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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Fuling Yunhua Granules
Fuling Yunhua Granules placebo
Dihuang Baoyuan Granules
Dihuang Baoyuan Granules placebo
Peking University People's Hospital
Beijing, China
RECRUITINGChange in HbA1c concentrations (%) from baseline
Change in HbA1c concentrations (%) from baseline
Time frame: 12 weeks
Change in FPG (mmol/L) from baseline
Change in FPG (mmol/L) from baseline
Time frame: 12 weeks
The proportion of participants who achieved HbA1c target
The proportion of participants who achieved HbA1c target (HbA1c\<7.0% and \<6.5% Patient percentage)
Time frame: 12 weeks
Changes in TIR from baseline
Changes in TIR from baseline
Time frame: 7 days
Changes in TBR from baseline
Changes in TBR from baseline
Time frame: 7 days
Changes in TAR from baseline
Changes in TAR from baseline
Time frame: 7 days
Changes in MAGE from baseline
Changes in MAGE from baseline
Time frame: 7 days
Changes in fasting lipid profiles
Changes in fasting lipid profiles from baseline(mmol/L)
Time frame: 12 weeks
Change in weight
Change in weight from baseline(kg)
Time frame: 12 weeks
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