To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Mealtime Prandin (Repaglinide) Dosing Improves Glycemic Control in Type 2 Diabetes URL: http://www.pslgroup.com/dg/213C2A.htm Doctor's Guide January 30, 2002
AARHUS, DENMARK -- January 30, 2002 -- A new study shows that the oral antidiabetic drug repaglinide tablets (called Prandin® in the United States, NovoNorm® in Europe, and Gluconorm® in Canada), when taken before each of the three main daily meals, has a significant effect on the early release of insulin following meals and, as a result, improves various measures of glycemic control. The study also showed that compared to twice-daily dosing, taking repaglinide tablets with the three main daily meals resulted in greater improvements in certain measures of glycemic control. The findings were published in the February 2002 issue of Diabetes Care (1).
"During the past decade, a large body of evidence has underscored the important role of the early-phase insulin release in controlling the level of postprandial glycemia, the surge in blood glucose following food consumption," said Dr. Ole Schmitz, lead author of the study and professor and chief physician of the Department of Endocrinology at University Hospital in Aarhus, Denmark. He said that prospective studies are under way to examine the benefits of postprandial glucose control.
Repaglinide, 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).
In this double blind, four-week study, 19 individuals with type 2 diabetes who were naive to oral antidiabetic drug (OAD) therapy were randomly assigned to receive either a 0.25 mg dose of repaglinide before each of the three main meals, or a 0.5 mg repaglinide dose before breakfast and a 0.25 mg dose before the evening meal. Mealtime dosing was doubled after two weeks to a total daily dose of 1.5 mg in both groups. Both study treatment groups received the same total daily dose of repaglinide throughout the duration of the study.
For both treatment groups, repaglinide resulted in steeper initial rises in postprandial insulin concentration compared with baseline. Because the three-times-daily dosing group also had a lunch dose, this group showed higher early-phase post-lunch insulin secretion compared to the group who received no dose at lunch.
Consistent with the increased early phase insulin secretion, the study found that both groups had improved glycemic control. For example, compared to baseline, at the end of the study, patients taking three daily doses of repaglinide showed statistically significant improvements across the following indicators of glycemic control, including:
· Lower fasting glucose levels (151 mg/dL vs. 200 mg/dL) (8.4 mmol/L vs.
11.1 mmol/L), (p = 0.0311)
· Lower mean postprandial glucose levels:
* Breakfast (148 mg/dL vs. 247 mg/dL) (8.2 mmol/L vs. 13.7 mmol/L),
(p = 0.0047)
* Lunch (112 mg/dL vs. 176 mg/dL) (6.2 mmol/L vs. 9.8 mmol/L),
(p = 0.0151)
* Evening meal (176 mg/dL vs. 245 mg/dL) (9.8 mmol/L vs.
13.6 mmol/L), (p = 0.0073)
· Lower HbA1c (6.5 percent vs. 7.5 percent, p = 0.004)
Fasting, and postprandial glucose levels after each meal, were lower in patients receiving three doses compared with those receiving two doses. Reductions in HbA1c were significantly greater with three repaglinide doses than with two, despite the relatively short treatment period. No serious adverse events or major hypoglycemia episodes occurred in either group; minor adverse events were confined to mild hypoglycemia.
"The findings reinforce the value of flexible mealtime dosing of repaglinide by clearly demonstrating a near-normalization of glycemic control," said Professor Schmitz. "Repaglinide resulted in reductions not only in postprandial glucose, but also in fasting glucose and HbA1c levels, all of which are associated with reducing the risk of late diabetic complications. However, it is important to stress that not even the most efficient medical intervention can diminish the critical need for lifestyle intervention," he said.
Prandin is indicated as monotherapy or in combination with metformin for individuals with type 2 diabetes whose hyperglycemia 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 (3). 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 percent (3). 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.
References
(1) Schmitz O, Lund S, Andersen P, Jonler M, Porksen, N. Optimizing insulin secretagogue therapy in patients with Type 2 diabetes: a randomized double-blind study with repaglinide. Diabetes Care 2002; Jan 25, 2002.
(2) 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.
(3) Novo Nordisk Pharmaceuticals Inc. Data on file.
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