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| |  ADA MEETING: Combination Therapy With Prandin Effective For Type II Diabetics SAN DIEGO, CA -- June 22, 1999 -- Clinical data shows that using Novo Nordisk Pharmaceuticals, Inc.’s oral antidiabetic drug Prandin (repaglinide) tablets in combination with troglitazone tablets is effective in patients with type II diabetes The results were presented yesterday at the annual meeting of the American Diabetes Association. "Combining diabetes drugs with different mechanisms of action can enhance therapeutic response and may help patients achieve glycemic control," said lead investigator Philip Raskin, M.D., professor of medicine at The University of Texas Southwestern Medical Center at Dallas. Prandin is in a unique class of insulin secretagogues called meglitinides and is characterised by a rapid and short-acting stimulation of insulin secretion in response to glucose. Troglitazone belongs to the "Because the action of thiazolidinediones depends upon the presence of insulin, combining its use with a medication that will enhance insulin release makes sense," Dr. Raskin said. In this open-label, multicentre, 22-week study, a total of 256 patients were randomised to three treatment groups. These patients received either Prandin, troglitazone or a combination of Prandin and troglitazone. The percentage of patients who did not complete the study were 11 percent, 28 percent and 20 percent, respectively. Combination therapy was more effective for reducing HbA(1c) levels than either Prandin or The frequency of hypoglycaemia (percentage with at least one event) reported was five percent, six percent and three percent in the combination, Prandin and troglitazone groups, respectively. Hypoglycaemia was defined as symptoms with self-assessed blood glucose readings below 45 mg/dl. Changes in liver enzymes, greater than or equal to two times the upper normal limit, were reported in three patients on combination therapy and one patient each in the Prandin and troglitazone groups. Prandin has been approved by the U.S. Food and Drug Administration for first-line monotherapy as an adjunct to diet and exercise to lower the blood glucose in patients with type II diabetes. Prandin is also indicated for use in combination with metformin in patients inadequately controlled by either drug alone. In long-term clinical trials with Prandin versus sulfonylureas, no participants on Prandin reported hypoglycaemia that resulted in coma or required hospitalisation. In these clinical trials, hypoglycaemia was reported in 16 percent of Prandin-treated patients and 20 percent of sulfonylurea-treated patients (glyburide and glipizide). The most common adverse events leading to discontinuation in these trials were hyperglycemia, hypoglycaemia and related symptoms. Other than hypoglycaemia, the most common adverse events reported in clinical trials were cold- and flu-like symptoms, headache, diarrhea, joint ache and back pain.
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