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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