Diabetice
Conditions
Interventions
Daily subcutaneous injection of liraglutide 0.6 to 0.9 mg/day for 1 year
Daily subcutaneous injection of liraglutide 0.6 to 0.9 mg/day for 26 weeks, and administration of 10 mg of empargliflozin from
Sponsors
Sunagawa Medical Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have been in Sunagawa Medical Clinic more than 1 year. 2. Patients with Type 2 diabetes mellitus with overt emergent diabetic nephropathy (3rd and 4th stage). 3. Patients with a urine protein/Cr ratio of 500 mg/gCr or more. 4. Reduced salt guidance (6g/day). 5. Urinary protein/Cr ratio is 500mg/gCr more than twice. 6. RAS inhibitor administration for 6 months or more than twice. 7. At registration, eGFR is more than 20 ml/min/1.73m (2) 8. HbA1c is less than 10% at registration
Exclusion criteria
Exclusion criteria: 1. Diabetes with complications requiring hospitalization such as diabetic ketoacidosis 2. Severe heart failure, severe arrhythmia, angina pectoris, myocardial infarction, stroke developed within 6 months before the start of the study 3. Pregnant women or patients who may be pregnant and breast-feeding patients 4. Ingestion of SGLT2 inhibitor 5. Have a history of having serious side effects with GLP-1 receptor agonist and SGLT2 inhibitor 6. Patients who had positive urinary occult blood test at least twice within 6 months 7. Patients with malignant tumor complications 8. Patients complicated of mental illness without self-determination ability 9. Other patients judged inappropriate by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 12 months starting administration of decrease rate of estimated glomerular filtration rate (%DeGFR) | — |
Secondary
| Measure | Time frame |
|---|---|
| After 12 months starting administration of 0.Decrease amount of estimated glomerular filtration rate (DeGFR) 1.Changes in quantitative determination of urinary albumin 2.Changes in urine protein quantification 3.Change in HbA1c value 4.Change in weight 5.Frequency of hypoglycemia 6.Cardiovascular events: acute myocardial infarction, cerebral infarction (excluding lacunar infarction) 7.Renal event: Introduction of dialysis 8.Total death 9.Change in LDL-C value 10.Change in Non-HDL value 11.Change in TG value 12.Change in HDL-C value 13.Change in dynamic quantity evaluation 14.Change in intestinal flora 15.Changes in body composition | — |
Countries
Japan
Contacts
Public ContactKae SUNAGAWA
Sunagawa Medical Clinic Center of Clinical Research Support
Outcome results
None listed