Outcome Measures: |
Primary: Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin, The change from baseline in hemoglobin A1c(HbA1c) after 24 weeks treatment in vildagliptin 50 mg bid used in combination with metformin 500 mg bid is not inferior to that with metformin up to 1000 mg bid as monotherapy after 24 weeks, baseline, 24 weeks | Secondary: Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups, The changes from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment will be analyzed in pre-defined patient subgroups based on Body Mass Index(BMI) ( \<24, ≥ 24) and age (\<60 y and ≥ 60 y), baseline and 24 weeks|Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5%, The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% of two treatment arms in the overall population and in pre defined sub groups., baseline and 24 weeks|Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events, The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% without adverse GI events of two treatment arms in the overall population and in pre defined sub groups., baseline and 24 weeks|Mean change from baseline in fasting plasma glucose (FPG), Mean change from baseline in FPG will be calculated in the overall population and in pre defined sub groups., baseline, 24 weeks|Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample, Mean change from baseline in 2 hour post prandial glucose(PPG) in a sub sample of overall patients., baseline, 24 weeks|Number of patients with adverse events, serious adverse events and death, Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards., up to 24 weeks
|