Study to examine the effects of tofogloflozin on sleep disorders

JRCT ID: jRCTs031240077

Registered date:13/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 13/05/2024
• Target sample size: 86
• Study type: Interventional
• Intervention(s): Patients with type 2 diabetes mellitus taking SGLT2 inhibitors other than tofogliflozin with sleep disturbance will be randomized 1:1 to change SGLT2 inhibitors to Tofogliflozin Hydrate or not to change SGLT2 inhibitors, and sleep and blood sugar assessments will be performed.

Outcome(s)

• Primary Outcome: from baseline (week 0) to week 10, Change in overall PSQI score

Secondary Outcome

1. Sleep diary; change in urination frequency (daily average over 1 month)
2. PSQI; amount of change in the following items;
Sleep quality (C1), time to fall asleep (C2), sleep duration (C3), sleep efficiency (C4), sleep difficulty (C5), use of sleeping pills (C6), difficulty waking during the day (C7)
3. ISI-J; total score and change in the following items
1-a difficulty falling asleep, 1-b mid-day awakening, 1-c early morning awakening, 2 satisfaction with sleep, 3 disturbance during the day, 4 awareness from others, 5 worry/discomfort
4. Amount of change in the following indicators of Fitbit charge 5;
Sleep score, sleep duration, percentage of time in REM sleep, percentage of time in shallow sleep, percentage of time in deep sleep, percentage of time below resting heart rate
5. Amount of change in the following items of CGM;
Percentage of time in sleep hours with blood glucose less than 70 mg/dl (TBR)
Time percentage of blood glucose above 70 and below 180 mg/dl during sleep time (TIR)
Percentage of time during sleep hours when blood glucose is 180 mg/dl or greater (TAR)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Patients who meet all of the following selection criteria will be eligible for the study and whose consent has been obtained
1) Patients diagnosed with type 2 diabetes
2) Patients whose HbA1c at the time of consent is at least 6% but less than 10%.
3) Patients who have been taking an SGLT2 inhibitor other than tofogliflozin for at least 3 months prior to obtaining consent
4) Patients with sleep disorder with a PSQI total score of 6 or more points during the previous observation period
5) Age: 18 years old or older but less than 80 years old at the time of obtaining consent
6) Gender: Any gender
7) Patients who have received sufficient explanation for participation in this study, and who have given written consent of their own free will based on sufficient understanding
8) Patients who are able to make outpatient visits and undergo examinations in accordance with the research schedule.

Exclude criteria

Patients who meet at least one of the following exclusion criteria will be excluded.
1) Patients who can be judged to be insulin-dependent or in a state similar to insulin dependence.
2) Patients with a history of drug allergy or serious adverse reaction to SGLT2 inhibitors
3) Patients with severe ketosis, diabetic coma, or pre-comatose state
4) Patients with severe infections, before or after surgery, or serious trauma
5) Patients with complications of malignancy
6) Patients with serious hepatic, renal, or circulatory disorders (judged with reference to Grade 3 of the JCOG version of CTCAE version 5.0)
7) Patients with psychiatric disorders such as depression
8) Pregnant or possibly pregnant
9) Lactating mothers
10) Night shift workers
11) Patients who are unable to comply with the necessary procedures described in the research protocol
12) Others who are deemed inappropriate to participate in this study by the principal investigator (subinvestigator)

Related Information

• Primary Sponsor: Asano Hiroshi
• Source(s) of Monetary Support: Kowa Company, Ltd.