Safety, Growth and Development After Dapagliflozin or Saxagliptin in Children With Type 2 Diabetes (T2NOW Follow-Up).

Abstract

Context: The T2NOW trial of dapagliflozin or saxagliptin versus placebo in pediatric patients with type 2 diabetes (T2D) demonstrated promising efficacy data for dapagliflozin and did not raise any safety concerns over 52 weeks.

Objective: Assess long-term effects of prior dapagliflozin/saxagliptin administration on safety, growth and development.

Design: Multicenter, randomized, double-blind phase 3 trial (T2NOW).

Patients: 210 children with T2D aged 10-17 years, followed for up to one year after treatment.

Interventions: Previous treatment with once-daily dapagliflozin (5, 10 mg), saxagliptin (2.5, 5 mg) or placebo as add-on to diet, exercise, metformin and/or insulin for 52 weeks, plus a 52-week non-treatment follow-up period.

Main outcome measures: Change in height, weight, body mass index (BMI), Tanner staging, growth and maturation markers, bone biomarkers and adverse events (AEs) from baseline to Week 104.

Results: As expected in a pediatric population, mean height and weight slightly increased from baseline to Week 104. BMI remained generally stable; Changes were similar across treatment groups. Sexual maturation progressed normally to Week 104, with similar shifts between Tanner stages and changes in growth and maturation markers and bone biomarkers across groups. The proportion of patients reporting ≥1 AE during the non-treatment follow-up period was similar across groups previously treated with dapagliflozin (18.5%) or saxagliptin (15.9%) compared to placebo (21.1%). No deaths occurred.

Conclusion: Prior treatment with dapagliflozin or saxagliptin for 52 weeks did not raise any safety concerns relating to height, weight, BMI, Tanner staging, growth and maturation markers, bone biomarkers or AEs for up to 52 weeks following treatment discontinuation, in pediatric patients with T2D.