Investigational Diabetes Drug Lowers Mealtime Glucose Spikes, Improves Glycemic Control, Researchers Report
BRUSSELS — September, 1999 — Clinical data presented here at the European Association for the Study of Diabetes (EASD) annual meeting have shown the benefits of nateglinide, an investigational drug for the treatment of type 2 (adult onset) diabetes, in controlling mealtime glucose spikes and reducing glycosylated hemoglobin (HbA1c).
"The studies showed that, by lowering the abnormal mealtime glucose spikes, nateglinide also reduced overall long-term blood glucose levels," reported Edward S. Horton, MD, Vice President and Director of Clinical Research, Joslin Diabetes Center, Boston, Massachusetts (USA), and the lead investigator for one of the studies. "Such long-term reductions in glucose levels have been shown to lower the patients' risk of diabetic complications, including damage to the eyes, kidneys and nervous system."
Dr. Horton cited the efficacy of nateglinide in short- and long-term glucose control based on multiple randomized, double-blind clinical studies that were conducted in several centers in the United States and Europe. A total of 1400 patients with type 2 diabetes participated in two 6-month studies in the United States and Europe. These included studies using nateglinide alone, at various doses, or in combination with metformin, a biguanide drug that decreases the production of glucose by the liver and enhances the uptake of glucose in skeletal muscle.
Nateglinide is an amino acid derivative and represents a new class of drugs that stimulate insulin release from the pancreas. "Unlike existing drugs, this substance has a very rapid onset and short duration of action," Dr. Horton said. "Nateglinide improved glycemic control by stimulating increased insulin secretion only at mealtimes, followed by prompt cessation of action when increased insulin levels are no longer needed. This promises to result in better overall diabetes control," he explained.
The studies further showed that nateglinide has an excellent safety profile with low potential for hypoglycemia. The incidence of other side effects was similar to placebo.
More than 135 million people worldwide have diabetes, a disease characterized by high blood levels of glucose. That total is predicted to rise to more than 300 million by 2025, according to the World Health Organization. More than 95 percent have type 2 diabetes, which results from defects in the body's ability to produce and/or use the hormone insulin.
Nateglinide is an investigational agent under development by Novartis Pharma AG of Basel, Switzerland. Dr. Horton is a member of the Novartis Diabetes Advisory Board in the United States.
