Inhaled insulin in Phase III trials

Published: 18-Sep-2002
Regulatory


Inhaled insulin administered via the AERx insulin Diabetes Management System (iDMS) has been shown to achieve the same level of glycaemic control in people with Type 2 diabetes as intensive multiple injection therapy. The new clinical proof of concept trial utilised the AERx iDMS, developed by Novo Nordisk and Aradigm Corporation, and has shown that inhaled mealtime insulin is safely and efficiently delivered via the electronic inhaled-insulin-system, without the need for a needle. As a result the product will now move on to Phase III trials

The study was a multi-centre, multinational, open-label randomised 12 week trial enrolling 107 non-smoking people with Type 2 diabetes with an average HbA1c of 8.5%. Participants were randomised 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 (sc). Both groups were given a night-time dose of NPH (basal insulin).

The results of the study showed a comparable and significant decrease in HbA1c in both groups. Participants receiving inhaled insulin via AERx iDMS reported 151 hypoglycaemic events versus 211 in the sc group.1

The AERx iDMS system allows for precise and reproducible dosing of inhaled insulin, through aerosolised liquid insulin delivered in single-unit increments and an electronic 'Breath Check' system that ensures deep-lung delivery of the insulin with every dose.

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