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Once Weekly Drug May Substitute for Pre-Meal Insulin

Posted: Sunday, April 15, 2012

A new drug has been found to be more effective in reducing postprandial blood glucose than insulin.

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 noninferior 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.

Source: http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=12621&catid=53&Itemid=8, News Release from GlaxoSmithKline April 4, 2012.