Efficacy and Safety of the SGLT2 Inhibitor Empagliflozin versus Placebo and the DPP-4 Inhibitor Linagliptin versus Placebo in Young People with Type 2 Diabetes (DINAMO): a Multicentre, Randomised, Double-blind, Parallel Group, Phase 3 Trial
Lancet Diabetes Endocrinol. 2023; online ahead of print DOI: 10.1016/S2213-8587(22)00387-4
The incidence of T2D in young people is increasing, but treatments remain limited. The double-blind DINAMO trial was conducted in 158 young people (aged 10−17 years) with T2D (HbA1c 6.5-10.5%) who had been previously treated with metformin or insulin. Participants were initially randomised to empagliflozin 10 mg, linagliptin 5 mg or placebo. Participants in the empagliflozin group who did not reach HbA1c <7.0% by week 12 were re-randomised at week 14 to either remain on empagliflozin 10 mg or have their dose increased to 25 mg. Participants in the placebo group were randomised at week 26 to linagliptin 5 mg or one of the empagliflozin doses (10 mg or 25 mg).
For the primary outcome, the adjusted mean HbA1c change from baseline at week 26 was -0.84% in the empagliflozin pooled group vs placebo (p=0.012); the corresponding change from baseline for linagliptin vs placebo was -0.34% (p=0.29). There were no AEs of concern and no AEs leading to discontinuation.
The authors concluded that empagliflozin provided clinically relevant HbA1c reductions, whereas linagliptin did not, and that empagliflozin might offer a new treatment option for young people with T2D.