[acb-diabetics] weekly injections of byetta

[Patricia LaFrance-Wolf]

Issue 500

 

Exenatide Once Weekly DURATION-5 Study Results Announced

Eli Lilly and Company, and Amylin announced positive results from a
head-to-head study comparing exenatide once weekly, an investigational
diabetes therapy,

to BYETTAR (exenatide) injection taken twice daily, in patients with Type 2
diabetes.   

 

After 24 weeks of treatment, patients taking exenatide once weekly
experienced a statistically superior reduction in A1c, a measure of average
blood sugar

over three months, of 1.6 percentage points from baseline, compared to a
reduction of 0.9 percentage points for BYETTA. Patients treated with
exenatide

once weekly achieved a mean A1c of 7.1 percent compared with a mean A1c of
7.7 percent in those treated with BYETTA. Both treatment groups achieved
statistically

significant weight loss by the end of the study, with an average loss of 5.1
pounds for patients taking exenatide once weekly and 3.0 pounds for patients

taking BYETTA.

 

These findings are consistent with the results of other studies of exenatide
once weekly and BYETTA. The companies conducted DURATION-5 to support
regulatory

submissions outside of the U.S. and provide additional controlled clinical
data on the commercially manufactured product. DURATION is a series of
clinical

trials designed to test the superiority of exenatide once weekly as compared
to currently available Type 2 diabetes medications.

 

"The DURATION-5 data reinforce the efficacy of BYETTA and potential of
exenatide once weekly in improving blood glucose control as measured by A1c,
and

build upon other successful DURATION trials," said Orville G. Kolterman,
M.D., senior vice president of research and development, Amylin
Pharmaceuticals.

"More importantly, these results continue to suggest that if approved,
exenatide once weekly could play an important role in advancing the
treatment of

Type 2 diabetes by providing patients the opportunity for improved A1c
control and weight loss with just one dose per week."

 

Approximately 80 percent of patients completed the study. Consistent with
previous DURATION trials, the most frequently reported adverse event in both
groups

was nausea, reported less frequently by exenatide once weekly users (14
percent) than by BYETTA users (35 percent). There were no major hypoglycemic
events.

Cases of minor hypoglycemia in both groups were limited to patients using
background sulfonylurea therapy.

 

The 24-week, open-label superiority study included approximately 250
participants with Type 2 diabetes who were not achieving adequate glucose
control using

background therapies that included diet and exercise, metformin,
sulfonylurea, thiazolidinediones or a combination of the agents. Patients
were randomized

to receive either exenatide once weekly or BYETTA.  Patients in the
exenatide once weekly treatment arm received 2 milligrams once a week, while
patients

in the BYETTA arm received 5 micrograms twice a day for the first four weeks
and 10 micrograms twice a day for the remaining 20 weeks. The primary
endpoint

was reduction in A1c; secondary endpoints included change in body weight and
fasting plasma glucose, safety and tolerability.

 

Amylin, Lilly and Alkermes submitted a new drug application (NDA) for
exenatide once weekly to the U.S. Food and Drug Administration (FDA) in May
2009;

the NDA was accepted for review in July 2009. Lilly will be responsible for
marketing exenatide once weekly outside the U.S. and expects to submit a
marketing

application to the European Medicines Agency by the end of the second
quarter in 2010.

 

-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://www.acb.org/pipermail/acb-diabetics/attachments/20091220/76d502f2/attachment.htm>