Hyperuricemia complicated with diabetes
Conditions
Interventions
Topiroxosta: Topiroxostat is orally taken twice a day after breakfast and supper for 24 weeks. At every observation point, patients visit hospital without taking and test are performed. Responsible i
t fall below 3.0 m/dL. If a serum urine acid level becomes<
3.0 m/dL, the amount of topiroxostat is back to the previous amount. However, whenever gouty arthritis is admitted during the study, the investigator may stop increasing the amount or suspend the a
Sponsors
Toho University Medical Center Sakura Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. Male with hyperuricemia 2. Patients aged at 50 years or older, and younger than 80 years at the time of giving their consent 3. Type 2 diabetic patients with HbA1c lower than 9.0% during the last 12 weeks from the consent 4. Patients who are with a uric acid level 7.0 mg/dL or higher and without any medication for hyperuricemia, or hyperuricemic patients who are currently using benzbromarone 5. Patients with ability of giving their written consent
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study. 1. Female 2. Patients complicated with arteriosclerosis obliterans, or ABI 0.9 or lower 3. Complicated with atrial fibrillation 4. Using any type of insulin treatment 5. Using any type of SGLT2 inhibitors 6. Patients with gouty arthritis at baseline 7. Patients who may show hypersensitiveness to topiroxostat 8. Patients who are currently on mercaptopurine hydrate or azathioprine, or planning to take one of them 9. Patients with liver function failure or cirrhosis of the liver 10. Patients complicated with chronic liver hepatitis (type B, or C), and classified as active hepatitis 11. Patients with kidney stone, or severe renal function failure 12. Patients with malignant tumor (excluding those completely cured) 13. Other conditions that investigators judge to be inappropriate to join the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Amount of change in CAVI at the week 24 2. Amount and percent change in blood XOR activity at the 24 week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Index for hyperuricemia: amount of changes in serum uric acid levels , and the amount and percent changes of blood XOR activity 2. Index for arteriosclerosis: changes in CAVI and hsCRP values 3. Index for renal function: change in eGFR, and the amount and rate of changes in ACR (urine albumin/Cr ratio) 4. Index for acid stress: changes in d-ROM, and MDA-LDL 5. Changes in general blood and urine tests items, body weight, BMI, blood pressure, and pulse 6. All measured raw data listed above 7. Incidence rate of abnormality found in liver function tests 8. Frequencies of the occurrence of gouty arthritis attack during the study 9. Correlation between CAVI and blood XOR activity | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed