UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022329 |
|---|---|
| Receipt number | R000025728 |
| Scientific Title | Inadequate suspension of premixed insulin analogs in Japanese people with type 2 diabetes: Clinical importance of improving injection techniques |
| Date of disclosure of the study information | 2016/06/15 |
| Last modified on | 2017/01/26 17:36:01 |
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Basic information
Public title
Inadequate suspension of premixed insulin analogs in Japanese people with type 2 diabetes: Clinical importance of improving injection techniques
Acronym
The study of inadequate suspension of premixed insulin analogues
Scientific Title
Inadequate suspension of premixed insulin analogs in Japanese people with type 2 diabetes: Clinical importance of improving injection techniques
Scientific Title:Acronym
The study of inadequate suspension of premixed insulin analogues
Region
| Japan |
Condition
Condition
Japanese people wiyh type 2 diabetes receiving premixed insulin analogs therapy
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated whether users re-suspend their premix insulin analogs correctly by assessing the optical density (OD) of the insulin solutions.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
ODs for the patient's premixed insulin analogs compared to standard insulin curves
Key secondary outcomes
The differences of ODs compared to standard insulin curves among each of premix insulin analogs
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese people with type 2 diabetes receiving premixed insulin analogs therapy
Key exclusion criteria
N/A
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Aso |
Organization
Dokkyo Medical University
Division name
Endocrinology and Metabolism
Zip code
Address
880, Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL
0282-87-2150
yaso@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiro Suzuki |
Organization
Dokkyo Medical University
Division name
Endocrinology and Metabolism
Zip code
Address
880, Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL
0282-87-2150
Homepage URL
kuni-s@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical 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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s13300-017-0228-9
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 | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study included 151 patients taking premixed insulin analogs. Informed consent was obtained from all patients participating in this study. Patients provided their current prefilled insulin pens for analysis. OD is a standard biochemical technique for assessing the turbidity of a given solution. It was measured at a wavelength of 415 nm on an EnSpire 2300 plate reader (Perkin Elmer, Inc. MA, USA). Each prefilled insulin pen in-use was provided by patients, residual insulin volumes of at least 5% have been accurately mixed, and compared with the range of OD values obtained from a series of unused control insulin pens that were correctly mixed. The ODs of pens provided by patients were measured in triplicate, and the mean was used in this assessment. The OD of the residual insulin was compared to standard insulin curves, and the results were expressed as the degree of mixture (%).
Management information
Registered date
| 2016 | Year | 05 | Month | 16 | Day |
Last modified on
| 2017 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025728
| Research Plan | |
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| 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 |
