UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010467 |
|---|---|
| Receipt number | R000012235 |
| Scientific Title | Anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2013/04/11 |
| Last modified on | 2022/01/21 10:00:12 |
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Basic information
Public title
Anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus
Acronym
Anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus
Scientific Title
Anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus
Scientific Title:Acronym
Anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate anti-atherosclerotic effect of glinide or sulfonylurea in Japanese patients with type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postprandial glucose and insulin level after the meal tolerance test, IMT, PWV
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
glinide
Interventions/Control_2
sulfonylurea
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HbA1c>6.5%
Key exclusion criteria
Renal failure, Liver dysfunction
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Okura |
Organization
Tottori University Faculty of Medicine
Division name
Division of Cardiovascular Medicine, Endocrinology and Metabolism
Zip code
6838504
Address
36-1 Nishi-Cho
TEL
0859386517
ohkura@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Okura |
Organization
Tottori University Faculty of Medicine
Division name
Division of Cardiovascular Medicine, Endocrinology and Metabolism
Zip code
6838504
Address
36-1 Nishi-Cho
TEL
0859386517
Homepage URL
ohkura@tottori-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Endocrinology and Metabolism, Department of Molecular Medicine and Therapeutics, Tottori University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Endocrinology and Metabolism, Department of Molecular Medicine and Therapeutics, Tottori University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori University Faculty of Medicine
Address
36-1 Nishi-Cho
Tel
0859386517
ohkura@tottori-u.ac.jp
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
| 2013 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
No longer recruiting
Date of protocol fixation
| 2006 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 27 | 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
| 2013 | Year | 04 | Month | 11 | Day |
Last modified on
| 2022 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012235
