This was a Phase 3, prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy, safety, and tolerability of D-tagatose (as compared to placebo). Prior to the start of treatment, subjects participated in an 8-week run-in period during which diabetes education was provided and diet and exercise treatment stabilized. Efficacy analyses were conducted on data from 4 and 6 months.