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GlaxoSmithKline: Upbeat results on diabetes study

April 3, 2012, 2:17 a.m. EDT

LONDON (MarketWatch) --

GlaxoSmithKline PLC , a research-based pharmaceutical and healthcare company said Tuesday it received topline results from seven of the eight 'Harmony' Phase III studies investigating the use of albiglutide in type 2 diabetes.

MAIN FACTS:

-Albiglutide is an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist.

-In Harmony 6, the second of the phase III 'Harmony' studies to complete, albiglutide was compared to preprandial insulin, each administered on top of long-acting insulin glargine.

-In this study, the first of its kind for the class, albiglutide produced clinically significant reductions in HbA1c from baseline and non-inferiority versus preprandial lispro insulin after 26 weeks of treatment, achieving theprimary endpoint.

-Results showed a reduction in HbA1c from baseline of 0.82% for patients receiving albiglutide compared to a reduction of 0.66% for preprandial lispro insulin.

-The company also announced that 2 year data read-outs from five ongoing phase III studies (Harmony 1 through Harmony 5) have been received.

-These read-outs present the final results for primary endpoint data up to two years. As the five ongoing studies have not completed, these data have to remain confidential to protect the integrity of the ongoing blinded studies and in line with our agreements with regulators.

-Harmony 8 will complete in mid 2012 and the five ongoing studies will complete in early 2013.

-GSK has now reviewed primary endpoint data--6 months to 2 years-- on the efficacy and safety of albiglutide, verses placebo and active controls, across seven Phase III studies.

-GlaxoSmithKline shares closed Monday at GBP14.29, valuing the company at GBP72.06 billion.
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http://www.marketwatch.com/story/glaxosmithkline-upbeat-results-on-diabetes-study-2012-04-03

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