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Amylin Pharmaceuticals: Insulin
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Researchers at Amylin Pharmaceuticals reported on the progress of clinical trials of a synthetic exendin-4, likely to be the first of this new class of drugs to reach the marketplace for type 2 diabetes. It works by multiple mechanisms of action -- stimulation of insulin secretion, slowing gastric emptying, and inhibiting production of glucose by the liver -- in contrast to most oral drugs that work by only one mechanism. Further, it seems to suppress appetite and promote weight loss.
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Amylin functions as part of the endocrine pancreas and contributes to glycemic control. Amylin's metabolic function is now somewhat well characterized as an inhibitor of the appearance of nutrient [especially glucose] in the plasma. It ... functions as a synergistic partner to insulin, with which it is cosecreted from pancreatic beta cells in response to meals. The overall effect to slow the rate of appearance (Ra) from the meal is mediated via a coordinate reduction of food intake, slowing of gastric emptying, inhibition of digestive secretion [gastric acid, pancreatic enzymes, and bile ejection]. Appearance of new glucose is slowed by inhibiting secretion of the gluconeogenic hormone glucagon. These actions, which are mostly mediated via a glucose-sensitive part of the brain stem, the area postrema, may be over-ridden during hypoglycemia.
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Amylin's work in helping diabetes patients centered on a namesake peptide named amylin, discovered by researchers at Oxford University in 1987, the year of Amylin's formation. Researchers at Oxford discover that amylin was made in and secreted from the same cells--beta cells--that make and secrete insulin. In someone not afflicted with diabetes, amylin complements the actions of insulin, with the two hormones working together with another pancreatic hormone, glucagon, to maintain normal glucose concentrations. In normal physiology, insulin and amylin concentrations increase after food is ingested. Glucagon levels, in contrast, decrease after food is ingested. In diabetic patients, the complementary functions of the three pancreatic hormones are thrown out of balance.
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Amylin ... announced today that the FDA has issued a "Not Approvable" letter for SYMLIN use with basal insulin (without mealtime insulin) in patients with type 2 diabetes who have not achieved desired glucose control. SYMLIN is currently approved in the U.S. for patients with type 2 or type 1 diabetes who use mealtime insulin and need improved glucose control.
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"SymlinPen 120 and SymlinPen 60 offer patients improved convenience and accuracy," said Daniel M. Bradbury, President and CEO, Amylin Pharmaceuticals. "For people with diabetes using mealtime insulin, the addition of SYMLIN can enhance glucose control with the potential for weight loss."
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Diabetes is a complex metabolic disease manifesting with a defect in the beta cells in the pancreas, resulting in a deficiency of both insulin and amylin secretion. Poor control of blood sugar may result in severe long-term complications such as kidney failure, nerve damage, blindness, amputation and cardiovascular disease.
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