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.

UMIN ID: UMIN000017619

Registered date:19/05/2015

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 2014/06/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional,observational

Intervention(s)

Vildagliptin
Gliclazide
control (diabetic patients without coronary artery diseases)

Outcome(s)

• Primary Outcome: Time spent in range 70-140 mg/dl

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Teikyo University School of Medicine
• Source(s) of Monetary Support: Novartis Pharma K.K.