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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012303
Receipt No. 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

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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
Email 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
Email shusaku_tozaka@bd.com

Sponsor
Institute Diabetes Center
Kitasato University Kitasato Institute Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014390

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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