UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038149 |
|---|---|
| Receipt number | R000043485 |
| Scientific Title | Efficacy of thrice-weekly long-acting insulin degludec provided by nurses in handicapped patients with type 2 diabetes on maintenace hemodialysis teratment |
| Date of disclosure of the study information | 2019/10/20 |
| Last modified on | 2019/09/29 20:52:59 |
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Basic information
Public title
Efficacy of thrice-weekly long-acting insulin degludec provided by nurses in handicapped patients with type 2 diabetes on maintenace hemodialysis teratment
Acronym
thrice-weekly long-acting insulin degludec provided by nurses in handicapped patients
Scientific Title
Efficacy of thrice-weekly long-acting insulin degludec provided by nurses in handicapped patients with type 2 diabetes on maintenace hemodialysis teratment
Scientific Title:Acronym
thrice-weekly long-acting insulin degludec provided by nurses in handicapped patients
Region
| Japan |
Condition
Condition
type2 diabetes on hemodialysis treatment
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the efficacy of thrice-weekly long-acting insulin degludec provided by nurses in hadicapped patients with type2 dabetes on maitenace hemodialysis ntreatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
control of blood glucose status at 3 months after fixting insulin dosage
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. type 2 diabetes
2. hemodialysis patients
3. poor control of blood glucose even after dietary therapy and OHA
4. self-injection is impossible
Key exclusion criteria
1. type 1 diabetes
2. self-injection is impossible
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nakao |
Organization
Organization for Kidney and Metabolic Disease Ttreatment
Division name
Bouosei nishishinjuku shinryojo
Zip code
160-0023
Address
3-12-12, Nishishinjuku, Shinjuku ward, Tokyo, 160-0023, Japan
TEL
03-5340-5680
t-nakao@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nakao |
Organization
Organization for Kidney and Metabolic Disease Ttreatment
Division name
Bouosei nishishinjuku shinryojo
Zip code
160-0023
Address
3-12-12, Nishishinjuku, Shinjuku ward, Tokyo, 160-0023, Japan
TEL
03-5340-5680
Homepage URL
t-nakao@tokyo-med.ac.jp
Sponsor or person
Institute
Organization for Kidney and Metabolic Disease Ttreatment
Institute
Department
Personal name
Funding Source
Organization
Organization for Kidney and Metabolic Disease Ttreatment
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Toyu Ethics Review Committee for Medical Study
Address
9-10, Saiwaichou, Atsugi city, Kanagawa prefecture
Tel
046-220-1704
h sagehasi@mtz.co.jp
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
望星西新宿診療所 Bousei Nishishinnjuku Shinryoujo
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 20 | 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
| 2019 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothoing
Management information
Registered date
| 2019 | Year | 09 | Month | 29 | Day |
Last modified on
| 2019 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043485
