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Prospective trial to validate effect of evogliptin on coronary atherosclerosis in patients with type 2 diabetes mellitus

Effect of evogliptin on coronary artery plaque in patients with type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0005239
Enrollment
106
Registered
2020-07-16
Start date
2020-08-31
Completion date
Unknown
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The subjects are to be randomly assigned to either the evogliptin group or the glimepride group. -Evogliptin group : Evogliptin 5 mg tablets to be administered orally, once a day for 104 weeks
s blood sugar control.

Sponsors

Kyungpook National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
The changes in atherosclerotic plaque analyzed by coronary CT angiography

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactInkyu Lee

Kyungpook National University Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026