UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effectiveness of the orexin receptor antagonist (Suvorexant) for type 2 diabetes with untreated sleep disorder.
Title of the study (Brief title)	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	Takahisa Hirose
Organization	Toho University School of Medicine
Division name	Divsion of diabetes, metabolism and endocrinology
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	Takahisa Hirose
Organization	Toho University School of Medicine
Division name	Divsion of diabetes, metabolism and endocrinology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 07 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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