UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012303 |
|---|---|
| Receipt number | R000014390 |
| Scientific Title | Comparison Study of Two Types of Insulin Pen Needles |
| Date of disclosure of the study information | 2013/12/02 |
| Last modified on | 2014/07/22 17:56:53 |
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Basic information
Public title
Comparison Study of Two Types of Insulin Pen Needles
Acronym
Comparison Study of Insulin Pen Needles
Scientific Title
Comparison Study of Two Types of Insulin Pen Needles
Scientific Title:Acronym
Comparison Study of Insulin Pen Needles
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare ratings of usage features, such as ease of injection and frequency of defects and incidents, in clinical use between BD Micro-fine Ultra 32Gx4mm and TERUMO NANOPASS Pen Needle II 34Gx4mm. Also to analyze the relationship between needle preference and the background of the subjects including the thumb strength of diabetic patients by carrying out manual muscle testing.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Preference for the ease of pushing the injection button when injecting insulin.
Key secondary outcomes
*Pain when administering injection (at the time of the insertion).
*Smoothness when inserting the needle.
*Pain when injecting insulin.
*Overall preference.
*Whether the needle bend/breakage or not when administering injection (at the time of the insertion).
*Whether pain or resistance is felt when removing the needle or not.
*Whether there is any leakage of insulin from the skin or not.
*Whether there is any leakage of insulin from the needle tip after removal of the needle or not.
*Whether the needle tip is bend/breakage after removal or not.
*Relationship between needle preference and the background of diabetic subjects.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects shall use two needles for one (seven day) week each in turn.
TERUMO NANOPASS Pen Needle II 34Gx4mm -> BD Micro-fine Ultra 32Gx4mm
Interventions/Control_2
Subjects shall use two needles for one (seven day) week each in turn.
BD Micro-fine Ultra 32Gx4mm -> TERUMO NANOPASS Pen Needle II 34Gx4mm
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
*Type 1 and Type 2 diabetic patients who are 20 years old and over.
*Subjects who have been using an insulin pen for injecting insulin for one year or more.
*Subjects who are getting injections in the abdomen twice daily or more.
*Subjects have every intention of completing all of the survey procedures.
*Subjects who are able to fill in their results in a CRF.
*Subjects understand the contents of the consent form information and are willing to participate in this study.
Key exclusion criteria
*Subjects who are using FlexTouch (Novo Nordisk Pharma Ltd.) for insulin pen injector.
*Subjects who are pregnant or may be pregnant.
*Subjects who are breastfeeding.
*Subjects with serious neuropathy.
*Subjects with a physical condition which precludes them from carrying out study procedures (such as patients who cannot administer self-injection).
*Subjects who are currently participating in another clinical study.
*Subjects who have already had a full discussion with staff of BD Japan or other subjects of this clinical study.
*ubjects whose doctor in charge or doctor in partial charge decided that participating in this clinical study would involve risk for the subject.
*Subjects who may have become confused in their interpretation of the study results. Or subjects who have a possibility of such.
*Subjects who are staff of a pharmaceutical company or medical equipment company.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Yamada |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Diabetes Center
Zip code
Address
9-1, 5-chome, Shirogane, Minato-ku, Tokyo, Japan
TEL
03-3444-6161
yamada-s@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shusaku Tozaka |
Organization
Nippon Becton Dickinson Company, Ltd.
Division name
Medical Affairs
Zip code
Address
15-1, 4-chome, Minato-ku, Tokyo, Japan
TEL
03-6234-5628
Homepage URL
shusaku_tozaka@bd.com
Sponsor or person
Institute
Diabetes Center
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Becton Dickinson Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
学校法人 北里研究所北里大学北里研究所病院（東京都）/Kitasato University Kitasato Institute Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 02 | 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
| 2013 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 15 | Day |
Last modified on
| 2014 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014390
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