UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009540 |
|---|---|
| Receipt number | R000011198 |
| Scientific Title | Evaluation of method of measuring serum insulin glargine concentration after subcutaneous administration of insulin glargine in healthy male subjects. |
| Date of disclosure of the study information | 2012/12/15 |
| Last modified on | 2013/01/08 12:20:42 |
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Basic information
Public title
Evaluation of method of measuring serum insulin glargine concentration after subcutaneous administration of insulin glargine in healthy male subjects.
Acronym
Evaluation of method of measuring serum insulin glargine concentration
Scientific Title
Evaluation of method of measuring serum insulin glargine concentration after subcutaneous administration of insulin glargine in healthy male subjects.
Scientific Title:Acronym
Evaluation of method of measuring serum insulin glargine concentration
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the method of measuring serum insulin glargine concentration after subcutaneous administration of insulin glargine in healthy male subjects
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum insulin glargine concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subcutaneous administration of insulin glargine, 0.2IU/kg.
Interventions/Control_2
Subcutaneous administration of insulin glargine, 0.4IU/kg.
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1, Healthy Japanese male subjects who provide signed written informed consent.
2, Subjects between 20 and 40 (inclusive) year of age at the time of consent.
3, Subjects with BMI <=18.5 and >25.0 at the time of screening.
4, Subjects judged as adequate for this study by study physician.
Key exclusion criteria
1, Subjects with present illness which requires treatment.
2, Subjects with past medical history which was considered not adequate for this study.
3, Subjects with past history of drug allergy.
4, Subjects who took prescribed medicine and/or OTC drug 1 week prior to admission to the clinic.
5. Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood component within 2 weeks prior to admission.
6, Subjects who were participated in a clinical trial and administered new compound study drug within 4 weeks, or any kind of study drug within 3 weeks prior to admission.
7, Subjects with history of alcohol and/or drug abuse.
8, Subjects who was judged not appropriate for this study by study physician.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akimasa Watanabe |
Organization
Medical Co. LTA
Clinical Pharmacology Center
Hakata Clinic
Division name
Clinical Pharmacology Department
Zip code
Address
Random square 5-7 F, 6-8 Tenyamachi, Hakata-ku, Fukuoka 812-0025, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Medical Co. LTA, Clinical Pharmacology Center, Hakata Clinic
Division name
Clinical Pharmacology Department
Zip code
Address
TEL
092-283-7701
Homepage URL
Sponsor or person
Institute
Medical Co. LTA, Clinical Pharmacology Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
JCL bioassay corporation
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
医療法人相生会 博多クリニック（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 15 | 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
| 2012 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 13 | Day |
Last modified on
| 2013 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011198
