Diabetic nephropathy
Conditions
Interventions
Henagliflozin treatment group:On the basis of metformin treatment(=1500mg/d), combined with henagliflozin 100mg/d
Insulin degludec treatment group:On the basis of metformin treatment(=1500mg/d), combined with subcutaneous injections of insulin degludec once-daily
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign informed consent, be able to understand the procedures and methods of the study, and be willing to strictly follow the clinical trial protocol to complete the study; 2. The age of screening is 18-75 years old (including both ends), male and female; 3. Diagnosed with type 2 diabetes according to WHO standards in 1999; 4. On the basis of regular diet control and exercise, receive stable dose of metformin (=1500mg/d) for more than 8 weeks; 5. 7.5%=HbA1c=10.5%; 6. Fasting plasma glucose =13mmol/L; 7.19 =kg/m2BMI=40kg/m2; 8. 100mg/g=ACR=300mg/g, eGFR=60 mL/min/ 1.73m2; 9. Receive stable dose of ACEI/ARB drugs for more than 4 weeks.
Exclusion criteria
Exclusion criteria: 1. The investigator suspects that the subject may be allergic to the study drug; 2. Any of the following drugs or treatments were used before screening: 1) Growth hormone therapy within 6 months prior to screening; 2) A history of drug or alcohol abuse within 6 months prior to screening; 3) Long-term (more than 7 consecutive days) intravenous administration, oral administration, or intra-articular administration of corticosteroids within 2 months before screening; 4) Participated in clinical trials of any drug or medical device within 3 months prior to screening; 5) Use of any drug that, in the judgment of the investigator, may interfere with the interpretation of efficacy and safety data, or use of any drug or Chinese herbal medicine known to have common toxic effects on major organs before screening; 3. History or evidence of any of the following conditions prior to screening: 1) Acute metabolic complications (such as ketoacidosis, lactic acidosis, or hypertonic coma) have occurred in the 6 months prior to screening; 2) A history of severe episodes of hypoglycemia (such as hypoglycemia causing drowsiness, disturbance of consciousness, delirium, or even coma, requiring the assistance of others to treat hypoglycemia), or recurrent episodes of hypoglycemia (=3 episodes of symptomatic hypoglycemia within a week, or at least 3 episodes of blood glucose 3 ×ULN; 4) Significantly abnormal 12-lead electrocardiogram (ECGs) results that investigators believe may affect the safety of subjects; 5. Pregnant or lactating women, fertile men or women unwilling to use contraception during the study period; 6. Any other circumstances in which the investigator considers the subject unsuitable f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Content of BCAA (leucine, isoleucine, valine) in urine; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;FPG;ACR;Markers of early renal injury;BMI;IL-1ß;IL-6; | — |
Countries
China
Contacts
Public ContactHou Rongrong
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed