UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008077 |
|---|---|
| Receipt number | R000009513 |
| Scientific Title | The Effect of Alogliptin on Progression of Atherosclerosis and Renal Function in Type 2 Diabetes Patient with Coronary Artery Disease |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2020/02/16 06:36:27 |
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Basic information
Public title
The Effect of Alogliptin on Progression of Atherosclerosis and Renal Function in Type 2 Diabetes Patient with Coronary Artery Disease
Acronym
The Effect of Alogliptin on Atherosclerosis and Renal Function
Scientific Title
The Effect of Alogliptin on Progression of Atherosclerosis and Renal Function in Type 2 Diabetes Patient with Coronary Artery Disease
Scientific Title:Acronym
The Effect of Alogliptin on Atherosclerosis and Renal Function
Region
| Japan |
Condition
Condition
Type 2 diabetes patient with coronary artery disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of Alogliptin on progression of atherosclerosis and renal function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The progression of coronary artery plaque, endothelial function and renal function at 6 months after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Alogriptin 25mg/day (12.5mg/day for patient with renal dysfunction) for 6 months
Interventions/Control_2
Voglibose 0.9mg/day 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patient with coronary artery disease
Key exclusion criteria
The patients contraindication for Alogriptin, type 1 diabetes patient, the patients already receiving medication for diabetes
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Furuse |
Organization
Tottori University
Division name
Faculty of Medicine, Department of Molecular Medicine and Therapeutics
Zip code
6838504
Address
36-1 Nishimachi, Yonago, Japan
TEL
0859-38-6517
yfuruse-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Furuse |
Organization
Tottori University
Division name
Faculty of Medicine, Department of Molecular Medicine and Therapeutics
Zip code
6838504
Address
36-1 Nishimachi, Yonago, Japan
TEL
0859-38-6517
Homepage URL
yfuruse-circ@umin.ac.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine, Department of Molecular Medicine and Therapeutics
Institute
Department
Personal name
Funding Source
Organization
Tottori University Faculty of Medicine, Department of Molecular Medicine and Therapeutics
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, Department of Molecular Medicine and Therapeutics
Address
36-1 Nishimachi, Yonago, 683-8504, Japan
Tel
0859-38-6517
yfuruse-circ@umin.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
鳥取大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.umin.ac.jp/ctr/index.htm
Publication of results
Unpublished
Result
URL related to results and publications
https://www.umin.ac.jp/ctr/index.htm
Number of participants that the trial has enrolled
4
Results
The trial was closed due to lack of applicants.
Results date posted
| 2020 | Year | 02 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The trial was closed due to lack of applicants.
Participant flow
The trial was closed due to lack of applicants.
Adverse events
The trial was closed due to lack of applicants.
Outcome measures
The trial was closed due to lack of applicants.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 01 | Day |
Last modified on
| 2020 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009513
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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