Skip to content

Randomized controlled trial of the efficacy and safety of Henagliflozin in lowering uric acid in type 2 diabetes patients with hyperuricemia

Randomized controlled trial of the efficacy and safety of Henagliflozin in lowering uric acid in type 2 diabetes patients with hyperuricemia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083831
Enrollment
Unknown
Registered
2024-05-06
Start date
2024-06-06
Completion date
Unknown
Last updated
2025-01-13

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

Test group: 10mg of Henagliflozin,Qd
Control group:Primary hypoglycemic background drugs (non-SGLT2I OADs)

Sponsors

The Affiliated Hospital Of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old = the age of T2DM =75 years old 2. 7.0%=HbA1c=11.0% 3. Combined with hyperuricemia, as defined in the Chinese Guidelines for Diagnosis and Treatment of Hyperuricemia and Gout (2019) 4.Patients with or without gout, and non-acute gout 5. sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. patients allergic to Henagliflozin 2. patients diagnosed with secondary gout 3. Taking drugs that affect uric acid metabolism in the blood, such as atorvastatin, losartan, dihydrocrethiazide, furosemide, riuric acid, pyrazinamide, low-dose aspirin, etc., and drugs containing the above ingredients, such as compound antihypertensive tablets; Or had taken glucocorticoids within 1 month before enrollment; Use of non-steroidal anti-inflammatory drugs or other pain medications in the 48 hours prior to baseline evaluation 4. Xanthinuria patients 5. Patients with severe hypertriglyceridemia 6. Patients with severe cardiovascular and cerebrovascular diseases 7. Joint disease caused by rheumatoid arthritis and other causes requiring treatment 8. Type 1 diabetes 9. T2DM with a history of ketoacidosis (DKA) 10. eGFR < 30 mL/min/1.73 m2 11. Currently using or having used SGLT2i drugs within 3 months 12. Patients with diagnosed malignant tumors 13. Pregnant and lactating women and women of childbearing age who do not want to use reliable contraception 14. Patients participating in other clinical trials within 3 months 15. According to the investigators' judgment, the patient had other conditions that were not suitable for enrollment 16. In addition to the above, the investigators judged that the patients were not suitable to participate in this clinical trial

Design outcomes

Primary

MeasureTime frame
change of serum uric acid from baseline in each group;

Secondary

MeasureTime frame
HbA1c;UACR;

Countries

China

Contacts

Public ContactWang Yangang

The Affiliated Hospital Of Qingdao University

wangyg1966@126.com+86 186 6180 7293

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026