The goal of the study is to more fully define the safety and efficacy of the AIR insulin system in patients with type 1 diabetes. This study is part of a comprehensive phase III clinical program that began in July 2005, which includes pivotal efficacy studies and additional long-term safety studies in both type 1 and type 2 diabetes patients.
The phase III open-label, randomized study is designed to evaluate the safety and efficacy of the AIR insulin system compared to injected pre-meal insulin in nearly 400 non-smoking patients with type 1 diabetes.
Patients are being treated for 24 months with a two-month follow-up period. Pulmonary safety tests are used to assess safety. The trial will also evaluate the non-inferiority of AIR insulin to injected insulin lispro with respect to A1C levels – the average measure of blood glucose over a three-month period.
“We are pleased to have completed enrollment in this phase III study, which is a key step in our progress toward the new drug application filing for the AIR insulin system,” said Elliot Ehrich, chief medical officer of Alkermes. “We and Lilly are highly encouraged by the clinical data compiled from our AIR insulin system studies conducted to date and are committed to conducting the studies needed to further establish the safety and efficacy of inhaled insulin.”
The two companies recently initiated another study required as part of the phase III pivotal trial program. This phase III open-label, noninferiority study is designed to evaluate whether the AIR insulin system is at least as effective in improving glucose control as injected pre-meal insulin over six months.
Approximately 400 insulin-naive patients with type 2 diabetes who are taking at least one oral antidiabetic medication will be randomized to one of the two treatment groups. The efficacy of the AIR insulin system will be assessed at six months, and the safety will be evaluated at 12 and 24 months.