UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013817 |
|---|---|
| Receipt number | R000016126 |
| Scientific Title | Jikei-Evaluation of basal insulin analogue on (nocturnal) glycemic variability with continuous glucose monitoring -existing basal insulin analogue versus Tresiba ; insulin degludec - a new basal insulin analogue, in basal-bolus treatment in type 1 diabetes- |
| Date of disclosure of the study information | 2014/04/26 |
| Last modified on | 2016/10/26 12:42:38 |
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Basic information
Public title
Jikei-Evaluation of basal insulin analogue on (nocturnal) glycemic variability with continuous glucose monitoring
-existing basal insulin analogue versus Tresiba ; insulin degludec - a new basal insulin analogue, in basal-bolus treatment in type 1 diabetes-
Acronym
JET-1
Scientific Title
Jikei-Evaluation of basal insulin analogue on (nocturnal) glycemic variability with continuous glucose monitoring
-existing basal insulin analogue versus Tresiba ; insulin degludec - a new basal insulin analogue, in basal-bolus treatment in type 1 diabetes-
Scientific Title:Acronym
JET-1
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare glucose control of Degludec to ohter long-acting basal insulin analogue in Japanese patient with type 1 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Continuous glucose value of 24 hours by CGM
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
insulin degludec
Interventions/Control_2
long-acting insulin analogue other than insulin degludec
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
Type 1 diabetes receiving Basal-bolus insulin therapy.
Key exclusion criteria
Type 2 diabetes.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rimei NIshimura |
Organization
The Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo,Japan
TEL
+81334331111
rimei@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rimei NIshimura |
Organization
The Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo,Japan
TEL
+81334331111
Homepage URL
rimei@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine Japan Diabetes Foundation
Institute
Department
Personal name
Funding Source
Organization
Japan Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2014 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Comparison of glycemic variability in Japanese patients with type 1 diabetes receiving insulin degludec versus insulin glargine using continuous glucose monitoring: A randomized, cross-over, pilot study.
Onda Y, Nishimura R, Ando K, Takahashi H, Tsujino D, Utsunomiya K.
Diabetes Res Clin Pract. 2016 Oct;120:149-55. doi: 10.1016/j.diabres.2016.07.019.
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 | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 26 | Day |
Last modified on
| 2016 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016126
| 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 |
