UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020854 |
|---|---|
| Receipt number | R000024068 |
| Scientific Title | The effect of an SGLT2 inhibitor on sleep apnea in obese patients with sleep apnea syndrome and type 2 diabetes mellitus. |
| Date of disclosure of the study information | 2016/02/03 |
| Last modified on | 2018/04/23 21:15:54 |
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Basic information
Public title
The effect of an SGLT2 inhibitor on sleep apnea in obese patients with sleep apnea syndrome and type 2 diabetes mellitus.
Acronym
The effect of Canagliflozin on sleep apnea in obese patients with sleep apnea syndrome and type 2 diabetes mellitus.
Scientific Title
The effect of an SGLT2 inhibitor on sleep apnea in obese patients with sleep apnea syndrome and type 2 diabetes mellitus.
Scientific Title:Acronym
The effect of Canagliflozin on sleep apnea in obese patients with sleep apnea syndrome and type 2 diabetes mellitus.
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus with sleep apnea syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to examine whether treatment with canagliflozin, an SGLT2 inhibitor, improve the extent of sleep apnea in obese patients with type 2 diabetes mellitus and mild-moderate obstructive sleep apnea syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Apnea-hypopnea index after treatment with canagliflozin for 6 months
Key secondary outcomes
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
Treatment with canagliflozin(100mg/day, everyday, 6 months)
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with an HbA1c level more than 6.5%.
2) Patients with BMI more than 25 kg/m2.
3) Patients recieved dietary and exercise treatment for more than 8 weeks.
4) Patients who understand the protocol of this study and are able to give written informed consent based on their own decision.
Key exclusion criteria
1) Women in pregnacy, with breastfeeding or possibility of pregnancy.
2) Patients suffered from severe ketosis or diabetic coma in the past 6 months.
3) Patients with contraindication to canagliflozin administration.
4) Patients with serum creatine levels more than 1.5mg/dL.
5) Patients with critical illness such as severe heart failure, respiratory failure and malignacy.
6) Patients with treatment with insulin, GLP-1 analogue or other SGLT2 inhibitors.
7) Patients who are considered unsuitable for this study by responsible investigators of this study,
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Ichiki |
Organization
Harasanshin Hospital
Division name
Cardiology
Zip code
Address
Taihakuchou 1-8, Hakata-ku, Fukuoka
TEL
092-291-3434
ichiki@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Ichiki |
Organization
Harasanshin Hospital
Division name
Cardiology
Zip code
Address
Taihakuchou 1-8, Hakata-ku, Fukuoka
TEL
092-291-3434
Homepage URL
ichiki@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Harasanshin Hospital
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma
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
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
| 2016 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 02 | Day |
Last modified on
| 2018 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024068
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
