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June 24, 2024

Mannkind: Study proves inhaled insulin effective for adults with Type-1 diabetes

Contributed Afrezza, produced by Danbury-based Mannkind, is a rapid-acting insulin that can be inhaled.
By David Krechevsky

MannKind Corp., a biopharmaceutical company based in Danbury, on Saturday announced positive results from a study that showed inhaling insulin is as effective as injecting it for treating adults with Type 1 diabetes.

The 17-week Inhale-3 study was a Phase 4 U.S. clinical trial evaluating the results of using Mannkind’s drug Afrezza, which is inhaled, vs. usual care, which can include multiple daily injections or an insulin pump.

Type 1 diabetes affects 11.6% of the U.S. population and millions more worldwide, requiring ongoing insulin therapy to manage blood glucose levels. 

The study was presented last week by the Inhale-3 investigation team at the American Diabetes Association’s (ADA) 84th Scientific Sessions in Orlando, Florida.

It was conducted over 17 weeks at 19 centers in the U.S., and included 123 adults with type 1 diabetes divided into two groups: one receiving Afrezza 
plus basal insulin, and the other continuing their usual care, which included automated insulin delivery systems in about half or multiple daily injections.

The study's primary goal was to produce a change in HbA1c levels, a critical marker of long-term blood glucose control. Secondary goals included changes in time-in-range (referring to the number of hours a patient’s blood sugar levels remain in the target range) and changes in hypoglycemia measured with continuous glucose monitoring.

Key study findings included:
More subjects using inhaled insulin achieved glycemic targets, with 30% of the inhaled insulin group reaching less than 7% HbA1c at 17 weeks vs. 17% of the usual care group.
21% of the inhaled insulin group vs. 0% of the usual care group met A1c goal of less than 7% if baseline was greater than 7%.
24% of the Afrezza group and 13% of the usual care group achieved time-in-range above 70%, with no increased hypoglycemia in the inhaled insulin group.

The study also found no difference in continuous glucose monitoring-measured hypoglycemia between the groups.

Mannkind did note that while more people met the A1c target with Afrezza, some patients worsened when switching from usual care to inhaled insulin. The company said that is potentially due to patients missing doses of inhaled insulin during the day and/or underdosing before bedtime.

“The Inhale-3 study delivered data that supports inhaled insulin being an important treatment option for adults living with diabetes,” said Dr. Irl Hirsch, professor of medicine and diabetes treatment and teaching chair at the University of Washington and the Inale-3 study protocol chair.

MannKind Corp. says it focuses on developing and commercializing inhaled therapeutic products and devices to address serious unmet medical needs for those with endocrine and orphan lung diseases.

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