Status:
RECRUITING
Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients
Lead Sponsor:
Beijing Supreme Life Pharmaceutical Technology Co., Ltd.
Collaborating Sponsors:
Peking University People's Hospital
Conditions:
Diabetes Mellitus, Type 2
Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 (prescript...
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...
Eligibility Criteria
Inclusion
- 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
- 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 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.
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06575478
Start Date
July 31 2024
End Date
January 30 2025
Last Update
August 28 2024
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China