UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation of the effectiveness by dapagliflozin on severity of sleep disorder breathing (SDB) among the Japanese patients with type 2 diabetes mellitus
Title of the study (Brief title)	Dapagliflozin-SDB study
Region	Japan

Condition
Condition	Japanese patients with type2 diabetes mellitus
Classification by specialty	Medicine in general Pneumology Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effectiveness for SDB by dapagliflozin among Japanese patients with type 2 diabetes mellitus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The change of 3% ODI value in 24 weeks
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dapagliflozin 5mg/10mg Once a day 24 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key 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
Key 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.
Target sample size	30

Research contact person
Name of lead principal investigator	Shinya Furukawa
Organization	Ehime University Graduate School of Medicine
Division name	Department of Epidemiology and Preventive Medicine
Address	Shitsukawa, Toon, Ehime, Japan
TEL	0899605283
Email	shinfuru@m.ehime-u.ac.jp

Public contact
Name of contact person	Shinya Furukawa
Organization	Ehime University Graduate School of Medicine
Division name	Department of Epidemiology and Preventive Medicine
Address	Shitsukawa, Toon, Ehime, Japan
TEL	0899605283
Homepage URL
Email	shinfuru@m.ehime-u.ac.jp

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

Funding Source
Organization	AstraZeneca KK Ono Phamaceutical CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 15 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 07 Month 17 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2016 Year 07 Month 31 Day
Date of closure to data entry	2016 Year 10 Month 31 Day
Date trial data considered complete	2016 Year 10 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/30047511
Results	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.
Other related information

Management information
Registered date	2015 Year 08 Month 07 Day
Last modified on	2018 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021365