UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010563 |
|---|---|
| Receipt number | R000012245 |
| Scientific Title | Evaluation of the clinical utility of ultrasensitive C-peptide assay in insulin dependent diabetic patients |
| Date of disclosure of the study information | 2013/04/24 |
| Last modified on | 2014/10/28 10:51:12 |
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Basic information
Public title
Evaluation of the clinical utility of ultrasensitive C-peptide assay in insulin dependent diabetic patients
Acronym
Evaluation of the clinical utility of ultrasensitive C-peptide assay in insulin dependent diabetic patients
Scientific Title
Evaluation of the clinical utility of ultrasensitive C-peptide assay in insulin dependent diabetic patients
Scientific Title:Acronym
Evaluation of the clinical utility of ultrasensitive C-peptide assay in insulin dependent diabetic patients
Region
| Japan |
Condition
Condition
Insulin dependent diabetic patients whose C-peptide level less than 0.5 by the standard assay
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the clinical utility of ultrasensitive C-peptide assay in insulin dependent diabetic patients whose C-peptide level less than 0.5 by the standard assay
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c level
Key secondary outcomes
(1)Frequency and severity of hypoglycemic episode
(2)Duration of diabetes
(3)Morbidity rate of diabetic complication
(4)Morbidity rate of estimated duration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultrasensitive C-peptide
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Insulin dependent diabetic patients during intensive insulin therapy whose C-peptide level less than 0.5 by the standard assay
Key exclusion criteria
(1)Patients with serious liver or renal insufficiency
(2) Judged as ineligible by clinical investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fuki Ikeda |
Organization
Juntendo University Graduate School of Medicine
Division name
Dept. of Metabolism and Endocrinology
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo, JAPAN
TEL
03-3813-3111
fuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuki Ikeda |
Organization
Juntendo University Graduate School of Medicine
Division name
Dept. of Metabolism and Endocrinology
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo, JAPAN
TEL
03-3813-3111
Homepage URL
fuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
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
| 2013 | Year | 04 | Month | 24 | 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
| 2013 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 24 | 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 | 04 | Month | 23 | Day |
Last modified on
| 2014 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012245
