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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004469
Receipt No. 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

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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
Email

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
Email shusaku_tozaka@bd.com

Sponsor
Institute Department of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005328

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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