Shankar RR, Zeitler P, Deeb A, et al. - In youth with type 2 diabetes (T2D), glycemic control was not significantly improved with sitagliptin-induced DPP-4 inhibition. A general good tolerability of sitagliptin was evident with a safety profile similar to that reported in adults.

• A 54-week, double-blind, randomized, controlled clinical trial to assess DPP-4 inhibition with sitagliptin 100 mg once daily as initial oral therapy in youth with T2D [n=190, aged 10-17 years, HbA1c 6.5%-10% (7.0%-10% if on insulin)].

• Participants were overweight/obese at screening or diagnosis, and the trial was placebo controlled for the first 20 weeks, thereafter metformin replaced placebo.

• With sitagliptin vs placebo, least squares mean changes from baseline to Week 20 in HbA1c were -0.01% and 0.18%, respectively; between-group difference (95% CI) = -0.19% (-0.68, 0.30), p = 0.448.

• Alterations in HbA1c at Week 54 were: 0.45% (sitagliptin) and -0.11 (placebo/metformin).

• Adverse event profiles through Week 54 did not differ notably between groups.