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Title: Successful Addition of Pramlintide to Intensive Insulin Regimen Possible in Type 1 Diabetics: Presented at ADA

"Successful Addition of Pramlintide to Intensive Insulin Regimen Possible in Type 1 Diabetics: Presented at ADA"

By Jill Stein NEW ORLEANS, LA -- June 16, 2003 -- Pramlintide can be successfully added to an intensified insulin regimen using dose titration, resulting in manageable side effects and less need for short-acting insulin, investigators said here on June 15th at the 63rd Scientific Sessions of the American Diabetes Association. Their findings also showed that this approach maintains the glycemic and weight benefits seen in previous studies. Dr. Orville Kolterman, from Amylin Pharmaceuticals, in San Diego, California, United States presented interim 16-week data from a triple-blind, 29-week study that determined whether pramlintide dose titration at 15, 30, 45, and 60 mcg, with a temporary decrease in short-acting preprandial insulin, helps prevent transient nausea and the increased risk of severe hypoglycemia previously seen in type 1 diabetes patients. The study included 295 type 1 diabetics who underwent intensive insulin therapy by multiple daily injections or insulin pump therapy for more than 6 months of screening. Subjects were randomized to pramlintide or placebo maintenance therapy at 30mcg or 60 mcg, with insulin doses intensively adjusted to optimize glycemic control. Upon completion of 29 weeks of therapy, about 80% of pramlintide-treated subjects were at the 60-mcg dose and about 20% were at the 30-mcg dose. In addition, pramlintide-treated subjects had a greater reduction in short-acting preprandial insulin use and a smaller increase in basal insulin use compared to placebo. A pramlintide-associated decrease in postprandial glucose concentrations was observed during formal standardized meal tests as well as during self-monitored glucose measurements. This effect was sustained throughout 29 weeks of pramlintide therapy. A similar decrease in mean hemoglobin A1c from baseline was achieved by pramlintide- and placebo-treated subjects after 29 weeks of therapy. In addition, pramlintide-treated patients showed a significant and persistent decrease in mean body weight throughout the duration of the trial. A higher incidence of nausea was observed among pramlintide patients compared to placebo. As expected, the incidence of nausea decreased at each subsequent pramlintide dose level (from 35.1% at 15 mcg to 8.2% at 60 mcg). The higher incidence of nausea in the pramlintide-treated group was primarily due to high incidence among patients treated with the 30-mcg dose (44.7%). The 60-mcg group had a slightly higher incidence of nausea (19.8%) compared to placebo (14.7%). Most nausea was mild or moderately severe. Among pramlintide-treated subjects, 1.4% withdrew because of nausea compared to 0.7% in the placebo-treated group. The severe hypoglycemia event rate per subject year was lower in the present study during the pramlintide initiation and insulin dose optimization periods compared to previous long-term clinical trials. The severe hypoglycemia event rate seen in treated patients was comparable to that observed in the intensive-insulin group of the Diabetes Control and Complications Trial (DCCT). "Our results show that in type 1 diabetics treated with intensive insulin therapy and approaching glycemic targets, pramlintide can be successfully added to the insulin regimen, by pramlintide dose titration in conjunction with a reduction in short-acting insulin," Dr. Kolterman said. The study was sponsored by Amylin Pharmaceuticals.

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