UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001327 |
|---|---|
| Receipt number | R000001427 |
| Scientific Title | Jikei-EValuation of insulin Lispro mixture on pharmacodynamics and glycemic VariencE |
| Date of disclosure of the study information | 2008/08/20 |
| Last modified on | 2010/08/20 18:29:02 |
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Basic information
Public title
Jikei-EValuation of insulin Lispro mixture on pharmacodynamics and glycemic VariencE
Acronym
J-EVOLVE
Scientific Title
Jikei-EValuation of insulin Lispro mixture on pharmacodynamics and glycemic VariencE
Scientific Title:Acronym
J-EVOLVE
Region
| Japan |
Condition
Condition
type 2 diabetes using insulin
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to test the difference between humalog 25 mix and humalog 50 mix using continuous glucose monitoring
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
continuous glucose values monitored for 24 hours
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
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
humalog mix 25
Interventions/Control_2
humalog mix 50
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
type 2 diabetes using humalog mix 25 or humalog mix 50
Key exclusion criteria
type 2 diabetes using insulin other than humalog mix 25 or humalog mix 50
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rimei Nishimura |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
TEL
03-3433-1111
Homepage URL
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
donation
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
| 2008 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
http://www.cardiab.com/content/9/1/16
Publication of results
Published
Result
URL related to results and publications
http://www.cardiab.com/content/9/1/16
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
| 2008 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 20 | Day |
Last modified on
| 2010 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001427
