Type 2 diabetes mellitus
Conditions
Interventions
To subscribe 10mg or 25mg/day empagliflozin (Jadiance) for 3 years
Sponsors
Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those aged = or >20 and <80 2) HbA1c = or >6.5% 3) Type 2 diabetes mellitus patients with mild (60 = or < eGFR <90 mL/min/1.73m2) or moderate (30 = or <eGFR<60 mL/min/1.73m2) renal dysfunction 4) Those who can cope with dehydration 5) Those who can suspend taking medicine appropriately on sick days with fever, diarrhea, vomiting, or appetite loss 6) Those who have given written informed consent on the use of their data for the study
Exclusion criteria
Exclusion criteria: 1) Those with past histories of hypersensitivity to SGLT2 inhibitors 2) Those with severe ketosis, diabetic coma or precoma 3) Those at perioperative stages, or those with severe infection or serious injury 4) Those with followings: 1. Hypopituitarism or adrenal insufficiency 2. Malnutrition, starvation, irregular or insufficient food intake, or debilitating condition 3. Excessive muscular exercise 4. Excessive alcohol drinker 5 ) Those with urinary tract or genital infection 6) Those with severe liver dysfunction 7) Those who are pregnant or hoping pregnancy 8) Those with a malignant tumor currently or in the past 5 years 9) Those who are treated currently with SGLT2 inhibitors 10) Those who are considered not eligible for the study by attending doctors because of any medical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the association between the concentration of urinary megalin and its ligand molecules such as alpha1-microglobulin and beta2-microglobulin and the change in renal function (eGFR) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The change in eGFR 2) Notable adverse effects (hypoglycemia, urinary tract, and genital infection, etc) 3) Serious adverse events (serious hypoglycemia, sepsis, hypovolemia, cerebral infarction, ischemic heart disease, ketoacidosis, acute kidney injury, and serious eruption, etc) 4) Other biomarkers such as urinary podocalyxin 5) Dietary evaluation using self-administered diet history questionnaire (DHQ) 6) Ambulatory blood pressure monitoring (ABPM) | — |
Countries
Japan
Contacts
Public ContactAkihiko Saito
Niigata University Graduate School of Medical and Dental Sciences Department of Applied Molecular Medicine
Outcome results
None listed