Actively Recruiting
Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients
Led by Beijing Supreme Life Pharmaceutical Technology Co., Ltd. · Updated on 2024-08-28
72
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
B
Beijing Supreme Life Pharmaceutical Technology Co., Ltd.
Lead Sponsor
P
Peking University People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Diagnosed with type 2 diabetes for at least 8 weeks based on 2020 WHO criteria
- Blood sugar controlled by diet and exercise for 3 months before screening without hypoglycemic drugs, or used hypoglycemic drugs no more than 2 weeks within 3 months before screening and none within 1 month before screening
- Body mass index of 19 kg/m2 or higher
- Glycated hemoglobin (HbA1c) between 7.0% and less than 10.5% at screening
- Fasting plasma glucose less than 13.9 mmol/L at screening
- Able to understand and willing to follow study procedures and sign informed consent
You will not qualify if you...
- Type 1 diabetes, gestational diabetes, or special types of diabetes
- Acute diabetes complications within 6 months before screening (e.g., diabetic ketoacidosis)
- Unstable or treated chronic diabetes complications within 6 months before screening (e.g., severe neuropathy)
- More than 3 episodes of severe hypoglycemia in the past 6 months
- Use of systemic glucocorticoids for 7 days or more within 3 months before screening
- Severe infection within 3 months before screening
- Malignant tumors diagnosed within 5 years before screening (except certain cured skin or cervical cancers)
- Severe cardiovascular disease or significant arrhythmias within 6 months before screening
- Diseases affecting drug absorption or metabolism within 6 months before screening
- Uncontrolled thyroid dysfunction
- Poorly controlled hypertension despite treatment
- History of organ transplantation or severe autoimmune diseases
- History of major allergic or atopic diseases
- Major surgery within 6 months before screening or planned surgery during the study
- Abnormal liver, kidney, or blood test results beyond specified limits
- Positive for hepatitis B surface antigen (with exceptions), hepatitis C, HIV, or syphilis antibodies
- Blood donation or major blood loss over 400 mL within 3 months before screening
- Pregnant or breastfeeding women, or those planning pregnancy or not using contraception
- History or suspicion of alcohol, tobacco, or drug abuse
- Participation in other drug trials within 3 months before screening
- Allergy to study drugs or ingredients
- Any other factors deemed inappropriate by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
Q
Qian Ren
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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