally three times daily, before breakfast, lunch and dinner. Receives: Drug: Fuling Yunhua Granules; Drug: Dihuang Baoyuan Granules |
| Low-Dose Placebo Group | Placebo comparator | Participants receive placebos matching Dihuang Baoyuan Granules and Fuling Yunhua Granules, administered in the same alternating 4-week sequence and on the same schedule as the sequential treatment groups: Dihuang Baoyuan Granules matched placebo in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules matched placebo in weeks 5-8, 13-16 and 21-24. One bag is taken orally twice daily, before breakfast and dinner, for 24 weeks. Receives: Drug: Fuling Yunhua Granules Matched Placebo; Drug: Dihuang Baoyuan Granules Matched Placebo |
| High-Dose Placebo Group | Placebo comparator | Participants receive placebos matching Dihuang Baoyuan Granules and Fuling Yunhua Granules, administered in the same alternating 4-week sequence and on the same schedule as the sequential treatment groups: Dihuang Baoyuan Granules matched placebo in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules matched placebo in weeks 5-8, 13-16 and 21-24. One bag is taken orally three times daily, before breakfast, lunch and dinner, for 24 weeks. Receives: Drug: Fuling Yunhua Granules Matched Placebo; Drug: Dihuang Baoyuan Granules Matched Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Glycated Hemoglobin (HbA1c) at Week 24
Measured: Baseline and Week 24
Secondary outcomes (20)
Proportion of Participants With Type 2 Diabetes Clinical Remission at 12 Weeks After Discontinuation of Study Drug (Clinical remission defined as HbA1c <6.5%)
Measured: 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Glycated Hemoglobin (HbA1c) at Weeks 8, 12, 16, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 8, 12, 16, and 12 Weeks After Discontinuation of Study Drug
Proportion of Participants With HbA1c <6.5% at Weeks 8, 12, 16, and 24
Measured: Weeks 8, 12, 16, and 24
Proportion of Participants With HbA1c <7.0% at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 4, 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in 2-Hour Postprandial Glucose (PPG) at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Continuous Glucose Monitoring (CGM) Time in Range (TIR) at Week 24
Measured: Baseline and Week 24
Change from Baseline in Continuous Glucose Monitoring (CGM) Time Below Range (TBR) at Week 24
Measured: Baseline and Week 24
Change from Baseline in Continuous Glucose Monitoring (CGM) Time Above Range (TAR) at Week 24
Measured: Baseline and Week 24
Change from Baseline in Insulin Sensitivity (HOMA-IS) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Beta-Cell Function (HOMA-β) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in C-Peptide Index (CPI) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Fasting Lipid Profile (Total Cholesterol [TC], LDL-C, HDL-C, Triglycerides [TG]) at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Systolic and Diastolic Blood Pressure at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Serum Uric Acid at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Fasting Body Weight at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Waist Circumference at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Hip Circumference at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in TCM Syndrome Score and Proportion of Participants by TCM Efficacy (Cured, Markedly Effective, Effective, Ineffective) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Measured: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start20 Nov 2026 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Supreme Life Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920640
- Sponsor's protocol ID
- JYHS-BAII-Pro-25001
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Adult Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control Despite Diet and Exercise Intervention
- ClinicalTrials.gov ID
- NCT07920640
- Acronym / sponsor ID
- JYHS-BAII-Pro-25001
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Supreme Life Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 5 Nov 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 trial tests whether Fuling Yunhua Granules and Dihuang Baoyuan Granules, alone or in sequence, lower blood sugar in adults with type 2 diabetes whose blood sugar remains high despite diet and exercise. It will also assess their safety.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. About 150 participants aged 18-70 will be randomly assigned to one of six groups: Fuling Yunhua monotherapy, Dihuang Baoyuan monotherapy, sequential low-dose, sequential high-dose, low-dose placebo, or high-dose placebo. Neither participants nor researchers will know who gets which treatment.
The trial includes a 4-week run-in period (diet and exercise only), 24 weeks of daily treatment, and a 12-week follow-up after stopping treatment. Participants whose blood sugar stays healthy may continue follow-up for up to 52 weeks after stopping treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Fuling Yunhua Granules Monotherapy Group | Experimental | Drug: Fuling Yunhua GranulesFuling Yunhua Granules, one bag taken orally three times daily before breakfast, lunch and dinner, for 24 weeks. |
| Dihuang Baoyuan Granules Monotherapy Group | Experimental | Drug: Dihuang Baoyuan GranulesDihuang Baoyuan Granules, one bag taken orally three times daily before breakfast, lunch and dinner, for 24 weeks. |
| Sequential Treatment Low-Dose Group | Experimental | Drug: Fuling Yunhua Granules, Drug: Dihuang Baoyuan GranulesParticipants receive Dihuang Baoyuan Granules and Fuling Yunhua Granules alternately every 4 weeks for 24 weeks: Dihuang Baoyuan Granules in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules in weeks 5-8, 13-16 and 21-24. One bag is taken orally twice daily, before breakfast and dinner. |
| Sequential Treatment High-Dose Group | Experimental | Drug: Fuling Yunhua Granules, Drug: Dihuang Baoyuan GranulesParticipants receive Dihuang Baoyuan Granules and Fuling Yunhua Granules alternately every 4 weeks for 24 weeks: Dihuang Baoyuan Granules in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules in weeks 5-8, 13-16 and 21-24. One bag is taken orally three times daily, before breakfast, lunch and dinner. |
| Low-Dose Placebo Group | Placebo comparator | Drug: Fuling Yunhua Granules Matched Placebo, Drug: Dihuang Baoyuan Granules Matched PlaceboParticipants receive placebos matching Dihuang Baoyuan Granules and Fuling Yunhua Granules, administered in the same alternating 4-week sequence and on the same schedule as the sequential treatment groups: Dihuang Baoyuan Granules matched placebo in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules matched placebo in weeks 5-8, 13-16 and 21-24. One bag is taken orally twice daily, before breakfast and dinner, for 24 weeks. |
