Phase 2 Clinical Trial Begins for Insulin Nasal Spray to Treat Diabetes

Rapid-Acting, Non-Invasive Nasal Spray Dosage form is Patient Friendly and Avoids Potential Safety Concerns of Pulmonary Delivery. Nastech Pharmaceutical Company Inc announced the start of  a Phase 2 clinical trial evaluating the Company’s rapid-acting Insulin Nasal Spray in approximately 20 patients with type 2 diabetes. The study is a randomized, crossover study evaluating formulations of Insulin Nasal Spray as compared to NovoLog(R) insulin aspart (rDNA origin), an approved, rapid-acting injectable insulin, on post-meal glycemic control.

Data from Nastech’s earlier Phase 1 pharmacokinetic and safety studies demonstrated that the Company’s Insulin Nasal Spray achieved faster time to maximum plasma levels than NovoLog injection and Exubera(R) (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 2 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.

"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," stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech.

Additional information about Nastech is available at https://www.nastech.com.

================================

FACT:
New Diabetes Breath Test Monitors Glucose Levels : Scientists say it may be possible to use a breath test to monitor blood sugar levels in people with diabetes. US researchers have discovered people with type 1 diabetes exhale higher levels of methyl nitrates when their blood sugar levels are too high. The team from the University of Irvine in California hope their work could replace the need for regular blood tests. This study shows the possibility of non-invasive methods that can help the millions who have this chronic disease  The researchers used a chemical analysis technique developed to test for air pollution. Methyl nitrate concentrations were as much as 10 times higher in children with type 1 diabetes when they were in a hyperglycemic state, than when their blood sugar levels were normal. "More research will be needed to prove that breath-analysis testing can be an effective way of monitoring blood glucose (sugar) levels for people with diabetes."