MannKind Corporation has announced on Saturday at the 42nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Copenhagen, the results from its phase 3 clinical study of inhaled insulin in patients with type 2 diabetes. This study was designed to evaluate whether the MannKind Technosphere Insulin system showed similar safety and efficacy compared to patients treated with insulin aspart NovoLog, an injected rapid-acting insulin analog (RAA).
"This study demonstrated that patients with type 2 diabetes using Technosphere Insulin achieved comparable improvements in glycemic control (HbA1c) to patients treated with an injected RAA. In addition, we observed no adverse effect on pulmonary function in either treatment group. However, unlike the injected RAA group, Technosphere Insulin patients lost weight during the treatment period," said Dr Peter Richardson, Chief Scientific Officer of MannKind.
Alfred Mann, Chairman of the Board and CEO of MannKind, commented, "The results of this first phase 3 efficacy study show that Technosphere Insulin can be differentiated from other inhaled insulin systems. With the recent completion of enrolment of the major phase 3 safety study, all of our pivotal phase 3 trials are now well underway, suggesting that Technosphere Insulin could be the next pulmonary insulin product to reach the market."
The study included 308 patients with Type 2 diabetes who where randomized to the mealtime use of either Technosphere Insulin (n=150) or injected RAA, (n=158), plus insulin glargine as basal insulin.
After a transfer period, patients were followed for 24 weeks during which individual adjustments of therapy were made. Glycemic control in both treatment groups was assessed by periodic determinations of HbA1c levels, which measure the average blood glucose levels during the preceding three to four months. Pulmonary function was assessed by serial measurements of forced expiratory volume (FEV1) and forced vital capacity (FVC). FEV1 is the volume of air that can be forced out in one second after taking a deep breath, and FVC is a measure of pulmonary capacity.
After the treatment period, patients reverted to conventional therapy and pulmonary function was followed for an additional 24 weeks.