Diabetes Mellitus, Type 2Phase 2NCT06575478
Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients
A Phase 2 study testing Fuling Yunhua Granules and Dihuang Baoyuan Granules in people with Diabetes Mellitus, Type 2 and Diabetes, run by Beijing Supreme Life Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
The goal of this investigator-initiated clinical trial is to investigate the efficacy and safety of sequential therapy of Fuling Yunhua Granules (prescription A) and Dihuang Baoyuan Granule (prescription B) in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes, Type2diabetes
- What is being tested?
- Fuling Yunhua Granules and Dihuang Baoyuan Granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2024to 27 Jan 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years (inclusive), male or female;
- Patients diagnosed with T2DM ≥ 8 weeks according to the 2020 WHO diagnostic criteria and classification;
- Have controlled blood sugar through diet and exercise for 3 months before screening and did not receive any hypoglycemic drugs, or used hypoglycemic drugs for no more than 2 weeks within 3 months before screening and did not use hypoglycemic drugs within 1 month before screening;
- Body mass index (BMI) ≥ 19 kg/m2;
- Glycated hemoglobin (HbA1c) ≥ 7.0% and < 10.5% at screening;
- Fasting plasma glucose (FPG) < 13.9 mmol/L at screening;
- Able to understand the procedures and methods of this study, willing to strictly abide by the clinical research protocol to complete this study, and voluntarily sign the ICF
Who cannot join
- Non-type 2 diabetes: type 1 diabetes, gestational diabetes, special types of diabetes;
- History of acute complications of diabetes within 6 months before screening (diabetic ketoacidosis, diabetic hyperglycemic hyperosmolar syndrome or lactic acidosis, etc.);
- History of chronic complications of diabetes with unstable condition or requiring treatment within 6 months before screening (proliferative retinal disease, severe diabetic neuropathy or intermittent claudication, etc.);
- Experienced more than 3 episodes of grade 3 hypoglycemia within 6 months before screening;
- Have used systemic (intravenous, oral or intra-articular) glucocorticoids continuously or cumulatively for ≥ 7 days within 3 months before screening;
- Severe infection within 3 months before screening;
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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);
- Severe cardiovascular disease, such as heart failure (New York Heart Association [NYHA] grade III-IV), myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention, occurred within 6 months before screening, Sustained and clinically significant arrhythmia (such as second- or third-degree atrioventricular block or QTc interval prolongation ≥470 ms in men and ≥480 ms in women), acute coronary syndrome or transient ischemic attack or stroke wait;
- Suffering from 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 important gastrointestinal surgery (such as : Gastrectomy, gastrointestinal anastomosis, or intestinal resection), etc.;
- Accompanied by thyroid dysfunction that cannot be controlled with stable drug dosage during screening;
- History of hypertension and take antihypertensive treatment regularly for more than 4 weeks but still have poor blood pressure control, with systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg;
- History of organ transplantation or severe autoimmune diseases in the past or present;
- History of clinically significant drug allergy or atopic allergic disease (asthma, urticaria, eczematous dermatitis);
- History of major surgery (intrathoracic, intracranial, abdominal, etc.) within 6 months before screening, or those who plan to undergo surgery during the study that may affect study completion or compliance;
- Any laboratory test meets any of the following criteria during screening:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN) × 2.5 times Glomerular filtration rate (eGFR) calculated using the CKD-EPI formula < 60 mL/min /1.73m2 Total bilirubin (TBIL)>ULN×1.5 times Fasting triglyceride (TG)>5.7 mmol/L Fasting C-peptide <0.8 ng/ml (or 0.26 nmol/L)
- Those who are positive for hepatitis B surface antigen during screening (except those whose quantitative test results of hepatitis B virus deoxyribonucleic acid [HBV-DNA] are lower than the lower limit of the detection reference range and who are not using anti-hepatitis B virus drugs during screening), or who are receiving anti-hepatitis B virus drug treatment , or those who are hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, or Treponema pallidum antibody positive;
- Blood donation or massive blood loss (>400 mL) within 3 months before screening;
- 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;
- History of alcohol, tobacco addiction or drug abuse is known or suspected at the time of screening;
- Participated in any interventional drug clinical research within 3 months before screening;
- Allergic to study drugs and their ingredients;
- Participants who the researcher believes have any other factors that are inappropriate for participating in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Type 2 Diabetes Patients With Poor Blood Glucose Control After Diet and Exercise Intervention: a Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study
The goal of this investigator-initiated clinical trial is to investigate the efficacy and safety of sequential therapy of Fuling Yunhua Granules (prescription A) and Dihuang Baoyuan Granule (prescription B) in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study, including a up to 2-week screening period, a 1-week baseline period, a 12-week treatment period and a 1-week follow-up period.
