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Title: Repaglinide Appears More Effective in Improving Blood Glucose Control in Type 2 Diabetes Better Than Nateglinide

"Repaglinide Appears More Effective in Improving Blood Glucose Control in Type 2 Diabetes Better Than Nateglinide"

PRINCETON, NJ -- May 26, 2004 -- In people with type 2 diabetes, the oral antidiabetic drug repaglinide (called Prandin® in the United States, NovoNorm® in Europe, and Gluconorm® in Canada) improves blood glucose control (glycemic control) better than nateglinide, according to a study published in the current issue of Diabetes Care.(1) The study is the first full report of a direct comparison of the two oral agents when taken as monotherapy. "When diet and exercise no longer provide adequate glycemic control, an oral agent is often added to the patient's treatment -- the question is, which agent should the clinician recommend"" said lead investigator Julio Rosenstock, M.D., a known research endocrinologist with the Dallas Diabetes and Endocrine Center in Dallas, Texas. "Our findings showed that monotherapy with repaglinide resulted in significantly greater reductions in measures of blood glucose control than with nateglinide, and provide clinicians with important information for making treatment decisions," he said. Both repaglinide and nateglinide rapidly stimulate insulin secretion from the pancreas for a short period of time, and are taken in conjunction with meals, to increase insulin levels when the need for blood glucose reduction is greatest. Study and findings The 16-week, open-label, randomized, multicenter trial enrolled 150 adult participants with type 2 diabetes who had inadequate glycemic control, as determined by A1C levels (average 8.9 percent at baseline). A1C is the percent hemoglobin with glucose attached, and an indicator of long-term glycemic control; values less than 7.0 percent in diabetes are desirable, as defined by the 2004 ADA guidelines. The participants had been treated with only diet and exercise for three months before entering the study. Upon entering the study, the participants were randomly assigned to mealtime repaglinide or nateglinide; doses were increased, up to the maximum recommended in the product labels, over the next 13 weeks if target blood glucose levels were not achieved. By the end of the study, average A1C values decreased significantly more in the repaglinide vs. the nateglinide group: to 7.3 percent vs. 7.9 percent, respectively (p = 0.002 for comparison of the decrease vs. baseline in the two groups). Average fasting plasma glucose levels were also significantly lower: 156 mg/dL vs. 183 mg/dL, respectively (p < 0.001 for comparison of the decrease vs. baseline in the two groups). Average levels of self-monitored blood glucose -- assessed at eight times daily, from breakfast until 2 am -- were statistically significantly lower for the repaglinide vs. the nateglinide group (p < 0.05). Postprandial surges in blood glucose after a test meal were reduced more in the repaglinide than the nateglinide group (p = 0.005). Eight percent (n = 6) and 16 percent (n = 12) of participants in the repaglinide and nateglinide groups, respectively, discontinued the study because of lack of efficacy, adverse events, noncompliance or some other reason. No episodes of major hypoglycemia (requiring assistance of another person) were reported. Minor episodes of hypoglycemia were reported by 7 percent of participants in the repaglinide group and none in the nateglinide group. The average weight gain was 1.8 kg in the repaglinide group vs. 0.7 kg in the nateglinide group. The most common other adverse events (between 3 and 10 percent in both groups) were upper respiratory tract infection, sinusitis, constipation, arthralgia, headache and vomiting. About Prandin® (Repaglinide) Tablets Repaglinide (Prandin), the first product of a unique class (the meglitinides), rapidly stimulates insulin secretion, and its action profile coincides with mealtime dosing to control postprandial glycemia.(2) Prandin is indicated for monotherapy use as an adjunct to diet and exercise in patients with type 2 diabetes; it is also indicated for combination use with metformin or thiazolidinediones (pioglitazone or rosiglitazone) in patients who cannot be controlled by diet and exercise plus monotherapy with metformin, thiazolidinediones (TZD), sulfonylureas or repaglinide. In the thiazolidinedione combination studies, hypoglycemia occurred in patients on combination therapy (7 percent), with Prandin alone (7 percent), and with TZD alone (2 percent). Peripheral edema was reported in patients on combination therapy (5 percent) and TZDs alone (4 percent) per 24 weeks treatment (adjusted for dropout rates), with none for Prandin alone. Two combination therapy patients with coronary artery disease history reported edema with congestive heart failure. Mean weight change was +4.9 kg for combination therapy. In one-year monotherapy clinical trials, the most common adverse events leading to discontinuation of Prandin therapy were hyperglycemia, hypoglycemia and related symptoms. About Diabetes The prevalence of diabetes is skyrocketing in many countries around the world. According to the International Diabetes Federation, the number of people worldwide with the condition was estimated at 30 million in 1985, 135 million in 1995, and 194 million in 2003, and is expected to increase to at least 333 million by 2025.(3) For individual countries, the direct health care costs of diabetes are from 2.5 percent to 15 percent of annual national health care budgets, depending on the prevalence of diabetes in the country and the sophistication of the treatment available.(4) In the United States, 18.2 million people, or 6.3 percent of the population, have diabetes, though 5.2 million (or nearly one-third) are unaware they have the disease. In addition, it is estimated that at least 20.1 million Americans have pre-diabetes. Total costs of diabetes in the U.S. in 2002 are estimated at approximately $132 billion, including $92 billion in direct medical expenditures and $40 billion in indirect expenditures due to lost workdays, restricted activity days, mortality, and permanent disabilities due to diabetes.(5) Full prescribing information for Prandin is available by contacting Novo Nordisk Pharmaceuticals, Inc. or visiting http://www.novonordisk-us.com. Prandin, NovoNorm and Gluconorm are registered trademarks of Novo Nordisk A/S and are protected by U.S. and foreign patents and patents pending. References: (1) Rosenstock J, Hassman DR, Madder RD, Brazinsky SA, Farrell J, Khutoryansky N, Hale PM, for the Repaglinide Versus Nateglinide Comparison Study Group. Repaglinide versus nateglinide monotherapy. Diabetes Care June 2004; 27(6): 1265-1270. (2) Owens DR, Luzio SD, Ismail I, Bayer T. Increased prandial insulin secretion following a single preprandial oral dose of repaglinide in patients with type 2 diabetes. Diabetes Care 2000; 23(4):518-523. (3) International Diabetes Federation. Diabetes prevalence. http://www.idf.org/home/index.cfm"node=264. Accessed 5/11/2004. (4) The World Health Organization. The Cost of Diabetes. Fact Sheet number 236, revised September 2002. http://www.who.int/mediacentre/factsheets/fs236/en/. Accessed 5/11/2004. (5) American Diabetes Association. National Diabetes Fact Sheet. http://www.diabetes.org/diabetes-statistics/national-diabetes-fact- sheet.jsp. Accessed 5/11/2004. SOURCE: Novo Nordisk Pharmaceuticals, Inc.

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