Assessment of safety and effectiveness: the clinical use of tofogliflozin in patients with type 2 diabetes mellitus

Assessment of safety and effectiveness: the clinical use of tofogliflozin in patients with type 2 diabetes mellitus - AYUMI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000014129

Enrollment

10000

Registered

2014-05-31

Start date

2014-06-01

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

Type 2 diabetes mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with Type 2 diabetes mellitus 2.Receiving tofogliflozin under usual care within 8 weeks before registration 3.Aged 20 and over 4.No use of SGLT2 inhibitor before tofogliflozin

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity to tofogliflozin 2.Patients who had severe ketosis or diabetic coma or precoma 3.Severe infection or trauma, perioperative 4.End stage renal disease with hemodialysis or peritoneal dialysis 5.Patients whose participation is deemed inappropriate at the discretion of the attending physician

Design outcomes

Primary

Measure	Time frame
The following side effects:events, grades, occurrence rates, etc Hypoglycemia Urinary tract infection and Genital infection Volume depletion (Dehydration, Polyuria/Pollakiuria, Hypotension) Diabetic ketoacidosis Renal dysfunction Hepatic dysfunction Fracture Malignant tumor Major adverse cerebro-cardiovascular events Skin disorders	—

Countries

Japan

Contacts

Public ContactNobuyuki Shihara

Japan Association for Diabetes Education and Care secretariat

shihara@nittokyo.or.jp03-3514-1721

Outcome results