NCT06575478

Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Beijing Supreme Life Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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. 72 participants who meet the enrollment requirements will enter the baseline period, during which 7 days of CGM data will be collected. After entering the treatment period, participants will be randomly assigned to prescription ABA group, prescription ABA-matched placebo group, prescription BAB group and prescription BAB-matched placebo group in a ratio of 2:1:2:1 and receive corresponding treatment. It is expected that an interim analysis will be conducted after 30 participants have completed 4 weeks of treatment and 4 weeks of their data is obtained. Based on the CGM data of the participants in the 4th week of treatment, the change of TIR in the 4th week compared with the baseline will be analyzed, and the IDMC will make a decision based on the results of this analysis.

Conditions

• Diabetes Mellitus, Type 2
• Diabetes
• Type2diabetes

Interventions

Type	Name	Description
DRUG	Fuling Yunhua Granules	Fuling Yunhua Granules
DRUG	Fuling Yunhua Granules matched placebo	Fuling Yunhua Granules placebo
DRUG	Dihuang Baoyuan Granules	Dihuang Baoyuan Granules
DRUG	Dihuang Baoyuan Granules matched placebo	Dihuang Baoyuan Granules placebo

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2024-08-28
• Last updated: 2024-08-28

Locations

1 site across 1 country: China