Significant Reductions in Weight and Fewer Reports of Hypoglycemia
Compared to Lantus Also Observed
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company
(NYSE: LLY) and Alkermes,
Inc. (Nasdaq: ALKS) today announced positive results from a study
comparing subjects randomized to either exenatide once weekly or Lantus®
(insulin glargine). Patients randomized to exenatide once weekly
experienced a statistically superior reduction in A1C, a measure of
average blood sugar over three months, of 1.5 percentage points from
baseline, compared to a reduction of 1.3 percentage points for Lantus
after completing 26 weeks of treatment. At the end of the study,
patients treated with exenatide once weekly achieved a mean A1C of 6.8
percent compared with a mean A1C of 7.0 percent in those treated with
Lantus. Treatment with exenatide once weekly also produced a
statistically significant difference in weight, with a mean weight loss
of 5.8 pounds at 26 weeks, compared with a mean weight gain of 3.1
pounds for Lantus, a difference of 8.9 pounds between the treatments.
In addition, although patients treated with exenatide once weekly
experienced a greater reduction in blood glucose than those treated with
Lantus, they also reported significantly fewer episodes of confirmed
hypoglycemia.
These intent-to-treat results were from DURATION-3, the third in a
series of studies designed to test the superiority of exenatide once
weekly, an investigational diabetes therapy, as compared to other
diabetes medications. This 26-week open-label, clinical study compared
exenatide once weekly to once-daily doses of Lantus in 467 patients with
type 2 diabetes taking stable doses of metformin alone or in combination
with a sulfonylurea. Exenatide once weekly was administered once a week
in a fixed dose while Lantus was administered daily in a variable dose
determined by patient blood sugar levels.
“Exenatide once weekly outperformed Lantus in this superiority study by
meeting its primary endpoint,” stated Orville G. Kolterman, M.D., senior
vice president of research and development, Amylin Pharmaceuticals.
“Both treatment arms started with a baseline A1C of 8.3 percent and
exenatide once weekly provided statistically significantly greater A1C
reduction, weight loss versus weight gain and fewer episodes of
hypoglycemia.”
More than 90 percent of patients completed the study. During the 26-week
treatment period, the most frequently reported adverse events were upper
respiratory infection, including nasopharyngitis, in both treatment
arms, as well as gastrointestinal events, including nausea, in the
exenatide once weekly treatment group. Patients treated with exenatide
once weekly experienced less confirmed hypoglycemia; the incidence of
hypoglycemia was 4 percent with exenatide once weekly versus 19 percent
with Lantus for patients on metformin background therapy, and 20 percent
with exenatide once weekly versus 44 percent with Lantus for patients on
metformin and a sulfonylurea background therapy, differences that are
statistically significant in both treatment groups.
Study Design
The 26-week open-label, superiority study included 467 subjects with
type 2 diabetes who were not achieving adequate glucose control using
metformin therapy alone or in combination with a sulfonylurea.
