UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013872 |
|---|---|
| Receipt number | R000016174 |
| Scientific Title | Investigation of efficacy and safety of insulin degludec or insulin glargine in type 2 diabetes with basal-bolus therapy |
| Date of disclosure of the study information | 2014/05/07 |
| Last modified on | 2014/11/02 23:23:47 |
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Basic information
Public title
Investigation of efficacy and safety of insulin degludec or insulin glargine in type 2 diabetes with basal-bolus therapy
Acronym
JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study 4
Scientific Title
Investigation of efficacy and safety of insulin degludec or insulin glargine in type 2 diabetes with basal-bolus therapy
Scientific Title:Acronym
JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study 4
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of efficacy and safety of insulin degludec or insulin glargine with basal-bolus therapy in type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. MAGE and MODD by CGM
2. nocturnal hypoglycemia frequency
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
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
Conventional group: to adjust the amount of insulin glargine according to the algorithm
Interventions/Control_2
Change group: to perform switching in the same unit to insulin degludec from insulin glargine, to adjust the amount of insulin according to the algorithm
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Fasting blood glucose is inadequately-controlled patients at 140 mg/dl or more
2)Patients who have done more than 6 months Basal-Bolus Therapy
3)BMI less than 35kg/m2
Key exclusion criteria
1)hypersensitivity to degludec
2)patient with hypoglycemia
3)patient with serious liver and kidney disease
4)patient with proliferative retinopathy
5)during pregnancy and lactation
Target sample size
60
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
Department of Metabolism & Endocrinology
Zip code
Address
1-1, Hongo 3-chome, Bunkyo-ku, Tokyo
TEL
03-3813-311
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
Department of Metabolism & Endocrinology
Zip code
Address
1-1, Hongo 3-chome, Bunkyo-ku, Tokyo
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
| 2014 | Year | 05 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | 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
| 2014 | Year | 05 | Month | 02 | Day |
Last modified on
| 2014 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016174
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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