Multicenter, Open Label, Randomized Controlled Superiority Trial for Availability to Reduce Nocturnal Urination Frequency: Study Protocol for a TOP-STAR Study

Nocturia is a common disease in patients with type 2 diabetes mellitus that can reduce the quality of life. Sodium glucose co-transporter (SGLT2) inhibitors increase urine volume and are often discontinued when polyuria occurs, although tofogliflozin, which has short half-life blood, may improve nocturia by managing hyperglycemia hypertension, without aggravating nocturia. As excessive sodium intake worsens increases volume, restriction also effective This multicenter, open-label, randomized parallel-group trial will examine 80 who experienced After baseline examination, randomly stratified into two groups receive tofogliflozin treatment or for 12 weeks. The primary outcome frequency at secondary outcomes daytime urine, changes home blood pressure.