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A randomized controlled study of proline hengaricin tablets for the treatment of type 2 diabetes mellitus and prevention of early progression of diabetic kidney disease

A randomized controlled study of proline hengaricin tablets for the treatment of type 2 diabetes mellitus and prevention of early progression of diabetic kidney disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087971
Enrollment
Unknown
Registered
2024-08-08
Start date
2024-08-28
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

diabetic kidney disease

Interventions

intervention group:Henagliflozin Proline Tablets or in combination with metformin
control group:Sitagliptin phosphate or in combination with metformin

Sponsors

Guangdong Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years and =75 years; (2) Meet the clinical diagnostic criteria for diabetes mellitus; (3) Meet the clinical diagnostic criteria for DKD stage 3; (4) Urine albumin creatinine ratio of 30mg/g-300mg/g on two out of three occasions and glomerular filtration rate =60 [ml/(min-1.73m2)]; (5) Signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Persons who are pregnant or breastfeeding; (2) Persons with psychiatric illnesses who are unable to understand the nature, scope, and possible results of the study or who are unable to comply with medical advice; (3) Those with acute complications such as diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, and diabetic lactic acidosis; (4) Those with hematuria, obvious abnormal urinary tubular pattern, systemic or urinary tract infections, urinary stones, those with other renal diseases and renal vascular diseases in combination, severe cardiac and hepatic insufficiency, connective tissue disease, malignant tumors, stress, and those who have had a cardiac infarction, angina pectoris, or cerebral infarction within the last 6 months; (5) History of using nephrotoxic drugs within 1 month; (6) Sudden onset of edema with normal renal function. (7) Intractable hypertension.

Design outcomes

Primary

MeasureTime frame
UACR;eGFR;

Secondary

MeasureTime frame
serum creatinine;urea nitrogen;

Countries

China

Contacts

Public ContactFan Guanjie

Guangdong Hospital of Traditional Chinese Medicine

fanguanjie@gzucm.edu.cn+86 139 2511 9990

Outcome results

None listed

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