UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004469 |
|---|---|
| Receipt number | R000005328 |
| Scientific Title | Clinical Study for the Comparison of Blood Insulin Pharmacokinetics in different insulin pen needles |
| Date of disclosure of the study information | 2010/11/05 |
| Last modified on | 2011/06/25 22:01:17 |
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Basic information
Public title
Clinical Study for the Comparison of Blood Insulin Pharmacokinetics in different insulin pen needles
Acronym
Comparison of Blood Insulin Pharmacokinetics in different insulin pen needles
Scientific Title
Clinical Study for the Comparison of Blood Insulin Pharmacokinetics in different insulin pen needles
Scientific Title:Acronym
Comparison of Blood Insulin Pharmacokinetics in different insulin pen needles
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
To investigate blood insulin pharmacokinetics and blood glucose change of subcutaneously injected insulin in different insulin pen needles, BD MicroFine Plus Thinwall 32G x 4mm (BD32Gx4), Penneedle 32G x 6mm (NV32Gx6) and BD MicroFine Plus Thinwall 31G x 8mm (BD31Gx8).
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The equivalency of pharmacokinetic parameters (Cmax, Tmax, AUC0-180)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
BD32GX4 -> 3-7days -> NV32GX6 -> 3-7days -> BD31GX8
Interventions/Control_2
BD32GX4 -> 3-7days -> BD31GX8 -> 3-7days -> NV32GX6
Interventions/Control_3
NV32GX6 -> 3-7days -> BD32GX4 -> 3-7days -> BD31GX8
Interventions/Control_4
NV32GX6 -> 3-7days -> BD31GX8 -> 3-7days -> BD32GX4
Interventions/Control_5
BD31GX8 -> 3-7days -> BD32GX4 -> 3-7days -> NV32GX6
Interventions/Control_6
BD31GX8 -> 3-7days -> NV32GX6 -> 3-7days -> BD32GX4
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy and normal adult males, who voluntary register to enroll in this study at the medical institution, must meet the following criteria. A Healthy and normal adult male means one who satisfies the required conditions that his liver, kidney and electrocardiogram are normal and he is not infected by Hepatitis B, Hepatitis C, HIV and syphilis, etc, to become a subject for the phase 1 clinical study for drugs.
*20 years old and over but under 40 years old.
*Weight:55.0 kg and over but under 80.0kg
*BMI:18.5kg/m2 and over but under 25.0kg/m2
*Body fat ratio:15% and over but under 20%
*Systolic blood pressure: 90mmHg and over but under 140mmHg
*Diastolic blood pressure:under 90mmHg
*Pulse rate:40/min and over but under 100/min
*HbA1c : under 5.2% (JDS value)
*At 75g oral glucose tolerance test, fasting blood glucose level (venous plasma glucose level) is under 110mg/dl, and blood glucose level (venous plasma glucose level) is under 140mg/dl 120 minutes after glucose loading.
*Subjects have every intention of completing all of the study procedures.
*Subjects understand the contents of the consent form information and are willing to enroll in this study.
Key exclusion criteria
*Diabetic subjects, including treatment history
*Subjects currently enrolled in another clinical study
*Subjects who have risk in this study which is determined by a physician at the study site
*Subjects who may have or may have had potentially a confusing factor in the interpretation of study results
*Subjects who may be unsuitableness which is determined by a physician at the study site.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Hirose |
Organization
Juntendo University Graduate School of Medicine
Division name
Depart of Medicine, Metabolisam and Endocrinology
Zip code
Address
2-1-2 Hongo Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nippon Becton Dickinson Company, Ltd.
Division name
Medical Affairs
Zip code
Address
TEL
03-6234-5628
Homepage URL
shusaku_tozaka@bd.com
Sponsor or person
Institute
Department of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of 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
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
| 2010 | Year | 11 | Month | 05 | 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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 28 | Day |
Last modified on
| 2011 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005328
