To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Starlix (Nateglinide) For Type 2 Diabetes URL: http://www.pslgroup.com/dg/1EE36E.htm Doctor's Guide December 27, 2000
EAST HANOVER, NJ -- December 27, 2000 -- Novartis Pharmaceuticals Corporation received marketing approval from the U.S. Food and Drug Administration (FDA) for Starlix® (nateglinide) for the treatment of type 2 diabetes, a disease with serious consequences that is increasing at an alarming rate among Americans. Starlix, a D-phenylalanine (amino-acid) derivative, is the first in a new class of drugs for type 2 diabetes. It is indicated for use as both monotherapy and in combination with metformin, another oral antidiabetic medication, in patients whose blood glucose (sugar) is not controlled by diet and exercise. Type 2 diabetes is a disease in which the body does not produce or properly use a hormone called insulin that is responsible for controlling the level of glucose in the blood. Early insulin secretion by the pancreas is compromised in patients with type 2 diabetes. Starlix works by stimulating rapid, short-acting insulin secretion. By this action, Starlix effectively lowers overall blood sugar levels as measured by HbA1c (average level of glucose in the blood) and blunts increases in blood glucose levels or "mealtime glucose spikes" that most people with type 2 diabetes experience following meals. "The uncontrolled rise in blood glucose after meals may contribute to serious long-term damage to vital organs," said Lawrence S. Phillips, MD, nateglinide clinical investigator and Professor of Medicine in the Division of Endocrinology and Metabolism at Emory University School of Medicine. "Nateglinide has been demonstrated to blunt mealtime rise in glucose while improving overall glucose control. Thus, the development of nateglinide addresses an evolving and often unmet treatment challenge for patients with type 2 diabetes and their physicians." Postprandial hyperglycemia, or elevated mealtime glucose, is common in people with type 2 diabetes, yet often goes undetected. Data show that patients spend a significant part of their day in the postprandial state. These mealtime/postprandial elevations contribute to overall blood glucose levels as measured by HbA1c. However, because diabetes management has traditionally focused on fasting plasma glucose levels (measurement of glucose in the absence of food), the surges in glucose that typically occur in type 2 diabetes patients after eating are often not evaluated. According to Ginger Kanzer-Lewis, RNC, EdM, CDE, president of the American Association of Diabetes Educators, "It is important for people with type 2 diabetes and their healthcare providers to understand the significance of high blood sugar and the need to control it. Aggressive treatment is needed earlier in the progression of the disease to achieve glucose control. Numerous studies have shown that this glucose control can help prevent serious complications of the disease like kidney failure, amputations and blindness, and this control may also be associated with lowering the risk of cardiovascular morbidity and mortality." Starlix, a D-phenylalanine (amino-acid) derivative, has a chemical structure distinct from other oral antidiabetics. Its approval as monotherapy or in combination with metformin was based on data from clinical trials involving more than 3,100 patients with type 2 diabetes. Studies show that Starlix has a "fast on, fast off" mode of action on the beta-cell (the cell in the pancreas that produces insulin) that stimulates rapid, short-acting insulin secretion, addressing a basic defect in type 2 diabetes. In addition, Starlix does not cause late hyperinsulinemia which reduces the risk of hypoglycemia (low blood sugar). One 24-week, randomized, double-blind, placebo-controlled study of 701 patients with type 2 diabetes evaluated the effects of Starlix, metformin, and the combination of Starlix with metformin on glycemic control, including postprandial glucose control, and assessed the tolerability and safety of these treatment regimens. The study reported that Starlix effectively controlled mealtime glucose spikes and reduced overall glucose levels as measured by HbA1c. Researchers concluded that the combination of Starlix and metformin was complementary and resulted in even greater reductions in HbA1c than either agent alone. Notably, within this study, Starlix demonstrated reductions in HbA1c comparable to metformin in a subgroup of 197 treatment-naive patients. In all studies, Starlix was well-tolerated with an overall safety profile comparable to placebo. Low blood sugar, or hypoglycemia, in 2.4 percent of patients was the only treatment-emergent adverse reaction observed. In clinical trials, only 0.3 percent of Starlix patients discontinued due to hypoglycemia. Related Link: Novartis Pharmaceuticals Corporation. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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