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Use of Mealtime SYMLIN(R) Compared to Rapid-Acting Insulin for Diabetes Therapy Intensification in Patients With Type 2 Diabetes Using Basal Insulin

Tuesday, June 10, 2008 General News J E 4
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SAN FRANCISCO, June 9 Amylin Pharmaceuticals,Inc. (Nasdaq: AMLN) today announced data showing that the use of mealtimeSYMLIN(R) (pramlintide acetate) injection with basal insulin therapy for24 weeks resulted in more patients achieving diabetes treatment goals ofimproved glucose control without weight gain or hypoglycemia compared to theuse of rapid-acting insulin (RAI) with basal insulin in patients with type 2diabetes. The results were detailed in an oral presentation at the AmericanDiabetes Association's (ADA) 68th Annual Scientific Sessions in San Francisco.

"These findings are promising because they suggest that treating adeficiency of the hormone amylin in type 2 diabetes can have a beneficialeffect on glucose control even when mealtime insulin is not used," saidMatthew Riddle, M.D., Professor of Medicine and Head of the Section ofDiabetes, Division of Endocrinology at Oregon Health Sciences University andclinical trial investigator. "The effect of SYMLIN was similar to that ofmealtime rapid-acting insulin when either was added to basal insulin treatmentin this study, with SYMLIN use resulting in no weight gain and lesshypoglycemia."

The study was designed to demonstrate improvement in pre-definedcomprehensive diabetes treatment goals that included achieving a target A1Cand experiencing no weight gain or episodes of severe hypoglycemia. Amongthose treated with mealtime SYMLIN, 1 in 3 achieved this composite set ofgoals while only 1 in 10 patients treated with RAI achieved the same results(30 percent vs. 11 percent; P<0.05). Mild or moderate hypoglycemia incidencewas lower in SYMLIN-treated patients (55 percent) compared to RAI-treatedpatients (82 percent) and no severe hypoglycemia was experienced in eithergroup.

At week 24, similar improvements in glucose control were achieved in theSYMLIN- and RAI-treated groups. SYMLIN-treated patients achieved an A1Creduction of 0.9 percent from baseline compared with a 1.1 percent reductionfor RAI. Fasting glucose was also similar between groups. RAI treatment wasassociated with increased body weight (+9.3 pounds) while SYMLIN treatment wasnot associated with weight gain (-0.5 pound, P<0.001). The most common sideeffect associated with SYMLIN in the study was nausea (21 percent vs. 0percent with RAI), which was primarily mild or moderate nausea and decreasedwith time.

Study Details

This 24-week multi-center, randomized, open-label study, called INSTEAD(INitiating Symlin Therapy: Evaluating Alternatives in Diabetes), compared thesafety and efficacy of the addition of mealtime SYMLIN or RAI to basal insulintherapy for 24 weeks in 112 patients with type 2 diabetes. Basal insulindosage was titrated throughout the study seeking a target fasting glucose of70 to <100 mg/dL. Patients were randomized to receive either mealtime SYMLINat a fixed dose of 120 micrograms at major meals or RAI titrated to achievepre-meal blood glucose of >70 to <100 mg/dL. Patients who entered the studytaking oral diabetes medicines continued with their usual regimen throughoutthe study. Average baseline A1C for the study population was 8.2 percent andbody weight was approximately 233 pounds.

In a second phase of the study designed to further understand thecomplementary effects of RAI and SYMLIN, patients not achieving a target A1Cof 6.5 percent or less began using both SYMLIN and RAI at mealtime. Resultsfrom this phase of the study will be presented in a future scientific forum.

About SYMLIN

Taken at mealtime, SYMLIN is the first and only amylin mimetic for use inpatients with diabetes treated with mealtime insulin. SYMLIN is a syntheticanalog of human amylin, a naturally occurring hormone that is made in the betacells of the pancreas, the same cells that make insulin. In patients with type2 diabetes who use insulin, and in patients with type 1 diabetes, those cellsin the pancreas are e
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