Type 2 Diabetes Mellitus Patients with Hyperuricemia
Conditions
Interventions
G3 Group (eGFR >30 mL/min/1.73 m^2 to =90mL/min/1.73m^2):Take Ganagliflozin Proline Tablets
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 years or older; 2. Meeting the diagnostic criteria for type 2 diabetes (refer to the "Chinese Guidelines for the Prevention and Treatment of Diabetes [2024 Edition]"); 3. HbA1c between >=6.5% and <=11% as tested by the local laboratory during screening, with a stable diabetes treatment regimen within 12 weeks prior to enrollment; 4. Body mass index (BMI) between 18–35 kg/m² (inclusive); 5. Concurrent hyperuricemia, with or without a history of gout (diagnosed according to the 2015 ACR/EULAR gout classification criteria), defined according to the "Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout [2019]": regardless of gender, having two fasting serum uric acid measurements on different days exceeding 420 µmol/L, meeting any of the following conditions: (1) One laboratory test within 12 weeks prior to screening (results from different hospitals in the same province are acceptable) plus one test at the study center during the screening period; (2) Or any two tests at the study center on different days during the screening period; 6. Willing to voluntarily participate in this study and sign the informed consent form, willing to take medications and undergo assessments according to the study protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals with type 1 diabetes or other special types of diabetes; 2. Individuals with poorly controlled blood pressure during screening, including those with hypertension that remains uncontrolled despite short-term treatment adjustments (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg) or clinically significant hypotension (systolic blood pressure =12 weeks; 7.Within 12 weeks prior to screening, participants must not have recently used medications with uric acid-raising effects (e.g., thiazide diuretics, loop diuretics, pyrimethamine, low-dose aspirin, levodopa, cyclosporine, or imidazolium). If participants have been regular long-term users of such medications, they may be included if the dose has been stable for >=12 weeks; 8.Within 24 weeks prior to screening, participants must not have experienced myocardial infarction, angina pectoris, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack (TIA); 9.Participants who experienced a Grade 3 hypoglycemic event (requiring assistance from others for treatment and accompanied by changes in consciousness and/or physical status, but without a specific blood glucose threshold) or frequent hypoglycemia (three or more episodes of blood glucose 3 times the upper limit of normal, or total bilirubin (TBIL) > 2 times the upper limit of normal; 13. Individuals with a history of malignant tumors within the past 5 years (exceptions: cured squamous cell carcinoma of the skin, basal cell carcinoma, and cervical carcinoma in situ, or malignant tumors deemed cured by the investigator with the lowest risk of recurrence); 14.Participants with severe kidney stones (causing serious complications such as urinary tract obstruction, renal failure, uremia, etc.) or a history of severe recurrent kidney stones at screening; 15. Participants with a urinary tract or genital infection within
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum uric acid; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting insulin;C-reactive protein;erythrocyte sedimentation rate;HOMA-ß;HbA1c;Urine albumin creatinine ratio;FPG;Glomerular filtration rate;HOMA-IR; | — |
Countries
China
Contacts
Public ContactLi Xia
Second Xiangya Hospital of CSU
Outcome results
None listed