Prospective trial to validate effect of evogliptin on coronary atherosclerosis in patients with type 2 diabetes mellitus
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005239
- Lead Sponsor
- Kyungpook National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 106
1. T2DM patients, diagnosed at least 3 months ago
2. HbA1c 6.5~10%
3. Age 30-90 years
4. Drug naïve or with previous metformin +/- insulin users
5. 10~75% of coronary stenosis in the initial coronary CT angiography.
1. T1DM, secondary diabetes
2. Patients with advanced CKD (eGFR <50)
3. Patients with severe allergic reaction to contrast media
4. Patients with prior CABG/PCI
5. Severe liver dysfunction (OT/PT, above 120 IU/l)
6. Previous history of DPP4-inhibitor administration more than 6 months
7. Presence of severe infectious disease, before or after surgery or severe trauma
8. Moderate to severe heart failure (above NYHA stage III)
9. Pregnant, lactating, possibly pregnant women
10. Past medical history of hypersensitivity to investigational drugs
11. Clopidogrel, cilostazol users (aspirin or statin users are allowed to be enrolled)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The changes in atherosclerotic plaque analyzed by coronary CT angiography
- Secondary Outcome Measures
Name Time Method The change of intima-medial thickness;The change of ankle-brachial index;The changes of plaque volume(Non-calcified, calcified, fibrous, fibrous fatty, and low attenuation plaque) using CCTA;The change of body composition