UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012271 |
|---|---|
| Receipt number | 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 11:43:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
s.itou@machida-city-hp.jp
Sponsor or person
Institute
Machida Municipal Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011347
