Efficacy and safety of ultra‐rapid lispro versus lispro in children and adolescents with type 1 diabetes: The PRONTO‐Peds trial
Authors' conclusion
In children and adolescents with T1D, URLi demonstrated good glycaemic control, and noninferiority to lispro in HbA1c change for mealtime and postmeal URLi. When dosed at the beginning of meals, URLi reduced 1-hour PPG and PPG excursions versus lispro.
Study context
- Population
- Children and adolescents with T1D on pre-study basal insulin (degludec, detemir or glargine), after a 4-week lead-in to optimize basal insulin
- Participants
- 280 / 138 / 298
- Comparison
- Mealtime and postmeal ultra-rapid lispro vs lispro
- Mealtime ultra-rapid lispro (URLi)n = 280
- Postmeal URLin = 138
- Lispron = 298reference
- Primary endpoint
- HbA1c change from baseline (noninferiority margin 4.4 mmol/mol [0.4%])
- Follow-up
- 26 weeks
Methodological detailsphase 3, treat-to-target, double-blind (mealtime arms), open-label (postmeal URLi), noninferiority
- Phase 3
- Treat-to-target
- Double-blind (mealtime arms)
- Open-label (postmeal URLi)
- Noninferiority
Primary result
As reported in the abstract
HbA1c change from baseline
Each group vs lisproEstimated treatment difference, mmol/mol (95% CI)
Mealtime URLi
−0.23(−1.84 to 1.39)
Postmeal URLi
−0.17(−2.15 to 1.81)
Further findings
| Outcome | P value |
|---|---|
| 1-hour PPG daily meanMealtime URLi vs Lispro · reduced with mealtime URLi | P = 0.001 |
| Premeal to 1 hour postmeal PPG excursion daily meanMealtime URLi vs Lispro · reduced with mealtime URLi | P < 0.001 |
Safety
Injection site reaction
- Postdose hypoglycaemia (<3.0 mmol/L) at ≤2 hours · Mealtime URLi vs Lispro · rate higher with mealtime URLi
- P = 0.034
Severe, nocturnal or documented hypoglycaemia (<3.0 mmol/L [54 mg/dL])
- Rate and incidence similar for all treatments
Treatment-emergent adverse events
- Incidence similar for all treatments
Original publication
Efficacy and safety of ultra‐rapid lispro versus lispro in children and adolescents with type 1 diabetes: The PRONTO‐Peds trial. Diabetes Obes Metab. Published 8 September 2022. doi:10.
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