Issue 177 Item 13 Aerodose Insulin Inhaler Delivers Predictable Insulin Dose and

The Aerodose insulin inhaler delivers a pharmacologically predictable insulin dose to patients with type 2 diabetes that is indistinguishable whether insulin is delivered via the subcutaneous or inhaled route.

The Aerodose insulin inhaler is designed to deliver aerosolized liquid insulin for the treatment of patients with diabetes. Although several systems of this type are currently in development, a head-to-head comparison of the dose response of inhaled and subcutaneously injected insulin has not previously been reported.

In a recent American study, Dennis Kim, MD, of the Veterans Affairs San Diego Healthcare System, California, and colleagues determined the inhalation-to-subcutaneous injection conversion ratio across three doses in patients with type 2 diabetes.

The study included 24, non-smoking participants ranging in age from 36 to 80 years (21 males). Each patient received 2 of 3 subcutaneously injected doses of insulin (8, 16, or 24 units) and 2 of 3 corresponding inhaled doses of insulin (80, 160, or 240 units) on 4 separate study days.

Glucose infusion rates (GIR) and serum insulin concentrations were monitored for 8 hours after each dose was administered.

A plot of insulin-area under the curve (AUC) versus GIR-AUC revealed overlapping dose responses for inhaled and subcutaneously injected insulin. The data points for both treatments appeared to fit on a common dose response curve, and comparison of the curve slopes showed no significant differences between the two treatments (p=0.62).

"In the dose range studied, the overall glucose lowering effect of increasing doses of insulin is indistinguishable whether insulin is delivered via the subcutaneous or inhaled route," concludes Dr. Kim.

The similar dose response for the 2 treatments was reflected in a consistent relative bioavailability and relative biopotency across the doses tested, indicating a consistent injection-to-inhalation conversion ratio.

In addition, serum insulin levels were found to be higher for inhalation treatments than for subcutaneously injected treatments immediately following dosing, indicating a rapid absorption following inhalation. Time to maximum insulin concentration (Tmax) and time-to-peak metabolic effects (TGIRmax) were shorter for inhaled insulin compared with subcutaneous injections.

"From a therapeutic standpoint, this feature of inhalation treatment should allow for insulin dosing closer to the start of a meal and shorten or possibly eliminate the waiting period between insulin dosing and mealtime," suggests Dr. Kim.

All adverse events occurring during the study were considered to be mild to moderate, and no clinically relevant effects on lung function were noted.
Diabetes Care 2003 Oct;26:10:2842-7.

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FACT: Researchers estimate that if an individual "is diagnosed at age 40 years, men will lose 11.6 life-years…and women will lose 14.3 life-years." Among those born in 2000, if diagnosed with diabetes at the age of 10 years, the researchers project males will live with diabetes for 49.0 years and will lose 18.7 life-years, while females will live with diabetes for 55.5 years and will lose 19.0 life-years. If diagnosed with diabetes at age 40 males will live with diabetes for 28.0 years and lose 11.6 life-years while same age females will live with diabetes for 30.8 years and will lose 14.3 life-years.
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