72 participants who meet the enrollment requirements will enter the baseline period, during which 7 days of CGM data will be collected. After entering the treatment period, participants will be randomly assigned to prescription ABA group, prescription ABA-matched placebo group, prescription BAB group and prescription BAB-matched placebo group in a ratio of 2:1:2:1 and receive corresponding treatment.
It is expected that an interim analysis will be conducted after 30 participants have completed 4 weeks of treatment and 4 weeks of their data is obtained. Based on the CGM data of the participants in the 4th week of treatment, the change of TIR in the 4th week compared with the baseline will be analyzed, and the IDMC will make a decision based on the results of this analysis.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes, Type2diabetes
- 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, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuling Yunhua GranulesDrug
Also called prescription A
Fuling Yunhua Granules
Dihuang Baoyuan GranulesDrug
Also called prescription B
Dihuang Baoyuan Granules
Fuling Yunhua Granules matched placebo/Dihuang Baoyuan Granules matched placeboDrug
Also called prescription A matched placebo/B matched placebo
Fuling Yunhua Granules placebo/Dihuang Baoyuan Granules placebo
| Study group | Role | What they receive |
|---|---|---|
| prescription ABA | Experimental | Fuling Yunhua Granules and Dihuang Baoyuan Granules Receives: Drug: Fuling Yunhua Granules |
| prescription BAB | Experimental | Fuling Yunhua Granules and Dihuang Baoyuan Granules Receives: Drug: Dihuang Baoyuan Granules |
| prescription ABA-matched placebo/ BAB-matched placebo | Placebo comparator | Fuling Yunhua Granules placebo and Dihuang Baoyuan Granules placebo Receives: Drug: Fuling Yunhua Granules matched placebo/Dihuang Baoyuan Granules matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c Concentrations (%) From Baseline
Change in HbA1c concentrations (%) from baseline is the numerical difference between a participant's hemoglobin A1c (HbA1c) level at a specified follow-up time point(s) and their baseline level (initial assessment before intervention). HbA1c, a glycated hemoglobin biomarker, reflects average blood glucose over 8-12 weeks. Venous blood is collected via standard phlebotomy, and HbA1c is quantified using a laboratory-certified method (e.g., high-performance liquid chromatography [HPLC] or immunoassay) for accuracy. Calculated as: Follow-up HbA1c (%) - Baseline HbA1c (%), positive values mean increased average blood glucose, negative values mean decreased. This metric evaluates intervention efficacy (e.g., medications, lifestyle modifications) for glycemic control in diabetes or prediabetes populations.
Measured: 12 weeks
Secondary outcomes (8)
Change in FPG (mmol/L) From Baseline
Change in Fasting Plasma Glucose (FPG) (mmol/L) from baseline is the numerical difference between a participant's FPG level at follow-up and their baseline FPG. FPG measures plasma glucose concentration after an 8-12 hour fast, reflecting overnight glycemic control. Venous blood samples are collected via standard phlebotomy, with glucose quantified using laboratory methods (e.g., hexokinase assay). Calculated as: Follow-up FPG (mmol/L) - Baseline FPG (mmol/L), positive values indicate increased fasting glucose, negative values a decrease. This metric assesses intervention efficacy in regulating fasting glycemia, critical for diabetes management.
