type 2 diabetes mellitus, nocturia
Conditions
Interventions
Group A: Standard treatment group, 20 mg of tofogliflozin is orally administered once daily before or after breakfast. The duration of tofogliflozin administration in this study is 12 weeks (9-14 week
C575086, D004039
tofogliflozin, sodium restriction diet
Sponsors
Hamaguchi Masahide
Fukui Michiaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study; 1. patients with type 2 diabetes mellitus 2. patients with one or more episodes of nocturia 3. Male and female aged 20 years or older and younger than 90 years at giving their consent 4. Patients who provide their consent in a written form by themselves
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study. The latest values of laboratory tests within 14 weeks before giving their consent should be referred. 1. patients who have used SGLT2 inhibitors within 3 months before giving their consent 2. patients who have already been instructed by a dietitian to limit salt intake 3. patients with an estimated salt intake of less than 6 g by casual urine test at giving their consent 4. patients with contraindications to tofogliflozin 5. patients with HbA1c of more than 10% within 3 months before giving their consent 6. patients with recurrent severe hypoglycemia, urinary tract infection, or genital infection 7. patients with suspected carbohydrate restriction diet 8. severly lean patients (BMI of less than 18.5kg/m2) 9. patients with eGFR of less than 15ml/min/1.73m2, serum creatinine of more than 3.5mg/dL, or dialysis 10. patients with hypotension (less than 100/60mmHg) 11. patients with unstable hypertension 12. patients with ADL of PS2 or higher, and aged 65 years or older 13. patients with heart failure of NYHA class III or IV 14. patients who are pregnant or planning to become pregnant during the study period 15. patients undergoing treatment for malignant neoplasms 16. patients with moderate-to-severe anemia (Hb 10g/dL or less) which is not caused by diabetic nephropathy 17. patients with hypoalbuminemia (serum albumin 3.5 g/dL or less) which is not caused by diabetic nephropathy 18. patients with nephrotic syndrome (urinary protein 3.5 g/day or more and serum albumin 3.0 g/dL or less) which is not caused by diabetic nephropathy 19. patients with excessive drinking of alcohol (the net alcohol intake is more than 60g/day for male or 30g/day for female) 20. patients with poor adherence judged by the attending physician 21. patients who require a regal representative to give their consent 22. patients with other conditions that the attending physician think inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nocturnal urination frequency/day at week 12 (urination frequency after bedtime, mean value) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following items from baseline to week 12 1. frequency of urination/day (mean) 2. change in nocturnal voiding index 3. change in nocturnal urine volume 4. change in diurnal urine volume 5. total urinary Na excretion and other urinalysis markers (including urine collection test) 6. change in blood test markers 7. change in nocturnal home blood pressure 8. change in Inbody (skeletal muscle mass, skeletal muscle mass to total body weight ratio, fat mass) 9. change in questionnaire scores (DTSQ, DDRQOL-R, BDHQ, Core Lower Urinary Tract Symptoms score (CLSS)) 10. Frequency of adverse events and diseases-or-the-like | — |
Contacts
Public ContactMasahide Hamaguchi
University Hospital, Kyoto Prefectural University of Medicine
Outcome results
None listed