Efficacy of dual therapy of TOfogliflozin and dietary instruction of sodium-restriction in type 2 diabetes Patients with nocturia; multicenter, open-label, randomized-controlled, Superiority Trial for Availability to Reduce nocturnal urination frequency

JRCT ID: jRCTs051210212

Registered date:30/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: type 2 diabetes mellitus, nocturia
• Date of first enrollment: 30/03/2022
• Target sample size: 80
• Study type: Interventional

Intervention(s)

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 weeks).
Group B: Group with instruction on salt intake restriction. 20 mg of tofogliflozin is administered orally once daily before or after breakfast, and instruction on salt intake restriction is provided by a dietitian. The duration of tofogliflozin administration in this study is 12 weeks (9-14 weeks).

Outcome(s)

• Primary Outcome: Nocturnal urination frequency/day at week 12 (urination frequency after bedtime, mean value)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hamaguchi Masahide
• Secondary Sponsor: Fukui Michiaki
• Source(s) of Monetary Support: Kowa Company, Ltd.