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The therapeutic effect of SGLT2 inhibitor Canagliflozin in type 2 diabetes mellitus with hyperuricemia

The therapeutic effect of SGLT2 inhibitor Canagliflozin in type 2 diabetes mellitus with hyperuricemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021231
Enrollment
Unknown
Registered
2019-02-02
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-02-04

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

Conditions

Type 2 Diabetes Mellitus

Interventions

Case Series:Canagliflozin

Sponsors

Beijing Luhe Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The main criteria for inclusion were as follows: 1. Participants were diagonsed with type 2 diabeteswith hyperuricemia (serum uric acid =420µmol/l); 2. Participants were new-onset diabetes or treated with stable oral anti-diabetic agents for at least 8 weeks; 3. The glycated hemoglobin level of the patients were at the range of 7.0% and =10.5%; 4. The participants were 18-75 years old; 5. The participants could understand the procedure of the study and promise to finish the trail, and sign the informed consent; 6. The participants promise to keep the same life habit and take the medicine on time.

Exclusion criteria

Exclusion criteria: 1. Known allergies, hypersensitivity, or intolerance to canagliflozin or its excipients; 2. Current use of, or likely to require treatment with, a corticosteroid medication within 6 months; 3. Participants involvement in other studies within 3 months; 4. History of drug or alcohol abuse within 3 years before screening; 5. History of gout attacks or kidney stone attacks; 6. Myocardial enzyme level >3.0 times; 7. Increased serum amylase and lipase level; 8. ALT levels >2.0 times the ULN or total bilirubin >1.5 times the ULN, at screening; 9. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 at screening; 10. History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; 11. Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening; 12. Arrhymia need to be treated; 13. History of major surgery (ie, requiring general anesthesia) within 3 months of the screening visit; 14. History of malignancy within 5 years before screening; 15. History of HIV antibody positive; 16. The expected lifespan less than 1 yeas; 17. urinary infection at screen; 18. History of arterial occlusion of lower extremity; 19. Pregnant or breast-feeding or planning to become pregnant or breast-feed during the study; 20. The participants were thought to be allergic or intolerance to the agent by the researcher; 21. History of diabetic foot.

Design outcomes

Primary

MeasureTime frame
Serum uric acid;Glycosylated hemoglobin;

Countries

China

Contacts

Public ContactDong Zhao

Beijing Luhe Hospital, Capital Medical University

zhaodong@ccmu.edu.cn+86 18911598827

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026