PHILADELPHIA — When one of Amylin Pharmaceuticals' diabetes drugs is used with mealtime insulin, both Type 1 and Type 2 diabetes patients maintain blood sugar in the normal glucose range on a daily basis, according to two analyses presented at the 72nd Scientific Sessions of the American Diabetes Association.
The analyses, which are based off of previously completed clinical studies, aimed to demonstrate how patients taking Symlin (pramlintide acetate) injection treatment (in conjunction with insulin) achieved a greater proportion of blood-glucose measurements in the normal range. In both analyses, researchers looked at each patient's self-monitored blood-glucose readings before and after breakfast, lunch and dinner, and determined what proportion of those readings fell within the normal range, according to the targets set by American Diabetes Association and the American Association of Clinical Endocrinologists. Normal glucose range was defined as 70-130 mg/dL pre-meal and 70-180 mg/dL post-meal using ADA guidelines, and 70 to less than 110 mg/dL pre-meal and 70 to less than 140 mg/dL post-meal using AACE guidelines.
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% at baseline to 54.6% at six months, according to ADA guidelines, and from 19.7% to 28.4%, according to AACE guidelines. Similar improvements also were 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% at baseline to 52.5% (ADA) at six months and from 27.7% to 32.7% (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% to 43.9% for 115 Symlin-treated patients, compared with an increase from 38.2%to 40.9% in 133 patients receiving placebo.
"These results showed that Symlin, when used with mealtime insulin, helped patients maintain their blood sugar in the normal glucose range on a daily basis," said David Maggs, VP medical research and development at Amylin. "These data provide a 'real-world' analysis into the management of daily glucose levels as many patients, whether they have Type 1 or Type 2 diabetes, struggle to maintain target blood glucose levels despite treatment with mealtime insulin."