The investigation of the effectiveness by dapagliflozin on severity of sleep disorder breathing (SDB) among the Japanese patients with type 2 diabetes mellitus

The investigation of the effectiveness by dapagliflozin on severity of sleep disorder breathing (SDB) among the Japanese patients with type 2 diabetes mellitus - Dapagliflozin-SDB study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018592

Enrollment

Registered

2015-10-15

Start date

2015-08-01

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

Japanese patients with type2 diabetes mellitus

Interventions

Dapagliflozin 5mg/10mg Once a day 24 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes mellitus, 20 - 80 years old 6.5% HbA1c 3% ODI 5 events/hr Body mass Index 23 estimated GFR 45 Written informed consent was obtained from all patients enrolled in the this Study

Exclusion criteria

Exclusion criteria: contraindication of dapagloflozin, type 1 diabetes mellitus, cancer, history of severe hypoglycemia, ketoacidosis, skin disease during treatment, repeated genital infection and urinary tract infection Sleep disorder related to the otolaryngology disease, neurological disease, hypothyroidism and acromegaly. Severe hepatic insufficiency defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN. Total bilirubin >2.0 mg/dL . Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IgG, Hepatitis B viral antibody IgM, Hepatitis B surface antigen and Hepatitis C virus antibody. History of unstable or rapidly progressing renal disease. Volume depleted patients. Recent Cardiovascular Events in a patient: Acute Coronary Syndrome (ACS) within 2 months prior to enrolment, Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment, Acute Stroke or TIA within two months prior to enrolment, and Less than two months post coronary artery revascularization Pregnant or breastfeeding patients. Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure. Patients using other SGLT2 inhibitor.

Design outcomes

Primary

Measure	Time frame
The change of 3% ODI value in 24 weeks	—

Secondary

Measure	Time frame
Remission rate of SDB (< 5 3% ODI), HbA1c, weight, circumference(neck and abdomen), total-cholesterol, TG, HDL, Epworth sleep scale score, Fasting glucose level, Lipoprotein function	—

Countries

Japan

Contacts

Public ContactShinya Furukawa

Ehime University Graduate School of Medicine Department of Epidemiology and Preventive Medicine

shinfuru@m.ehime-u.ac.jp0899605283

Outcome results

None listed

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