Measured: 12 weeks
The Proportion of Participants Who Achieved HbA1c Target
The proportion of participants who achieved HbA1c target (HbA1c<7.0% and <6.5% Patient percentage)
Measured: 12 weeks
Changes in TIR From Baseline
Changes in Time in Range (TIR) from baseline refers to the difference between a participant's TIR at follow-up and their baseline TIR. TIR is the percentage of time blood glucose levels stay within a target range (typically 3.9-10.0 mmol/L [70-180 mg/dL] for most people with diabetes) over a specified period, measured via continuous glucose monitoring (CGM) devices. Calculated as: Follow-up TIR (%) - Baseline TIR (%), positive values indicate increased time in target range, negative values a decrease. This metric assesses glycemic stability and intervention effectiveness (e.g., medication adjustments, lifestyle changes) in managing blood glucose control.
Measured: 12 weeks
Changes in TBR From Baseline
Changes in Time Below Range (TBR) from baseline is the difference between a participant's TBR at follow-up and their baseline TBR. TBR is the percentage of time blood glucose levels fall below a target range (e.g., <3.9 mmol/L [70 mg/dL] for adults) over a specified period, measured via continuous glucose monitoring (CGM). Calculated as: Follow-up TBR (%) - Baseline TBR (%), positive values indicate increased time below range, negative values a decrease. This metric evaluates risks of hypoglycemia and intervention impact on maintaining glucose above target levels.
Measured: 12 weeks
Changes in TAR From Baseline
Changes in Time Above Range (TAR) from baseline refers to the difference between a participant's TAR at follow-up and their baseline TAR. TAR is the percentage of time blood glucose levels exceed a target range (e.g., >10.0 mmol/L [180 mg/dL] for most adults with diabetes) over a specified period, measured via continuous glucose monitoring (CGM). Calculated as: Follow-up TAR (%) - Baseline TAR (%), positive values indicate increased time above range, negative values a decrease. This metric assesses risks of hyperglycemia and intervention effectiveness in keeping glucose within target levels.
Measured: 12 weeks
Changes in MAGE From Baseline
Changes in Mean Amplitude of Glycemic Excursions (MAGE) from baseline is the difference between a participant's MAGE at follow-up and their baseline MAGE. MAGE quantifies the average magnitude of significant blood glucose fluctuations (exceeding a threshold, typically 1.4 mmol/L [25 mg/dL]) over a specified period, derived from continuous glucose monitoring (CGM) data. Calculated as: Follow-up MAGE - Baseline MAGE, higher values indicate greater glycemic variability, lower values more stable glucose. This metric evaluates intervention impact on reducing glucose swings, relevant for assessing glycemic stability in diabetes management.
Measured: 12 weeks
Change From Baseline in Total Cholesterol (TC) at Week 12
TTotal cholesterol (TC) was measured in venous blood samples and reported in mmol/L. Change from baseline was calculated as the TC value at Week 12 minus the baseline TC value. Negative values indicate a reduction in total cholesterol.
Measured: 12 weeks
Change From Baseline in Body Weight at Week 12
Body weight was measured in kilograms. Change from baseline was calculated as body weight at Week 12 minus baseline body weight. Negative values indicate weight loss, and positive values indicate weight gain.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start31 Jul 2024
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Supreme Life Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575478
- Sponsor's protocol ID
- JYHS-BAIIT-Pro-24001
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2024
- Last updated
- 5 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Type 2 Diabetes Patients With Poor Blood Glucose Control After Diet and Exercise Intervention: a Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06575478
- Acronym / sponsor ID
- JYHS-BAIIT-Pro-24001
- Conditions
- Diabetes Mellitus, Type 2, Diabetes, Type2diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Beijing Supreme Life Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Posted 5 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this investigator-initiated clinical trial is to investigate the efficacy and safety of sequential therapy of Fuling Yunhua Granules (prescription A) and Dihuang Baoyuan Granule (prescription B) in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study, including a up to 2-week screening period, a 1-week baseline period, a 12-week treatment period and a 1-week follow-up period.
72 participants who meet the enrollment requirements will enter the baseline period, during which 7 days of CGM data will be collected. After entering the treatment period, participants will be randomly assigned to prescription ABA group, prescription ABA-matched placebo group, prescription BAB group and prescription BAB-matched placebo group in a ratio of 2:1:2:1 and receive corresponding treatment.
