The study is a randomized, crossover study evaluating formulations of insulin nasal spray as compared to NovoLog insulin aspart, an approved, rapid-acting injectable insulin, on post-meal glycemic control.
Data from Nastech’s earlier Phase I pharmacokinetic and safety studies demonstrated that the insulin nasal spray achieved faster time to maximum plasma levels than NovoLog injection and Exubera (insulin human [rDNA origin]) inhalation powder in healthy subjects. Additionally, the intranasal formulations tested were well-tolerated and did not show any clinically significant hypoglycemia.
The Phase II study design will evaluate different doses of Nastech’s insulin nasal spray compared to NovoLog and a placebo. Over the course of the study, patients will receive different doses of insulin nasal spray or NovoLog prior to a standardized meal. Following the meal, glucose levels will be measured at specific time points with the objective of achieving glycemic control without hypoglycemia. Screening of patients is being conducted and dosing is scheduled to begin in October.
Steven Quay, chairman, president and CEO of Nastech, said: “Nastech’s insulin nasal spray has the potential to offer a unique product profile for diabetic patients and their physicians compared to existing marketed products due to its rapid onset of action and patient friendly, non-invasive dosage form that we believe avoids the potential safety concerns of pulmonary delivery. The initiation of the Phase II trial is a significant step forward in the clinical program and the results, if positive, could be a catalyst towards partnering the product with a major pharmaceutical company.”