Issue 162 Item 9 Repaglinide Vs. Nateglinide in Type 2 Diabetes

Administration of the oral antidiabetic drug (OAD) repaglinide (called Prandin® in the United States, NovoNorm® in Europe, and Gluconorm® in Canada) in people with type 2 diabetes resulted in significantly greater reductions in blood glucose markers than nateglinide when taken in combination with metformin.

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 report shows that repaglinide therapy results in greater improvement in levels of A1C . The study is the first head-to-head comparison of repaglinide and nateglinide in combination with metformin.

"Improving glycemic control is one of the main goals in diabetes therapy," said lead investigator Philip Raskin, M.D., professor of medicine and Clifton and Betsy Robinson Chair in Biomedical Research at the University of Texas Southwestern Medical Center in Dallas, Texas. "Our findings suggest that repaglinide, when compared with nateglinide, in combination with metformin, offers healthcare professionals greater control over both A1C, and FPG in type 2 diabetes — and controlling both of these parameters is necessary for optimal glycemic control," he said.

The open-label, randomized, multicenter trial enrolled 192 participants with type 2 diabetes who had inadequate glycemic control, as determined by A1C levels (>7% < 12%). Prior to the study, the participants had been treated with other OADs: a sulfonylurea, or low-dose combination therapy with metformin and the sulfonylurea glyburide.

At the beginning of the study, participants discontinued their previous therapy and, during a four-week run-in period, started dose escalation with metformin (to 1000 mg twice daily). Participants were then randomly assigned to additional therapy with either repaglinide (1-4 mg/meal, n=96) or nateglinide (120 mg/meal [dose could be reduced to 60 mg/meal if hypoglycemic events made it necessary], n=96) for 16 weeks. During the study, participants self-monitored blood glucose (SMBG) levels before and two hours after each meal, and at bedtime and 2 am. Blood levels of glucose, insulin and glucagon were assessed after participants consumed a standard liquid test meal at the beginning and end of the study.

Findings showed participants taking repaglinide achieved better glycemic control than did those taking nateglinide. From the fourth week of the study on, the repaglinide group had significantly lower A1C values than the nateglinide group. By the end of the study, the change in A1C from baseline was significantly greater for the repaglinide group (-1.28% vs. -0.67%, respectively, p < 0.001). From the first week of the study on, the repaglinide group also had significantly lower FPG levels than the nateglinide group. By the end of the study, the change in FPG from baseline was significantly greater for the repaglinide group (-39 vs. -21 mg/dL, respectively, p=0.002). Mean SMBG values were consistently lower for repaglinide vs. nateglinide, and were significantly lower for measurements taken before breakfast, before lunch, and at 2:00 am. Baseline-adjusted blood levels of glucose, insulin and glucagon following the liquid test meal were not significantly different for the two treatment groups at the end of the study.(1)

"Reductions in A1C and FPG with repaglinide were significantly greater than with nateglinide," said Dr. Raskin. He added that the larger effect of repaglinide was not due to dosing differences, since the median final dosage of repaglinide was only 31 percent of the recommended maximum vs. 100 percent of the recommended maximum for nateglinide.

Minor hypoglycemic episodes occurred in 7 percent of the patients in the repaglinide/metformin group vs. 2 percent of patients in the nateglinide/metformin group. Both repaglinide and nateglinide were associated with small weight changes (+0.6 kg vs -0.5 kg, respectively).
Diabetes Care 2003 July; 26(2):2063-2068 SOURCE: Novo Nordisk

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