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Research Shows Repaglinide (Prandin) Improves Blood Glucose Control More Effectively Than Nateglinide In Type 2 Diabetes : Presented at ADA

SAN FRANCISCO, CA -- June 17, 2002 -- New findings in people with type 2 diabetes show that the oral antidiabetic drug (OAD) repaglinide (called Prandin® in the United States, NovoNorm® in Europe, and Gluconorm® in Canada) improves the control of blood glucose more effectively than nateglinide (Starlix®, Novartis) when either OAD is taken alone or in combination with metformin, according to a presentation(1) made here at the annual meeting of the American Diabetes Association. Although both agents are designed for people with type 2 diabetes to take with meals to control the rise in blood glucose following food consumption, the new findings suggest that the use of repaglinide results in greater improvement in overall blood glucose control (glycemic control).

"Improving glycemic control in diabetes is critical to reducing the risk of long-term complications,(2)(3)" said Mohammed Saad, M.D., the lead author of the presentation and chief of the Division of Clinical Epidemiology and Preventive Medicine at the UCLA School of Medicine Los Angeles, Calif. Complications in type 2 diabetes include coronary heart disease, retinopathy (a common cause of blindness), nephropathy (kidney disease), and microvascular complications and neuropathy (which can lead to limb amputations).

Research findings
The presentation by Dr. Saad included findings from two randomized open- label multicenter studies involving more than 330 adult subjects with type 2 diabetes. All had inadequate glycemic control, as determined by HbA(1c) levels (>7% less than/equal to 12%). HbA(1c) is the percent hemoglobin with glucose attached, and is a commonly used indicator of long-term glycemic control. Subjects in a "monotherapy" study were previously treated by diet and exercise only. Those in a second "combination therapy" study with metformin had been previously treated with other OADs: a sulfonylurea, which stimulates insulin production; metformin, which increases responsiveness to insulin; or low-dose combination therapy with metformin and the sulfonylurea glyburide (Glucovance(R), Bristol-Myers Squibb).

After a three-week dose optimization period, subjects in the monotherapy study continued on either repaglinide or nateglinide for 13 weeks. Those in the combination therapy study first underwent a four-week metformin run-in period, and then continued on either repaglinide or nateglinide for 16 weeks (two-week dose optimization period).

Subjects taking repaglinide in both studies achieved better glycemic control than did those taking nateglinide. In both studies, the repaglinide group had a significantly greater decrease from baseline in HbA(1c) than did the nateglinide group (Monotherapy study:

-1.58% vs -1.07% for the repaglinide and nateglinide treatments respectively, p =.003; Metformin combination therapy study: -1.25% vs -0.71% for the repaglinide and nateglinide treatments respectively, p< .001). Repaglinide-treated subjects in both studies also showed significantly greater improvements in fasting plasma glucose than did nateglinide-treated subjects (Monotherapy study: -51.6 mg/dL vs -27 mg/dL for the repaglinide and nateglinide treatments respectively, p < .001; Metformin combination therapy study: -44.0 mg/dL vs -21.7 mg/dL for the repaglinide and nateglinide treatments respectively, p< .001).

The decrease in the glucose AUC 0-240 min after a standard liquid test meal was significantly greater for the repaglinide than nateglinide treatments (Monotherapy study: - 29.2% vs - 20.8% for the repaglinide and nateglinide treatments respectively, p=0.017; Metformin combination therapy study: - 25.2% vs -16.6% for the repaglinide and nateglinide treatments respectively, p=0.005). The insulin AUC 0-240 min after a standard liquid test meal was similar for both the repaglinide and nateglinide treated groups in both studies.

Use of repaglinide in monotherapy and in combination with metformin was more effective than nateglinide in controlling HbA(1c), FPG, and glucose AUC 0-240 min after a standard liquid test meal.

"Repaglinide offers the healthcare professional an effective means of controlling all three glycemic parameters: HbA(1c), FPG, and PPG, necessary to achieve optimal glycemic control," said Dr. Saad.

In clinical trials, the most common adverse events leading to discontinuation of Prandin therapy were hyperglycemia, hypoglycemia and related symptoms. The most common other side effects reported were cold- and flu-like symptoms, headache, diarrhea, joint ache and back pain.

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 as monotherapy or in combination with metformin for individuals with type 2 diabetes whose hyperglycemia (abnormally high blood glucose) cannot be controlled by diet and exercise alone. While it improves overall glycemic control, Prandin was developed specifically for dosing at mealtime, to control postprandial hyperglycemia. In addition, Prandin is associated with a low risk of severe hypoglycemia(5). It also may allow greater flexibility in eating patterns.

In clinical trials, there was no average gain in body weight when patients previously treated with oral hypoglycemic agents were switched to Prandin. The average weight gain in patients treated with Prandin and not previously treated with sulfonylurea drugs was 3.3%.(5)

About diabetes
It is estimated that approximately 150 million people worldwide have diabetes(6), which is more than 2% of the population. Severe health-related complications of diabetes account for about 6% of total health budgets in developed countries.(7)

Full prescribing information for Prandin(R) is available by contacting the manufacturer 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. patents and patents pending.

Starlix is a registered trademark of Novartis, Inc.

Glucovance is a registered trademark of Bristol-Myers Squibb.

Novo Nordisk is a focused healthcare company and the world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.

With headquarters in Denmark, Novo Nordisk employs approximately 17,500 people in 68 countries and markets its products in 179 countries. For further company information visit http://www.novonordisk.com .

References
(1) Saad MF, Hale P, Khutoryansky N. Efficacy of repaglinide vs. nateglinide: as monotherapy or metformin combination therapy. Poster 536, presented at: American Diabetes Association annual meeting, San Francisco, CA, June 15, 2002.
(2) UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with Type 2 diabetes (UKPDS 33). Lancet 1998; 352;9131: 837-53.
(3) The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. NEJM 1993; 329:977-86.
(4) Owens S, 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; 23:513-523.
(5) Novo Nordisk Pharmaceuticals Inc. Data on file.
(6) International Diabetes Federation Website, June 10, 2002.
http://www.idf.org/index.cfm/fuseaction/page/page/894
(7) International Diabetes Federation Task Force on Diabetes Health Economics. Diabetes health economics: facts, figures and forecasts. Brussels, Belgium 1999: 1-32.


SOURCE: Novo Nordisk

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