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Exenatide Effective for Type 2 Diabetes
Exenatide Effective for Type 2 Diabetes -- Posted by Gumbo on 12-08-04 04:43
Exenatide Effective for Type 2 Diabetes
on Tuesday, November 16 @ 17:13:18 EST
"Exenatide significantly reduced HbA1c in patients with type 2 diabetes
failing maximally effective doses of a sulfonylurea.
"Sulfonylureas, a class of commonly prescribed antidiabetic drugs, are
generally safe and efficacious in monotherapy and in combination with other
oral agents and insulin in patients with type 2 diabetes," write John B.
Buse, MD, PhD, from the University of North Carolina School of Medicine in
Chapel Hill, and colleagues from the Exenatide-113 Clinical Study Group.
"However, hypoglycemia and weight gain often accompany their use, and
sulfonylurea therapy eventually fails to provide adequate glycemic control
in the majority of patients with type 2 diabetes. Exenatide (exendin-4) is a
39-amino acid peptide incretin mimetic that exhibits glucoregulatory
activities similar to those observed with the mammalian incretin hormone
glucagon-like peptide (GLP)-1."
At 101 sites in the U.S., investigators in this triple-blind study enrolled
377 subjects with type 2 diabetes refractory to maximally effective doses of
a sulfonylurea as monotherapy. Mean age was 55 ± 11 years, 60% of subjects
were men, body mass index (BMI) was 33 ± 6 kg/m2, and mean HbA1c level was
8.6% ± 1.2%.
After a four-week, single-blind, placebo lead-in period, subjects were
randomized to receive 5 µg subcutaneous exenatide twice daily, before
breakfast and dinner (groups A and B, respectively) or placebo. After four
weeks of this regimen, the dose of exenatide in group B was increased to 10
µg twice daily. All subjects continued sulfonylurea therapy.
At week 30, HbA1c changes from baseline were -0.86 ± 0.11 in the 10-µg
group, -0.46 ± 0.12 in the 5-µg arm, and 0.12% ± 0.09% in the placebo group
(adjusted P < .001).
Of 237 evaluable subjects with baseline HbA1c levels greater than 7%, HbA1c
after treatment was 7% or less in 41% of patients in the 10 µg group, 33% in
the 5 µg group, and 9% in the placebo group (P < .001). Compared with
placebo, the 10-µg group had decreased fasting plasma glucose concentrations
(P < .05). Dose-dependent, progressive weight loss occurred in both
exenatide groups, with an end-of-study loss in the 10-µg group of -1.6 ± 0.3
kg from baseline (P < .05 vs placebo).
Adverse events were typically mild or moderate; no severe hypoglycemia was
observed; and the most frequent adverse events were gastrointestinal,
especially nausea.
"Exenatide significantly reduced HbA1c in patients with type 2 diabetes
failing maximally effective doses of a sulfonylurea," the authors write.
"Exenatide was generally well tolerated and was associated with weight
loss.... The incidence of hypoglycemic risk associated with sulfonylurea
treatment increased with exenatide administration as overall glycemic
control improved."
Exenatide's mechanisms of action include glucose-dependent enhancement of
insulin secretion, suppression of high glucagon secretion, and slowing of
gastric emptying. It improves ß-cell function, weight loss, and may have an
insulin-sensitizing effect. Both 10 and 5 µg of exenatide twice daily
improve glycemic control and are associated with weight loss over 30 weeks.
Diabetes Care. 2004;27:2628-2635
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