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Safety, Growth, and Development After Dapagliflozin or Saxagliptin in Children With Type 2 Diabetes (T2NOW Follow-Up)
Naim Shehadeh1, Pietro Galassetti2, Nayyar Iqbal2
1Azrieli Faculty of Medicine, Bar-Ilan University, Safed, 1311502, Israel.
Insights
Prior treatment with dapagliflozin or saxagliptin in children with type 2 diabetes (T2D) showed no long-term safety concerns for growth or development. Follow-up assessments confirmed normal growth, maturation, and similar adverse event rates compared to placebo.
Area of Science:
- Pediatric Endocrinology
- Metabolic Disorders
- Clinical Pharmacology
Background:
- The T2NOW trial indicated dapagliflozin's efficacy in pediatric type 2 diabetes (T2D) without initial safety issues over 52 weeks.
- Long-term safety data for SGLT2 inhibitors in pediatric T2D populations are crucial for clinical practice.
Purpose of the Study:
- To evaluate the long-term safety of prior dapagliflozin or saxagliptin treatment in pediatric patients with T2D.
- To assess the impact of these treatments on growth, sexual maturation, and overall development up to 52 weeks post-discontinuation.
Main Methods:
- A multicenter, randomized, double-blind Phase 3 trial (T2NOW) involving 210 pediatric T2D patients (aged 10-17 years).
- Patients received dapagliflozin, saxagliptin, or placebo for 52 weeks, followed by a 52-week non-treatment follow-up.
- Key outcomes included changes in height, weight, BMI, Tanner staging, growth markers, bone biomarkers, and adverse events (AEs).
Main Results:
- Mean height and weight increased slightly, with stable BMI across all groups.
- Sexual maturation and growth markers progressed normally, with no significant differences between prior treatment groups and placebo.
- Adverse event rates were similar across groups: dapagliflozin (18.5%), saxagliptin (15.9%), and placebo (21.1%). No deaths were reported.
Conclusions:
- Fifty-two weeks of prior dapagliflozin or saxagliptin treatment did not present safety concerns regarding growth, development, or biomarkers in pediatric T2D patients.
- These findings support the long-term safety profile of SGLT2 inhibitors in adolescents with type 2 diabetes.
Context:
The T2NOW trial of dapagliflozin or saxagliptin vs 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:
This work aimed to assess long-term effects of prior dapagliflozin/saxagliptin administration on safety, growth, and development.
Methods:
A multicenter, randomized, double-blind phase 3 trial (T2NOW) was conducted among 210 children with T2D aged 10 to 17 years, followed for up to 1 year after treatment. Participants were previously treated with once-daily dapagliflozin (5, 10 mg), saxagliptin (2.5, 5 mg), or placebo as an add-on to diet, exercise, metformin, and/or insulin for 52 weeks, plus a 52-week nontreatment follow-up period. Main outcome measures included 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 or more AEs during the nontreatment 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.
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