Amylin Pharmaceuticals, Inc. announced 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. 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.
"This study showed that the addition of Symlin provided benefits in addition to A1C improvement for patients failing to meet glucose targets using individualized regimens of basal insulin," said Orville Kolterman, MD, senior vice president of Clinical and Regulatory Affairs. "Achieving improved glucose control without weight gain represents an unmet need in the management of patients with diabetes requiring insulin therapy."
The study was designed to demonstrate improvement in pre-defined diabetes treatment goals including achieving a target A1C improvement, limiting post- meal glucose increases, and experiencing no weight gain or episodes of severe hypoglycemia. One in four Symlin patients achieved the composite set of goals while less than one in ten 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.
In this randomized, double-blind study, 211 patients with type 2 diabetes who were not achieving target glucose control using an established basal insulin glargine regimen received either placebo or Symlin with major meals in addition to their insulin glargine for 16 weeks. The basal insulin glargine doses were adjusted at regular intervals based on an established algorithm to target predefined fasting glucose levels. Symlin dose began at 60 micrograms and increased to 120 micrograms as instructed. Patients using common oral diabetes medicines including a sulfonylurea, metformin, or a thiazolidinedione continued with their usual regimen throughout the study. Baseline A1C for the study population was 8.5%, and average body weight was approximately 225 pounds.
Symlin is an antihyperglycemic drug for use in patients with type 1 or type 2 diabetes treated with mealtime insulin. Symlin is a synthetic analog of human amylin, a naturally occurring hormone that is made in the beta cells of the pancreas, the same cells that make insulin. In patients with type 2 diabetes who use insulin, and in patients with type 1 diabetes, those cells in the pancreas are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals. The use of Symlin contributes to glucose control after meals and has been shown to reduce body weight.