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Inhaled Insulin Benefits Kids With Diabetes, Too
TOPLINE:
Mannkind Corporation expects to submit a request for a supplemental new drug application meeting to the US Food and Drug Administration for its inhaled human insulin (Afrezza Inhalation Powder). Currently indicated to improve glycemic control in adults with diabetes, the company announced 6-month results from its Phase 3 INHALE-1 study of inhaled human insulin in children and adolescents aged 4-17.
METHODOLOGY:
- INHALE-1 is a 26-week, open-label clinical trial that randomized 230 subjects aged 4-17 years with type 1 or type 2 diabetes to either inhaled pre-meal insulin or multiple daily injections (MDI) of rapid-acting insulin analog, both in combination with basal insulin.
- The primary endpoint was a noninferior change in A1c levels compared with MDI after 26 weeks.
- A 26-week extension phase in which all remaining MDI patients were switched to inhaled insulin is ongoing.
TAKEAWAY:
- In the full intent-to-treat (ITT) population analysis, the between-group difference in mean A1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), but this was largely driven by the variability of a single patient who didn’t adhere to the study protocol.
- A modified ITT analysis excluding that person did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing noninferiority of inhaled insulin with MDI.
- Over 26 weeks of treatment, there were no differences in lung function parameters between the treatment groups, with mean forced expiratory volume at 1 second (FEV1) at baseline vs 26 weeks of 2.901 liters (99.6% of predicted) vs 2.934L (96.6%) in the inhaled insulin group and 2.948L (102.3%) vs 2.957 (98%), respectively, in the MDI group.
- There were no differences between groups or concerns in other safety measures, including hypoglycemia.
IN PRACTICE:
“It was exciting to partner with MannKind and help lead this study to potentially expand the use of inhaled insulin, which is currently used successfully by many adults with diabetes, to a population that hasn’t had a treatment option other than injectable insulin in the history of their care,” said INHALE-1 investigator Roy W. Beck, MD, PhD, founder of the Jaeb Center for Health Research, Tampa, Florida.“The 6-month results are clinically meaningful and show Afrezza as a potential future treatment option for a growing pediatric population living with type 1 and type 2 diabetes,” Beck added.
SOURCE:
The results of the study were announced at a Mannkind press release on December 16, 2024.
SAFETY INFORMATION:
- Inhaled insulin is not recommended for the treatment of diabetic ketoacidosis or in patients who smoke or have recently stopped smoking.
- Warning: Risk for acute bronchospasm in patients with chronic lung disease
- Acute bronchospasm has been observed in Afrezza-treated patients with asthma and chronic obstructive pulmonary disease (COPD)
- Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD
- Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients
- Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.
DISCLOSURES:
This study was funded by MannKind Corporation.
