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Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients
Date:6/6/2009

Latest data on ultra rapid acting insulin presented at the American Diabetes Association's 69th Scientific Sessions

NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- The findings of two 52-week studies show that the investigational ultra rapid acting insulin AFRESA(R) (insulin human [rDNA origin]) Inhalation Powder combined with basal insulin is comparable to standard of care therapies in controlling post-meal blood sugar levels, and also results in significantly less weight gain and risk of hypoglycemia for adult patients with diabetes. The data were presented today at the American Diabetes Association's 69th Scientific Sessions.

"The unique pharmacokinetic profile of AFRESA allows this product to rapidly achieve peak insulin levels," said John Gerich, M.D., Program Director, Clinical Research Center, Department of Medicine, University of Rochester School of Medicine and Dentistry. "These results indicate that AFRESA may be a promising new therapy for patients with type 1 and type 2 diabetes, as it controls post meal-time glucose levels with the added benefits of less weight gain and lower risk of hypoglycemia."

AFRESA is a novel, ultra rapid acting mealtime insulin therapy with an action profile that mimics meal-related early insulin release. Based on an extensive phase 3 clinical program, a New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) requesting approval to market AFRESA Inhalation Powder and the AFRESA Inhaler for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. AFRESA is conveniently administered by oral inhalation.

Type 2 Study Design and Key Findings

Patients with type 2 diabetes who were inadequately controlled (A1C 7.0% and </=11.0%) despite insulin with/ without oral anti-hyperglycemic therapy were randomized to a 52-week course of either AFRESA
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SOURCE MannKind Corporation
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