UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008806 |
|---|---|
| Receipt number | R000010343 |
| Scientific Title | The effects of a DPP4 inhibitor on endothelial function in diabetic patients with coronary artery disease |
| Date of disclosure of the study information | 2012/08/30 |
| Last modified on | 2015/03/30 16:17:03 |
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Basic information
Public title
The effects of a DPP4 inhibitor on endothelial function in diabetic patients with coronary artery disease
Acronym
The effects of a DPP4 inhibitor on endothelium
Scientific Title
The effects of a DPP4 inhibitor on endothelial function in diabetic patients with coronary artery disease
Scientific Title:Acronym
The effects of a DPP4 inhibitor on endothelium
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus with coronary artery disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether DPP4 inhibitors could improve endothelial dysfunctions in diabetic patients with coronary artery disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Reactive hyperemia peripheral arterial tonometry index
Key secondary outcomes
High-sensitivity C-reactive Protein
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
Additional treatment of Sitagliptin
Interventions/Control_2
conventional treatment
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 mellitus (DM) patients with coronary artery disease
1. Uncontrolled DM patients with diet and exercise therapy
2. Uncontrolled DM patients treated with insulin injections or oral anti-diabetic drugs except DPP-4 inhibitors
Patients with coronary artery disease documented by CAG or CT with organic coronary stenosis of >50% in major coronary arteries.
Key exclusion criteria
1. Patients receiving GLP-1 receptor analogues injection and glinide drugs
2. Patients needed rapidly intensive glucose control
3. Patients with heart failure (New York Heart Association functional class II to IV)
4. Patients with active systemic inflammatory disease, chronic renal failure requiring hemodialysis, active hepatic disease, and presence of malignant tumor
5. Patients with acute coronary syndrome within 3 months preceding admission
6. Ineligible patients for any other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Matsubara |
Organization
Kumamoto University, Faculty of Life Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL
096-353-5175
j-matsu@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Matsubara |
Organization
Kumamoto University, Faculty of Life Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL
096-373-5175
Homepage URL
j-matsu@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
None
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
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
熊本大学医学部附属病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | 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
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 30 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010343
