Type 2 diabetes mellitus
Conditions
Interventions
The patients are assigned to empagliflozin treated or placebo treated group. In the patients of both groups, the agent is orally administered at the dose of 10 mg once daily. The patients are prohibit
Sponsors
Makino Hisashi
Nippon Boehringer Ingelheim Co ., Ltd.
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 20 years old or older, less than 85 years old with type 2 diabetes mellitus HbA1c of 6.5% or higher, and less than 10.0% Urinary albumin excretion of 30mg/gCr or higher, and less than 300mg/gCr, and eGFR more than 30ml/min/1.72m2 No change in internal use of renin-angiotensin system inhibitors within 3 months of consent No change in internal use of hypoglycemic drugs within 3 months of consent
Exclusion criteria
Exclusion criteria: BMI less than 18.5 kg/m2 Patients who diagnosed as chronic glomerulonephritis Patients who are /want to pregnant, or are breast feeding Patients taking SGLT2 inhibitors within 3 months of consent Patients with heart failure of NYHA III or IV New York Heart Association functional classification Patients who diagnosed as acute coronary syndrome or stroke within 3 months of consent Patients who performed PCI or CABG within 3 months of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in urinary albumin and L-FABP excretion | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in serum VEGF, adrenomedullin, ANGPTL2, and ANGPTL4 Change from baseline in urinary NGAL, and KIM-1 | — |
Contacts
Public ContactHisashi Makino
National Cerebral and Cardiovascular Center
Outcome results
None listed