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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012271
Receipt No. R000011347
Scientific Title Effect of melatonin receptor agonist(ramelteon) for sleep disorder with type 2 diabetes mellitus
Date of disclosure of the study information 2013/11/15
Last modified on 2013/11/12

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Basic information
Public title Effect of melatonin receptor agonist(ramelteon) for sleep disorder with type 2 diabetes mellitus
Acronym Effect of ramelteon for sleep disorder with diabetes
Scientific Title Effect of melatonin receptor agonist(ramelteon) for sleep disorder with type 2 diabetes mellitus
Scientific Title:Acronym Effect of ramelteon for sleep disorder with diabetes
Region
Japan

Condition
Condition Type 2 Diabetes mellitus with sleep disorder
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the beneficial effect of ramelteon for Type 2 Diabetes mellitus with sleep disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of HbA1c and contents of sleep
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization 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 Ramelteon 8mg/day
Interventions/Control_2 Lifestyle instruction
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who give informed consent
Key exclusion criteria Patients who has contraindication with Ramelteon
Patients who judged as ineligible by clinical investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Ito
Organization Machida municipal hospital
Division name Endocrine/diabetes
Zip code
Address 2-15-41 Asahimachi Machida-city Tokyo Japan
TEL 0427-22-2230
Email s.itou@machida-city-hp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Ito
Organization Machida Municipal Hospital
Division name Endocrine/diabetes
Zip code
Address 2-15-41 Asahimachi Machida-city Tokyo Japan
TEL 0427-22-2230
Homepage URL
Email s.itou@machida-city-hp.jp

Sponsor
Institute Machida Municipal Hospital
Institute
Department

Funding Source
Organization Machida Municipal Hospital
Organization
Division
Category of Funding Organization Local Government
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
2013 Year 11 Month 15 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
2012 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 12 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
2013 Year 11 Month 12 Day
Last modified on
2013 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011347

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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