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| |  ADA: Starlix (Nateglinide) Enhances Early Insulin Release And Controls Mealtime Blood Glucose SAN ANTONIO, TX -- June 12, 2000-- Starlix® (nateglinide), an investigational agent for the treatment of type 2 diabetes, enhanced early insulin release and appeared to mimic the body's normal insulin response to mealtime increases in blood glucose, according to data presented today during the American Diabetes Association's 60th Annual Scientific Sessions in San Antonio. This enhancement of early insulin release provided mealtime glucose control while reducing total insulin exposure. "Reducing mealtime glucose spikes contributes to overall glycemic control. Such control has been linked to the reduction of long-term complications, such as blindness, kidney disease and nerve disease," said Priscilla A. Hollander, MD, PhD, medical director of the Ruth Collins Diabetes Center at the Baylor University Medical Center in Dallas. "In the study, Starlix appeared to mimic the body's natural response to food by restoring early phase insulin release and reducing the large increases in blood glucose that patients with diabetes experience at mealtime," she said. One eight-week study of 152 patients with type 2 diabetes compared the effects of nateglinide with those of the sulfonylurea, glyburide, on mealtime glucose levels and insulin secretion. In the double-blind, placebo-controlled study, patients were randomized to treatment with nateglinide (120 mg immediately before three meals) or glyburide (10 mg once daily). Nateglinide primarily reduced mealtime glucose levels, while glyburide reduced fasting glucose levels. Nateglinide did not increase fasting insulin, as did glyburide. Because nateglinide specifically increased mealtime insulin, total insulin exposure was half of that seen with glyburide treatment. A second study presented during the Association's 60th Annual Scientific Sessions examined the role of early insulin secretion, by measuring beta-cell function and glucose elimination from the blood after a meal. Patients with type 2 diabetes received single doses of nateglinide (120 mg), glyburide (10 mg) or placebo, in random order. Nateglinide demonstrated different kinetics of insulin secretion compared to glyburide and placebo. In the study, nateglinide increased first phase and stimulated earlier second phase insulin secretion and improved glucose elimination from the blood with a low incidence of hypoglycemia. Starlix is a derivative of the amino-acid phenylalanine that has a chemical and pharmacologic structure distinct from any other oral antidiabetic currently available. Studies indicate that Starlix has a rapid onset/short duration of action on the beta-cell (cell in the pancreas which produces insulin) that primarily acts to restore early phase insulin secretion and control mealtime glucose spikes. Loss of early phase insulin secretion is a fundamental defect in type 2 diabetes, which leads to uncontrolled mealtime In clinical trials, Starlix was well-tolerated. In these studies, a low incidence of mild hypoglycemia was the only treatment-related side effect associated with Starlix. On December 17, 1999, Novartis Pharmaceuticals Corporation submitted a new drug application (NDA) to the U.S. Food & Drug Administration for Starlix. The NDA includes an indication for Starlix monotherapy (60, 120 and 180 mg doses) and in combination with metformin.
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