UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011960 |
|---|---|
| Receipt number | R000013972 |
| Scientific Title | Effects of Teneligliptin improvement endotherial dysfunction, inflammation, coagulation and oxidative stress in patients with coronary artery disease and diabetes, pilot study(Tiramisu study). |
| Date of disclosure of the study information | 2013/10/05 |
| Last modified on | 2017/06/03 10:45:23 |
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Basic information
Public title
Effects of Teneligliptin improvement endotherial dysfunction, inflammation, coagulation and oxidative stress in patients with coronary artery disease and diabetes, pilot study(Tiramisu study).
Acronym
Tiramisu study
Scientific Title
Effects of Teneligliptin improvement endotherial dysfunction, inflammation, coagulation and oxidative stress in patients with coronary artery disease and diabetes, pilot study(Tiramisu study).
Scientific Title:Acronym
Tiramisu study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of DPP4 inhibitor in patients with coronary artery diesease and diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
improvement of endothelial function
Key secondary outcomes
HbA1c,Glycated albumin,1.5-anhydro-D-glucitol,fasting plasma glucose,
immunoreactive insulin, HOMA-IR, HOMA-beta, hs-CRP, IL-6, MCP-1, TNF-alpha
Red blood cell, White blood cell, platelet, D dimer, FDP, fibrinogen, 8-OHdG, BNP, body weight
Base
Study type
Interventional
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
Teneligliptin
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
Diabetic patients with coronary artery disease
Key exclusion criteria
Type I diabetes
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Murata Makoto |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Biological Science
Zip code
Address
3-39-15.Showa-Machi,Maebashi-Shi,Gunma-Ken,JAPAN
TEL
+81-27-220-8153
yarukimanmann2000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Murata Makoto |
Organization
Gunma University
Division name
Division of Cardiology
Zip code
Address
3-39-15.Showa-Machi,Maebashi-Shi,Gunma-Ken
TEL
027-220-7111
Homepage URL
yarukimanmann2000@yahoo.co.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
群馬大学
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2013 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 04 | Day |
Last modified on
| 2017 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013972
