|
[an error occurred while processing this directive]
|
Item #5
Nateglinide
Improves Early Insulin Secretion and Controls Postprandial Glucose
Excursions in a Prediabetic Population
Nateglinide
is safe and effective in reducing postprandial
hyperglycemia in subjects with IGT
The
purpose of this study was to evaluate the metabolic
effectiveness, safety, and tolerability of nateglinide in
subjects with impaired glucose tolerance (IGT) and to identify
a dose appropriate for use in a diabetes prevention study.
This
multicenter, double-blind, randomized, parallel-group,
fixed-dose study of 8 weeks’ duration was performed
in a total of 288 subjects with IGT using a 2:2:2:1
randomization. Subjects received nateglinide (30, 60,
and 120 mg) or placebo before each main meal. Metabolic effectiveness
was assessed during a standardized meal challenge performed
before and after the 8-week treatment. All adverse events
(AEs) were recorded, and confirmed hypoglycemia was defined as
symptoms accompanied by a self-monitoring of blood glucose measurement
 3.3
mmol/l (plasma glucose
3.7
mmol/l).
The
results showed that Nateglinide elicited a dose-related increase
of insulin and a decrease of glucose during
standardized meal challenges, with the predominant
effect on early insulin release, leading to a
substantial reduction in peak plasma glucose levels. Nateglinide
was well tolerated, and symptoms of hypoglycemia were the
only treatment-emergent AEs. Confirmed hypoglycemia
occurred in 28 subjects receiving nateglinide (30 mg, 0
[0%]; 60 mg, 5 [6.6%]; 120 mg, 23 [26.7%]) and in 1
(2.3%) subject receiving placebo.
From
the results it was concluded that, Nateglinide was safe and
effective in reducing postprandial hyperglycemia in
subjects with IGT. Preprandial doses of 30 or 60 mg
nateglinide would be appropriate to use for longer-term
studies to determine whether a rapid-onset, rapidly
reversible, insulinotropic agent can delay or prevent the
development of type 2 diabetes.
Diabetes
Care 25:2141-2146, 2002
[an error occurred while processing this directive]
|
[an error occurred while processing this directive]
|
