NIPH Clinical Trials Search

Effects of one of antidiabetic agents, teneligliptin, on the vascular endothelium function of ACS patients with diabetes

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Acute Coronary Syndrome (ACS) and diabetes
Date of first enrollment	2015/04/01
Target sample size	50
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Group A: Teneligliptin group (20mg tablet once a day for 28 weeks) Group B: Control group (regular treatment)

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude 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