UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004642 |
|---|---|
| Receipt number | R000005537 |
| Scientific Title | Comparison of glycemic control among diabetics using the defferent insulin pen needles. |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2012/07/03 19:52:11 |
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Basic information
Public title
Comparison of glycemic control among diabetics using the defferent insulin pen needles.
Acronym
Comparison of glycemic control
Scientific Title
Comparison of glycemic control among diabetics using the defferent insulin pen needles.
Scientific Title:Acronym
Comparison of glycemic control
Region
| Japan |
Condition
Condition
Type 1 and 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate efficacy and safety of BD Microfine plus 32G x 4mm Pen Needle by examining whether it provides equivalent glycemic control in diabetic subjects as Novo Pen needle 32G x 6mm by measuring glycated albumin values. Survey patient comfort on this new needle as well.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Average variation rates between glycated albumin level after one-month use of BD Microfine plus 32G x 4mm and that after one-month use of Novo Pen needle 32G x 6mm.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use BD Microfine plus 32G x 4mm for insulin injection during the first 4 weeks and use Novo Pen needle 32G x 6mm during next 4 weeks.
Interventions/Control_2
Use Novo Pen needle 32G x 6mm for insulin injection during the first 4 weeks and use BD Microfine plus 32G x 4mm during next 4 weeks.
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 1 and 2 diabetic patients at the age of 20 years or older
2)Insulin-requiring diabetics who have used a pen device for at least one year prior to Study Visit 0
3)Patients who need two or more injections per day.
4)Patients who measure blood glucose level themselves at home.
5)Patients who have maintained a stable Hemoglobin A1C level from 5.5% to 8.5%.
6)Body Mass Index is under 35.
7)Patients who have a will to complete all the procedures of this investigation.
8)Patients who can fill in results on the CRFs.
9)Patients who can understand informed consent and have a will to enroll in this investigation.
Key exclusion criteria
1)Pregnancy or possibility of pregnancy.
2)Lactating women
3)Serious neurological diseases
4)Physical conditions which unable subjects to carry out the study procedures (e.g., Incapability to inject by themselves).
5)Thyroid deficiencies and/or nephrotic syndrome.
6)Patients who are currently enrolled in another clinical study
7)Patients who have already discussed details with employees of BD Japan or enrolled study subjects regarding the Investigation.
8)Patients for whom Principle Investigator or Investigators consider that their enrollment could expose them to any risk.
9)Patients who can confuse the interpretation of investigation results or who have done.
10)Employees of pharmaceutical or medical device companies.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Odawara |
Organization
Tokyo Medical University
Division name
The 3rd Department of Internal Medicine
Zip code
Address
160-0023 6-7-1, Shinjuku-ku, Nishi-shinjuku, Tokyo
TEL
03-3342-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Miwa |
Organization
Tokyo Medical University
Division name
The 3rd Department of Internal Medicine
Zip code
Address
160-0023 6-7-1, Shinjuku-ku, Nishi-shinjuku, Tokyo
TEL
03-3342-6111
Homepage URL
miwa-t@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
The 3rd Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Becton Dickinson Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
東京医科大学病院（東京都）/Tokyo Medical University Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 01 | 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
| 2010 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 01 | Day |
Last modified on
| 2012 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005537
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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