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GSK Report Data From PhaseIII Study Of Once-weekly Albiglutide In Type2 Diabetes

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6/9/2012 5:51 PM ET

GlaxoSmithKline Plc (GSK: Quote, GSK.L) announced new 52-week data from phase III study of once-weekly albiglutide in type 2 diabetes. The company said that detailed findings from a Phase III study comparing the investigational glucagon-like peptide-1 (GLP-1) receptor agonist albiglutide to prandial insulin (Lispro), were presented at the American Diabetes Association Meeting or ADA in Philadelphia, USA, and show that the effect is maintained out to 52 weeks.

In Harmony 6, a 52-week randomised open label multicentre study among patients with Type 2 diabetes who were inadequately controlled on intermediate or long-acting insulin, albiglutide (30mg with optional titration to 50mg) was compared to Lispro, each administered in combination with long-acting insulin glargine. As previously disclosed, at 26 weeks, albiglutide showed clinically and statistically significant reductions.

The company noted that data also show that weight changes from baseline observed at 26 weeks for patients in the albiglutide arm (-0.73kg loss) vs the Lispro arm (+0.81kg gain) were sustained at 52 weeks (-0.96kg vs +1.66kg; p<0.0001 for treatment difference).

The company stated that Fasting plasma glucose (FPG) decreased from baseline in both study arms throughout the 52 week period (-27mg/dL in the albiglutide arm compared to -16mg/dL in the Lispro arm; p=0.0281 for treatment difference.

Results of Harmony 7, a 32-week head-to-head study comparing albiglutide (50mg) to once-daily liraglutide (1.8mg), were also presented as a poster at the ADA. As previously disclosed, albiglutide demonstrated a statistically significant reduction in HbA1c from baseline (-0.78%; p<0.0001) but did not meet the pre-specified primary endpoint of non-inferiority to liraglutide (-0.99%; 95% CI: 0.08-0.34%; p=NS).

The proportion of patients achieving a clinically meaningful HbA1c target level of <7.0 at week 32 was higher in the liraglutide arm (52%) compared to the albiglutide arm (42%; p=0.0023 for treatment difference).

Albiglutide is an investigational biological, injectable form of human GLP-1. It is not yet approved as a treatment for type 2 diabetes or any other indication anywhere in the world.

GSK is developing albiglutide as a once-weekly injection using a fine gauge needle for reconstitution and subcutaneous administration by the patient.

In a separate press release, Human Genome Sciences said that it is entitled to fees and milestone payments that could amount to as much as $183 million - including $33.0 million received to date - in addition to single-digit net royalties on worldwide sales if albiglutide is commercialized.

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by RTT Staff Writer

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