Addition of sitagliptin to ongoing metformin monotherapy improves glycemic control in Japanese patients with type 2 diabetes over 52 weeks

Aims/Introduction The efficacy and safety of sitagliptin, a highly selective dipeptidyl peptidase‐4 inhibitor, when added to metformin monotherapy was examined in Japanese patients with type 2 diabetes. Materials and Methods In this 52‐week, add‐on to metformin study, 149 patients were randomly assigned to receive sitagliptin 50 mg or placebo once daily in a double‐blind fashion for 12 weeks. Thereafter, all patients who completed the double‐blind period of the study received open‐label sitagliptin 50 mg once daily for 40 weeks, with the investigator option of increasing sitagliptin to 100 mg once daily for patients who met predefined glycemic thresholds. Results After 12 weeks of treatment, the mean change from baseline in glycated hemoglobin (HbA1c) significantly decreased with sitagliptin relative to placebo (between‐group difference [95% confidence interval] = −0.7% [−0.9 to −0.5] P