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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018592
Receipt No. R000021365
Scientific Title The investigation of the effectiveness by dapagliflozin on severity of sleep disorder breathing (SDB) among the Japanese patients with type 2 diabetes mellitus
Date of disclosure of the study information 2015/10/15
Last modified on 2018/08/09

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Basic information
Public title The investigation of the effectiveness by dapagliflozin on severity of sleep disorder breathing (SDB) among the Japanese patients with type 2 diabetes mellitus
Acronym Dapagliflozin-SDB study
Scientific Title The investigation of the effectiveness by dapagliflozin on severity of sleep disorder breathing (SDB) among the Japanese patients with type 2 diabetes mellitus
Scientific Title:Acronym 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
1st name
Middle name
Last name Shinya Furukawa
Organization Ehime University Graduate School of Medicine
Division name Department of Epidemiology and Preventive Medicine
Zip code
Address Shitsukawa, Toon, Ehime, Japan
TEL 0899605283
Email shinfuru@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Furukawa
Organization Ehime University Graduate School of Medicine
Division name Department of Epidemiology and Preventive Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30047511
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 07 Month 17 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021365

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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