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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017731
Receipt No. R000019885
Scientific Title The effect of ramelteon on glucose metabolism and sleep quality in insomniac patients with type 2 diabetes
Date of disclosure of the study information 2015/05/28
Last modified on 2015/05/28

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Basic information
Public title The effect of ramelteon on glucose metabolism and sleep quality in insomniac patients with type 2 diabetes
Acronym The effect of ramelteon on glucose metabolism and sleep quality in insomniac patients with type 2 diabetes
Scientific Title The effect of ramelteon on glucose metabolism and sleep quality in insomniac patients with type 2 diabetes
Scientific Title:Acronym The effect of ramelteon on glucose metabolism and sleep quality in insomniac patients with type 2 diabetes
Region
Japan

Condition
Condition type 2 diabetes
insomnia
Classification by specialty
Endocrinology and Metabolism Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1.To evaluate the effect of ramelteon on glucose metabolism and sleep quality in insomniac patients with type 2 diabetes

2.To evaluate the effect on glucose metabolism and sleep quality whether administration
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The change of HbA1c from baseline to 6 months after administration of ramelteon
Key secondary outcomes The change of folowing items from baseline to 6 months after administration of ramelteon
1 glucose metabolism (IRI, sCPR, FPG, GA)
2 PSQI
3 SF-36
4 TC, LDL-C, TG, HDL-C, hsCRP, ferritin
5 blood pressure, body weight
6 adverse event after administration of ramelteon

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The group that oral medication of 8 mg ramelteon tablet once daily before sleep for 6 months
Interventions/Control_2 The group that oral medication of 8 mg ramelteon tablet once daily for first 3 months and then withdrawal of it for 3 months
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1.The insomnic patients with type 2 diabetes who signed the informed consent in this study

2.HbA1c fluctuation is less than 0.5% over the last 3 months

3.HbA1c level is less than 8% over the last 3 months

4.Neither new start nor change of medications for diabetes and insomnia required at least 3 months before and after administration.
Key exclusion criteria 1.Past history of administration for insomnia over the last 3 months

2.Medication for psychiatric disorder

3.severe liver disorder

4.Patients determined to be inappropriate by physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuji Tsunoda
Organization Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Division name Department of Endocrinology & Metabolism
Zip code
Address Katsura-chou 132, Sakae-ku, Yokohama, Kanagawa, Japan
TEL 045-891-2171
Email t-tunoda@yokohamasakae.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuji Tsunoda
Organization Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Division name Department of Endocrinology & Metabolism
Zip code
Address Katsura-chou 132, Sakae-ku, Yokohama, Kanagawa, Japan
TEL 045-891-2171
Homepage URL
Email t-tunoda@yokohamasakae.jp

Sponsor
Institute Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Institute
Department

Funding Source
Organization None
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
2015 Year 05 Month 28 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 Completed
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 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
2015 Year 05 Month 28 Day
Last modified on
2015 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019885

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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