Unique ID issued by UMIN | UMIN000018592 |
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Receipt number | 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 18:21:04 |
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
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
Japan |
Japanese patients with type2 diabetes mellitus
Medicine in general | Pneumology | Endocrinology and Metabolism |
Adult |
Others
NO
To assess the effectiveness for SDB by dapagliflozin among Japanese patients with type 2 diabetes mellitus.
Efficacy
Exploratory
Explanatory
Not applicable
The change of 3% ODI value in 24 weeks
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Dapagliflozin 5mg/10mg
Once a day
24 weeks
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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.
30
1st name | |
Middle name | |
Last name | Shinya Furukawa |
Ehime University Graduate School of Medicine
Department of Epidemiology and Preventive Medicine
Shitsukawa, Toon, Ehime, Japan
0899605283
shinfuru@m.ehime-u.ac.jp
1st name | |
Middle name | |
Last name | Shinya Furukawa |
Ehime University Graduate School of Medicine
Department of Epidemiology and Preventive Medicine
Shitsukawa, Toon, Ehime, Japan
0899605283
shinfuru@m.ehime-u.ac.jp
Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine
AstraZeneca KK
Ono Phamaceutical CO.,LTD.
Profit organization
NO
2015 | Year | 10 | Month | 15 | Day |
Published
https://www.ncbi.nlm.nih.gov/pubmed/30047511
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.
Main results already published
2015 | Year | 07 | Month | 17 | Day |
2015 | Year | 08 | Month | 01 | Day |
2016 | Year | 07 | Month | 31 | Day |
2016 | Year | 10 | Month | 31 | Day |
2016 | Year | 10 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2015 | Year | 08 | Month | 07 | Day |
2018 | Year | 08 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021365
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