UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018936 |
|---|---|
| Receipt number | R000021223 |
| Scientific Title | Effects of one of antidiabetic agents, teneligliptin, on the vascular endothelium function of ACS patients with diabetes |
| Date of disclosure of the study information | 2015/09/08 |
| Last modified on | 2019/03/04 18:21:39 |
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Basic information
Public title
Effects of one of antidiabetic agents, teneligliptin, on the vascular endothelium function of ACS patients with diabetes
Acronym
Effects of one of antidiabetic agents, teneligliptin, on the vascular endothelium function of ACS patients with diabetes
Scientific Title
Effects of one of antidiabetic agents, teneligliptin, on the vascular endothelium function of ACS patients with diabetes
Scientific Title:Acronym
Effects of one of antidiabetic agents, teneligliptin, on the vascular endothelium function of ACS patients with diabetes
Region
| Japan |
Condition
Condition
Acute Coronary Syndrome (ACS) and diabetes
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess effects of teneligliptin on blood glucose and lipid metabolism as well as serum DPP-4 concentration, serum SDF1-alpha concentration, EPC induction, vascular endothelium function, expansion and contraction of myocardium, and coronary artery lesion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Count of peripheral blood EPCs (at time of pre-treatment/0 week, and 28 weeks after intervention)
2. Serum DPP-4 activity (at time of pre-treatment/0 week, and 28 weeks after intervention)
3. Serum SDF1-alpha concentration (at time of pre-treatment/0 week, and 28 weeks after intervention)
Key secondary outcomes
1. Assessment of vascular endothelium function by FMD
2. Heart function test, expansionability, by echocardiography (E/A ratio and e/e' ratio of mitral annulus)
3. Cardiac catheter test, IVUS for coronary artery lesion: plaque cross-sectional area of the lesion
4. Blood glucose level (fasting, postprandial [2 hours from a meal], HbA1c)
5. Serum lipid parameter: fasting serum triglyceride, LDL, HDL, fatty acid 4-fractions, RLP, and Lp(a)
6. Urinary 8-OHdG
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Group A: Teneligliptin group (20mg tablet once a day for 28 weeks)
Interventions/Control_2
Group B: Control group (regular 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Only those patients who meet all of the following criteria are included in this study:
1. Newly start using a DPP-4 inhibitor
2. Hospitalized due to ACS (max CPK is not over 1000, and heart function is not damaged) and underwent angioplasty
3. No restriction for age and gender
4. Mild diabetes mellitus: casual blood glucose 200 mg/dL level, or HbA1c < 7%
5. In combination of using other medication, such as aspirin, statin, etc. are allowed under a condition that antihyperglycemic agents such as BG, alpha-glucosidase inhibitor, SU, glinide, etc. are not used.
6. Fully understand the purpose of the study after an explanation given by a researcher, and are able to provide their written consent by their free will to participate in this study
Key exclusion criteria
For those who fall into any of the following criteria are excluded from the study:
1. With a condition of significantly elevated blood glucose, multiple medication or insulin treatment is desirable
2. The CPK level is over 1000 after ACS onset with suspected cardiomyopathy
3. With medical history of heart disease
4. With sever ketoacidosis, diabetic
coma, or precoma
5. Serious infection
6. Perioperative
7. Serious physical injury
8. Showing hypersensitiveness to any compound of teneligliptin
9. Other conditions where the patient is judged by a physician to be inappropriate to participate in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomio Umemoto |
Organization
Saitama Medical Center,
Jichi Medical University
Division name
Division of Cardiovascular Medicine
Zip code
Address
1-847 Amanumacho, Omiyaku, Saitama-city, Saitama, Japan 330-8503
TEL
048-647-2111
sugayoshi1@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takayama |
Organization
Soiken Inc.
Division name
Division of Clinical Study Support
Zip code
Address
NBF Bld. 4th Floor, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Saitama Medical Center,
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
自治医科大学附属さいたま医療センター
Saitama Medical Center, Jichi Medical University
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 08 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | 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
| 2015 | Year | 09 | Month | 08 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021223
