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New treatment option for Diabetes Mellitus, Type 2
Official title Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients
ClinicalTrials.gov ID: NCT06575478
What this study is testing
What is Fuling Yunhua Granules?
Fuling Yunhua Granules is an investigational medicine, being studied as a potential treatment for diabetes mellitus, type 2.
Also referred to as prescription A.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Body mass index (BMI) ≥ 19 kg/m2;
- Glycated hemoglobin (HbA1c) ≥ 7.0% and \< 10.5% at screening;
You likely can't join if
- 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...
- History of chronic complications of diabetes with unstable condition or requiring treatment within 6 months before screening (proliferative retinal...
- 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;
See the full eligibility criteria
- 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...
- 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
- 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;
- 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...
- 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...
- 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)...
- 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...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.