Statistical tests for the efficacy analyses were to be two-sided, with no p-value adjustment, and were to focus on the responses of the ITT population with the PP population being used in supportive analyses. To assess the primary end-point of change in HbA1c level from baseline, the general linear model (analysis of covariance) adjusted for baseline and important stratification factors, e.g., baseline HbA1c and site, was used. In this analysis, in order to protect the statistical degrees of freedom, sites were pooled according to location and other factors. The closed test procedure was to be used for the secondary end-points in order protect the Type I Error rate of α = 0.05. For this procedure, the secondary end-points were to be analyzed in the following order: 1. Body Mass Index 2. Triglycerides 3. LDL 4. Total cholesterol 5. Fasting blood glucose 6. Proportion of subjects achieving HbA1c <7% and/or ≤6.5% 7. Insulin 8. HDL