Clinical Trial Details
| Trial ID: | L2002 |
| Source ID: | NCT06222476 |
| Associated Drug: | Dorzagliatin |
| Title: | Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study. |
| Acronym: | |
| Status: | NOT_YET_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetic Nephropathy Type 2 |
| Interventions: | DRUG: Dorzagliatin|DRUG: Gliclazide |
| Outcome Measures: | Primary: Participants' personal information, Self-reported information (age in years, gender，course of disease ), 1 day|Physical assessments, BMI (body mass index) in kg/m\^2, 1 day|renal function, changes of renal function (eGFR, creatinine, cystatin C, TNF-1), 1 day|renal magnetic resonance imaging(MRI), Changes of perirenal fat content, renal proton density fat fraction and degree of renal fibrosis, 1 day | Secondary: blood sugar, fasting blood sugar、2-hour postprandial blood sugar, 1 day|insulin, fasting insulin、2-hour insulin, 1 day|HOMA2-β, 20\*fasting insulin（mIU/L）/（fasting blood sugar（mmol/L）-3.5）, 1 day|HOMA2-IR, fasting blood sugar（mmol/L）\*fasting insulin（mIU/L）/22.5, 1 day|HOMA2-IS, 22.5/fasting blood sugar（mmol/L）\*fasting insulin（mIU/L）, 1 day |
| Sponsor/Collaborators: | Sponsor: Yan Bi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 106 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2024-02-20 |
| Completion Date: | 2026-06-30 |
| Results First Posted: | |
| Last Update Posted: | 2024-01-24 |
| Locations: | Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, 210008, China |
| URL: | https://clinicaltrials.gov/show/NCT06222476 |
