Clinical data presented by Novo Nordisk and its partner, Aradigm Corporation, demonstrate that inhaled insulin administered via the electronic inhaled insulin system, AERx insulin Diabetes Management System (iDMS), achieves a level of glycemic control in people with type 2 diabetes comparable to the current gold standard, multiple injection therapy.
The data were presented at the American Diabetes Association's 62nd Annual Scientific Sessions.An intensified insulin injection regimen has repeatedly been shown to bring people with diabetes under tight glucose control. However, multiple insulin injections have also been shown to be inconvenient and a burden to many patients.
These new data now show that mealtime insulin can be delivered via the first electronic inhalation insulin system, without the need for a needle and without the need to compromise on glycemic control. AERx iDMS allows a high level of dose precision and the ability for the user to select the dose. It also delivers immediate information to the user about the previous delivered dose.
"It is a promising development for the 17 million people in the US and over 150 million people worldwide ' who have diabetes, to know that glycemic control may not be reliant on insulin injections. Inhaled insulin administered electronically through the sophisticated AERx iDMS should provide a viable alternative for patients to manage their disease," stated lead investigator, Dr Kjeld Hermansen, University Hospital, Aarhus, Denmark.
The multi-center, multinational, open-label randomized 12 week trial included 107 non-smoking people with type 2 diabetes with an average baseline HbA1c of about 8.5%. Participants were randomized to either Group 1, who received three insulin inhalations via the AERx iDMS, or to Group 2, who received three injections of human soluble insulin subcutaneously (s.c.). Both groups were given a nighttime dose of NPH (basal insulin).
The results of the study showed a comparable mean decrease in HbA1c of 0.74% in both groups. There were no major safety issues seen in the trial.
Jan Fallsvik from Sweden has diabetes and participated in the trial, "When I first started using the AERx system, it wasn't very difficult to learn to use it and I liked the way I could easily adjust the amount of insulin I had to take."
The idea of an inhaled insulin delivery system is not new; researchers have been striving to develop it ever since the introduction of insulin therapy in the 1920s. But as good as such a system is in theory, translating it to a product that can perform as well as injections has proved to be very difficult.
The unique AERx iDMS system addresses the key requirements for inhaled insulin, making it a valuable alternative to subcutaneous insulin. The system uses a liquid insulin formulation that allows optimal particle sizing and a unique electronic 'Breath Check' system that guides users to the correct breathing technique in order to ensure deep lung delivery of the insulin dose with every inhalation. These features will help users monitor their insulin dose. The system also features the ability to adjust the insulin dose in one AERx unit increments and a data downloading system that allows users to review dosing data and breathing technique.
"We are delighted by the results of the Clinical Proof of Concept trial. They confirm our expectations for the AERx iDMS system and mean that we can now finalize our preparations for the Phase III trials in order to make our delivery system available to patients as quickly as possible," said Mads Krogsgaard Thomsen, executive vice president and chief science officer, Novo Nordisk.