Acute Coronary Syndrome (ACS) and diabetes
Conditions
Interventions
Group A: Teneligliptin group (20mg tablet once a day for 28 weeks)
Group B: Control group (regular treatment)
Sponsors
Saitama Medical Center, Jichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Division of Clinical Study Support
Outcome results
None listed