Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes P… (NCT06575478) | Clinical Trial Compass
RecruitingPhase 2
Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients
China72 participantsStarted 2024-07-31
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 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
Exclusion criteria
✕. 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.);
✕
What they're measuring
1
Change in HbA1c concentrations (%) from baseline
Timeframe: 12 weeks
Trial details
NCT IDNCT06575478
SponsorBeijing Supreme Life Pharmaceutical Technology Co., Ltd.
. 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 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;