UMIN-CTR Clinical Trial

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

Type 1 and 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

The equivalency of pharmacokinetic parameters (Cmax, Tmax, AUC0-180)

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Single blind -participants are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Nippon Becton Dickinson Company, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

11

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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