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Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with glucose intolerance, and changes of blood and urine purine compounds.

Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with glucose intolerance, and changes of blood and urine purine compounds. - Effect of febuxostat and inosine on glucose intolerance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024316
Enrollment
5
Registered
2017-08-31
Start date
2016-08-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glucose intolerance

Interventions

Administration of febuxostat 20 mg and inosine 0.5 g twice a day for 2 weeks

Sponsors

Tsukuba International Clinical Pharmacology Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese male adult who showed HbA1c of not lower than 6.5%, fasting blood glucose of not lower than 126 mg/dL, casual blood glucose of not lower than 200 mg/dL or abnormal glucose tolerance judged by glucose tolerance test during the latest 6 months. 2. Subject with the ability to express his consent who, after a full explanation of the objective and contents of the present clinical study, has voluntarily expressed his consent to participate in the present clinical study. 3. Japanese with 20 to 60 years of age 4. Subject with BMI of not lower than 17.6 and lower than 28.0 on the day of screening test.

Exclusion criteria

Exclusion criteria: 1. Routine user of medicine or supplement. 2. Subject who is currently being treated for diabetes. 3. Subject who has or had renal function disorder. 4. Subject with a history of gout, hyperuricemia or urolithiasis. 5. Subject who has a history of renal disorder. 6. Subject who has or had hypersensitivity, idiosyncracy (allergy) to drug. 7. Subjects taking azathioprine, mercaptopurine or other purine analogs 8. Subject with a disease or a disorder in heart, kidney, pulmonary organ, digestive organ or blood function that are considered to affect absorption, distribution, metabolism or excretion of a drug. 9. Subject who participated in another clinical study for a drug with a new compound within 4 weeks before the administration of drug in the present study. 10. Subject who donated 400 mL of blood within 12 weeks, 200 mL of blood within 4 weeks or blood components within 2 weeks. 11. Subject who used other drugs (including herbs) or supplements within 2 weeks before the administration of drug in this study. 12. Sujbect who plans to take other drugs (including herbs) or supplements before the end of the present study. 13. Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.

Design outcomes

Primary

MeasureTime frame
Difference of blood glucose at 2 hours of glucose intolerance test between before and after the administration of febuxostat and inosine for 2 weeks

Countries

Japan

Contacts

Public ContactMasanori Suzuki

Tsukuba International Clinical Pharmacology Clinic Division for Volunteers

m-suzuki@tsukuba-icp.jp029-839-1150

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026