Type 2 diabetes mellitus with chronic kidney disease
Conditions
Interventions
Control group:None
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The age must be > 18 years at the time of signing the informed consent form. Moreover: 1) Meet the American Diabetes Association's diagnostic criteria for type 2 diabetes 2) Screening period eGFR >=25 mL/min/1.73 m2 3) Screening period random urine albumin/creatinine ratio (UACR) >= 30mg/g or urinary albumin excretion rate (UAER) >=30mg/24h 4) K+ level <= 5.0 mmol/L during screening, sex and contraception/barrier requirements 5) Regular use of RASI for more than four weeks, unless such drugs are contraindicated or not tolerated 6) Regular use of SGLT2 inhibitors for more than four weeks
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes and other types of diabetes 2) Renal replacement therapy (dialysis, kidney transplantation status) 3) Acute kidney injury requiring dialysis within 6 months prior to the screening visit 4) Combination of cytochrome P450 isoenzyme 3A4 (CYP3A4) potent inhibitor or inducer and/or CYP3A4 medium-potency inhibitor erythromycin (discontinued at least 7 days prior to randomization), in pregnancy or lactation, or planning pregnancy during the study 5) Combined with systemic wasting diseases (malignant tumors, etc.) 6) CV event within 3 months before screening visit or percutaneous coronary intervention treatment within 1 month before screening visit 7) Known allergy to investigational drugs (including active ingredients or excipients), Addison's disease, and hepatic insufficiency up to Child-Pugh class C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine albumin creatinine ratio;Glomerular filtration rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic indicators;Body composition;Muscle strength;Adverse drug reactions; | — |
Countries
china
Contacts
Public Contactliufang
West China Hospital, Sichuan University
Outcome results
None listed