UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034506 |
|---|---|
| Receipt number | R000039343 |
| Scientific Title | Evaluation of the psychological burden for the medical treatment on patients with type 2 diabetes measured by Diabetic Treatment Burden Questionnaire (DTBQ). |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2018/10/15 16:32:38 |
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Basic information
Public title
Evaluation of the psychological burden for the medical treatment on patients with type 2 diabetes measured by Diabetic Treatment Burden Questionnaire (DTBQ).
Acronym
Evaluation of the psychological burden for the medical treatment on patients with type 2 diabetes measured by Diabetic Treatment Burden Questionnaire (DTBQ).
Scientific Title
Evaluation of the psychological burden for the medical treatment on patients with type 2 diabetes measured by Diabetic Treatment Burden Questionnaire (DTBQ).
Scientific Title:Acronym
Evaluation of the psychological burden for the medical treatment on patients with type 2 diabetes measured by Diabetic Treatment Burden Questionnaire (DTBQ).
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare psychological burden between once-daily injection and once-weekly injection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diabetes Treatment Burden Questionnaire (DTBQ)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
once-weekly injection
Interventions/Control_2
once-daily injection
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HbA1c>=7.0% and <10.0%
Have 2 or more oral anti-diabetics
Have never been treated with insulin and GLP-1 receptor agonist
Have stable regimen of anti-diabetics for more than 12 weeks
Key exclusion criteria
Type 1 diabetes
patient who are not competent
Patient who are inappropriate judged by investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nozaki Aya |
Organization
Nagasaki Harbor Medical Center
Division name
Diabetes and Endocrinology
Zip code
Address
6-39, shinchi-machi, Nagasaki, Nagasaki
TEL
095-822-3251
aya_s0714@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozaki Aya |
Organization
Nagasaki Harbor Medical Center
Division name
Diabetes and Endocrinology
Zip code
Address
6-39, shinchi-machi, Nagasaki, Nagasaki
TEL
095-822-3251
Homepage URL
aya_s0714@yahoo.co.jp
Sponsor or person
Institute
Nagasaki Harbor Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Harbor Medical Center
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
長崎みなとメディカルセンター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 15 | 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
| 2018 | Year | 10 | Month | 15 | Day |
Last modified on
| 2018 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039343
