UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015381 |
|---|---|
| Receipt number | R000017902 |
| Scientific Title | Effects of dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin, on coronary atherosclerosis in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2014/10/09 |
| Last modified on | 2018/10/15 18:27:19 |
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Basic information
Public title
Effects of dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin, on coronary atherosclerosis in patients with type 2 diabetes mellitus
Acronym
Effects of dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin, on coronary atherosclerosis in patients with type 2 diabetes mellitus
Scientific Title
Effects of dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin, on coronary atherosclerosis in patients with type 2 diabetes mellitus
Scientific Title:Acronym
Effects of dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin, on coronary atherosclerosis in patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes mellitus who were suspected as having ischemic heart disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of DPP-4 inhibitor, alogliptin, on coronary atherosclerosis evaluated by coronary computed tomography angiography (CCTA)in patients with type 2 diabetes mellitus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of FFR evaluated by CCTA (FFRCT)
Key secondary outcomes
Change in plaque volume evaluated by CCTA
Change in CT values evaluated by CCTA
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Alogliptin
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients with type 2 diabetes mellitus(2)Patients as having mild atherosclerosis (diameter stenosis less than 50%) evaluated by CCTA at baseline (3)Patients who are judged by physician to administrate alogliptin
Key exclusion criteria
(1)Patients who are suspected as having significant stenosis evaluated by CCTA and require to receive percutaneous coronary intervention (PCI)
(2)Patients with acute coronary syndrome within 30 days
(3)Patients with the past history of PCI(4)Patients with post coronary artery bypass grafting (CABG)
(5)Patients with complex congenital heart disease
(6)Patients with body mass index >35kg/m2
(7)Patients with the past history of heart failure
(8)Patients with the past history of ketoacidosis or diabetic coma
(9)Patients with hepatic disorder or with AST (GOT) or ALT (GPT) greater than 2 times of the upper limits of normal (10)Patients with renal dysfunction (estimated glomerular filtration rate 30 ml/min/1.73m2 or lower)
(11)Patients with severe infection, pre or post operation, or severe trauma
(12)Patients with a history of hypersensitivity to any of the components of alogliptin
(13)Pregnant women, women suspected of being pregnant, or lactating women
(14)Patients ineligible for the study determined by physicians
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Michishita |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
132 Katsura-cho, Sakae-ku, Yokohama
TEL
045-891-2171
i-michishita@yokohamasakae.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Nozue |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
132 Katsura-cho, Sakae-ku, Yokohama
TEL
045-891-2171
Homepage URL
nozue2493@yahoo.co.jp
Sponsor or person
Institute
Kanagawa PTCA Conference
Institute
Department
Personal name
Funding Source
Organization
Japana Diabetes 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
| 2014 | Year | 10 | Month | 09 | 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
| 2014 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | 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
| 2014 | Year | 10 | Month | 09 | Day |
Last modified on
| 2018 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017902
