Type 2 Diabetic Nephropathy
Conditions
Interventions
600 mg:Two TBN tablets
1200 mg:Four TBN tablets
placebo:placebo
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Male and female, patient aged from 18 to 75 years inclusive; (2) Diagnosed with type 2 diabetes and treated with hypoglycemic drugs for at least 6 months; Glycosylated HbA1c = 9.0%; (3) UACR >300 mg/g (33.9 mg/mmol) and =45 mL/min/1.73 m2(CKD-EPI) before randomization; (5) Treated with normal dosage of ACEIs or ARBs for at least 3 months; (6) Blood pressure were controlled under 160/90 mmHg with appropriate treatment before randomization; (7) Willing to take effective contraceptive measures from the date of signing written informed consent until 6 months after the last dose; (8) Willing to participate and sign informed consent, and able to understand and follow the process of this trial.
Exclusion criteria
Exclusion criteria: (1) Type 1 diabetes; (2) Serum potassium >=5.5 mmol/L; (3) Abnormal liver test results (refers to AST or/and ALT or/and ALP > 3 ULN) when screening, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis; (4) Patients with acute urinary tract infection within 2 weeks before randomization; (5) Concomitant chronic renal disease such as glomerulonephritis, pyelonephritis, Ischemic nephropathy, etc. (6) A medical history of familial glucose-galactose malabsorption or primary renal glycosuria; (7) A medical history of severe acute complications of diabetes (Ketoacidosis, lactic acidosis, hyperosmolar non-ketotic diabetic coma, hypoglycemic coma) within 6 months before screening; (8) A medical history of organ transplant, such as Liver transplantation, kidney transplantation etc; (9) A medical history of acute coronary syndrome, heart failure (NYHA III-IV), heart-related diseases surgery, stroke, and poor prognosis of stroke (mRS>1) within 6 months prior to randomization; (10) Inability or unwillingness to co-operate due to concomitant mental illness or language impairment; (11) A medical history of autoimmune diseases like systemic lupus erythematosus etc; (12) A medical history of malignant tumor; (13) Allergic to the investigational product or ligustrazine; (14) Had participated in other drug clinical trials within 3 months prior to randomization (refers to having been enrolled and recevied investigational product); (15) Pregnant or lactating female; (16) The investigator determined that the subject is not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UACR; | — |
Secondary
| Measure | Time frame |
|---|---|
| eGFR;AER; | — |
Countries
China
Contacts
Public ContactNiansong Wang
Shanghai Sixth People's Hospital
Outcome results
None listed