Approximately 550 enrolled subjects were to be randomized into the study. Subjects were randomized to one of the two treatments in a 1:1 ratio. Each eligible subject was randomized to a group assignment on the basis of a randomly generated number. Randomization was stratified by the screening HbA1c values (<7.5% and ≥7.5%) to ensure an even distribution of subjects between the two treatments. Randomization was to take place through an Integrated Web-based Randomization System (IWRS) which sites accessed in order to make randomized treatment assignments.