[acb-diabetics] once a week drug may be better than pre meal insulin

Sat Apr 14 21:52:14 EDT 2012

Albiglutide, another once-weekly formulation of a glucagon-like peptide-1
(GLP-1) agonist, appears to be effective at controlling blood sugar compared
with insulin, according to a release.

In a trial in its phase III Harmony program, GlaxoSmithKline's
investigational albiglutide significantly reduced glycated hemoglobin
(HbA1c) levels and proved noninferior to preprandial insulin shots over 26
weeks, the company said. Both treatments were given on top of insulin
glargine (Lantus).

Patients taking the investigational agent saw an HbA1c reduction of 0.82%
compared with a 0.66% reduction for those on preprandial lispro insulin
(P<0.0001 for noninferiority).

They also shed more pounds -- a loss of 0.73 kg (1.6 lbs) versus a gain of
0.81 kg (1.8 lbs) for patients on insulin (P<0.0001 for treatment
difference).

As with other GLP-1 agonists, the most common adverse events in the
albiglutide group were nausea (13% versus 2.1% in insulin group) and
vomiting (7% versus 1.4% in insulin group).

Last November, the company released top-line results from another trial in
the Harmony series, which found that albiglutide significantly reduced
HbA1c, but didn't prove no inferior to daily liraglutide (Victoza), a GLP-1
agonist approved for use in type 2 diabetes.

Though the company said 2-year data from five other ongoing studies in the
series had to remain confidential at this point, it concluded in a release
that the "data reviewed to date support progression to regulatory submission
as a possible once-weekly treatment for type 2 diabetes."

The statement said the company expects the Harmony program to be complete by
early 2013.

Only one weekly version of a GLP-1 agonist is currently on the market.
Bydureon, or extended-release exenatide (Byetta), was approved in late
January after years of back and forth with FDA. Initially submitted for
approval in 2009, delays ensued after concerns about potential
cardiovascular side effects, pancreatitis, and thyroid cancer.

News Release from GlaxoSmithKline April 4, 2012

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