TOPLINE:

Inhaled Technosphere insulin was found to be safe for youth with type 1 diabetes (T1D), offering greater satisfaction and less weight gain than rapid-acting analog insulin. However, compared with rapid-acting analog insulin, inhaled Technosphere insulin did not meet the noninferiority criteria for A1c in the intent-to-treat analysis.

METHODOLOGY:

• Achieving optimal glycemic control in youth with diabetes is challenging; a pharmacokinetics study on the use of Technosphere insulin in children found no safety issues and a similar action profile to that in adults; however, there has been no trial of it in a pediatric population.
• Researchers conducted a randomized controlled trial across 38 endocrinology practices in the US involving 230 youth aged 4-17 years (38% women; 77% White individuals; mean A1c level at randomization, 8.2%) with T1D (n = 225) or type 2 diabetes (n = 5), all treated with multiple daily insulin injections for at least 2 weeks.
• Participants were randomly assigned to receive either inhaled Technosphere insulin (n = 117) or rapid-acting analog insulin (n = 113), with both groups continuing basal insulin and undergoing continuous glucose monitoring.
• Technosphere insulin was administered via inhaler for meals and correction dosing, with initial doses based on doubling the rapid-acting analog insulin dose and adjusted according to glucose response to the meal. The rapid-acting analog group continued using insulin aspart, lispro, or glulisine, with dosing adjustments based on premeal glucose levels over a 3-day period.
• The primary outcome was the change in A1c levels from baseline to 26 weeks, tested for noninferiority between the two groups with a margin of 0.4%. Other outcomes included treatment satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire change version, pulmonary function assessed based on the forced expiratory volume in 1 second, and adverse events.

TAKEAWAY:

• In the intent-to-treat analysis, the adjusted difference in mean A1c levels between the Technosphere insulin and rapid-acting analog groups at 26 weeks was 0.18% (95% CI, -0.07 to 0.43; P for noninferiority = .091), not meeting the noninferiority criteria.
• Continuous glucose monitoring-measured time in range (70-180 mg/dL) showed no significant difference between groups; however, participants using Technosphere insulin reported greater treatment satisfaction than those receiving the rapid-acting analog (P = .004).
• Participants in the Technosphere insulin group experienced less weight gain at 26 weeks than those in the rapid-acting analog insulin group (P = .009).
• Severe hypoglycemia occurred in two participants in the Technosphere insulin group and one participant in the rapid-acting analog group, and diabetic ketoacidosis was reported in one participant in the rapid-acting analog group. Cough associated with Technosphere insulin use was usually mild and transient and led to five discontinuations.

IN PRACTICE:

“Although the primary intent-to-treat analysis did not meet the prespecified criteria for [A1c] noninferiority, the safety results plus the findings of greater treatment satisfaction and less weight gain support TI [Technosphere insulin] being a treatment option for some pediatric patients with type 1 diabetes, particularly for youth who choose not to or are unable to use an AID [automated insulin delivery] system,” the authors wrote.

SOURCE:

This study was led by Michael J. Haller, University of Florida, Gainesville, Florida. It was published online in Diabetes Care.

LIMITATIONS:

The number of participants with T2D was small. Reliance on self-reported adherence to insulin dosing in the Technosphere insulin group may not have accurately reflected the actual adherence. The 26-week duration limited the assessment of long-term efficacy and safety. This study only included users of multiple daily injections, not accounting for those using automated insulin delivery systems.

DISCLOSURES:

This study was funded by MannKind, which was involved in protocol development, study oversight, and manuscript review, providing comments. Some authors disclosed receiving consultancy fees, research support, advisory board fees, honoraria, and study supplies from various pharmaceutical and medical device companies including MannKind. One of the authors reported serving as a scientific advisory board member for MannKind, and another reported serving as a principal investigator in MannKind-funded research.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.