Randomized, Open-label Trial of Inhibitory Effect of Evogliptin on Progression of CAVD

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess an inhibitory effect of Evogliptin on the progression of mild-to-moderate aortic stenosis in patients with T2DM and calcific aortic stenosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborators: REDNVIA; REDNVIA Co., Ltd.

Criteria

Inclusion Criteria:

1. Male and female aged 19 years or older

2. Subjects who were diagnosed with type 2 diabetes mellitus and being treated with oral hypoglycemic drugs

3. Subjects whose Doppler echocardiography or Heart CT performed within 8 weeks prior to or during Screening Visit (Visit 1) is satisfying any of the followings:

• Doppler echocardiogrphy (aortic valve calcification and/or hypertrophy with aortic peak velocity≥2.0 m/s); or

• Heart CT (aortic valve calcium score≥300 AU)

4. Subjects who decided to take part in this study on his/her own volition after listening to the details of this study

Exclusion Criteria:

1. Subjects with severe aortic valve stenosis (aortic peak velocity>4.0 m/s, mean pressure gradient >40 mmHg, or aortic valve area≤0.75 cm2)

2. Subjects with left ventricular ejection fraction < 40%

3. Heart failure patients: Subjects with heart failure of NYHA functional class II-IV

4. Subjects with an estimated glomerular filtration rate (eGFR) of <30ml

5. Subjects with type 1 diabetes or diabetic ketoacidosis

6. Subjects with serious hypersensitivity to DPP-4 inhibitors

7. Subjects who have received/are receiving any of the following medication therapies:

• Vitamin K

• Calcium supplement (or osteoporosis medication)

8. Subjects whose aortic valve stenosis is not caused by degenerative or bicuspid valve disease (e.g. rheumatic valve disease)

9. Subjects who have received or are expected to receive (as of Visit 1) aortic valve surgery during the study.

10. Subjects for whom a two-year clinical course investigation is not possible due to malignant tumor or cerebrovascular disease

11. Pregnant or lactating women

12. Women of childbearing potential who are sexually active and do not agree to use proper contraception during the study

• Proper contraception means physical barrier method including condom, contraceptive diaphragm or cervix cap. The use of contraceptive or oral contraceptive containing hormones that may induce drug-drug interaction with the investigational product is not allowed during the study (with the exception of an oral contraceptive administered to cure menopausal symptoms, only if the dosage has been consistent for the past 8 weeks)

13. Any other subjects deemed not eligible for this study by an investigator