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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023827
Receipt No. 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

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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
Email 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
Email takahisa.hirose@med.toho-u.ac.jp

Sponsor
Institute Toho University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027024

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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