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| |  Novonorm (Repaglinide) Improves Glycemic Control Without Significant Weight Gain In Type 2 Diabetes COPENHAGEN, DENMARK -- February 1, 2001-- A recently published multinational study shows the oral antidiabetic drug (OAD) NovoNorm® (repaglinide, called Prandin® in the United States) tablets, in a flexible mealtime regimen, improved glycemic control without significantly increasing body weight in patients with type 2 diabetes. The findings, published in the January 2001 issue of Diabetes Care(1), are important because weight gain is a common problem with many other OADs as well as with insulin therapy, and excess body weight increases the health risk of type 2 diabetes. "Our results suggest that NovoNorm may offer advantages over longer-acting OADs because its flexible mealtime response limits weight gain while still achieving glycemic control," said lead investigator Robert Moses, M.D., Director of Diabetes Services, Wollongong, New South Wales, Australia. Weight gain is known to be associated with therapies that increase a patient's total exposure to insulin, including long-acting OADs such as sulfonylureas and certain forms of insulin(2). This poses a major challenge to clinicians because excess body weight contributes to the development of type 2 diabetes as well as to cardiovascular complications; therefore, weight loss is a cornerstone of therapy for many patients(3). People with diabetes take OADs or insulin to maintain "glycemic control," the control of blood glucose concentration. After a meal, blood glucose increases, which normally stimulates the secretion of insulin -- known as the prandial insulin response. Insulin in turn stimulates glucose uptake by muscle and other body tissues, thus lowering blood glucose levels back to normal. Because patients with type 2 diabetes are less sensitive to insulin, they are often treated with OADs to produce more of the hormone or, if necessary, with insulin itself. Inadequate amounts of insulin can result in chronically high blood glucose levels, which increases the risk of developing cardiovascular disease, kidney disorders, blindness, and circulatory and nervous system problems. Excess insulin can reduce glucose levels too low (hypoglycemia), which can cause acute symptoms such as shakiness, dizziness, and confusion, and require the patient to consume sugar-containing foods or drinks to bring glucose back to normal. NovoNorm belongs to a unique class of so called "glinides" and rapidly stimulates insulin secretion(4), which makes it especially well suited for dosing at mealtime, when insulin is required. Because NovoNorm stops stimulating insulin secretion within a very short time(4), the risk of hypoglycemia is less than with longer-acting OADs(5). "Treatments such as NovoNorm, designed to manage diabetes by selectively stimulating the prandial insulin response, may have a low propensity for causing weight gain. And because basal insulin output is not increased, the consequent reduction in the risk of hypoglycemia reduces the need for snacking," said Dr. Moses. He added that NovoNorm allows patients flexibility in their meal patterns, in contrast with longer acting OADs, which usually must be used as part of a regimen of fixed dosing and mealtimes. Most patients prefer the flexible meal patterns allowed by NovoNorm, as was recently demonstrated in a large, prospective study in nearly 6000 patients(6). In the double-blind, placebo-controlled study, a total of 408 type 2 diabetes patients from 61 centers in 13 countries were randomly assigned to take either NovoNorm, 0.5-1.0 mg (n = 270) or placebo (n = 138) immediately prior to main meals. The patients were new to OAD therapy, and were free to follow a flexible meal schedule throughout the 16 weeks of the trial. A total of 316 patients completed the study. Those taking NovoNorm showed a significant improvement in glycemic control, as shown by an average decrease in the blood marker HbA1c of 1.14 percentage points, and a reduction of fasting blood glucose of 1.8 mmol/l (both changes were significant, p < 0.001). These improvements were achieved without a significant increase in body weight (mean body weight gain: 0.35 kg, a nonsignificant change), irrespective of the patients' meal patterns. Placebo-treated patients showed no improvement in glycemic control and a slight, nonsignificant weight gain. As expected, the most frequent adverse event was minor episodes of hypoglycemia, reported by 17 percent of NovoNorm patients and 3 percent of placebo patients. Other adverse events were infrequent and similar for both groups. Other long-term clinical trials have also shown no clinically significant weight gain with NovoNorm(6). In clinical trials, the most common adverse events leading to discontinuation were hyperglycemia, hypoglycemia, and related symptoms. The most common adverse events reported were cold- and flu-like symptoms, headache, diarrhea, joint ache and back pain. References:
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