Repaglinide
Vs. Nateglinide in Type 2 Diabetes
After 16 weeks of treatment, mean reductions of
HbA1c were -1.6% for the repaglinide group and
-1.0% for the nateglinide group.
In two separate randomized trials presented at
the American Academy of Clinical Endocrinology
annual meeting, repaglinide was more effective
than nateglinide in type 2 diabetes. Reductions
in HbA1c and fasting plasma glucose were greater
with repaglinide regardless of whether it was
used as monotherapy or in combination with metformin.
The first trial was a parallel-group, open-label,
multicenter trial in 150 patients with type 2
diabetes previously treated with diet and exercise.
During the three months preceding enrollment,
HbA1c values were greater than 7% but not greater
than 12%.
Lead author Mohammed F. Saad, MD, FRCP, a professor
of medicine at the University of California at
Los Angeles said, "This clinical trial was
the first direct comparison of repaglinide monotherapy
and nateglinide monotherapy." "This
study demonstrated that these two mealtime oral
treatments for type 2 diabetes differ in their
efficacy, with patients having approximately 0.5%
lower HbA1c values at the end of 16 weeks of treatment
if they were using repaglinide rather than nateglinide."
Patients were randomized to treatment with repaglinide
(0.5 mg/meal; maximum of 4 mg/meal) or nateglinide
(60 mg/meal increased to 120 mg/meal if needed)
to reach preprandial glycemic targets of 90 to
140 mg/dL. During the first three weeks of therapy,
secretagogue doses were adjusted.
After 16 weeks of treatment, mean reductions of
HbA1c were -1.6% for the repaglinide group and
-1.0% for the nateglinide group (P = .002). The
repaglinide group also fared better in terms of
final HbA1c values (7.3% vs. 7.9%) and mean reductions
of fasting plasma glucose (-57 mg/dL vs. -18 mg/dL;
P < .001).
Postprandial glycemic effects were similar in
both groups, and no episodes of major hypoglycemia
requiring assistance from another person were
reported in either group.
"The risk of minor hypoglycemia was 7% [for]
repaglinide vs. 0% [for] nateglinide patients,"
said Dr. Saad. "This study provides information
to healthcare providers directly comparing these
two agents."
Novo Nordisk Pharmaceuticals, Inc., the manufacturer
of repaglinide, supported this trial, employs
two of its authors (Naum Khutoryansky and Paula
Hale), and provided grant support for the trial
to the other two authors, Dr. Saad and Julio Rosenstock,
MD, FACE.
The second study, an open-label, parallel-group,
multicenter trial, designed to compare the two
drugs in combination with metformin, enrolled
192 patients with HbA1c values between 7% and
12% during previous treatment with a sulfonylurea,
metformin, or low-dose Glucovance (glyburide/metformin).
During four weeks of metformin run-in therapy,
doses were escalated to 1,000 mg twice daily.
Patients were randomized to the addition of repaglinide
(1 mg/meal; maximum of 4 mg/meal) or nateglinide
(120 mg/meal; reduced to 60 mg if needed) for
16 weeks. During the first two weeks of therapy,
repaglinide doses were adjusted to achieve preprandial
blood glucose of 80 to 140 mg/dL. Median final
doses were 5 mg/day for repaglinide and 360 mg/day
for nateglinide.
"In this study, lead author Philip Raskin,
MD, FACE, from the University of Texas Southwestern
Medical Center in Dallas said, “the efficacy
and safety of repaglinide and nateglinide were
directly compared under conditions where patients
also received metformin." "Repaglinide
plus metformin showed significantly greater efficacy
than nateglinide plus metformin after 16 weeks
of therapy. Reductions of HbA1c were roughly 0.5%
greater for repaglinide."
Compared with the nateglinide group, the repaglinide
group did better in terms of mean end-of-study
reductions of HbA1c (-1.28% vs. -0.67%; P <
.001); final mean HbA1c (7.1% vs. 7.5%); and mean
reductions in fasting plasma glucose (-39 mg/dL
vs. -21 mg/dL; P = .002).
Changes in area under the curve of glucose or
insulin were similar in both groups. Minor hypoglycemic
episodes (blood glucose < 50 mg/dL) occurred
in 7% of the repaglinide group and in 2% of the
nateglinide group.
"These results closely mirror the findings
of the monotherapy study," Dr. Raskin said.
"These two studies provide information to
the healthcare professional comparing repaglinide
and nateglinide, both in monotherapy and in combination
with metformin."
AA.AACE: [Study title: Repaglinide vs. Nateglinide
Monotherapy: A Randomized Multicenter, Open-Label
Study. Abstract 44]
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