UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004973 |
|---|---|
| Receipt number | R000005433 |
| Scientific Title | Evaluation of the effects of ultra-long acting insulin analogue on diabetic vascular complication |
| Date of disclosure of the study information | 2011/03/30 |
| Last modified on | 2016/08/10 17:09:37 |
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Basic information
Public title
Evaluation of the effects of ultra-long acting insulin analogue on diabetic vascular complication
Acronym
EVOLUTION
Scientific Title
Evaluation of the effects of ultra-long acting insulin analogue on diabetic vascular complication
Scientific Title:Acronym
EVOLUTION
Region
| Japan |
Condition
Condition
Type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of detemir or glargin treatment on atherosclerotic markers.
Basic objectives2
Others
Basic objectives -Others
To clarify the effects of detemir or glargin treatment on atherosclerotic markers.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Flow mediated vasodilatation
Key secondary outcomes
urinary albumin excretion, Vascular endothelial growth factor, Plasminogen activator inhibitor-1, , Adiponectin, Leptin, Ghrelin, high sensitive CRP
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
First, detemir treatment for 6 months, and then glargin treatment for 6 months
Interventions/Control_2
First, glargin treatment for 6 months, and then detemir treatment for 6 months
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
type 2 diabetic patients whose HbA1c level over 7%
Key exclusion criteria
Patients modified ACEI/ARB, statin, pioglitzone therapy within 1 months
Patients with pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Miyamoto |
Organization
National Cerebral Cardiovascular Center
Division name
Endocrinology and Metabolism
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Makino |
Organization
National Cerebral Cardiovascular Center
Division name
Endocrinology and Metabolism
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
EVOLUTION study group
Institute
Department
Personal name
Funding Source
Organization
Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2011 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | 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
| 2011 | Year | 01 | Month | 28 | Day |
Last modified on
| 2016 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005433
