once a week drug may be better than pre meal insulin

April 15, 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, GlaxoKline'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 GlaxoKline April 4, 2012

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