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Novartis receives FDA approval for Starlix, a new treatment for type 2 diabetes

Novel new treatment approved for treating type 2 diabetes

Studies show Starlix reduces mealtime glucose spikes

EAST HANOVER, N.J., December 22, 2000 Novartis Pharmaceuticals Corporation today 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 Glucose (PPG) and Overall Gly
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Contact: Anna Frable
anna.frable@pharma.novartis.com
973-781-7828
GCI Group
21-Dec-2000


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