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Analysis of the efficacy and safety of Hengliflozin combined with metformin in the treatment of diabetes mellitus complicated with hyperuricemia

Analysis of the efficacy and safety of Hengliflozin combined with metformin in the treatment of diabetes mellitus complicated with hyperuricemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109541
Enrollment
Unknown
Registered
2025-09-20
Start date
2025-09-22
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Diabetes mellitus complicated with hyperuricemia

Interventions

observation group:Empagliflozin and Metformin
control group:Metformin

Sponsors

The First Affiliated Hospital of Guilin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18 to 70 years old (inclusive), gender unrestricted; 2. Confirmed with type 2 diabetes according to the "Chinese Guidelines for the Prevention and Treatment of Diabetes Mellitus (2024 Edition)", with glycated hemoglobin levels between 6% and 9%; 3. Meeting the diagnostic criteria for hyperuricemia as per the "2023 Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Hyperuricemia-related Diseases in China", without painful attacks, and with uric acid levels between 420 and 480 µmol/L; 4. Able to understand the content and methods of this study.

Exclusion criteria

Exclusion criteria: 1. People who are allergic to canagliflozin, metformin hydrochloride or any of the excipients. 2. Contraindicated groups: Severe renal failure (eGFR < 45 mL/min/1.73m^2)acute conditions that may affect renal function, such as dehydration, severe infection, shock diseases that can cause tissue hypoxia (especially acute diseases or deterioration of chronic diseases), such as decompensated heart failure, respiratory failure, recent myocardial infarction and shock severe infection and trauma, major surgery, clinical hypotension and hypoxia, etc.pre-diabetic coma liver failure, acute alcohol poisoning, alcoholism uncorrected vitamin B12 and folic acid deficiency; 3. Pregnant women, lactating women and women of childbearing age who are unwilling to take reliable contraceptive measures. 4. Type 1 diabetes. 5. People who have experienced diabetic ketoacidosis, lactic acidosis or hyperosmolar non-ketotic coma within the last 6 months and required hospitalization. 6. Severe hypoglycemic events of unknown cause that required assistance from others to recover have occurred within the past 6 months; or frequent hypoglycemia: such as two or more hypoglycemic events (blood glucose < 3.9 mmol/L) within one month before screening. 7. Those with a history of recurrent urinary tract infections and/or genital infections; 8. Acute gouty arthritis attack period; 9. Those with critical conditions that make it difficult to make an accurate assessment of the efficacy and safety of this study.

Design outcomes

Primary

MeasureTime frame
HbA1c;Uric acid;

Countries

China

Contacts

Public ContactHuang Lili

The First Affiliated Hospital of Guilin Medical University

44143219@qq.com+86 773 2823742

Outcome results

None listed

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