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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
Date:6/9/2008

a incidence was lower in SYMLIN-treated patients (55 percent) compared to RAI-treated patients (82 percent) and no severe hypoglycemia was experienced in either group.

At week 24, similar improvements in glucose control were achieved in the SYMLIN- and RAI-treated groups. SYMLIN-treated patients achieved an A1C reduction of 0.9 percent from baseline compared with a 1.1 percent reduction for RAI. Fasting glucose was also similar between groups. RAI treatment was associated with increased body weight (+9.3 pounds) while SYMLIN treatment was not associated with weight gain (-0.5 pound, P<0.001). The most common side effect associated with SYMLIN in the study was nausea (21 percent vs. 0 percent with RAI), which was primarily mild or moderate nausea and decreased with time.

Study Details

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

In a second phase of the study designed to further understand the complementary effects of RAI and SYMLIN, patients not achieving a target A1C of 6.5 percent or less began using both SYMLIN and RAI at mealtime. Results from this phase of the study will be presented in a future scientific forum.

About SYMLIN

Taken at mealtime, SYMLIN is the first and only a
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SOURCE Amylin Pharmaceuticals, Inc.
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