Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison.

Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison. - Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017619

Enrollment

Registered

2015-05-19

Start date

2014-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Type 2 diabetes mellitus

Interventions

Vildagliptin Gliclazide control (diabetic patients without coronary artery diseases)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ?Type II diabetes mellitus ?Coronary intervention case ?Age 20-75 y. o. ?Diabetic patients treated with stable low dose of SU (Gliclazide 0~40mg) and/or Metformin (0~750mg) for at least four weeks.

Exclusion criteria

Exclusion criteria: 1) Exclusion criteria will comply with local label 2) Coronary bypass graft operation 3) Severe valvular heart disease 4) Severe arrhythmia (Extrasystole > 10% of total beats, atrial fibrillation, atrial flutter, pacemaker implantation, high grade heart block) 5) Congestive heart failure (NYHA III, IV) 6) Malignant neoplasms 7) Use of gluco-corticosteroids, immuno-suppressant 8) Serum Cr > 2.5 mg/dl 9) Cerebrovascular infarction or hemorrhage 10) Aneurysms in great artery 11) Liver cirrhosis 12) Recent (within 4 weeks) usage of incretin related drugs 13) Blood glucose > 400mg/dl or insulin usage 14) Recent change in diabetic treatment in one month 15) Use of Insulin, GLP-1 analogue, and OHAs excluding SU and metformin

Design outcomes

Primary

Measure	Time frame
Time spent in range 70-140 mg/dl	—

Countries

Japan

Contacts

Public ContactHiroyuki Matsuda

Teikyo university EBM Center

mazda@med.teikyo-u.ac.jp03-3964-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026