UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009562 |
|---|---|
| Receipt number | R000011218 |
| Scientific Title | Evaluation of the efficacy and safety for switching from premixed insulin to ultra-long acting insulin plus ultra-rapid insulin |
| Date of disclosure of the study information | 2012/12/17 |
| Last modified on | 2015/02/23 12:24:15 |
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Basic information
Public title
Evaluation of the efficacy and safety for switching from premixed insulin to ultra-long acting insulin plus ultra-rapid insulin
Acronym
Evaluation of the efficacy and safety for ultra-long acting insulin plus ultra-rapid insulin
Scientific Title
Evaluation of the efficacy and safety for switching from premixed insulin to ultra-long acting insulin plus ultra-rapid insulin
Scientific Title:Acronym
Evaluation of the efficacy and safety for ultra-long acting insulin plus ultra-rapid insulin
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the frequency of hypoglycemia, the convenience and the effect on glycemic control, by switching from premixed insulin to ultra-long acting insulin plus ultra-rapid insulin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease in HbA1c level
Decrease in casual blood glucose level
Key secondary outcomes
Frequency of hypoglycemia
Frequency of hyperglycemia
Change in body weight
Change in convenience to switch to ultra-long acting insulin plus ultra-rapid insulin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
twice daily ultra-long acting insulin plus ultra-rapid insulin injection
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.type 2 diabetes patients who were prescribed premixed insulin twice daily for more than 8 weeks
2.patients whose glycated hemoglobin level (NGSP) are between 6.5 and 10.0%
3.patients whose age are more than 20 years old
4.patients who can understand informed consent
Key exclusion criteria
1.patients who need insulin therapy newly during this study
2.patients who have allergy for insulin glargine or glulisine
3.patients who had suffered from severe ketosis and diabetic coma or pre-coma
4.patients with serious infection, inflammation, or injury pre- or post- operative state
5.patients who are pregnant, hope to be pregnant, or are in lactation period
6.patients had suffered from drug-induced muscle disorder
7.drug abuser or heavy alcohol drinker
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryosuke Kimura |
Organization
Nagoya City West Medical Center
Division name
Endocrinology and Metabolism
Zip code
Address
1-1-1 Hirate-cho Kita-ku Nagoya Aichi Japan
TEL
052-991-8121
r.kimura.21@west-med.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryosuke Kimura |
Organization
Nagoya City West Medical Center
Division name
Endocrinology and Metabolism
Zip code
Address
1-1-1 Hirate-cho Kita-ku Nagoya Aichi Japan
TEL
052-991-8121
Homepage URL
r.kimura.21@west-med.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism, Nagoya City West Medical Center
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
| 2012 | Year | 12 | Month | 17 | 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
| 2012 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 17 | Day |
Last modified on
| 2015 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011218
| 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 |
