Unique ID issued by UMIN | UMIN000012303 |
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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 |
Comparison Study of Two Types of Insulin Pen Needles
Comparison Study of Insulin Pen Needles
Comparison Study of Two Types of Insulin Pen Needles
Comparison Study of Insulin Pen Needles
Japan |
Diabetes
Endocrinology and Metabolism |
Others
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Preference for the ease of pushing the injection button when injecting insulin.
*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.
Interventional
Cross-over
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Device,equipment |
Subjects shall use two needles for one (seven day) week each in turn.
TERUMO NANOPASS Pen Needle II 34Gx4mm -> BD Micro-fine Ultra 32Gx4mm
Subjects shall use two needles for one (seven day) week each in turn.
BD Micro-fine Ultra 32Gx4mm -> TERUMO NANOPASS Pen Needle II 34Gx4mm
20 | years-old | <= |
Not applicable |
Male and Female
*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.
*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.
60
1st name | |
Middle name | |
Last name | Satoru Yamada |
Kitasato University Kitasato Institute Hospital
Diabetes Center
9-1, 5-chome, Shirogane, Minato-ku, Tokyo, Japan
03-3444-6161
yamada-s@insti.kitasato-u.ac.jp
1st name | |
Middle name | |
Last name | Shusaku Tozaka |
Nippon Becton Dickinson Company, Ltd.
Medical Affairs
15-1, 4-chome, Minato-ku, Tokyo, Japan
03-6234-5628
shusaku_tozaka@bd.com
Diabetes Center
Kitasato University Kitasato Institute Hospital
Nippon Becton Dickinson Company, Ltd.
Profit organization
NO
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)
2013 | Year | 12 | Month | 02 | Day |
Unpublished
Completed
2013 | Year | 09 | Month | 20 | Day |
2013 | Year | 12 | Month | 17 | Day |
2014 | Year | 06 | Month | 30 | Day |
2014 | Year | 06 | Month | 30 | Day |
2014 | Year | 06 | Month | 30 | Day |
2013 | Year | 11 | Month | 15 | Day |
2014 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014390
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