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Amylin Announces New Analyses Of Clinical Data Of Symlin

6/9/2012 5:20 PM ET

Amylin Pharmaceuticals Inc. (AMLN: Quote) announced results from new analyses of previously completed clinical studies demonstrating that patients with type 2 or type 1 diabetes achieved a greater proportion of blood glucose measurements in the normal range when Symlin (pramlintide acetate) injection treatment was used along with insulin.

The company said that two abstracts highlighting the analyses evaluated the proportion of readings from self-monitored seven-point glucose profiles that fell above, below or within glycemic targets based on guidelines set by the American Diabetes Association or ADA and American Association of Clinical Endocrinologists or AACE.

In the clinical data analysis of 138 patients with type 2 diabetes, the proportion of measurements in the normal range for Symlin-treated patients increased from 37.2 percent at baseline to 54.6 percent at six months according to ADA guidelines, and from 19.7 percent to 28.4 percent according to AACE guidelines.

Symlin-treated patients also experienced a decrease in the proportion of measurements in the hyperglycemic range from 61.3 percent to 41.9 percent (ADA) and from 78.8 percent to 68.1 percent or AACE. During all time periods, the proportion of measurements in the hypoglycemic range (less than 70 mg/dL) was low.

The company said that Similar statistically significant improvements were also seen in analyses of two studies of patients with type 1 diabetes. In the first analysis of 218 patients from an open-label clinical practice study, the percent of measurements in the normal range increased from 44.3 percent at baseline to 52.5 percent or ADA at six months and from 27.7 percent to 32.7 percent or AACE.

In the second analysis of 248 patients from a 29-week, placebo-controlled study, measurements in the normal range based on ADA criteria increased from 37.3 percent to 43.9 percent for Symlin-treated patients (n=115), compared to an increase from 38.2 percent to 40.9 percent in those receiving placebo (n=133).

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by RTT Staff Writer

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