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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026920
Receipt No. R000030882
Scientific Title Evaluation of the effectiveness of the orexin receptor antagonist for type 2 diabetes with sleep disorder upon glycemic control.
Date of disclosure of the study information 2017/04/17
Last modified on 2018/02/05

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Basic information
Public title Evaluation of the effectiveness of the orexin receptor antagonist for type 2 diabetes with sleep disorder upon glycemic control.
Acronym Evaluation of the effectiveness of the orexin receptor antagonist for type 2 diabetes with sleep disorder upon glycemic control.
Scientific Title Evaluation of the effectiveness of the orexin receptor antagonist for type 2 diabetes with sleep disorder upon glycemic control.
Scientific Title:Acronym Evaluation of the effectiveness of the orexin receptor antagonist for type 2 diabetes with sleep disorder upon glycemic control.
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the effectiveness of the orexin receptor antagonist for type 2 diabetes with sleep disorder upon glycemic control.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes of validation by continuous glucose monitor (CGM)
Key secondary outcomes changes of CES-D12, SF-8, parameters related to lipid, hepatic function and diabetes mellitus, 1 week later

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of suvorexant
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
25 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Adults who are 25 years or older and 80 years or younger
2.Type 2 diabetes patients
3.HbA1c 6.0% to 10.0%
4.Patients below BMI 35kg/m^2
5.Patients with Pittsburgh score 5.5 points or more
6.Patients who can understand consent sufficiently and having the agreement regarding participation in this examination
Key exclusion criteria 1.Patients who are diagnosed type2 diabetes within 6 months
2.Patients who are not considered to take a general levels of diet therapy
3.Patients who take considerable levels of exercise
4.Excessive common custom drinker
5.Patients with severe liver disease
6.Patients who had severe hypoglycemia within 3 months
7.Patients who had a record of Anti-GAD Antibody positive
8.A pregnant woman or the woman who may be pregnant
9.Patients who are breastfeeding
10.Patients who take medications on a sleep disorder
11.Patients who will be considered inappropriate by an attendant physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Ishikawa
Organization Toda Chuo General Hospital
Division name Internal Medicine
Zip code
Address 1-19-3 Honmachi, Toda, Saitama 335-0023, Japan
TEL 0484421111
Email tactash@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Ishikawa
Organization Toda Chuo General Hospital
Division name Internal Medicine
Zip code
Address 1-19-3 Honmachi, Toda, Saitama 335-0023, Japan
TEL 0484421111
Homepage URL
Email tactash@yahoo.co.jp

Sponsor
Institute Toda Chuo General Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 04 Month 17 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 Terminated
Date of protocol fixation
2017 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 24 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
2017 Year 04 Month 10 Day
Last modified on
2018 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030882

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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