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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020854
Receipt No. 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

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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
Email 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
Email ichiki@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute Harasanshin Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024068

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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