Type 2 diabetes mellitus complicated with CKD
Conditions
Interventions
Experimental group:Sangzhi alkaloids
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. be 18-75 years old and of either sex; 2. meet the 1999 World Health Organisation (WHO) diagnostic criteria regarding type 2 diabetes mellitus; 3. patients with poor glycaemic control (7 mmo/L = 3 months, UACR: 30-1000 mg/g, e-GFR: 45-90 mL /min (CKD-EPI formula); 5. At the time of signing the ICF, treatment with a stable dose of antihypertensive medication (including at least ACEI/ARB analogues or a combination of the two) for at least 4 weeks and a blood pressure >=90/60 mmHg and <140/90 mmHg at the time of screening (with the exception of subjects without comorbid hypertension and not using antihypertensive medication); 6. The patient is compliant with the diabetic CKD diet; 7. The patient is fully informed and agrees to participate in this trial by signing an informed consent form;
Exclusion criteria
Exclusion criteria: 1. Other types of diabetes mellitus other than T2DM; 2. previous diagnosis or coexistence of definite other renal diseases, such as IgA nephropathy, membranous nephropathy, crescentic nephritis, etc. (Note: subjects with a history of childhood renal disease with no sequelae may be eligible to participate in the study); renal artery stenosis; or the presence of clinical conditions suggestive of non-DKD, such as a rapid decline in eGFR in a short period of time, rapid increase in urinary proteins or the development of a nephrotic syndrome, the presence of active urinary sedimentation, recalcitrant Hypertension, abnormal renal ultrasound findings, eGFR decline >30% within 2-3 months of ACEI/ARB treatment, etc; 3. those who have used other drugs to improve renal disease such as Morus alba total alkaloids tablets, a-glucosidase inhibitors, Riglitazone, SGLT-2i, GLP-1RA, fenetyllone, and xanthoquin capsules within 8 weeks prior to enrolment; and those who are currently/long-term users of glucocorticosteroids, immunosuppressants, antimicrobials, chemotherapeutic agents, antidepressant medications, and monoamine oxidase inhibitors, and who are using diuretics and can't discontinue their medications during the study period Subjects; 4. patients with volume deficiencies. Patients at risk of volume loss due to comorbidities or combination medications (e.g., diuretics) should have their volume status carefully monitored; 5. history of acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar non-ketotic diabetic coma) within 6 months prior to screening; 6. chronic gastrointestinal disorders with significant digestive and absorption disturbances, especially inflammatory bowel disease; patients with disorders that may be worsened by intestinal flatulence (e.g., Roemheld's syndrome, severe hiatus hernia, intestinal obstruction, and intestinal ulcers); 7. Patients with other diseases or comorbidities that may affect the diagnosis and judgement of efficacy for the target indication; 8. Long-term use of NSAIDs is not permitted, except as a medication for non-chronic indications (sports injuries, headache or back pain, etc.), however may not be taken within 2 weeks prior to a renal function test; 9. current urinary tract infection and active nephritis; 10. dialysis or renal transplant patients; 11. Any of the following laboratory tests during the Screening Period: 1) Glutamate aminotransferase (ALT) > 3.0 x upper limit of normal (ULN) or aspartate aminotransferase (AST) > 3.0 x ULN, or total bilirubin > 2 x UNL; 2) Blood potassium > 5.5 mmol/L or < 3.5 mmol/L; 3) Haemoglobin <= 90 g/L 4) Haemoglobin <= 30 g/L. 12. history of cardiovascular disease within 6 months, including: acute coronary syndrome, chronic heart failure, stroke, or transient ischaemic neurological disorder; 13. uncontrolled thyrotoxicosis, untreated hypothyroidism; 14. history of previous organ transplantation; 15. any malignancy (except cured basal cell carcinoma) within 5 years prior to screening; 16. any serious infection in the last two weeks; 17. history of or actual serious mental illness; 18. history of alcohol abuse or drug addiction within 6 months prior to screening; 19. certain people at high risk, such as lactating women, pregnant women, or patients who may become pregnant during the trial who are allergic to Morus alba Total Alkaloids Tablets, and those who are critically ill with the potential for an unforeseen event; 20. patients judged to be disab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UACR;Urinary alpha-1 microglobulin; | — |
Countries
China
Contacts
Public ContactXiaohong Wu
Zhejiang Provincial People's Hospital
Outcome results
None listed