NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000017619

Registered date:19/05/2015

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.

Basic Information

Recruitment status Open public recruiting
Health condition(s) or Problem(s) studiedType 2 diabetes mellitus
Date of first enrollment2014/06/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional,observational
Intervention(s)Vildagliptin Gliclazide control (diabetic patients without coronary artery diseases)

Outcome(s)

Primary OutcomeTime spent in range 70-140 mg/dl
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include 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.
Exclude criteria1) 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

Contact

public contact
Name Hiroyuki Matsuda
Address 2-11-1 Kaga, Itabashi-ku, Tokyo Japan
Telephone 03-3964-1211
E-mail mazda@med.teikyo-u.ac.jp
Affiliation Teikyo university EBM Center
scientific contact
Name Taiji Furukawa
Address 2-11-1 Kaga, Itabashi-ku, Tokyo Japan
Telephone 03-3964-1211
E-mail tfrkw@med.teikyo-u.ac.jp
Affiliation Teikyo university school of medicine Department of Clinical Laboratory Medicine