Safety, Growth, and Development After Dapagliflozin or Saxagliptin in Children With Type 2 Diabetes (T2NOW Follow-Up)
Authors' 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.
Study context
- Population
- Children with T2D aged 10 to 17 years, previously treated as add-on to diet, exercise, metformin and/or insulin
- Participants
- 210 children
- Comparison
- Prior dapagliflozin or saxagliptin vs placebo
- Primary endpoint
- Main outcomes: change in height, weight, BMI, Tanner staging, growth and maturation markers, bone biomarkers and adverse events (AEs)
- Follow-up
- Baseline to week 104
Methodological detailsmulticenter, double-blind, phase 3, 52-week nontreatment follow-up
- Multicenter
- Double-blind
- Phase 3
- 52-week nontreatment follow-up
Primary result
As reported in the abstract
week 104
- Mean height and weight slightly increased from baseline to week 104
- Body mass index (BMI) remained generally stable; changes similar across treatment groups
- Sexual maturation progressed normally, with similar Tanner stage shifts and changes in growth and maturation markers and bone biomarkers across groups
Further findings
- No deaths occurred
Safety
≥1 AE during nontreatment follow-up · nontreatment follow-up period
≥1 AE during nontreatment follow-up · nontreatment follow-up period
- Similar across groups
Original publication
Safety, Growth, and Development After Dapagliflozin or Saxagliptin in Children With Type 2 Diabetes (T2NOW Follow-Up). J Clin Endocrinol Metab. Published 24 October 2024. doi:10.
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