Efficacy and safety evaluationThe primary efficacy criterion was thechange in HbA1c level from baseline to theend of the double-blind treatment for theintent-to-treat (ITT) population, whichincluded any patient who had both abaseline value and at least one postrandomization efficacy value.Secondary efficacy parameters included the change in fasting and postprandial plasma glucose and insulin levelsand serum triglyceride levels from baseline to the end of treatment, measured at0, 60, 90, and 120 min after a standardized liquid test breakfast (55% carbohydrate, 30% fat, and 15% protein;providing ;450 kcal). The study medica