UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026920 |
|---|---|
| Receipt number | 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 07:09:18 |
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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
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
tactash@yahoo.co.jp
Sponsor or person
Institute
Toda Chuo General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030882
| Research Plan | |
|---|---|
| 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 |