It is expected that an interim analysis will be conducted after 30 participants have completed 4 weeks of treatment and 4 weeks of their data is obtained. Based on the CGM data of the participants in the 4th week of treatment, the change of TIR in the 4th week compared with the baseline will be analyzed, and the IDMC will make a decision based on the results of this analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| prescription ABA | Experimental | Drug: Fuling Yunhua GranulesFuling Yunhua Granules and Dihuang Baoyuan Granules |
| prescription BAB | Experimental | Drug: Dihuang Baoyuan GranulesFuling Yunhua Granules and Dihuang Baoyuan Granules |
| prescription ABA-matched placebo/ BAB-matched placebo | Placebo comparator | Drug: Fuling Yunhua Granules matched placebo/Dihuang Baoyuan Granules matched placeboFuling Yunhua Granules placebo and Dihuang Baoyuan Granules placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years (inclusive), male or female;
- Patients diagnosed with T2DM ≥ 8 weeks according to the 2020 WHO diagnostic criteria and classification;
- Have controlled blood sugar through diet and exercise for 3 months before screening and did not receive any hypoglycemic drugs, or used hypoglycemic drugs for no more than 2 weeks within 3 months before screening and did not use hypoglycemic drugs within 1 month before screening;
- Body mass index (BMI) ≥ 19 kg/m2;
- Glycated hemoglobin (HbA1c) ≥ 7.0% and < 10.5% at screening;
Key exclusion criteria (23 listed)
- Non-type 2 diabetes: type 1 diabetes, gestational diabetes, special types of diabetes;
- History of acute complications of diabetes within 6 months before screening (diabetic ketoacidosis, diabetic hyperglycemic hyperosmolar syndrome or lactic acidosis, etc.);
- History of chronic complications of diabetes with unstable condition or requiring treatment within 6 months before screening (proliferative retinal disease, severe diabetic neuropathy or intermittent claudication, etc.);
- Experienced more than 3 episodes of grade 3 hypoglycemia within 6 months before screening;
- Have used systemic (intravenous, oral or intra-articular) glucocorticoids continuously or cumulatively for ≥ 7 days within 3 months before screening;
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 GranulesAlso: prescription AFuling Yunhua Granules | Drug | prescription ABA |
| Dihuang Baoyuan GranulesAlso: prescription BDihuang Baoyuan Granules | Drug | prescription BAB |
| Fuling Yunhua Granules matched placebo/Dihuang Baoyuan Granules matched placeboAlso: prescription A matched placebo/B matched placeboFuling Yunhua Granules placebo/Dihuang Baoyuan Granules placebo | Drug | prescription ABA-matched placebo/ BAB-matched placebo |
Primary outcome
Change in HbA1c Concentrations (%) From Baseline
Time frame: 12 weeks
Change in HbA1c concentrations (%) from baseline is the numerical difference between a participant's hemoglobin A1c (HbA1c) level at a specified follow-up time point(s) and their baseline level (initial assessment before intervention). HbA1c, a glycated hemoglobin biomarker, reflects average blood glucose over 8-12 weeks. Venous blood is collected via standard phlebotomy, and HbA1c is quantified using a laboratory-certified method (e.g., high-performance liquid chromatography [HPLC] or immunoassay) for accuracy. Calculated as: Follow-up HbA1c (%) - Baseline HbA1c (%), positive values mean increased average blood glucose, negative values mean decreased. This metric evaluates intervention efficacy (e.g., medications, lifestyle modifications) for glycemic control in diabetes or prediabetes populations.
8 secondary outcomes
Change in FPG (mmol/L) From Baseline
Time frame: 12 weeks
The Proportion of Participants Who Achieved HbA1c Target
Time frame: 12 weeks
Changes in TIR From Baseline
Time frame: 12 weeks
Changes in TBR From Baseline
Time frame: 12 weeks
Changes in TAR From Baseline
Time frame: 12 weeks
Changes in MAGE From Baseline
Time frame: 12 weeks
Change From Baseline in Total Cholesterol (TC) at Week 12
Time frame: 12 weeks
Change From Baseline in Body Weight at Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Diabetes, 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 7 inclusion and 23 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: finished, as of the sponsor's last update on 5 Oct 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?
Yes. Results are posted in the registry (first posted 5 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c Concentrations (%) From Baseline (time frame: 12 weeks). 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 Oct 2026.