Novo Nordisk and Aradigm Corporation announced the initiation of the Phase 3 clinical programme for NN1998 - the AERx insulin Diabetes Management System (iDMS). The first Phase 3 study, in people with type 1 diabetes, is designed to show that the long-term safety and efficacy profile of inhaled human insulin is comparable to that of subcutaneous injections.
"We are pleased that the Phase 3 studies are now underway to help us make this innovative treatment available to the patients," said Mads Krogsgaard Thomsen, executive vice president and chief science officer, Novo Nordisk.
This 24-month study is a multi-centre, open-label study with patients receiving either inhaled insulin via the AERx system or subcutaneous injections of NovoRapid (NovoLog in the US) three times daily before meals. Additionally, both groups are receiving basal insulin once or twice daily.
"With this important milestone for Aradigm, we are one step closer to bringing a significant alternative to insulin injections to patients with diabetes," said Richard Thompson, president and chief executive officer of Aradigm. "Encouraging data from our earlier studies have enabled us to design a robust Phase 3 clinical programme."
In addition to investigating long-term pulmonary safety, the study will also study the incidence of hypoglycaemic events, insulin antibody formation, glycaemic control (blood glucose profiles) and overall treatment satisfaction.
In recent meetings with regulatory authorities a plan to demonstrate safety and efficacy in people with both type 1 and type 2 diabetes was agreed. Since type 1 patients are more sensitive to minor health and life events such as illness, changes in exercise regimen, or travel, significant attention is paid to meeting the greater requirements of these people.