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Amylin: Symlin improved diabetes control in type 2 patients
By E. Janene Geiss
Philadelphia, Sept. 7 - Amylin Pharmaceuticals, Inc. announced Thursday positive results from a 16-week study evaluating the safety and efficacy of adding Symlin (pramlintide acetate) to an established regimen of basal insulin glargine (with or without oral antidiabetic agents) in patients with type 2 diabetes who have not progressed to mealtime insulin therapy.
At study end, patients receiving Symlin on average had better overall glucose control (A1C), reduced glucose fluctuations, used less insulin and experienced weight loss, compared to those using basal insulin glargine without Symlin, the San Diego pharmaceutical company said in news release.
Results from this study will form the basis of a supplemental New Drug Application submission to the Food and Drug Administration, currently planned for late 2006.
One in four patients achieved the composite set of goals of glucose control, no weight gain and less insulin use while less than one in 10 patients on basal insulin without Symlin achieved the target results.
Overall rates of hypoglycemia were similar between groups and Symlin patients reported mild nausea, consistent with previous study observations.
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