UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021939 |
|---|---|
| Receipt number | R000025305 |
| Scientific Title | The analysis of day-to-day glucose excursions when switching from biphasic insulin 30 to insulin degludec and aspart |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2017/04/17 19:29:36 |
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Basic information
Public title
The analysis of day-to-day glucose excursions when switching from biphasic insulin 30 to insulin degludec and aspart
Acronym
Switching from biphasic insulin 30 to insulin degludec and aspart
Scientific Title
The analysis of day-to-day glucose excursions when switching from biphasic insulin 30 to insulin degludec and aspart
Scientific Title:Acronym
Switching from biphasic insulin 30 to insulin degludec and aspart
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate which insulin provide less glucose excursions when using biphasic insulin 30 or insulin degludec and aspart.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
day-to-day glucose excursions caluculated from patients self glucose mesuring over a month in both insulin periods
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with type 2 diabetes using biphasic insulin 30
Key exclusion criteria
patients who cannnot mesure blood glucose
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanta Fujimoto |
Organization
Kobe City Medical Center General Hospital
Division name
Internal Medicine of Diabetes and Endocrinology
Zip code
Address
2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe, Japan
TEL
075-302-4321
kantachi@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanta Fujimoto |
Organization
Kobe City Medical Center General Hospital
Division name
Internal Medicine of Diabetes and Endocrinology
Zip code
Address
2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe, Japan
TEL
075-302-4321
Homepage URL
kantachi@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization
Local Government
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
| 2016 | Year | 04 | Month | 18 | 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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 04 | Month | 16 | Day |
Last modified on
| 2017 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025305
