Fuling Yunhua Granules and Dihuang Baoyuan Granules in Adults With Type 2 Diabetes and Inadequate Glycemic Control on Metformin Therapy
NCT07929350, Phase 2, Not yet recruiting, Beijing Supreme Life Pharmaceutical Technology Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Fuling Yunhua Granules and Dihuang Baoyuan Granules in Adults With Type 2 Diabetes and Inadequate Glycemic Control on Metformin Therapy | ClinicalTrials.gov |
| NCT number | NCT07929350 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing Supreme Life Pharmaceutical Technology Co., Ltd. | ClinicalTrials.gov |
| Conditions | Diabetes Mellitus, Type 2 | ClinicalTrials.gov |
| Interventions | Fuling Yunhua Granules, Dihuang Baoyuan Granules, Fuling Yunhua Granules Matched Placebo, Dihuang Baoyuan Granules Matched Placebo, Metformin, Metformin Matched Placebo | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from Baseline in Glycated Hemoglobin (HbA1c) at Week 24 | Baseline and Week 24 | ClinicalTrials.gov | |
| Secondary | Proportion of Participants Achieving Clinical Glycemic Target at 12 Weeks After Discontinuation of Study Drug (Clinical achievement defined as HbA1c <6.5% under continued background therapy with or without metformin) | 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Glycated Hemoglobin (HbA1c) at Weeks 8, 12, 16, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 8, 12, 16, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Proportion of Participants With HbA1c <6.5% at Weeks 8, 12, 16, and 24 | Weeks 8, 12, 16, and 24 | ClinicalTrials.gov | |
| Secondary | Proportion of Participants With HbA1c <7.0% at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 4, 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in 2-Hour Postprandial Glucose (PPG) at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Continuous Glucose Monitoring (CGM) Time in Range (TIR) at Week 24 | Baseline and Week 24 | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Continuous Glucose Monitoring (CGM) Time Below Range (TBR) at Week 24 | Baseline and Week 24 | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Continuous Glucose Monitoring (CGM) Time Above Range (TAR) at Week 24 | Baseline and Week 24 | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Insulin Sensitivity (HOMA-IS) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Beta-Cell Function (HOMA-β) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in C-Peptide Index (CPI) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Fasting Lipid Profile (Total Cholesterol [TC], LDL-C, HDL-C, Triglycerides [TG]) at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Systolic and Diastolic Blood Pressure at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Serum Uric Acid at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Fasting Body Weight at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Waist Circumference at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Hip Circumference at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Traditional Chinese Medicine Syndrome Score at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug | The Traditional Chinese Medicine Syndrome Scale for Type 2 Diabetes Mellitus. The total score ranges from 0 to 33 or 0 to 36, depending on the TCM syndrome pattern. Higher scores indicate more severe symptoms (worse outcome). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)