A study to verify the efficacy of the selective SGLT2 inhibitor tofogliflozin hydrate in reducing nocturia

A study to verify the efficacy of the selective SGLT2 inhibitor tofogliflozin hydrate in reducing nocturia - The VESTITO Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049753

Enrollment

Registered

2022-12-19

Start date

2022-12-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturia coexisting with diabetes

Interventions

The SGLT2 inhibitor will be changed to tofogliflozin hydrate.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Sleep is interrupted more than once during the night to urinate. - Nocturnal polyuria index more than 0.33 (more than 65 years old) or more than 0.20 (65 years old or younger) - Taking a selective SGLT2 inhibitor other than tofogliflozin hydrate

Exclusion criteria

Exclusion criteria: HbA1c >8.5% eGFR <45 mL/min/1.73m^2

Design outcomes

Primary

Measure	Time frame
Change in nocturnal micturition frequency after 4 weeks	—

Secondary

Measure	Time frame
(1) Changes after 4 weeks: 24-hour urine volume, nocturnal urine volume, nocturnal polyuria index, N-QOL, PSQI (2) Comparison at enrollment and 4 weeks later: HbA1c, serum Na	—

Countries

Japan

Contacts

Public ContactKazumasa Torimoto

Kouseikai Takai Hospital Urology

torimoto@naramed-u.ac.jp+81-743-65-0372

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026