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

Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine0 sites30 target enrollmentOctober 15, 2015

ConditionsJapanese patients with type2 diabetes mellitus

Overview

Phase: 未知
Intervention: Not specified
Conditions: Japanese patients with type2 diabetes mellitus
Sponsor: Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine
Enrollment: 30
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

After administration of dapagliflozin, fasting glucose and HbA1c decreased significantly. The improvement of 3% ODI was observed in patients with moderate to severe SDB but not mild SDB.

Registry

who.int

Start Date

October 15, 2015

End Date

July 31, 2016

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

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

Eligibility Criteria

Inclusion Criteria

Not provided

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.