UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017731 |
|---|---|
| Receipt number | 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 20:45:47 |
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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
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
t-tunoda@yokohamasakae.jp
Sponsor or person
Institute
Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019885