| High-Dose Placebo Group | Placebo comparator | Drug: Fuling Yunhua Granules Matched Placebo, Drug: Dihuang Baoyuan Granules Matched PlaceboParticipants receive placebos matching Dihuang Baoyuan Granules and Fuling Yunhua Granules, administered in the same alternating 4-week sequence and on the same schedule as the sequential treatment groups: Dihuang Baoyuan Granules matched placebo in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules matched placebo in weeks 5-8, 13-16 and 21-24. One bag is taken orally three times daily, before breakfast, lunch and dinner, for 24 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 70 years (inclusive), male or female;
- Body weight ≥50 kg for men and ≥45 kg for women at both screening and baseline; body mass index (BMI) between 23.0 and 35.0 kg/m2 (inclusive) at both visits;
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months according to the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Diabetes;
- Maintained diet control and exercise therapy for 3 months prior to screening, and did not receive any systemic treatment for diabetes during this period (no prior use of hypoglycemic agents, or prior use of hypoglycemic agents but no use within 3 months before screening);
- Glycated hemoglobin (HbA1c) ≥7.5% and <11.0% at screening (local laboratory); HbA1c ≥7.0% and <11.0% at baseline (central laboratory);
Key exclusion criteria (27 listed)
- History of allergic reaction to any component of the study drugs, or history of significant allergic or hypersensitivity reaction to concomitant medications specified in this trial;
- Non-type 2 diabetes mellitus: type 1 diabetes, gestational diabetes, or special types of diabetes (such as diabetes due to pancreatic injury, Cushing syndrome, or acromegaly);
- History of acute diabetic complications within 6 months before screening (diabetic ketoacidosis, hyperosmolar hyperglycemic state, or lactic acidosis), requiring treatment as diagnosed by the investigator;
- Personal or family history of medullary thyroid C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or localized multiple endocrine neoplasia [MEN] type 2A or 2B syndrome);
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, or pancreatic injury, or other high-risk factors for pancreatitis deemed unsuitable for this trial by the investigator;
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 |
|---|---|---|
| Fuling Yunhua GranulesTraditional Chinese herbal medicine granules, 12 g per bag, taken orally before meals. | Drug | Fuling Yunhua Granules Monotherapy Group, Sequential Treatment High-Dose Group, Sequential Treatment Low-Dose Group |
| Dihuang Baoyuan GranulesTraditional Chinese herbal medicine granules, 18 g per bag, taken orally before meals. | Drug | Dihuang Baoyuan Granules Monotherapy Group, Sequential Treatment High-Dose Group, Sequential Treatment Low-Dose Group |
| Fuling Yunhua Granules Matched PlaceboMatched placebo for Fuling Yunhua Granules; identical in appearance (shape, color and packaging), odor and taste, but containing no active herbal components. Granules, 12 g per bag, taken orally before meals. | Drug | High-Dose Placebo Group, Low-Dose Placebo Group |
| Dihuang Baoyuan Granules Matched PlaceboMatched placebo for Dihuang Baoyuan Granules; identical in appearance (shape, color and packaging), odor and taste, but containing no active herbal components. Granules, 18 g per bag, taken orally before meals. | Drug | High-Dose Placebo Group, Low-Dose Placebo Group |
Primary outcome
Change from Baseline in Glycated Hemoglobin (HbA1c) at Week 24
Time frame: Baseline and Week 24
20 secondary outcomes
Proportion of Participants With Type 2 Diabetes Clinical Remission at 12 Weeks After Discontinuation of Study Drug (Clinical remission defined as HbA1c <6.5%)
Time frame: 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Glycated Hemoglobin (HbA1c) at Weeks 8, 12, 16, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 12, 16, and 12 Weeks After Discontinuation of Study Drug
Proportion of Participants With HbA1c <6.5% at Weeks 8, 12, 16, and 24
Time frame: Weeks 8, 12, 16, and 24
Proportion of Participants With HbA1c <7.0% at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 4, 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in 2-Hour Postprandial Glucose (PPG) at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Continuous Glucose Monitoring (CGM) Time in Range (TIR) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Continuous Glucose Monitoring (CGM) Time Below Range (TBR) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Continuous Glucose Monitoring (CGM) Time Above Range (TAR) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Insulin Sensitivity (HOMA-IS) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Beta-Cell Function (HOMA-β) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in C-Peptide Index (CPI) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Fasting Lipid Profile (Total Cholesterol [TC], LDL-C, HDL-C, Triglycerides [TG]) at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Systolic and Diastolic Blood Pressure at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Serum Uric Acid at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Fasting Body Weight at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Waist Circumference at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Hip Circumference at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in TCM Syndrome Score and Proportion of Participants by TCM Efficacy (Cured, Markedly Effective, Effective, Ineffective) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
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 5 Nov 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fuling Yunhua Granules and Dihuang Baoyuan Granules in people with Diabetes Mellitus, Type 2, run by Beijing Supreme Life Pharmaceutical Technology Co., Ltd. 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 8 inclusion and 27 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 5 Nov 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shen Wu (+86-10-64028110, wushen@tcmlive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Glycated Hemoglobin (HbA1c) at Week 24 (time frame: Baseline and Week 24). 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 5 Nov 2026.