Open-label, randomized study of inhibitory effect of evogliptin, the dipeptidyl peptidase-4 inhibitor, on the progression of aortic valve calcification in patients with type 2 diabetes mellitus and mild-to-moderate aortic stenosis
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0005375
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
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 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)Sujects who decided to take part in this study on his/her own volition after listening to the details of this study
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 maligant 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 treat 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in aortic valve calcium volume in Evogliptin Group against Comparison Group at Week 96 from the baseline
- Secondary Outcome Measures
Name Time Method Change in aortic valve calcium volume at Week 48 from the baseline;Change in aortic valve calcium score at Week 48 and Week 96 from the baseline;Rate of change (%) in aortic valve calcium volume at Week 48 and Week 96 from the baseline;Change in peak aortic-jet velocity at Week 48 and Week 96 from the baseline;Change in aortic peak & mean pressure gradient (peak & mean PG) at Week 48 and Week 96 from the baseline;Change in aortic valve area at Week 48 and Week 96 from the baseline;Time of major cardiovascular event *The major cardiovascular event includes death, surgical procedure (aortic valve replacement) or hospitalization due to worsening symptoms