Actively Recruiting
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
Led by Beijing Supreme Life Pharmaceutical Technology Co., Ltd. · Updated on 2024-08-28
72
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effectiveness and safety of sequential therapy using two herbal granules, Fuling Yunhua Granules (prescription A) and Dihuang Baoyuan Granules (prescription B), in adults with type 2 diabetes who have poor blood sugar control despite diet and exercise. This Phase 2 trial is designed as a multicenter, randomized, double-blind, placebo-controlled study to compare these treatments in patients who have not used diabetes drugs or have minimal prior drug use. The study aims to improve blood sugar control and measures changes in HbA1c as the main outcome. The study includes several periods: a 2-week screening, a 1-week baseline during which continuous glucose monitoring (CGM) data is collected, a 12-week treatment phase, and a 1-week follow-up. Participants are randomly assigned to one of four groups receiving either the active granules in different sequences or placebos matching these granules. An interim analysis will be done after 30 participants complete 4 weeks of treatment to evaluate glucose control changes and guide study decisions. Participants will undergo regular assessments including blood tests for HbA1c, fasting plasma glucose, lipid profiles, and body weight. CGM data will be used to monitor glucose levels and variability. Safety and adherence will be closely observed throughout the treatment and follow-up periods. The total study duration per participant is approximately 16 weeks, including screening, treatment, and follow-up.
CONDITIONS
Brief 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 between 18 and 75 years, male or female
- Diagnosed with type 2 diabetes for at least 8 weeks according to 2020 WHO criteria
- Blood sugar controlled by diet and exercise for 3 months without diabetes drugs, or used diabetes drugs for no more than 2 weeks within 3 months and none in the month before screening
- Body mass index (BMI) of 19 kg/m2 or higher
- Glycated hemoglobin (HbA1c) between 7.0% and less than 10.5% at screening
- Fasting plasma glucose below 13.9 mmol/L at screening
- Able to understand study procedures and willing to follow the protocol and sign informed consent
You will not qualify if you...
- Having non-type 2 diabetes such as type 1 or gestational diabetes
- History of acute diabetic complications within 6 months before screening
- Unstable or recently treated chronic diabetic complications within 6 months
- More than 3 episodes of severe hypoglycemia in past 6 months
- Use of systemic glucocorticoids for 7 days or more within 3 months before screening
- Severe infection within 3 months before screening
- Diagnosis of malignant tumors 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
- Uncontrolled thyroid dysfunction
- Poorly controlled hypertension despite treatment
- History of organ transplantation or severe autoimmune diseases
- Significant drug allergies or allergic diseases
- Major surgery within 6 months before screening or planned during study
- Abnormal lab tests including liver enzymes, kidney function, bilirubin, triglycerides, or C-peptide outside specified limits
- Positive for certain infections including hepatitis B, hepatitis C, HIV, or syphilis
- Blood donation or major blood loss within 3 months
- Pregnant or breastfeeding, or not willing to use contraception if able to become pregnant
- History of substance abuse at screening
- Participation in other drug trials within 3 months
- Allergy to study drugs or their ingredients
- Any other condition judged inappropriate by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 week
Participants undergo a baseline period during which continuous glucose monitoring (CGM) data is collected.
1 baseline visit
Duration - 12 weeks
Participants receive assigned granule treatments or matched placebos as part of the active treatment phase.
Visits scheduled according to treatment protocol
Duration - 1 week
Participants are monitored for one week after treatment ends to assess outcomes.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
Q
Qian Ren
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here