Hyperuricemia
Conditions
Interventions
Control group:Placebo, once a day
Experimental group:Insulin Degludec 10mg, once a day
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form before the start of the activities related to this trial, and be able to understand the procedures and methods of this trial, and be willing to strictly follow the clinical trial protocol to complete this trial; 2. Age between 18 and 75 years old (inclusive of both ends, based on the date of signing the informed consent form), regardless of gender; 3. Fasting serum uric acid >= 420 µmol/L at the screening time; 4. Patients with asymptomatic hyperuricemia and non-frequent gout patients (acute attacks = 18.5 kg/m^2; 6. No history of diabetes.
Exclusion criteria
Exclusion criteria: 1. Use any of the following drugs or participate in clinical trials: A. Have participated in any investigational drug (including investigational vaccines) clinical trials and taken the investigational drugs within 3 months before enrollment or within the half-life period of the drug (whichever is longer); B. Have participated in any clinical trial of medical devices within 3 months before enrollment (excluding subjects with screening failure); C. Have used other drugs for lowering uric acid (allopurinol, febuxostat, probenecid, benzbromarone, recombinant uricase) within 2 weeks before enrollment; D. Have used any diuretic within 2 weeks before enrollment; E. Have added or adjusted the following drugs within 2 weeks before enrollment: angiotensin receptor blockers (such as losartan), calcium channel blockers (such as amlodipine), fibrates for lipid reduction (such as fenofibrate), statins for lipid reduction (such as atorvastatin), lipid amines, acetarsulfan. 2. The investigator suspects that the patient may be allergic to SGLT2 inhibitor drugs. 3. Drug or alcohol abusers; 4. Those who have used weight-loss drugs or undergone surgeries that can cause unstable weight within 3 months before enrollment, or have participated in any clinical trials of drugs or medical devices; 5. Those who have received long-term (more than 7 consecutive days) administration of corticosteroid hormones within 2 months before enrollment (including intravenous administration, oral administration, intra-articular administration); 6. Those with clinically significant urinary tract infections or/and genital infections, or those with a history of recurrent urinary tract infections or/and genital infections; 7. Those with any of the following laboratory test indicators meeting the following criteria: alanine aminotransferase > 3.0 times ULN and/ or aspartate aminotransferase > 3.0 times ULN and/ or total bilirubin > 2.0 times ULN; eGFR < 30 ml/min/1.73 m^2; eGFR calculation formula: 175 × [ (blood creatinine (µmol/L) / 88.4) ] - 1.234 × [ age (years) ] - 0.179 × 0.79 (female) or × 1 (male); 8. Pregnant or lactating women, or men or women with reproductive capacity who are unwilling to use contraception during the trial; 9. The investigator believes that the patient has any other factors that may affect the efficacy or safety evaluation of this study; 10. Patients with diagnosed malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in serum uric acid from baseline;Proportion of subjects with serum uric acid = 360µmol/L; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in 24-hour urine microalbumin level, blood glucose, blood lipids, blood pressure, HOMAIR, body weight, BMI, waist-to-hip ratio, uric acid excretion fraction; | — |
Countries
China
Contacts
Public ContactHaibing Chen
Shanghai Tenth People's Hospital
Outcome results
None listed