NIPH Clinical Trials Search

SOS Study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Type 2 diabetes
Date of first enrollment	17/02/2026
Target sample size	80
Countries of recruitment
Study type	Interventional
Intervention(s)	Switching from other SGLT2 inhibitors to tofogliflozin and take in for 12 weeks

Outcome(s)

Primary Outcome

Change in nocturnal urination frequency from before switching to SGLT2 inhibitors to one week after switching

Secondary Outcome

-Change in nocturnal urination frequency from before switching to an SGLT2 inhibitor to 4 weeks after switching -Change in nocturnal polyuria index from before switching to an SGLT2 inhibitor at 1 week and 4 weeks after switching -Change in lower limb fluid volume and upper/lower limb fluid volume ratio from before switching to an SGLT2 inhibitor at 1 week and 4 weeks after switching -Change in extracellular water ratio from before switching to an SGLT2 inhibitor at 1 week and 4 weeks after switching -Change in nocturnal urinary sodium and nocturnal urinary sodium/daytime urinary sodium from before switching to an SGLT2 inhibitor at 1 week and 4 weeks after switching -Changes in nighttime urinary glucose and nighttime urinary glucose/daytime urinary glucose from before switching to SGLT2 inhibitors, 1 week after switching, and 4 weeks after switching. -Changes in nighttime urinary osmolality and nighttime urinary osmolality/daytime urinary osmolality from before switching to SGLT2 inhibitors, 1 week after switching, and 4 weeks after switching. -Changes in various QOL scores from before switching to an SGLT2 inhibitor to 1 and 4 weeks after switching -Occurrence of illnesses,etc. -HbA1c over time

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 79age old
Gender	Both
Include criteria	(First registration) 1. Patient with type 2 diabetes being treated at the Department of Diabetes and Endocrinology, Nara Medical University Hospital 2. Patients with type 2 diabetes who have been taking an SGLT2 inhibitor other than tofogliflozin hydrate for at least three months 3. Patients aged 20 to 79 years old 4. Patients who wake up at night to urinate two or more times 5. Patients with an HbA1c level of less than 9.0% 6. Patients who have provided written consent to participate in this study (Second registration) 1. Patients enrolled in the primary enrollment 2. Patients with an SGLT2 inhibitor adherence rate of 75% or higher for 28 days after primary enrollment 3. Patients with a median nocturnal urination frequency of 2 or more times in the 3 days immediately prior to secondary enrollment
Exclude criteria	(First registration) 1. Patients with allergies to the study drug 2. Patients with liver disease (AST (GOT) or ALT (GPT) >= 100 IU/L) 3. Patients with impaired renal function (eGFR<30mL/min/1.73m2) 4. Patients prescribed SGLT2 inhibitors for the purpose of treating both type 2 diabetes and chronic kidney disease (CKD) 5. Patients prescribed SGLT2 inhibitors for the purpose of treating both type 2 diabetes and heart failure 6. Patients with posterior pituitary disorders and primary or secondary adrenal dysfunction 7. Patients with malignant tumors 8. Pregnant patients 9. Patients who have participated in other clinical trials within 3 months prior to primary enrollment 10. Patients deemed inappropriate for study participation by the principal investigator or co-investigator (Second registration) 1. Patients with 50 or more WBCs in urine / HPF (1 field of view at 400x magnification) 2. Patients who have withdrawn consent 3. Patients deemed inappropriate for study participation by the principal investigator or co-investigator