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

Not Applicable

• Conditions: Japanese patients with type2 diabetes mellitus

• Registration Number: JPRN-UMIN000018592
• Lead Sponsor: Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-15
• Study Completion: 2016-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of 3% ODI value in 24 weeks

Secondary Outcome Measures

Name	Time	Method
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