Table 1.
Baseline characteristics of the phase 3 trials and independent studies on pediatric patients using new insulin.
| Autor/Company and year [Ref] | Country | Study design | Population -age range | Study period | Treatment prior study enrollment | Main outcomes | Follow up |
|---|---|---|---|---|---|---|---|
| Danne T, 2020 [29] | Multicentre | RCT | N = 463; aged 6–17 y | 2016–2018 | MDI | To compare efficacy and safety of insulin Gla-300 VS Gla-100 in children and adolescents with T1D | 6 m + 6 m safety extension period |
| Al Hayek AA, 2022 [30] | Saudi Arabia | OS | N = 86; aged 14˗40 y (n ꓿26 ≤ 20 yy ) | 2021 | MDI | To compare efficacy, safety and patient-reported satisfaction of insulin Gla-300 VS insulin Gla-100 in adolescents and young adults with T1D | 3 m |
| Bode BW, 2019 [33] | Multicentre | RCT | N = 777; aged 1–17 y | 2016–2018 | MDI | To compare efficacy and safety of faster aspart VS IAsp (both while on basal insulin degludec) in children and adolescents with T1D | 6 m |
| Costa C, 2022 [35] | Portugal | RS | N = 60; aged 3–19 y | 2019–2020 | N = 47 on CSII; n = 13 on MDI | To compare efficacy of faster aspart VS other rapid-acting insulin analogues in children and adolescents with T1D. | 3 m |
| Gonzalez de Buitrago ´ Amigo J, 2020 [36] | Spain | OS | N = 32; aged 7–17 y | 2019 | CSII (MiniMed640G) | To compare efficacy and safety of faster aspart VS IAsp in children and adolescents with T1D on CSII | 3 m |
| Eli Lilly and Company, “PRONTO-Peds” trial [42] | Multicentre | RCT | N = 716; aged 1–17 y | 2019–2021 | MDI | To compare efficacy and safety of URLi VS Humalog in children and adolescents with T1D. | 6 m |
| Mannkind Corporation, “Afrezza INHALE-1” Study in Pediatrics [44] | USA | RCT | N (estimated) = 264; aged 4–17 y | 2021- ongoing | MDI | To compare efficacy and safety of Afrezza VS rapid-acting insulin analogues plus basal insulin in children and adolescents with T1D or T2D. | 6 m + 6 m safety and efficacy extension period |
RCT: Randomized Controlled Trial; OS: Observational Study; RS: Retrospective Study; N: number; Y: years; M: months; MDI: Multiple Daily Injections; CSII: Continuous Subcutaneous Insulin Infusion; insulin Gla-300: insulin glargine 300 U/mL; insulin Gla-100: insulin glargine 100 U/mL; IAsp: Insulin Aspart; URLi: Ultra Rapid Lispro insulin; T1D: Type 1 Diabetes; T2D: Type 2 Diabetes.