Diverse Diabetes Care: Insights From The INHALE-3 Study

The INHALE-3 study, showcased at the American Diabetes Association’s 84th Scientific Sessions in Orlando, Florida, underscores the necessity of personalized diabetes treatment approaches. The study explored the efficacy of technosphere insulin (Afrezza) compared to traditional diabetes management methods.

Study Findings

Approximately 30% of individuals with type 1 diabetes (T1D) who used technosphere insulin alongside basal insulin achieved a hemoglobin A1c (HbA1c) level below 7% after 17 weeks. This contrasts with 17% in the usual care group, which included multiple daily injections (MDIs), automated insulin delivery (AID) systems, or non-automated insulin pumps.

Dr. Irl Hirsch, professor of Medicine and Diabetes Treatment at the University of Washington, highlighted the variability in patient responses: “For patients with HbA1c above 7%, inhaled insulin generally outperformed MDI but not AID. However, the results varied significantly depending on individual patient factors like engagement and phenotype.”

Study Design and Demographics

The randomized control trial involved patients using either degludec plus technosphere insulin with Dexcom G7 or standard care methods (AID, MDI, or non-automated pumps with CGM). The study duration was 17 weeks, including a 4-week dose titration phase. Both groups later utilized technosphere insulin during a 13-week extension phase.

Participants were recruited from 19 sites across the United States, comprising 123 individuals with an average age of 45, 54% of whom were female. The majority (89%) were white and non-Hispanic, with a mean diabetes duration of 23 years. Socioeconomic backgrounds varied, with 42% having less than a bachelor’s degree and 41% earning below $100,000 annually. Most participants (81%) had private insurance, and the average body mass index was 27.9 kg/m².

Efficacy and Safety Outcomes

The technosphere insulin group showed that 21% of participants reached an HbA1c goal of less than 7%, compared to none in the usual care group when starting levels were above 7%. There were no significant differences in CGM-measured hyperglycemia between the groups. The basal-bolus ratio was approximately 70/30 for technosphere insulin, versus 50/50 for the usual care group. Notably, around 50% of participants expressed interest in continuing with technosphere insulin.

However, the study also noted some drawbacks. Carol Levy, an endocrinologist at Mount Sinai, pointed out that while the primary outcome of non-inferiority was met, some patients experienced worsening conditions. Specifically, 26% of the technosphere insulin group had an HbA1c increase of more than 0.5%, compared to just 3% in the usual care group. On the flip side, 21% improved their HbA1c with technosphere insulin, versus 5% in the usual care group.

Adverse events (AEs) were reported by 77% of the technosphere insulin group, including one severe hypoglycemia case. In the usual care group, 64% experienced AEs, including hospitalizations for hyperglycemia/ketosis and an appendectomy. The most common AE for the technosphere insulin group was cough, followed by shortness of breath.