UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019525 |
|---|---|
| Receipt number | R000022564 |
| Scientific Title | a randomized crossover study between glargine U 300 and degludec in patients with type 1 diabetes |
| Date of disclosure of the study information | 2015/10/29 |
| Last modified on | 2015/10/28 00:50:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
a randomized crossover study between glargine U 300 and degludec in patients with type 1 diabetes
Acronym
a randomized crossover study between glargine U 300 and degludec in patients with type 1 diabetes
Scientific Title
a randomized crossover study between glargine U 300 and degludec in patients with type 1 diabetes
Scientific Title:Acronym
a randomized crossover study between glargine U 300 and degludec in patients with type 1 diabetes
Region
| Japan |
Condition
Condition
type 1 diabetes
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
comparison of the effectiveness between insulin glargine U 300 and degludec
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the degree of rising blood glucose value over 24 hours from insulin injection
Key secondary outcomes
frequency of hypoglycemia and insulin dose
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 glargine U 300 injection once daily for two months
Interventions/Control_2
insulin degludec injection once daily for two months
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
# diabetes duration >2 years
# multiple daily injection therapy
# long acting insulin injection once a day
# HbA1c under 9%
Key exclusion criteria
# pregnant
# oral steroid therapy
# advanced diabetes coomplication
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawamura Tomoyuki |
Organization
Osaka City University
Division name
Pediatrics
Zip code
Address
1-5-7 Asahi machi, Abenoku,Osaka
TEL
06-6645-3816
hirose810@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirose Masakazu |
Organization
Osaka City University
Division name
Pediatrics
Zip code
Address
1-5-7 Asahi machi, Abenoku,Osaka
TEL
06-6645-3816
Homepage URL
hirose810@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Osaka City University
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
大阪市立大学附属病院 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 27 | 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 | 10 | Month | 28 | Day |
Last modified on
| 2015 | 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=R000022564
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
