UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017474 |
|---|---|
| Receipt number | R000020250 |
| Scientific Title | Short-term efficacy and safety of Insulin Degludec in Japanese patiets with type 1 diabetes: a pilot study. |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2015/06/08 07:26:41 |
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Basic information
Public title
Short-term efficacy and safety of Insulin Degludec in Japanese patiets with type 1 diabetes: a pilot study.
Acronym
Efficacy and safety of Insulin Degludec in Japanese patiets with type 1 diabetes
Scientific Title
Short-term efficacy and safety of Insulin Degludec in Japanese patiets with type 1 diabetes: a pilot study.
Scientific Title:Acronym
Efficacy and safety of Insulin Degludec in Japanese patiets with type 1 diabetes
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was initiated to investigate efficacy and safety of insulin degludec as a basal insulin in patients with type 1 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of blood glucose variability at night by CGM
Key secondary outcomes
Base
Study type
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Insulin Degludec
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Type 1 diabetes
2.Patients were not treated with insulin degludec previously.
3.Patients were agreed to participate in this study with written informed consent.
Key exclusion criteria
Patients were free of severe infections, seriously wounded, alcohol abuser, malnutrition or staving, pregnant women and women suspected of being pregnant, with low compliance.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanari Kitazono |
Organization
Graduate School of Medical Sciences
Division name
Department of Medicine and Clinical Science
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
TEL
092-642-5256
kitazono@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Udai Nakamura |
Organization
Kyushu University Hospital
Division name
Department of Medicine and Clinical Science
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
TEL
092-642-5256
Homepage URL
uday@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences,Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Science, Graduate School of Medical Sciences,Kyushu University
Organization
Division
Category of Funding Organization
Other
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 | 08 | 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 | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 22 | 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 | 08 | Day |
Last modified on
| 2015 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020250
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
