Inhaled Technosphere Insulin in Children with Diabetes: The INHALE-1 Extension Study
Authors' conclusion
The INHALE-1 extension phase showed no safety concerns. Although HbA1c levels deteriorated slightly during the study, in view of the safety profile and increased patient satisfaction in the RCT portion of the trial, TI may be a useful treatment option for some pediatric patients with diabetes, particularly for those who choose not to or are unable to use an AID system.
Study context
- Population
- Children aged 4–17 yr with T1D (98%) or T2D (2%) on MDI, with continued long-acting basal insulin and continuous glucose monitoring (CGM)
- Participants
- 80 vs 88
- Comparison
- Technosphere insulin (TI) continued vs rapid-acting analog (RAA) crossover to TI
- TIn = 80
- RAA Crossovern = 88reference
Methodological detailsopen-label extension through 52 weeks
- Open-label extension through 52 weeks
Primary result
As reported in the abstract
- TI: mean change in HbA1c from 26 to 52 weeks
- 0.38% (95% CI 0.08%-0.67%, P = 0.003)
- RAA Crossover: mean change in HbA1c from TI initiation to 52 weeks
- 0.31% (95% CI −0.02%-0.64%, P = 0.08)
Further findings
HbA1c at start of RCT (TI) / TI initiation (RAA Crossover) · baseline
| Outcome | TI | RAA Crossover |
|---|---|---|
| HbA1c at 26 weeks | mean 8.2 (SD 1.2) % | — not stated in the abstract |
— not stated in the abstract
Safety
CGM time <54 mg/dL during TI use
Serious or unexpected pulmonary-related adverse events
- No serious or unexpected pulmonary-related adverse events
Change in mean % predicted FEV1 from start of TI to 4 weeks after discontinuation
- Change, both groups' TI exposure combined
- −0.5 (95% CI −1.9-0.9, P = 0.52)
Original publication
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