T2DM
Conditions
Interventions
Experimental group:Oral SZ-A
Control group:Oral empagliflozin
Sponsors
The affiliated hospital of southwest medical university
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Male or female aged 20-70 years with a BMI >= 25kg/m^2; 2.Diagnosed with type 2 diabetes within 6 years; 3.If the protein in the urine exceeds 100mg/L or exceeds 150mg/24h, the protein qualitative test is positive; 4.Able and willing to sign written informed consent and comply with the study protocol;
Exclusion criteria
Exclusion criteria: 1.Within 3 months before signing informed consent for enrollment, the investigator assessed that the subject had the following cardiovascular diseases: myocardial infarction, cardiac surgery or angioplasty (coronary artery bypass grafting or percutaneous coronary angioplasty), unstable angina, unstable heart failure, congestive heart failure graded by the New York Heart Association (NYHA) grade IV, transient ischemic attack or severe cerebrovascular disease, unstable or previously undiagnosed arrhythmia; 2.Treated with any other hypoglycemic drugs other than empagliflozin; 3.Weight loss of more than 5 kg within 6 months; 4.Pregnant women with a positive pregnancy test, women with intention to become pregnant during the study cycle, lactating women, or women of childbearing potential not using highly effective and medically proven effective contraceptive methods; 5.Previous acute complications of diabetes (e.g., ketoacidosis, hyperglycemic hyperosmolar state) or diabetes insipidus within 30 days; 6.Previous alcohol, drug abuse, or other conditions that may reduce study compliance or medication compliance within 3 months; 7.Have taken investigational drugs from other clinical trials within 30 days before the use of this study, or participated in other clinical trials; 8.Clinically evident disease of the hepatic biliary system, such as chronic active hepatitis with/without severe hepatic insufficiency. ALT or AST > 3-fold upper limit of normal, or total bilirubin > 34.2 µmol/L (>2 mg/dL); 9.Severe renal impairment or end-stage renal disease (eGFR <45mL/min/1.73 m^2); 10.Bariatric surgery or other gastrointestinal surgery leading to chronic absorption disorders within 2 years; 11.Previous malignant tumors or a history of thyroid cancer within 5 years of the enrollment visit; 12.Known immunocompromised, such as prior organ transplantation or diagnosis of acquired immunodeficiency syndrome (AIDS); 13.History of secondary fractures due to severe osteoporosis; 14.Signing informed consent, currently receiving systemic steroid hormone therapy, or having had thyroid hormone drug dose adjusted within 6 weeks, or suffering from uncontrolled endocrine diseases other than type 2 diabetes; 15.Administration of sibutramine, phentermine, orlistat, rimonaban, benzifytamine, bufiladone, methamphetamine, and phenylmorpholine within 30 days of the enrollment visit; 16.Currently (or within the past 3 months) participating in an organized weight loss program; 17.Hematologic malignancy or other disease causing lysis or destruction of red blood cells (e.g., malaria, babesiosis); 18.Administration of any other investigational drug within 30 days or 5 half-lives of the study drug prior to enrollment; 19.Subjects are unable to comply with the protocol requirements of this study or have any serious medical or psychiatric conditions that may affect the evaluation of efficacy and safety data, as judged by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine protein content;ROS/SOD;Urine Albumin-to-Creatinine Ratio;IL-1ß; | — |
Countries
China
Contacts
Public ContactGao Chenlin
The affiliated hospital of southwest medical university
Outcome results
None listed