UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023827 |
|---|---|
| Receipt number | R000027024 |
| Scientific Title | Evaluation of the effectiveness of the orexin receptor antagonist (Suvorexant) for type 2 diabetes with untreated sleep disorder. |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2016/09/14 18:20:29 |
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Basic information
Public title
Evaluation of the effectiveness of the orexin receptor antagonist (Suvorexant) for type 2 diabetes with untreated sleep disorder.
Acronym
SUCCESS(Suvorexant clinical study on diabetes with sleep disorder)
Scientific Title
Evaluation of the effectiveness of the orexin receptor antagonist (Suvorexant) for type 2 diabetes with untreated sleep disorder.
Scientific Title:Acronym
SUCCESS(Suvorexant clinical study on diabetes with sleep disorder)
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For type 2 diabetes patients, treated with anti-diabetic drugs in addition to diet and exercise therapy for 12 weeks or more, and diagnosed as a sleep disorder by Pittsuburgh score 6 points or more, orexin receptor antagonist (Suvorexant) sill be added or not.
The incidence of advrse events such as somnolence or dementia, usefulness in glycemic control, other metabolic parameter, and effects on the quality of life (QOL) between two groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes of validation by continuas glcose monitor (CGM) 16 weeks later.
Key secondary outcomes
(1)changes of quality of life(QOL),questionnaire about the sleep,and dietary intake 16 weeks later.
(2)a reduction degree of HbA1c,GA and fasting blood prasma glucose 16 weeks later.
(3)a reduction degree of lipid parameters(HDL cholesterol,LDL cholesterol,triglyceride)and albumin in urine 16 weeks later.
(4)changes of blood or urine hormone level 16 weeks later.
(5)changes of body weight,blood pressure,abdominal circumscription,and body composition 16 weeks later.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of svorexant
Interventions/Control_2
don't administretion of svorexant
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Type 2 diabetes patients controlled inadequately with HbA1c 6.0 to 9.9 and changed within 1
(2)Patient received drug medical treatment in addition to diet and exercise therapy for 12 weeks or more
(3)Adults who are 20 years or older and 80 years or younger
(4)Patients diagnosed having a sleep disorder by Pittsuburgh score 6 points or more
(5)Patients do not take a sleeping drugs or antipsychotic within one year
(6)Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination
Key exclusion criteria
(1) Type 1 diabetes mellitus patients or secondary diabetic mellitus
(2)Patients taking a sleeping drugs or antipsychotic within one year.
(3) Patients who had myocardial infarction within 3 months, or obvious heart failure case
(4) Patients with diabetic ketoacidosis or diabetic coma or risk of diabetic coma
(5) Patients with severe liver disease
(6) Patients with severe renal disease
(7) Patients with severe pancreas disease
(8) Patients with severe diabetic neuropathy
(9) Patients having a proliferative retinopathy
(10) Patients with a serious infectious disease or a serious injury
(11) Excessive common custom drinker
(12) A pregnant woman or the woman who may be pregnant
(13) In addition, the patients who will be judged inappropriate by an attendant physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Hirose |
Organization
Toho University School of Medicine
Division name
Divsion of diabetes, metabolism and endocrinology
Zip code
Address
Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL
03-3762-4151
takahisa.hirose@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Hirose |
Organization
Toho University School of Medicine
Division name
Divsion of diabetes, metabolism and endocrinology
Zip code
Address
Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL
03-3762-4151
Homepage URL
takahisa.hirose@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Toho University School of Medicine
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
| 2016 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | 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 | 08 | Month | 29 | Day |
Last modified on
| 2016 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027024
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