| Trial ID: | L6539 |
| Source ID: | NCT06575478
|
| Associated Drug: |
Fuling Yunhua Granules
|
| Title: |
Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Diabetes|Type2diabetes
|
| Interventions: |
DRUG: Fuling Yunhua Granules|DRUG: Fuling Yunhua Granules matched placebo|DRUG: Dihuang Baoyuan Granules|DRUG: Dihuang Baoyuan Granules matched placebo
|
| Outcome Measures: |
Primary: Change in HbA1c concentrations (%) from baseline, Change in HbA1c concentrations (%) from baseline, 12 weeks | Secondary: Change in FPG (mmol/L) from baseline, Change in FPG (mmol/L) from baseline, 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), 12 weeks|Changes in TIR from baseline, Changes in TIR from baseline, 7 days|Changes in TBR from baseline, Changes in TBR from baseline, 7 days|Changes in TAR from baseline, Changes in TAR from baseline, 7 days|Changes in MAGE from baseline, Changes in MAGE from baseline, 7 days|Changes in fasting lipid profiles, Changes in fasting lipid profiles from baseline(mmol/L), 12 weeks|Change in weight, Change in weight from baseline(kg), 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Beijing Supreme Life Pharmaceutical Technology Co., Ltd. | Collaborators: Peking University People's Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-07-31
|
| Completion Date: |
2025-01-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-28
|
| Locations: |
Peking University People's Hospital, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06575478
|
