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Use of Mealtime Pramlintide Added to Basal Insulin Showed Similar Improvements in Glycemic Control Compared to Rapid-Acting Insulin, With Lower Risk of Hypoglycemia and Without Weight Gain: Data Presented at ADA 2009
Date:6/7/2009

Additional Analyses Showed Pramlintide Improved Treatment Satisfaction and Quality of Life

NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced data showing that the use of mealtime SYMLIN(R) (pramlintide acetate) injection improved glucose control, treatment satisfaction and quality of life for patients with type 2 diabetes. These findings were detailed in oral and poster presentations at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans.

This 36-week, randomized, open-label study was designed to compare the efficacy and safety of mealtime pramlintide, rapid-acting insulin or both agents in patients with type 2 diabetes using basal insulin therapy. The multicenter study included 112 patients with type 2 diabetes with an average age of 54 years, baseline A1C of 8.2 percent, fasting plasma glucose of 160 mg/dL and body mass index (BMI) of 36 kg/m2.

Phase 1 of the study (24 weeks) compared mealtime SYMLIN 120 micrograms three times daily with mealtime rapid-acting insulin, when either agent was added to basal insulin. At the end of Phase 1 (week 24), 30 percent of patients treated with SYMLIN achieved the composite primary endpoint (A1C =7.0 percent, no weight gain and no severe hypoglycemia), compared with 11 percent of rapid-acting insulin patients. An A1C of 7 percent or less is the ADA goal for glycemic control for diabetic patients. SYMLIN recipients had a lower incidence of hypoglycemia (55 percent vs. 82 percent). Use of SYMLIN or rapid-acting insulin resulted in similar A1C reductions (-1.1 percent vs. -1.3 percent) and fasting plasma glucose concentrations (122 vs. 123 mg/dL) at week 24; however, significant weight gain from baseline was only seen with rapid-acting insulin treatment (+4.7 kg, P<0.001 vs. bas
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SOURCE Amylin Pharmaceuticals, Inc.
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