Patients using the Lilly/Alkermes inhaled insulin system achieved blood sugar levels similar to patients treated with injected insulin. In addition, 80% of patients in this study expressed a preference for the inhaled insulin system at mealtime over injected insulin.
Although the results from the trial are positive, it appears likely that the Lilly/Alkermes partnership will be beaten in the race to release the first inhaled insulin formulation, after Pfizer and Sanofi-Aventis’ Exubera treatment for type 1 and 2 diabetes was recommended for final approval by an FDA advisory panel.
Using the standard measure of blood sugar, A1C, patients achieved an average level of 7.9 using the Lilly/Alkermes inhaled insulin system, compared to 8.0 in the injected insulin group. A1C is an average measure of blood sugar (glucose) over a three-month period.
The study was designed to evaluate whether inhaled insulin delivered through the Lilly/Alkermes system and injected insulin showed similar safety and effectiveness at controlling blood sugar based on dosing regimens commonly used in the everyday management of diabetes.
These findings were presented at the 41st annual meeting of the European Association for the Study of Diabetes in Athens, Greece.
Researchers also presented results from a phase I dose response and equivalence study, which showed that the Lilly/Alkermes inhaled insulin system and injected insulin lispro were generally well-tolerated and the overall effect on blood sugar was similar, illustrating that doses could be reliably correlated.
“Our goal is to provide patients with an innovative product that offers a more acceptable treatment option for patients and may enable them to achieve better blood sugar control, a key aspect in managing diabetes,” said Dr Douglas Muchmore, Medical Fellow at Eli Lilly. “These studies, taken together, show that inhaled insulin delivered by the Lilly/Alkermes system is equivalent in various clinical measures to injected insulin.”
Lilly and Alkermes established an alliance in 2001 to develop an inhaled insulin system that delivers human insulin inhalation powder (known as HIIP), based on Alkermes’ AIR pulmonary drug delivery technology.