Patients with type 2 diabetes
Conditions
Interventions
Luseogliflozin 2.5 mg will be administered once a day for 48 weeks. In principle, 2.5 mg as Luseogliflozin will be administered once a day, but if the principal investigator or co-investigator judges
Sponsors
Nishitokyo Diabetes Research Group of Specified Nonprofit Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)A patient whose eGFR is less than 60 mL/min/1.73 m2 2)A patient aged 65 years or older 3)A patient whose HbA1c is 6.5% or more but less than 9.0% 4)A patient from whom written informed consent on his/her participation in this study can be obtained directly
Exclusion criteria
Exclusion criteria: 1)A patient with type 1 diabetes 2)A patient who received an SGLT2 inhibitor within 8 weeks before the start of the treatment phase 3)A patient with severe ketosis, diabetic coma, or precoma 4)A patient with severe infections, before and after surgery, serious trauma 5)A patient with a medical history of hypersensitivity to components of SGLT2 inhibitors 6)A patient with pituitary gland dysfunction or adrenal gland dysfunction 7)A patient showing poor nutritional status, starvation status, irregular meal intake, insufficient dietary intake, or hyposthenia 8)A patient with a medical history of urinary tract infections due to urinary outflow disorder, etc., a patient with a medical history of severe genital infection, or patients currently infected 9)A patient who is prone to dehydration 10)A patient with severe renal dysfunction or a patient with end-stage renal failure during dialysis 11)A patient who is judged unsuitable for participation in this study by his/her attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| eGFR variation before and after therapy at Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Variations of the following items before and after therapy at Week 48 1)Physical findings Body weight, BMI, blood pressure, pulse pressure, mean arterial pressure, pulse 2)Hematologic examination HbA1c, fasting blood glucose level, ketone body fraction (acetoacetic acid, 3-hydroxybutyric acid, total ketone body) 3)Urinalysis Urinary albumin/creatinine ratio, urine sugar (qualitative) 4)Double product | — |
Countries
Japan
Contacts
Public ContactMasafumi Kitaoka
IMS Miyoshi General Hospital Endocrine & Metabolism Center
Outcome results
None listed